BioTech Stock News And Analysis

2007-08-17T15:24:00.000-07:00

Dendreon Corp. (NASDAQ DNDN)
After Hours: 7.84 0.52 (7.10%) as of 6:10PM ET
Dendreon Corp. is breaking through both the 50 and 200 day moving averages in after hours trading.

DNDN is attracting buyers after a report indicated that Dendreon's vaccine Neuvenge "appears to be safe in women with advanced breast cancer and showed signs of actually slowing down tumors".

2007-07-15T11:11:00.000-07:00

The AMEX Biotechnology Index has strong support at the 200 day moving average of 770.

2007-07-01T14:20:00.000-07:00

Targanta Therapeutics
Proposed symbol TARG
IPO date not yet announced

Targanta Therapeutics is a biopharmaceutical company is developing new treatments for severe, drug-resistant bacterial infections, including those that attack the skin, blood, and bone. Its lead candidate is oritavancin, which may treat both skin and blood infections; the drug was first discovered by Eli Lilly and further developed by InterMune, from whom Targanta acquired the rights in 2005. The company plans to develop other antibiotics in addition to oritavancin; it is working on one earlier-stage candidate that may fight osteomyelitis, an inflammation of the bone caused by infection.

2007-07-01T14:16:00.000-07:00

ImaRx
Proposed symbol IMRX
IPO date not yet announced

ImaRx is a biopharmaceutical company which specializes in developing therapies for vascular disorders, particularly those relating to blood clots. Its SonoLysis therapy uses tiny ultrasound-activated bubbles to penetrate a blood clot and break it up; the company is developing SonoLysis as a stand-alone therapy and in combination with clot-busting drugs. The company has licensing deals with UNEMED and Bristol Myers Squibb for some of the technologies undergirding SonoLyse. ImaRx acquired FDA-approved Abbokinase, which dissolves blood clots in the lungs, from Abbott Laboratories in 2006.

2007-06-03T13:45:00.000-07:00

The AMEX Biotechnology Index is now in a period of consolidation with strong support at the 50 day moving average of 805.

Sector events such as this week's ASCO conference could once again push the index into record territory.

2007-04-29T13:16:00.000-07:00

The AMEX Biotechnology Index posted another strong week and continues to hit new record highs.

This breakout is an excellent sign for the Biotech sector as positive earning reports from sector giants such as Cephalon (NASDAQ CEPH) continue to propel the sector index to higher levels.

2007-04-17T09:12:00.000-07:00

The AMEX Biotechnology Index has broken out to new all time highs.

2007-04-17T09:07:00.000-07:00

Nanogen Inc (NASDAQ NGEN)., which develops medical test products, said it asked the Food and Drug Administration to approve its cystic fibrosis test kit and the Nanochip 400 microarray system.

The kit is intended to be used for carrier testing in adults, newborn screening and confirmatory tests in newborns and children. The nanochip system is an automated platform used for genetic sequencing.

2007-04-11T19:55:00.000-07:00

Biotechnology company Genentech Inc. on Wednesday reported a first-quarter profit surge of 68 percent over the same period last year behind continued strong sales of its stable of blockbuster cancer drugs.

For the quarter ended March 31, the company earned $706 million, or 66 cents per share, compared with $421 million, or 39 cents a share, a year ago.

Excluding special expenses, Genentech said it would have earned $792 million, or 74 cents a share. On that basis, the results exceeded the per-share estimate among Wall Street analysts by 7 cents, according to research firm Thomson Financial.

Revenue was $2.84 billion in the quarter, an increase of 43 percent from the $1.99 billion a year earlier.

Genentech reiterated that it expects profits to be 25 percent to 30 percent greater this year than last. The South San Francisco-based company's stock price has been rising steadily over the last three years as it posts double-digit growth every quarter.

2007-04-03T05:43:00.000-07:00

Shares of biopharmaceutical company Theravance Inc. (NASDAQ THRX) jumped in Tuesday premarket electronic trading after Theravance said two drugs it is developing with GlaxoSmithKline PLC were effective in midstage trials.

On Monday, Theravance said the two drugs, known as 444 and 797, were effective as once-a-day treatments for asthma and chronic obstructive pulmonary disease. The South San Francisco-based company said 444 was more effective in widening air passages in the lungs. The drug will be the company's main focus in future trials, while 797 will be developed as a backup

2007-03-26T12:16:00.000-07:00

The AMEX Biotech Index ($BTK) made a strong move off of the 200 day moving average. The index is currently at 753 (up from 719 on March 12). If the Biotech Index can now break through the 50 day moving average at 757 it would be a confirmed bullish breakout and signal that the Biotech sector is set to move toward the highs set at the first of the year.

2007-03-12T14:09:00.000-07:00

The AMEX Biotech Index ($BTK) has experienced tremendous selling pressure in recent weeks. The index is now testing support at the 200 day moving average. If support can hold it would be a strong technical indicator and suggest that the biotech sector is poised to move higher thus making the current levels a tremendous buying opportunity.

2007-03-12T14:03:00.001-07:00

Shares of La Jolla Pharmaceutical Co. shot to a two-year high Monday after a Pacific Growth Equities analyst said data from a clinical trial of Riquent, its lupus treatment, was better than expected.

Analyst Liana Moussatos upgraded La Jolla shares to "Buy" from "Neutral." On Thursday, the San Diego-based company reported that lupus patients treated with 300 milligrams or 900 milligrams of Riquent per week showed significantly more improvement than those treated given just 100 milligrams per week.

"We believe this is significant as 100 mg was the highest dose tested in previous pivotal studies and the level of antibody reduction achieved with 900 mg has been correlated with potential clinical benefit," Moussatos said. We anticipate a potential top-line data release in early 2009, launch in early 2010 and potential peak U.S. sales of about $378 million."

Shares of La Jolla Pharmaceuticals gained $1.79, or 30.3 percent, to close at $7.70 on the Nasdaq Stock Market, having hit a new high of $8.14 earlier in the session. Previously, the stock traded in a 52-week range of $2.77 and $6.85.

2007-03-07T08:45:00.000-08:00

Encysive Pharmaceuticals Inc. said Wednesday Australian regulators approved the company's marketing application for its pulmonary arterial hypertension drug Thelin.

Pulmonary arterial hypertension is marked by abnormally high blood pressure and narrowing in the small arteries of the lungs, making blood flow more difficult and thereby causing the right side of the heart to become enlarged. The condition causes shortness of breath, limits activity and can develop into progressive heart failure, which is fatal unless treated successfully with a heart/lung or lung transplant.

The drug is currently under review by the Food and Drug Administration, but the approval process has been delayed. In July, the agency requested more data on the drug in order to consider it for approval.

Thelin was approved by the European Commission and is available in Britain.

Shares of Encysive rose 5 cents to $3.45 in morning trading on the Nasdaq Stock Market.

2007-02-28T07:09:00.001-08:00

Drugmaker ViroPharma Inc. on Wednesday said fourth-quarter earnings fell 75 percent as net product sales decreased.

Net income totaled $18 million, or 25 cents per share, versus $72.7 million, or $1.17 per share in the year-ago period.

Revenue fell 5 percent to $38.6 million from $40.5 million in the prior-year quarter. Net product sales for its Vancocin treatment for intestinal bacterial infections fell 5 percent to $38.5 million, while milestone and license fee revenue was steady at $141,000.

Total costs and expenses increased 10 percent to $13.5 million, with marketing, general and administrative costs more than doubling to $7.1 million.

Analysts polled by Thomson Financial expected net income of 20 cents per share on revenue of $40 million.

For the year, net income fell 41 percent to $66.7 million, or 95 cents per share, from $113.7 million, or $2.02 per share in 2005.

Revenue grew 26 percent to $167.2 million from $132.4 million in 2005.

ViroPharma shares fell $1.60, or 9.8 percent, to $14.87 in morning trading on the Nasdaq.

2007-02-22T06:45:00.001-08:00

A JPMorgan analyst Thursday downgraded laboratory research products maker Invitrogen Corp., saying its shares were priced fairly and the company's restructuring plan would not pay off until 2008.

Analyst Tycho W. Peterson rated the stock at "Neutral," down from "Overweight." He said the Carlsbad, Calif., company is improving its operations, divesting its BioReliance subsidiary and combining other segments. However, he said it is risky to assume the stock will gain value in the short term.

"We believe the current restructuring will at least take the better part of this year, with benefits only beginning to be fully realized in 08," he said.

Although Peterson called Invitrogen's fourth quarter "modestly better than most had anticipated," he expects the company to post a bigger loss in the first quarter of 2007 than it did in the fourth quarter of 2007. He cut his earnings per share forecast for the year to $3.37 from $3.42.

Invitrogen shares closed at $66.99 Wednesday on the Nasdaq Stock Market. The stock has gained $10.40, or 18.4 percent, in 2007.

2007-02-20T08:25:00.000-08:00

Britain's Shire Plc has agreed to buy U.S. partner New River Pharmaceuticals for $2.6 billion to gain full control of the two firms' new drug for attention deficit hyperactivity disorder, Vyvanse.

Shire's shares jumped as much as 4.5 percent to a 5-1/2 year high of 1,123 pence on news of the deal on Tuesday. New River shares rose 8.8 percent to $63.50 before the opening in New York.

Shire, Britain's third-biggest drugmaker, expects Vyvanse to be approved by U.S. regulators later this week and thinks it can be a $1-billion-a-year successor to its top-selling ADHD drug Adderall XR, which is due to lose patent protection in 2009.

Shire said it would pay $64 a share in cash for New River and finance the deal with $2.3 billion of new debt facilities, as well as a placing of new shares to raise about $800 million.

The company later said it had placed a total of around 42.9 million new shares at 1,075p each, raising gross proceeds of around $900 million or 461 million pounds.

The new shares represented around 8.4 percent of Shire's share capital before the placing.

The price amounts to almost a 10 percent premium over New River's closing share price of $58.35 on Friday, when its shares rose 6 percent on the day. U.S. markets were closed on Monday.

2007-02-14T09:12:00.000-08:00

Aastrom Biosciences Inc., a developer of stem cell therapies, said Wednesday follow-up data on an early-to-midstage study indicated its tissue repair cells may help bone regeneration.

The 12-month follow-up showed that 18 of the 20 patients involved with severe long bone fractures had multiple bone bridges, which is a sign of bone regeneration. In all, 36 patients are involved in the follow-up, but only 20 have completed the 12-month period.

The patients all had fractures in either their tibia, femur or humerus bones which failed to heal with standard bone grafting and surgical treatments.

Shares of Aastrom rose 5 cents, or 3.5 percent, to $1.49 in morning trading on the Nasdaq.

2007-02-13T17:11:00.000-08:00

- Invitrogen Corp., which makes kits used by researchers for gene cloning, on Tuesday reported a loss for the fourth quarter on consolidation and acquisition charges.

The company lost $100.2 million, or $2.08 per share, compared with a profit of $45.5 million, or 87 cents per share, during the same period a year prior. Excluding charges, the company said it earned $1.01 per share.

Analysts polled by Thomson Financial expected profit of 73 cents per share, excluding charges.

Revenue rose to $329.8 million from $325.3 million. Analysts expected revenue of $314.7 million.

For the full year, the company lost $191 million, or $3.72 per share, compared with a profit of $132 million, or $2.33 per share. Revenue rose to $1.26 billion from $1.2 billion.

The company said it expects revenue from continuing operations to increase by the low-to-mid single digits in 2007. Profit, excluding charges, is expected to increase by two to three times the rate of revenue.

Shares of Invitrogen fell 53 cents to close at $60.36 on the Nasdaq. IN aftermarket electronic trading, shares gained $3.14, or 5.2 percent, to $63.50.

2007-02-12T15:58:00.000-08:00

The AMEX Biotech Index ($BTK) is heading toward testing support at the 50 day moving average. The index successfully tested support in January and another move off these levels could be a bullish signal as it confirms strong technical support at the 50 dma.

2007-02-12T07:50:00.001-08:00

Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. said Monday that they stopped a successful clinical trial for a liver cancer treatment and will seek global marketing approval.

Shares of Onyx jumped $5.74, or 46.8 percent, to $18 in electronic premarket activity, after closing at $12.26 Friday on the Nasdaq. Shares have traded between $10.38 and $29.10 over the past 52 weeks. American depositary shares of Bayer's parent rose 21 cents to $58.04.

West Haven, Conn.-based Onyx and the Emeryville, Calif-based unit of German drugmaker Bayer AG said a data monitoring committee determined that study data showed Nexavar, or sorafenib, significantly increased the survival rate in patients with advanced liver cancer compared with patients taking a placebo. The committee also found no significant difference in side effects between Nexavar and the placebo.

Based on the findings, the companies will stop the trial early and allow all patients in the study access to the drug.

The companies said they will approach the Food and Drug Administration and European regulators to try to get Nexavar approved as quickly as possible given the limited available therapies for advanced liver cancer.

Bayer and Onyx said they will release results of the trial at a major cancer meeting in June.

2007-02-08T09:48:00.001-08:00

British drugmaker GlaxoSmithKline PLC and XenoPort Inc. said Thursday they will partner to develop and market a XenoPort drug candidate to treat nerve pain and Restless Legs Syndrome (RLS).

XenoPort shares hit a 52-week high of $30.37, and were up $4.71, or 18.7 percent, to $29.95 in morning trading on the Nasdaq at more than four times their average trading volume. Shares have traded between $15.50 and $27.75 the past 52 weeks.

Under the exclusive agreement which is subject to U.S. antitrust review, GlaxoSmithKline will pay XenoPort $75 million up front for worldwide rights, with the exception of certain countries in Asia, to XP13512, an improved form of the nerve drug gabapentin.

XenoPort is also entitled to up to $65 million in development milestone payments, $210 million in other potential development and regulatory milestone payments and up to $290 million in potential sales milestone payments. Maximum milestone payments depend on getting drug market approval to treat neuropathic pain and RLS.

If XP13512 is approved for sale, XenoPort is also entitled to royalties.

The drug candidate is currently in late-stage clinical trials for RLS and in mid-stage clinical trials for neuropathic pain. RLS is a nerve disorder in which the limbs -- most often the legs -- tremble or twitch uncontrollably.

U.S. shares of GlaxoSmithKline rose 54 cents to $55.89 on the New York Stock Exchange.

2007-02-07T09:35:00.001-08:00

Increased sales of flu and child-respiratory drugs helped MedImmune Inc. post a fourth-quarter profit that beat expectations on Wednesday, bouncing back from a year-ago loss due to acquisition costs.

But the drugmaker's sales came up short of Wall Street's expectations and the stock fell $3.06, or 9 percent, to $30.95 in morning trading on the Nasdaq Stock Market.

Gaithersburg-based MedImmune earned $120.7 million, or 50 cents per share, compared with a loss of $22.4 million, or 9 cents per share, in the year-ago period. Excluding stock option expenses, the company reported earnings per share of $155 million, or 64 cents per share.

Analysts surveyed by Thomson Financial expected earnings per share of 54 cents, excluding stock option expenses.

In 2005, the drug company acquired Cellective Therapeutics Inc. Without the cost of the acquisition, the company reported earnings per share of 13 cents for the fourth quarter of 2005.

Revenue rose nearly 8 percent to $528.7 million in the latest quarter from $492 million in the year-ago period, as sales of respiratory virus treatment Synagis grew to $457 million from $439 million on strong U.S. sales. However, sales for the quarter were not up to Wall Street expectations. Analysts forecast revenue of $555.5 million, expecting strong performance on Synagis. For the year, Synagis sales were flat at $1.1 billion.

The company said sales of its inhaled influenza vaccine FluMist were up sharply in the fourth quarter, generating $18 million in revenue compared with $8 million in the 2005 fourth quarter.

FluMist -- once thought to be a blockbuster drug -- has been hobbled by limits on who can use it and requirements that it be stored in a freezer. In an attempt to revive the vaccine, MedImmune is preparing a version that can be more easily stored in a refrigerator and can be used for young children, a key patient group for flu vaccines. FluMist is made from weakened live virus and is sprayed into the nose. The traditional flu shot contains dead flu virus and is delivered through a needle jab in the arm.

Despite the higher fourth-quarter numbers, sales of 2.4 million doses for the 2006-2007 flu season still fell short of the company's projections of 3 million doses. Company Chief Executive Officer David Mott attributed the lower numbers to limits on who can use the drug and how it is stored, combined with a relatively light flu season.

"Hopefully we are not quite finished with this year's flu season," he said.

For the full year, the company said it exceeded its earnings guidance by posting net income of $48.7 million, or 20 cents per share, up from a loss of $16.6 million, or 7 cents per share, in 2005. Excluding stock option expenses, the company reported earnings per share of 30 cents for the latest year. Revenue rose to $1.28 billion from $1.24 billion.

2007-02-06T09:46:00.000-08:00

Millennium Pharmaceuticals Inc. reports earnings for the fiscal fourth quarter on Thursday. The following is a summary of key developments and analyst opinion related to the period.

OVERVIEW: Millennium announced early in the quarter that it would cut 14 percent of its staff to increase its focus on Velcade, the company's only commercial drug. The move leaves the company with about 1,000 employees. The company conceded to Genzyme in a bidding war over AnorMed Inc. Both companies had been one-upping the other to buy the Canadian company and obtain its lead drug candidate, Mozobil, a stem-cell transplant treatment in late-stage studies.

As a result of pulling out of the deal, AnorMed gave the Millennium a $19.5 million termination fee.

BY THE NUMBERS: Analysts polled by Thomson Financial expect fourth-quarter profit of 7 cents per share on revenue of $134.4 million. For the full year, analysts expect profit of 11 cents per share, excluding stock option expenses, on revenue of $481 million.

Millennium expects a full-year profit of between $10 million and $20 million, excluding charges, or a loss between $50 million and $60 million including charges.

ANALYST TAKE: Analysts don't expect any surprises in the company's fourth-quarter results, after Millennium announced full-year Velcade sales of $220 million.

Merrill Lynch analyst Tom McGahren expects the company's fourth-quarter profit to fall just shy of Wall Street expectations, coming in at 6 cents per share. More concerning, he wrote in a note to investors, is the 2007 outlook and updates on clinical trials for Velcade in front-line multiple myeloma and other forms of cancer.

Piper Jaffray analyst Rachel McMinn, looking toward 2007, said she doesn't expect Velcade sales to outperform the company's guidance of between $240 million and $260 million and has set 2007 sales expectations at $233 million.

"We continue to view 2007 as a challenging year for significant Velcade growth," she said, citing several factors.

Those factors include competition from Celgene Corp.'s Revlimid and limited potential for Velcade in its recently approved mantle cell lymphoma indication.

WHAT'S AHEAD: While Velcade is undergoing studies for several other indications, the company has a small mix of drug candidates in its clinical pipeline. Those include one drug candidate being tested in midstage trials for multiple sclerosis and atherosclerosis and another in midstage trials for rheumatoid arthritis.

STOCK PERFORMANCE: Shares of Millennium gained 10.1 percent over the quarter after opening Oct. 2 at $9.90 and closing Dec. 29 at $10.90 on the Nasdaq. The stock hit a 52-week high of $12.08 on Nov. 8.

2007-02-05T12:07:00.001-08:00

Shares Genetic variation analysis equipment maker Illumina Inc. fell Monday following a downgrade by Goldman Sachs citing the company's outlook for higher expenses in 2007.

The stock lost $1.43, or 3.9 percent, to reach $35.73 on the Nasdaq in afternoon trading. Shares have traded between $19.90 and $45.87 over the last 52 weeks.

On Thursday, the San Diego-based company reported a doubling of fourth-quarter revenue to $60.4 million and a profit of 34 cents per share compared with 1-cent per share a year prior.

Illumina forecast it would see revenue in 2007 above expectations, at a range between $295 million and $315 million and projected earnings -- including options expenses -- of 52 cents per share, shy of Wall Street's outlook for 57 cents per share. The company said its annual results would be shaved by about $20 million to $25 million for stock-options costs.

Additionally, predictions of a doubling in research and development costs to between $63 million and $73 million, as well as a sharp increase in selling, general and administrative costs, dragged down shares.

The company forecast first-quarter earnings of 7 cents per share, versus the 10 cents per share profit Wall Street is anticipating, and revenue of $64 million to $68 million.

Goldman Sachs analyst May-Kin Ho reaffirmed a "Neutral" rating for the stock in a note to investors late Friday, but cut earnings expectations to 60 cents per share and 96 cents per share from 73 cents per share and $1 per share, respectively for 2007 and 2008. Also, the target price calculation shifted to 2008 instead of 2007, Ho wrote and is now $41 instead of $36.

Illumina is involved in an ongoing patent lawsuit with rival Affymetrix Inc. and the trial could hang over the company for the long-term, Ho wrote.

"We expect increasing pressure on Illumina shares ahead of the trial against Affymetrix, which begins March 5," Ho wrote. "Appeals are likely and the final decision may take years to reach. A negative legal outcome could result in significant payments to Affymetrix and/or loss in sales."

2007-02-01T08:24:00.000-08:00

Drug maker Celgene Corp. said Thursday its fourth-quarter profit rose nearly sixfold as sales jumped.

Net income grew to $22.9 million, or 6 cents per share, from $3.9 million, or 1 cent per share, a year ago. Excluding stock option expenses, the company reported adjusted earnings of 18 cents per share, which matched expectations of analysts surveyed by Thomson Financial.

Revenue rose 84 percent to $275 million from $149.3 million last year, driven by sales of the cancer drugs Thalomid and Revlimid. Analysts expected revenue of $268.4 million.

For the full year, the company posted net income of $69 million, or 18 cents per share, up from $63.7 million, or 18 cents per share, in 2005. Revenue rose to $898.9 million from $536.9 million.

2007-01-31T12:30:00.001-08:00

- Biotechnology company Celgene Corp. reports earnings for the fourth-quarter on Thursday. The following is a summary of key developments and analyst opinion related to the period.

OVERVIEW: Celgene managed to nearly double its sales during the third quarter and entered the S&P 500 index in November. It offered 20 million shares at $51.60 a piece after its moved to the index.

December brought several executive changes, including the addition of David W. Gryska as chief financial officer to fill the position vacated by now President and Chief Operating Officer Robert J. Hugin. Thomas O. Daniel was named president of Celgene research.

The company bought a pharmaceutical ingredient plant from Switzerland-based Siegfried Ltd. for $46.5 million and said it plans on using the facility to make its multiple myeloma anemia treatment Revlimid. The year ended with Celgene facing a patent dispute by Barr Pharmaceuticals Inc., which plans to make a generic version of the drug Thalomid, which has been a key revenue driver.

BY THE NUMBERS: Analysts polled by Thomson Financial expect a fourth-quarter profit of 18 cents per share on revenue of $268.4 million.

The company did not issue guidance for the fourth quarter, but expects full-year earnings of 57 cents per share on revenue of $890 million, while analysts polled by Thomson Financial are looking for earnings of 53 cents per share on $891.9 million.

Celgene is predicting Thalomid sales between $425 million and $430 million for the full year, and annual Revlimid sales of $315 million to $320 million.

ANALYST TAKE: Analysts again expect strong sales of Thalomid and Revlimid to drive profit, while brushing off the patent dispute, with many saying Celgene has strong protection and the case could take several years.

"As expected, Celgene filed suit against Barr Labs to block the introduction of a generic Thalomid," said Merrill Lynch analyst Tom McGahren. "The suit triggers an injunction for 30 months or until a court decision (whichever is sooner) and we expect no impact other than legal fees for several years at least."

McGahren said the previous guidance for Thalomid and Revlimid reduces any surprise factor and expects the figures to fall within Celgene's estimates.

JP Morgan analyst Geoffrey Meacham also expects the company to meet Wall Street estimates for the fourth-quarter and full-year. He and other analysts are more focused on the company's 2007 outlook, which it has set just below Wall Street expectations. That guidance, he said, reflects uncertainty around Revlimid's European approval and launch and the early nature of its U.S. launch.

"We view the guidance as setting a low bar for Celgene, where upward revisions to guidance throughout the year would not surprise us," he said.

WHAT'S AHEAD: The company is anticipating European approval for Revlimid by the end of the first quarter. Additionally, interim data from a Phase II clinical trial testing Revlimid's effectiveness against new diagnosed multiple myeloma could be released during the first half of the year.

STOCK PERFORMANCE: Shares of Celgene jumped 33 percent during the quarter. The stock reached a 52-week high of $60.12 on Dec. 19 before falling back. The stock finished Tuesday at $54.25 on the Nasdaq, down 5.7 percent since the start of the year.

2007-01-30T10:40:00.001-08:00

Shares of Alfacell Corp. soared Tuesday after the company said federal regulators gave it exclusive rights to market its Onconase cancer drug for seven years, assuming the drug is approved.

The exclusive marketing rights for the drug are conditioned on a final OK from the Food and Drug Administration, which granted the so-called orphan drug status, Alfacell said in a press release.

The orphan drug status for Onconase also makes Alfacell eligible for tax credits and grant funding for research and development.

Onconase, which is in a late-stage clinical trial, aims to treat malignant mesothelioma, a rare form of cancer found in the chest, abdominal cavity lining or the lining around the heart. Around 4,000 to 5,000 new cases of the disease are found in the U.S. every year, according to the company.

Shares of Alfacell rose 29 cents, or nearly 18 percent, to $1.92 on the Nasdaq Stock Market in Tuesday morning trading.

2007-01-29T07:45:00.000-08:00

Swiss pharmaceutical company Roche Holding AG and OSI Pharmaceuticals Inc. said Monday the cancer drug Tarceva won approval from the European Commission as a treatment for pancreatic cancer in combination with standard chemotherapy.

Pancreatic cancer has the highest one-year mortality rate of any cancer and is Europe's sixth-deadliest cancer, the companies said.

"This is a much needed treatment advance for patients suffering with this difficult-to-treat disease," said William Burns, chief executive of Roche's pharmaceuticals unit, in a statement.

In 2002, there were more than 78,000 new cases of pancreatic cancer diagnosed in Europe, with a death rate of approximately 82,000 people per year, Roche said.

Pancreatic cancer is difficult to treat as it is often resistant to chemotherapy and radiotherapy and tends to spread quickly to other parts of the body, leading to a short life expectancy, the company said.

In November, Tarceva received approval from the Food and Drug Administration for the same use. In the U.S., OSI markets the treatment with biotech drugmaker Genentech Inc.

Tarceva is also approved to treat non small cell lung cancer.

Shares in Roche fell 0.3 percent to 232.30 Swiss francs ($185.38) in Zurich trading. Shares of OSI rose 21 cents to $33.39 in early trading on the Nasdaq.

2007-01-28T14:24:00.001-08:00

Drug maker Schering-Plough Corp. reports earnings for the fiscal fourth quarter on Monday. The following is a summary of key developments and analyst opinion related to the period.

OVERVIEW: In December, the company ended its shareholder rights, or "poison pill," plan and removed a provision that another such plan cannot be instated without getting shareholder approval within 12 months. Moody's also boosted its outlook for the company to "Positive" from "Stable" citing improved cash flow relative to debt.

In October, Schering-Plough Corp. got Food and Drug Administration approval to sell its anti-fungal medication Noxafil to treat an infection of the mouth and throat, a month after the agency approved it for life-threatening infections in leukemia patients.

EXPECTATIONS: Analysts surveyed by Thomson Financial estimate fourth-quarter earnings of 17 cents on revenue of $2.53 billion.

ANALYST TAKE: Prudential Equity's Tim Anderson, who rates the company "Overweight," raised his earnings estimate by 2 cents per share to match the Thomson consensus of 17 cents. Despite the rise of generic cholesterol-lowering drugs, Anderson sees higher-than-expected sales of Vytorin and Zetia, both sold through a joint venture with Merck & Co. Vytorin is a combination of Zetia and Merck & Co.'s Zocor.

Leerink Swann's Seamus Fernandez, another "Outperform," sees Schering-Plough coming in ahead of consensus on leverage from the cholesterol joint venture.

However, Citigroup's George Grofik is a little more cautious, thinking the company will hit consensus. He retained his "Hold," believing that the cholesterol joint venture has very small safety margin given several competitors in the field.

WHAT'S AHEAD: The company expects to gain approval to sell Zetia in Japan in 2007. Schering-Plough would co-promote the drug there with Bayer AG rather than Merck. Schering-Plough predicts that Japanese Zetia sales will contribute to top-line growth in 2007.

STOCK PERFORMANCE: Shares of Schering-Plough rose nearly 9 percent over the fourth quarter to close at $23.64, and grew by more than 13 percent over the year.

2007-01-26T10:38:00.000-08:00

Shares of biotechnology company Imclone Systems Inc. rose Friday after the company posted higher fourth-quarter profit and rival Amgen Inc. released some negative news about one of its own cancer drugs.

Imclone shares gained 88 cents, or 3.3 percent, at $27.72 on the Nasdaq in midday trading. Shares have traded between $26.28 and $43.08 over the last 52 weeks.

The company posted a $46.6 million, or 53 cents per share profit during the fourth-quarter, but missed Wall Street expectations by a penny. Erbitux sales jumped 39 percent during the quarter, but fell below estimates as the drug faced competition from Amgen Inc.'s Vectibix cancer treatment.

But rival Amgen reported negative news as it said a study showed Vectibix did not enhance treatment when used in combination with Genentech Inc.'s Avastin and chemotherapy.

Analysts had mixed assessments, mainly reaffirming a wide range of ratings for Imclone.

Bank of America analyst David Witzke kept a "Buy" rating on the company with a $48 price target, citing Amgen's Vectibix study.

"With an estimated duration therapy of less than two months, we believe Vectibix sales will quickly plateau, especially considering positive 1st and 3rd-line Erbitux (study) data," he wrote in a note to investors.

JP Morgan analyst Geoffrey Meacham reaffirmed a "Neutral" rating for Imclone. He noted an upcoming late-stage clinical trial could put Erbitux closer to being a first-line cancer treatment.

"Erbitux growth, not earnings per share, remains the value driver and accordingly, we expect Imclone shares to trade sideways for the near-term on pressure in the colon cancer market offset by moderating growth in head and neck (treatment)," he wrote in a note to investors.

Friedman, Billings, Ramsey analyst Jim Reddoch upgraded Imclone to "Market Perform" from "Underperform" and stuck with a price target of $25, citing share pricing and a possible decline in Vectibix competition.

"Currently half of Vectibix's sales come from patients who have already had Erbitux, and the rest through expected levels of share gains on Erbitux," he observed.

While Vectibix will likely continue its growth, he said, it is not differentiated enough to have a majority of the market. Also, the recent study results from Vectibix will likely ease Imclone investors' minds but will not necessarily help Erbitux significantly.

Citigroup analyst Yaron Werber, who has a "Sell" rating on Imclone, cut sales estimates for 2007 on Erbitux, citing competition from Vectibix, but raised his 2008 estimates with the expectation that Erbitux will gain approval as a first-line cancer treatment.

Amgen shares fell $3.59, or 4.8 percent, to $71.41 on the Nasdaq in midday trading.

2007-01-25T16:28:00.000-08:00

Amgen Inc., the world's most profitable biotechnology company, reported fourth-quarter earnings that were essentially flat, missing Wall Street expectations.

For the quarter ended Dec. 31, the Thousand Oaks company reported a profit of $833 million, or 71 cents a share, a 1 percent increase over the $824 million it earned in the same period last year.

If not for special expenses related to employee stock options and costs associated with three biotech company acquisitions, Amgen said it would have earned $1.06 billion, or 90 cents a share.

On that basis, the earnings undershot Wall Street analysts' expectations by 5 cents, according to a survey by Thomson Financial. The company also forecast earnings-per-share guidance for the year to be $4.30 to $4.50.

2007-01-24T10:58:00.000-08:00

Shares of pharmaceutical company Affymax Inc. jumped Wednesday after a pair of analysts upgraded the stock, citing its development pipeline and future prospects in the anemia treatment market.

Affymax shares rose $1.89, or 5.7 percent, to $34.89 on the Nasdaq in midday trading. The stock has traded between $29.30 and $37.20 since going public Dec. 15. It debuted at $30.

RBC Capital Markets analyst Jason Kantor initiated coverage at "Outperform" with a $44 price target, citing the company's focus on the EPO market. That price target implies growth of 33.3 percent over the stock's closing price Tuesday of $33.

EPO is short for erythropoietin, a natural protein that stimulates increased production of red blood cells. The anemia treatment market was worth an estimated $11.5 billion in 2006, up from $10.8 billion in 2005.

"The (EPO treatment) market for anemia is the largest and most lucrative market in biotech," Kantor wrote in a note to investors.

The drug under development, called Hematide, provides once monthly dosing versus competitor Amgen Inc.'s Epogen and Aranesp, with between a once-weekly and once every three weeks dose, Kantor said. The company has already reported positive data from a Phase II clinical trial.

Cowen and Co. analyst Phil Nadeau initiated coverage with an "Outperform" rating, also citing the sales potential for Hematide.

2007-01-23T07:09:00.000-08:00

Imclone Systems Inc. reports earnings for the fiscal fourth-quarter and full-year on Thursday. The following is a summary of key developments and analyst opinion related to the period.

OVERVIEW: Billionaire investor Carl Icahn won his battle for control of Imclone during the quarter after the board named him chairman in October. He was elected to the board during the third quarter and had been fighting to make several executive changes. Interim chief executive Joseph L. Fischer resigned immediately following Icahn's election victory.

Icahn previously said one of his top priorities is finding a new CEO.

In November, the company reported mixed results from two late-stage studies of its cancer treatment Erbitux, which is also its only marketed drug. The drug is approved to treat colon cancer and head and neck cancer.

In January, results from one study adding the drug to standard chemotherapy increased the survival rate of colon cancer patients. Imclone and its partner Bristol-Myers Squibb plan to file for approval of Erbitux as a first-line treatment for colon and pancreatic cancer.

BY THE NUMBERS: Analysts polled by Thomson Financial expect Imclone to earn 43 cents per share on revenue of $155.9 million during the fourth-quarter. For the full-year, analysts expect profit of $2.94 per share on revenue of $701.4 million.

ANALYST TAKE: Analysts expect sales of Erbitux to either meet or miss Wall Street expectations, with several citing the competition from Amgen's Vectibix as a factor in lost market share. Analysts are generally staying on the sidelines, taking a wait-and-see approach based on Erbitux numbers and management strategy.

"Vectibix-driven share erosion is inevitable, but to date, there has only been limited market growth," said Morgan Stanley analyst Steven Harr, in a note earlier this month.

The long-term potential of Erbitux, said Citigroup analyst Dr. Yaron Werber, could rely on the recent outcome of two late-stage trials. One study, called the Crystal study, showed Erbitux improved survival rates when added to chemotherapy. The drug could be able to capture between 10 percent and 20 percent of the first-line market, but would be going up against Genentech's Avastin.

Werber expects sales of Erbitux during the fourth quarter to reach about $170 million, below both Citigroup and Wall Street estimates.

WHAT'S AHEAD: The company is still without a CEO and Icahn has said finding one is a top priority. Several other executive positions, including the chief financial officer spot, also have to be filled.

On Thursday rival Amgen is set to release data from its study testing Vectibix with Avastin as a treatment. The results of that study could put more pressure on Erbitux as could the launch of Vectibix in Europe later this year.

Also, data on a study testing Erbitux as a pancreatic cancer treatment is expected later in the quarter.

STOCK PERFORMANCE: Shares of Imclone shed 5.7 percent during the quarter, opening Oct. 2 at $28.38 and closing at $26.76 Dec. 29. The stock hit a 52-week low of $26.28 on Dec. 27.

2007-01-22T08:02:00.000-08:00

Infinity Pharmaceuticals Inc. and Medimmune Inc. said Monday updated data from an early stage clinical trial of IPI-504 to treat gastrointestinal stromal tumors showed the drug cut the tumor's metabolic activity.

The updated results were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. The data showed that 44 percent of patients in the 18-person study showed a decrease in tumor uptake of 18-fluorodeoxyglucose, an imaging agent used to measure metabolic activity, that is, the tumor's distinctively elevated level of glucose absorption. The goal of the study, though, was to test safety and maximum tolerated dose.

Based on the results, the companies said they expanded the Phase I clinical trial. The results were first announced in November.

2007-01-19T10:49:00.000-08:00

Shares of specialty pharmaceutical company Pharmos Corp. sunk Friday after the company said its pain medication candidate cannabinor failed a midstage study.

Shares of Pharmos fell 17 cents, or 9.3 percent, to $1.64 on the Nasdaq in midday trading. The stock has traded between $1.55 and $2.93 over the last 52 weeks.

The Phase IIa study involving 24 healthy male volunteers showed the drug was not effective in treating pain from a non-noxious stimulus to the skin, when compared to placebo. The study was randomized and double-blinded. Previous safety data was confirmed by the study and there were no serious adverse events.

"While we are disappointed that cannabinor did not show efficacy in this pain model, we have a newly developed oral formulation of cannabinor targeting chronic neuropathic pain with repeated administration," said Haim Aviv, chairman and chief executive.

The company will move on with a program to develop orally administered cannabinor and conduct a Phase I safety study. Also, a separate ongoing Phase IIa clinical trial for nociceptive pain is expected to be completed during the first quarter.

2007-01-18T07:49:00.000-08:00

Drug developer Nastech Pharmaceutical Co. said Thursday it will raise up to $42.9 million in a public offering of 3.25 million of its common shares, priced at about $13.20 per share.

All of the shares are being sold by Nastech. The purchase price represents a 6 percent discount to Wednesday's closing price of $14.06 on the Nasdaq.

The company gave underwriters the option to buy an additional 487,500 shares to cover any over-allotments.

UBS Investment Bank is the sole bookrunner of the offering.

2007-01-17T07:59:00.000-08:00

Biopharmaceutical company Xoma Ltd. said Wednesday Schering-Plough Corp. exercised its right to continue its collaboration on developing antibody products.

Xoma said it received additional payments for each of the new programs and will receive research funding for each projects. The company did not release details on the additional programs or the amount paid upfront.

The companies started the collaboration May 23. Xoma is responsible for discovering antibodies selected by Schering-Plough. Additionally, Xoma is expected provide preclinical studies.

Shares of Xoma rose 14 cents, or 6 percent, to $2.49 on the Nasdaq in morning trading. Earlier in the session, shares traded as high as $2.55, topping a previous 52-week high of $2.50.

Shares of Schering-Plough fell 13 cents to $24.26 on the New York Stock Exchange, but earlier set a fresh year high of $25.17. The shares have traded between $17.88 and $25 over the past year.

2007-01-16T08:29:00.000-08:00

Biotech drug developer Dendreon Corp. said Tuesday that the Food and Drug Administration will grant a priority review for the company's prostate cancer drug.

A priority review means that the FDA will make a decision on the treatment within six months rather than the standard 10 months. The company submitted its marketing application in November, so now it expects the agency to render a decision by May 15.

Dendreon seeks approval for Provenge to treat asymptomatic, metastatic, androgen-independent prostate cancer, also known as hormone-refractory prostate cancer that has spread to other parts of the body.

Shares of Dendreon rose 32 cents, or 7.6 percent, to $4.55 in electronic premarket activity, after closing at $4.23 Friday on the Nasdaq Stock Market. Shares have traded between $3.68 and $5.77 over the past 52 weeks.

Prostate cancer is the most common non-skin cancer in the United States, with more than 1 million men living with the disease. An estimated 232,000 new cases are diagnosed each year in the U.S., and more than 30,000 men die each year of the disease.

In July, the company published data showing that Provenge enabled men with prostate cancer to live longer.

2007-01-12T06:55:00.000-08:00

Biopharmaceutical company Point Therapeutics Inc. on Friday said it will push testing of its treatment for metastic pancreatic cancer to completion after a second-phase study yielded encouraging results.

The company expects final results from the project in the middle of this year.

Point Therapeutics said during the second phase of the study it found no unexpected toxicities that would prevent the company from continuing to test talabostat in combination with gemcitabine. Talabostat is the company's lead product candidate.

Shares of Point Therapeutics rose 32 cents to $1.18 in premarket trading, having closed down Thursday at 85 cents on the Nasdaq Stock Market.

2007-01-11T08:44:00.000-08:00

Shares of Genentech Inc. jumped Thursday following fourth-quarter results showing a 75-percent surge in profit and management forecasts of continued double-digit growth in 2007.

The stock gained $3.31, or 4 percent, to reach $87.12 on the New York Stock Exchange in midday trading. Shares have traded between $75.58 and $90.75 over the last 52 weeks.

The boost in fourth-quarter profit, reported late Wednesday, came off double-digit growth in sales of Rituxan, Avastin and Herceptin. Profit for the year jumped 65 percent and the company said it plans on using 18 percent of its revenue in 2007 to fund research and development.

Genentech's earnings results beat Wall Street expectations by 1 cent. What surprised analysts was the sharp rise in sales of the age-related macular degeneration drug Lucentis, reaching $217 million during the quarter and beating estimates.

Merrill Lynch analyst Eric Ende raised his price target to $104 from $96 while reaffirming a "Buy" recommendation, citing the likelihood the company will gain more market share in the lung cancer treatment market with Avastin in 2007 and possible approval of the drug for breast cancer next year. Lucentis is quickly becoming the dominant drug in its field, he wrote, taking a 55-percent share in new patients.

Despite the performance, the drug does have market risks, he said.

"Because the number of treated patients has not grown since Lucentis' launch and the average number of doses per patient is likely to decline, significant additional growth may be a challenge in 2007."

Lazard Capital Markets analyst Joel Sendek, who maintains a $110 price target with a "Buy" recommendation, sees the drug moving the other way.

"We anticipate that a reduction in use related to the one-year anniversary of treatment in some patients currently on Lucentis will be met with increased use in newly diagnosed patients," he wrote in a note to investors.

RBC Capital Markets analyst Jason Kantor raised his price target to $95 from $91 and reaffirmed a "Outperform" rating, citing the strong sales growth from the company's three key drugs.

"The earnings outperformance is a testament to the strong operating leverage in the model which allows Genentech significant ability to invest in the business as well as drive earnings upside," he wrote in a note to investors.

He and other analysts are pointing toward several upcoming catalysts for the company, including data from a late-stage study on Avastin as a kidney cancer treatment and a first-line breast cancer treatment, as well as another study on Lucentis.

Lehman Brothers analyst Craig C. Parker said he remains "Neutral" on the stock, citing market risks with Avastin and a possible slowdown in sales of Lucentis. Other factors include competition with drugs including Amgen Inc.'s Vectibix and GlaxoSmithKline's Tykerb.

2007-01-10T10:29:00.000-08:00

The AMEX Biotech Index (BTK) is currently attempting to break through resistance at the 50 day moving average. The Biotech Index underwent a very powerful rally beginning in October and now, after a period of consolidation, appears ready to test the highs set in November.

2007-01-10T08:56:00.000-08:00

Blood substitute products maker Northfield Laboratories Inc. said Wednesday its fiscal second-quarter loss widened as costs increased.

The development-stage company is not yet profitable and does not have a revenue stream.

Northfield posted a loss of $7.6 million, or 28 cents per share, compared with a loss of $6.3 million, or 23 cents per share, last year. The company's fiscal year ends May 31.

Costs rose 18 percent to $8.3 million from $7 million, previously.

At the end of the quarter, the company had $56.2 million in shareholders' equity, with $51.6 million in cash and marketable securities.

Shares of Northfield rose a penny to $4.07 on the Nasdaq in morning trading.

2007-01-08T06:55:00.000-08:00

Biotech company ImClone Systems Inc. said late Sunday it expects to disclose results of a Phase III study of a metastatic colorectal cancer treatment before the end of the week, so it is withdrawing from a previously scheduled investment conference.

The company was scheduled to present at the JPMorgan Healthcare Conference.

Results from the Phase III trial on Erbitux plus Folfiri, known as the Crystal study, are currently being reviewed by statisticians and independent investigators.

2007-01-05T07:59:00.000-08:00

Serono SA said Friday that Germany's Merck KGaA has completed its share-purchase agreement with the Bertarelli family to take control of the Swiss pharmaceutical company.

That moves Merck closer to completion of its 10.6 billion euro ($13.9 billion) takeover, which is aimed at expanding its range of drugs and share of the global biotechnology market.

Merck now holds 84 percent of the capital and 89 percent of the voting rights in Serono, the company said.

The German company bought 66 percent of Serono's capital and 76 percent of the voting rights from the family, a statement said. Merck bought the remaining shares on the market.

Subject to clearance by the Swiss Takeover Board, Merck plans on Tuesday to offer the remaining shareholders the same 1,100 Swiss francs ($896) a share it paid the Bertarelli family under an agreement announced last September, Serono said.

Last month EU regulators gave their approval to the takeover, which Merck pursued after losing a bid to acquire Schering AG.

Serono has more than 4,750 employees and had worldwide revenues of $2.6 billion in 2005.

2007-01-04T07:08:00.000-08:00

Biotechnology company Biogen Idec Inc. said Thursday it is buying privately held Syntonix Pharmaceuticals Inc. for $40 million, with a possible additional $80 million in payments for development milestones.

The deal is expected to close during the first quarter.

Biogen will maintain Syntonix's 25,000-square-foot Waltham, Mass., facility. Both companies boards have approved the buyout.

Syntonix's lead product, FIX:Fc, is a treatment candidate for hemophilia B. The company focuses on using technology to develop inhalable treatments. The company plans to apply with the Food and Drug Administration to begin clinical trials in 2007.

"With this transaction, we continue to deliver on our strategic initiative to enhance our pipeline and expand into additional specialized markets," said James C. Mullen, Biogen Idec's president and chief executive.

Shares of Biogen shed 37 cents to $48.91 in morning trading on the Nasdaq.

2007-01-03T08:45:00.000-08:00

Shares of Biomira Inc. surged Wednesday after the Canadian biotech drugmaker said it is entitled to an undisclosed milestone payment from its partner, the German drug maker Merck KGaA, for beginning a late stage clinical trial for Stimuvax.

Biomira shares rose 13 cents, or 11.4 percent, to $1.27 in morning trading on the Nasdaq. The stock has traded between 85 cents and $2 over the past 52 weeks.

The Phase III clinical trial will study the cancer vaccine Stimuvax as a treatment in patients with advanced non-small cell lung cancer that cannot be removed through surgery. The trial will be run by Merck and its U.S. affiliate EMD Pharmaceuticals. Biomira expects the milestone payment sometime in January.

Biomira anticipates the clinical trial will enroll more than 1,300 patients in about 30 countries.

Separately, Biomira said it is enrolling patients in a mid-stage clinical trial for its PX-12 cancer drug for advanced pancreatic cancer. The company expects to enroll the trial's first patient this month. PX-12 is a small molecule intended to inhibit a protein that regulates the activity of cancer cells.

2006-12-28T14:50:00.000-08:00

After a strong run from September to November the Biotech HOLDRS Index (IBH) has pulled back significantly. The index may be poised to test support at the 200 day moving average. If support at 180 can hold the index should attempt another ascent toward the previous highs.

2006-12-28T07:56:00.000-08:00

Biotechnology company MedImmune Inc. said Thursday it plans to develop a monoclonal antibody to treat inflammatory diseases as part of a license agreement with Japan Tobacco Inc. -- maker of tobacco products, food and pharmaceuticals.

MedImmune's initial focus will be on an antibody to inhibit receptors controlling immune responses. The aim of the program is to develop treatments for inflammatory diseases and autoimmune disorders, such as rheumatoid arthritis.

Japan Tobacco will receive an upfront payment, milestone payments and royalties on future marketed products. MedImmune did not disclose the amount of the upfront payment or details on possible future payment arrangements. Japan Tobacco will have exclusive development and marketing rights for in Japan, while MedImmune will have exclusive rights worldwide for this antibody and others that may be developed under the agreement.

MedImmune shares fell 11 cents to $32.24 in morning trading on the Nasdaq.

2006-12-27T09:11:00.000-08:00

Biopharmaceutical company Oxigene Inc. said Wednesday its antitumor drug candidate passed a midstage study aimed at identifying the dose necessary to cut off blood flow to tumors.

The drug candidate, called CA4P, also proved safe and effective in the randomized, open-label Phase II study involving 13 patients, the company said. It was given in doses of 45 milligrams or 63 milligrams, followed by chemotherapy drugs paclitaxel and carboplatin.

The company said imaging confirmed that blood flow shutdown was observed in a wide variety of malignancies and safety was in line with expectations.

The results will be presented at an upcoming scientific meeting.

Shares of Oxigene rose 33 cents, or 7.1 percent, to $4.95 on the Nasdaq. The stock has traded between $2.82 and $5.88 over the last 52 weeks.

2006-12-26T07:56:00.000-08:00

Biotechnology company ImmunoGen Inc. said Tuesday it agreed to give French drug maker Sanofi-Aventis SA expanded access to its tumor-activated prodrug technology, earning $500,000.

Sanofi-Aventis already had the right to use the technology, which is used to produce antibody based cancer-cell killers, for targets included in an existing research collaboration between the companies.

The new agreement gives Sanofi-Aventis the option to extend the agreement beyond the scope of the existing collaboration and license the right to use the technology to develop new products.

Financial details of the agreement were not disclosed.

Shares of ImmunoGen rose 7 cents to $5.27 in morning trading on the Nasdaq.

2006-12-21T07:01:00.000-08:00

Praecis Pharmaceuticals Inc. said Thursday the company has entered in an agreement to be acquired by GlaxoSmithKline plc for approximately $58.4 million.

Waltham, Mass.-based Praecis and U.K.-headquartered GlaxoSmithKline said in a joint statement that GSK will acquire all outstanding shares of Praecis' common stock for a cash purchase price of $5.00 per share.

Praecis' PPI-2458 compound is in an early stage human clinical trial to treat non-Hodgkin's lymphoma and solid tumors.

"Praecis has created novel therapeutic programs and innovative chemical-synthesis and screening technology that will complement our own discovery capabilities," said Allen Oliff, Senior Vice President, Molecular Discovery Research, GSK.

2006-12-20T07:23:00.000-08:00

Biotech drug developer Kosan Biosciences Inc. said Wednesday that Pfizer Inc., the world's largest drugmaker, agreed to help develop a compound to treat gastrointestinal diseases.

Shares of Kosan rose 17.8 percent, to $5.75 in premarket electronic activity, after closing Tuesday at $4.88 on the Nasdaq. Shares have traded between $2.88 and $6.19 over the past 52 weeks.

Under the agreement, Pfizer will pay Kosan $12.5 million upfront and Kosan can receive milestone payments of up to $72.5 million. The agreement gives Pfizer worldwide rights to the compound. Kosan stands to make up to $250 million including royalties if the compound makes it to market for one indication. Kosan booked revenue of $13.4 million in 2005.

The companies will develop KOS-2187, a compound that stimulates the production of motilin, a hormone that is secreted by the small intestine and helps with movement in the gastrointestinal tract. Both companies will collaborate on filing regulatory paperwork to begin early stage clinical trials for the drug.

The compound has been shown in lab tests to be a good candidate as a treatment for gastro-esophageal reflux disease, or chronic heartburn, and diabetic gastroparesis, a condition when the stomach takes too long to empty its contents.

Kosan is entitled to other payments and milestones should Pfizer develop the compound for a second use.

2006-12-19T06:23:00.000-08:00

Wall Street analysts are largely shrugging off a recent disclosure of deaths from unapproved use of a drug developed and marketed by Genentech Inc. and Biogen Idec Inc.

Late Monday, the Food and Drug Administration said it wants more information on the cancer treatment Rituxan after Genentech and Biogen said two people died while using the treatment for an off-label condition.

The patients were using Rituxan to treat Systemic Lupus Erythematosus, an autoimmune condition, and died from a viral disorder called progressive multifocal leuklencephalopathy, or PML, according to the companies. The drug is approved for treating non-Hodgkins lymphoma and other conditions.

Analysts noted that the drug's association with PML is already listed on its label, and that PML could be caused by other conditions.

"In our view, there is little proof of cause-and-effect as a result of these two reported cases of PML," wrote Rodman & Renshaw's Michael G. King Jr. in a client note. He kept a "Market Outperform" rating and an $87 target price on shares of Genentech.

Credit Suisse's Michael Aberman, meanwhile, said the news could cause delays in approvals for other uses of Rituxan. He kept a "Neutral" rating on Genentech and trimmed his target price to $84 from $85.

"While we do not think this announcement will have an impact on oncology sales, we believe it will change physician perception (whether deserved or not) on the safety of Rituxan in autoimmune disease," wrote Aberman.

But May-Kin Ho of Goldman Sachs sees little impact on Genentech, and said doctors are comfortable with risks associated with the drug.

Baird Equity Research's Christopher J. Raymond likewise said he does not expect the news to have much of an impact. He reiterated a "Neutral" rating and $55 target price on the stock.

Genentech fell 62 cents to $80.34 in premarket trading after closing at $80.96 Monday on the New York Stock Exchange.

Shares of Biogen dropped $2.53, or 5 percent, to $47.70 in early activity after closing at $50.23 Monday on the Nasdaq.

2006-12-15T08:16:00.000-08:00

Encysive Pharmaceuticals Inc. said Friday it responded to a Food and Drug Administration request to reformat data in its marketing application for the hypertension drug Thelin.

Shares of Encysive rose 36 cents, or 6.5 percent, to $5.89 in premarket activity, after shedding about 7 percent on Thursday when the company announced it had to reformat the data. Shares have traded between $3.29 and $10 in the last 52 weeks.

The FDA began asking for more data back in July, when many had expected the drug to be approved. Shares dropped about 40 percent in one day to close at $3.69, when Thelin's approval was delayed.

In November, the company responded to FDA's July request.

Thelin is designed to treat pulmonary arterial hypertension, or chronic high blood pressure in the blood vessel that carries oxygen-poor blood to the lungs. The condition causes shortness of breath, decreased activity, and eventually death unless treated with a transplant of the heart, lungs, or both.

2006-12-14T07:24:00.000-08:00

Biotech drug maker BioPure (NASDAQ BPUR) said its fiscal fourth-quarter net loss narrowed to $6.3 million, or 13 cents a share, from $8.2 million, or 34 cents a share a year ago. Revenue for the quarter rose 31.4% to $431,000. Biopure also said it has closed its previously announced public offering of stock and warrants raising around $16.6 million for the company. Biopure said it had $6.6 million in cash at the end of October, which, combined with its stock offering, should be enough to fund the company through August 2007.

2006-12-13T07:10:00.000-08:00

Savient Pharmaceuticals Inc. said late Tuesday that a federal appeals court ordered Novartis AG unit Sandoz Pharmaceuticals and privately held Upsher-Smith Laboratories not to sell generic versions of Oxandrin until the court can review the case.

A temporary restraining order issued by U.S. District Court for the District of New Jersey against Sandoz and Upsher-Smith was to expire on Tuesday at 5:00 p.m. Savient appealed to the U.S. Court of Appeals for the Federal Circuit in Washington to keep the generic forms of the drug off the market for now.

Oxandrin is an oral anabolic steroid agent that helps patients gain weight after weight loss from surgery, infection or severe trauma. The lawsuit involves five Savient patents on the drug.

Representatives from Novartis and Upsher-Smith were not available for immediate comment.

2006-12-12T12:56:00.000-08:00

Peregrine Pharmaceuticals Inc. said Tuesday results from a preclinical study showed a developing cancer treatment decreased tumor growth in mice.

The study involved a mouse equivalent of the company's anti-phospholipid agent bavituximab. Preclinical results showed it reduced tumor growth by as much as 94 percent when used in combination with the chemotherapy drug docetaxel.

Bavituximab binds to a phospholipid, a type of fat normally located inside a cell but which becomes exposed on the outside of the cells that line blood vessels on tumors. The drug candidate is currently in Phase Ia clinical trials to test its safety as a stand-alone treatment and in Phase Ib clinical trials to test its safety when combined with cancer chemotherapy agents.

Shares of Peregrine rose 7 cents, or 5.8 percent, to $1.27 on the Nasdaq in midday trading. The stock has traded between 88 cents and $1.99 over the last 52 weeks.

2006-12-12T07:03:00.000-08:00

Indevus Pharmaceuticals Inc. Tuesday said it agreed to acquire Valera Pharmaceuticals Inc. in a stock swap worth about $120 million, plus potential contingent payments.

The two companies also entered into a co-promotion agreement under which Indevus' sales force will co-promote Vantas, a treatment for advanced prostate cancer, in the United States.

Indevus said it will pay $7.75 per share for Valera, a 43 percent premium to its Monday closing price. Valera has traded between $4.49 and $12 over the past 52 weeks and was recently up $2.34 in premarket trading, to $7.75.

The company has also agreed to make contingent payments of up to $3.50 per share based on the achievement of future product milestones.

Indevus said the purchase of Cranberry, N.J.-based Valera, which focuses on urology and endocrinology products, will add to its earnings within two years.

"Upon closing, Indevus' robust product portfolio will include three marketed products, and the combined company anticipates five new product launches within two years, including three products from Valera," said Glenn L. Cooper, chairman and chief executive of Indevus.

Under the co-promotion agreement, Indevus will get royalties of 13.5 percent on sales of Vantas up to a specified unit level and increases to 30 percent above the specified level. For sales of Vantas to specified specialty pharmacy accounts, Indevus will receive royalties of 35 percent. Indevus anticipates beginning to co-promote Vantas in January 2007.

Third-quarter sales of Vantas declined 21 percent to $2.9 million, reflecting decreases in Medicare reimbursement rates plus pressure on unit shipments because of price discounting of a competitive product, Valera said last month.

Indevus shares closed Monday at $7.86 on the Nasdaq, where they have traded in a 52-week range of $3.35 to $8.06.

2006-12-11T08:09:00.000-08:00

Biopharmaceutical company NeoPharm Inc. said Monday that in a clinical trial its experimental treatment for malignant tumors of the central nervous system didn't prove to be more effective than an existing treatment.

Shares of the company tumbled on the news, shedding $4.69, or 69.7 percent, to $2.03 in morning trading on the Nasdaq. Earlier in the session, the stock slumped to a fresh 52-week low of $1.80, well below its prior trough of $4.32.

The company said it was evaluating cintredekin besudotox for the treatment of recurrent glioblastoma mulitforme against Gliadel Wafer, which is implanted in the cavity the tumor once occupied after surgery. The wafer is made by MGI Pharma Inc.

Neopharm said its drug didn't show a statistically significant difference in the overall survival cures of patients with the tumors in a Phase III trial.

The company said it would work with its scientists and regulators to decided the best path forward for the drug.

2006-12-08T07:18:00.000-08:00

Biotech drug developer Acorda Therapeutics Inc. said Friday it will conduct an additional late-stage trial of its multiple sclerosis treatment based on feedback it received from a meeting with the Food and Drug Administration.

In September 2006, the company said its Fampridine-SR MS drug improved the walking speed in significantly more patients than a placebo in a late-stage clinical trial.

The trial was completed under a Special Protocol Assessment with the FDA, meaning Acorda sat down with officials to design a study that was most likely to yield the best results.

The FDA typically requires two well-controlled studies providing convincing results to substantially prove a drug is effective, according to the company.

Acorda said it will work with the agency to design the second study with a same or shorter duration than its previous late-stage trial.

2006-12-07T07:15:00.000-08:00

MannKind Corp., a developer of therapies for diabetes and cancer, on Thursday said it plans a public sale of 20 million common shares priced at $17.42 apiece.

Also, MannKind has agreed to sell $100 million aggregate principal amount of 3.75 percent senior convertible notes due 2013 in an underwritten public offering. The underwriters have a 13-day option to purchase up to $15 million in additional notes to cover overallotments.

Certain officers and directors, including the company's principal stockholder, Chairman and Chief Executive Alfred E. Mann, will purchase about 5.8 million shares in the offering. The underwriters have a 30-day option to buy up to another 3 million shares to cover overallotments.

JPMorgan Securities Inc. and Merrill Lynch & Co. are the joint lead managers and joint bookrunners of both offerings.

MannKind shares rose 39 cents, or 2.2 percent, in premarket activity. The stock closed at $17.42 Wednesday on the Nasdaq.

2006-12-06T14:24:00.000-08:00

Biopharmaceutical company Cerus Corp. said Wednesday it is selling $26.1 million in stock to selected institutional investors.

3.9 million shares are being sold at $6.68 apiece. Cerus expects to net $24.3 million from the deal.

The stock is being offered under a shelf registration previously filed with the Securities and Exchange Commission

Banc of America Securities LLC led the deal and Robert W. Baird & Co. was co-lead.

2006-12-06T05:05:00.000-08:00

MedImmune, which makes the FluMist influenza vaccine, on Wednesday reaffirmed its financial guidance for the current year and beyond.

The biotechnology company expects to post a 2006 profit -- excluding stock option expenses -- of 17 cents to 22 cents per share on revenue of $1.3 billion. Analysts polled by Thomson Financial, who also exclude stock option expenses, forecast earnings of 19 cents per share on sales of $1.3 billion.

For 2007, MedImmune expects earnings per share of 90 cents to 95 cents on sales of $1.5 billion. Analysts expect a profit of 85 cents per share and sales of $1.45 billion.

The company also confirmed its 2009 financial targets of $2 billion in revenue and net income of $2.00 per share.

2006-12-05T20:33:00.000-08:00

StemCells Inc. said Tuesday it promoted Ann Tsukamoto to the newly created job of chief operating officer.

She was previously vice president of research and development at the Palo Alto biopharmaceutical company, which has about 45 workers.

StemCells (NASDAQ STEM) seeks treatments for nervous system and other disorders using human stem cells.

The company also named Stephen Huhn, M.D., as the new boss of its neural program. He's a professor on leave from Stanford University School of Medicine. Maria Millan, M.D., another Stanford medical professor on leave, was promoted to vice president of the company. She's head of StemCells' liver program and its chief medical officer.

Chief Financial Officer Rodney Young was put in charge of the company's administrative functions, including personnel and information technology.

Before Christmas Dinner.....Perform A Background Check
On Your Daughter's Boyfriend

2006-12-05T09:09:00.000-08:00

Onyx Pharmaceuticals Inc.'s (NASDAQ ONXX) shares slid 30 percent Monday, the most since October 2004, after the company and partner Bayer AG reported that the cancer drug Nexavar failed to help save lives of patients with advanced melanoma.

The shares fell $5.32 to $12.18 in Nasdaq Stock Market composite trading Monday, after earlier sinking to $11.96. The last time the Emeryville-based company's shares dropped more was on Oct. 25, 2004, when they fell 33 percent.

Nexavar, Onyx's lead product, won U.S. regulatory approval last December for kidney cancer.

Bayer, based in Leverkusen, Germany, previously said Nexavar may bring in more than $1 billion in annual sales if the drug is approved to treat a range of malignancies. The companies are also testing the drug on patients with liver and lung cancers.

Investors had expected robust financial returns because of the size of the skin-cancer market, which is larger than that for kidney cancer, said Jim Reddoch, an analyst with Friedman Billings Ramsey & Co. in Arlington, Va.

"People were holding out for statistical significance," Reddoch said Monday. "There was no evidence that the drug was doing anything on top of the chemotherapy regimen."

Monday's news might limit the number of new uses sought for Nexavar, said Reddoch, who lowered worldwide sales estimates through 2010 to $551 million from $728 million.

The companies plan to continue research on the drug for melanoma even after Monday's results, Arthur Higgins, chief executive officer of Bayer HealthCare, said on a conference call with analysts and investors. Bayer doesn't expect the results to hurt recruitment to Nexavar trials, Higgins said.

Nexavar targets proteins involved in both tumor cell production and the formation of new blood vessels that support cancer cell growth, Onyx's Web site said.

2006-12-04T13:03:00.000-08:00

Shares of biopharmaceutical company Gilead Sciences Inc. jumped Monday after a Rodman & Renshaw analyst said Gilead is poised to benefit from a government recommendation that HIV testing become routine.

Analyst Michael G. King Jr. upgraded Gilead's stock to "Market Outperform" from "Market Perform" and set a $76 price target, saying Gilead is best poised to benefit from more testing and identification of HIV and that physicians expect the pool of patients receiving therapy for HIV to increase over the next few years.

Gilead's stock gained $2.17, or 3.3 percent, to $67.39 on the Nasdaq in morning trading. Shares have traded between $50.13 and $70 over the last 52 weeks.

In September, the Centers for Disease Control and Prevention released guidelines recommending that all Americans between the ages of 13 and 64 receive testing for HIV as part of a normal visit to the doctor. The recommendations were made as part of an effort to identify the estimated 250,000 to 300,000 Americans who have the virus and don't know it.

Foster City, Calif.-based Gilead makes several HIV treatments, including Viread, Emtriva and Truvada. Gilead contributes two of three components of a once-a-day HIV treatment the company markets called Atripla, which was cleared by the Food and Drug Administration in July. Bristol-Myers Squibb contributes the third component.

"We are significantly increasing our expectations for sales of Atripla on the basis of our analysis of prescription drug trends since (Atripla's) launch," he wrote in a note to investors.

Health officials place the number of new HIV cases at 40,000 each year, King said. He raised his fourth-quarter sales estimate for Atripla to $172 million from $96 million and full-year estimate to $240 million from $164 million.

The number is expected to rise sharply in 2007, with a forecast of $1.12 billion in revenue.

2006-12-04T08:04:00.000-08:00

Shares of biotech company Micromet (MITI) more than doubled on Monday after the biotech got a $10 million milestone payment from Serono on the company's adecatumumab treatment in metastatic breast cancer and prostate cancer.

The Carlsbad, Calif., company said it got the milestone payment on the completion of two Phase 2 clinical trials using the drug.

Adecatumumab is a human monoclonal antibody targeting tumor cells overexpressing the epithelial cell adhesion molecule. Micromet and Serono reported final data for the two Phase 2 studies on Oct. 2. The compound originated at Micromet and is being developed in collaboration between the companies.

Shares rose $2.94 to $4.96.

2006-12-01T09:03:00.000-08:00

Dutch biotechnology company Crucell N.V. said Friday it received $230 million in contracts from supranational organizations for its Quinvaxem and Hepavax-Gene pediatric vaccines.

The company did not name the organizations. A supranational organization often involves a group of nations, with one example being the European Union.

Quinvaxem, codeveloped with Novartis, protects against several childhood diseases including diphtheria, tetanus, whooping cough, hepatitis B, and a type of influenza. Hepavax-Gene protects against hepatitis B. The contracts cover the next three years.

American depository shares of Crucell rose 26 cents to $24.40 on the Nasdaq in morning trading.

2006-11-30T13:38:00.000-08:00

This one year chart of the AMEX Biotechnology Index (BTK) shows that the sector index has recently pulled back to the 760 range after recently breaking out to yearly highs. A successful test of support at 760 will be a very bullish signal for the Biotech Index in the coming weeks.

2006-11-30T07:18:00.000-08:00

Cadence Pharmaceuticals Inc. said late Wednesday its third-quarter loss grew sharply as operating costs more than doubled.

The company lost $7.8 million, or $6.01 per share, compared with a loss of $2.4 million, or $2.04 per share, a year ago. Cadence did not record revenue during the quarter.

Operating costs jumped to $8 million from $2.5 million, mainly attributable to costs associated with a late-stage clinical trial of the company's Omigard treatment, aimed at preventing local catheter site infections. Also, costs of additional personnel to support development efforts increased overall operating expenses.

As of Sept. 30, the company had cash and cash equivalents of $38.2 million. The company completed its IPO during the fourth quarter.

Shares of Cadence fell 30 cents, or 2.4 percent, to close earlier at $12 on the Nasdaq, having reached a new 52-week high of $12.50 earlier in the day.

2006-11-29T08:32:00.000-08:00

Biotechnology company Progen Industries Ltd. said the Food and Drug Administration gave it clearance to manufacture its anticancer drug candidate PI-88 for a late-stage clinical trial.

The Australian company's facility in Darra will make the first step of the process and a "large," U.S.-based manufacturer will produce the final ingredient, according to Progen. Up to 150,000 doses will be produced ahead of the study, which is expected to begin in mid-2007.

Shares of Progen rose 45 cents, or 15.3 percent, to $3.38 on the Nasdaq in morning trading after hitting a 52-week high of $3.93 shortly after the market opened.

2006-11-28T09:36:00.000-08:00

Hemispherx Biopharma Inc. named Anthony A. Bonelli president and chief operating officer on Tuesday.

Bonelli was previously CEO of Optigenex Inc., a New York life sciences company. Prior to that he was president of Anthony Bonelli Associates Inc., a health-care consulting firm; and president and COO of Neuman Health Services, a pharmaceutical wholesaler of Ridgefield, N.J.

Dr. William A. Carter, chairman and CEO of Hemispherx (AMEX HEB), believes Bonelli's "experience and expertise" will help the company develop strategies to expand revenue for its natural human interferon Alferon N injection, which has received Food and Drug Administration approval as a treatment for genital warts, and its experimental therapeutic Ampligen.

Carter said Hemispherx is getting ready to file a new drug application seeking approval for Ampligen as a treatment for chronic fatigue syndrome.

Bonelli is replacing Doug Hulse, who has been serving part-time as president and COO under a contract arrangement with health-care consultant The Sage Group of Branchburg, N.J., where he is executive director.

2006-11-27T14:38:00.000-08:00

Biotechnology company Cytokinetics Inc. said Monday it will assume responsibility for continuing development of two cancer treatment compounds under an amended agreement with GlaxoSmithKline.

The company announced in June that it was taking responsibility for further development of SB-743921 from its partner GlaxoSmithKline.

The revised agreement also assigns responsibility for development of ispinesib, or SB-715992, to Cytokinetics.

Glaxo has the option to resume responsibility for some or all of the development and marketing activities associated with the two drugs.

The companies have been collaborating in developing cancer treatments for five years and have extended the relationship for an additional year in June. The collaboration has already moved two drug candidates into clinical trials.

Cytokinetics said it is considering plans to conduct in 2007 a focused development program to supplement a broad series of Phase I and Phase II clinical trials on ispinesib. The trials, previously sponsored by GlaxoSmithKline, focused on lung and breast cancer patients. Cytokinetics' clinical trials would focus on breast cancer patients.

Shares of Cytokinetics fell 33 cents, or 4.3 percent, to close at $7.29 on the Nasdaq. The stock has traded between $5.20 and $9.35 over the last 52 weeks.

Shares of GlaxoSmithKline finished 17 cents lower at $51.48 on the New York Stock Exchange.

2006-11-27T09:56:00.000-08:00

Shares of biopharmaceutical company Trubion Pharmaceuticals Inc. jumped Monday after several analysts started coverage of the stock with a positive outlook, based on prospects for Trubion's rheumatoid arthritis candidate TRU-015.

The stock gained $1.22, or 7.6 percent, to reach $17.21 on the Nasdaq in morning trading, having earlier set a new 52-week high of $17.38 shortly after the market opened. Previously, the stock has traded between $12.70 and $16.24 over the last year.

The boost came after Morgan Stanley, Bank of America and Lazard Capital Markets initiated coverage with "Buy" and "Overweight" ratings, saying there is a low clinical risk associated with the arthritis treatment candidate. Analysts also believe TRU-015 would enter the market as a solid competitor to Genentech Inc.'s Rituxan.

The market itself for rheumatoid arthritis is expanding, analysts said, and with Wyeth as a partner in the drug's development, Trubion will have a reliable path into that field.

Seattle-based Trubion, which went public Oct. 18, is currently conducting mid-stage clinical trials of the treatment. Another drug candidate, TRU-016, is undergoing development for use as a cancer treatment.

"We have argued that until the next innovation in biotech, Trubion and other fast-follower players may offer the best risk-adjusted returns," said Morgan Stanley analyst Steven Harr, who rates the stock at "Overweight" with a $24 price target.

"Fast-follower" refers to a company that moves a product to market soon after the entrance of an initial, sometimes blockbuster, treatment. Harr expects to see data from the current TRU-015 trial during the second half of 2007, and late-stage clinical trials by early 2008. He forecasts the product will launch in late 2010.

Lazard analyst Joel Sendek initiated coverage with a "Buy" rating and a $22 price target, citing a similar outlook for TRU-015. The drug has a lower clinical risk than most biotech drugs, he said, because it is already directed against a validated target, uses a similar mechanism to Genentech's Rituxan and has so far shown positive results in clinical trials.

The rheumatoid arthritis market for biologic therapies is forecast to grow to $6.4 billion by 2009, Sendek said.

However, while Sendek said a survey of physicians showed 91 percent would switch to the drug from Rituxan, it faces not only an increasingly competitive market, but patent issues as well. Genentech and Trubion are currently disputing patents involved in the drug's use. That litigation, which has the potential to thwart TRU-015's release in both the United States and Europe, is on of the biggest risks facing the company.

Bank of America analyst David Witzke also started Trubion at "Buy" with a $23 price target, citing a similar positive outlook as well as lingering patent litigation concerns. He cited the collaboration with Wyeth on the drug as a strong point for the company, that validates the drug's market potential.

2006-11-24T16:00:00.000-08:00

The AMEX Biotechnology Index (BTK) is up almost 16% in 2006. This 9 month chart demonstrates that Biotech is outperforming the S&P 500 in recent months. 2007 setting up to be a banner year for the biotech sector as institutional money flows continue to increase.

2006-11-24T03:51:00.000-08:00

A federal judge Tuesday denied Johnson & Johnson's request for a preliminary injunction barring Amgen Inc. from offering discounts on certain drugs to treat side effects of chemotherapy, which J&J blames for declining sales of its anemia drug.

But J&J, of New Brunswick, N.J., Wednesday said it still plans to pursue a full trial in the case. J&J argues Amgen's discounts have hurt sales of Procrit, which treats chemotherapy-related anemia in cancer patients.

J&J has licensed Procrit from Amgen since the 1980s. Amgen sells the same drug under the brand Epogen, but under an agreement with J&J, Amgen only sells Epogen to treat anemia in kidney-dialysis patients, while J&J sells it in non-dialysis settings.

Amgen, Thousand Oaks, Calif., also sells a newer drug, Aranesp, to treat anemia in both dialysis and chemotherapy patients, thus competing directly with J&J's Procrit in chemotherapy settings.

To spur sales, Amgen offers cancer clinics discounts if they purchase certain amounts of Aranesp and two other Amgen chemotherapy-related drugs, Neupogen and Neulasta, which are designed to boost white blood cell counts and ward off infections. Partly as a result, Aranesp sales have taken off and gained market share from Procrit, rising 27 percent to $1.1 billion for the third quarter.

J&J sales of Procrit and Eprex _ the brand name it's sold under in Europe _ fell 5.3 percent to $2.4 billion for the third quarter.

J&J's Ortho Biotech unit sued Amgen in October 2005 in federal court in New Jersey alleging violations of antitrust law. J&J alleges the discounts constitute "unlawful tying" and an unlawful attempt to gain a monopoly. J&J also sought a preliminary injunction stopping Amgen from offering the discounts to oncology clinics.

Tuesday's ruling in Newark, N.J., by U.S. District Court Judge Stanley Chesler denies the preliminary injunction. He wrote that J&J's allegations, if true, can be remedied by monetary damages, so a preliminary injunction wasn't necessary.

"We believe that Amgen does not engage in anticompetitive practices in the sale of Aranesp," said David Scott, Amgen's senior vice president and general counsel.

Ortho Biotech also is seeking a permanent injunction against Amgen, which Chesler's ruling doesn't address. "The ruling does not resolve our underlying challenge to Amgen's anticompetitive contracting strategy," said Ortho Biotech.

J&J shares rose 17 cents to close at $66.77 on the New York Stock Exchange. Amgen shares fell 30 cents to $72.68 on the Nasdaq Stock Market.

2006-11-22T13:03:00.000-08:00

Amgen, Thousand Oaks, Calif., also sells a newer drug, Aranesp, to treat anemia in both dialysis and chemotherapy patients, thus competing directly with J&J's Procrit in chemotherapy settings.

J&J sales of Procrit and Eprex -- the brand name it's sold under in Europe -- fell 5.3 percent to $2.4 billion for the third quarter.

"We believe that Amgen does not engage in anticompetitive practices in the sale of Aranesp," said David Scott, Amgen's senior vice president and general counsel.

In afternoon trading J&J shares rose 17 cents to $66.77 on the New York Stock Exchange. Amgen shares fell 37 cents to $72.61 on the Nasdaq Stock Market.

2006-11-22T05:36:00.000-08:00

Drug developer PDL BioPharma Inc. said Tuesday Swiss drug maker Roche Holding AG pulled out of their partnership on to develop daclizumab as an organ transplant therapy.

The co-development agreement on the organ transplant program will formally end in May 2007. The move gives PDL exclusive rights for daclizumab's use in transplant maintenance.

"Roche made this decision subsequent to a periodic internal review of its development programs," PDL said in a statement.

Earlier this year, Roche pulled out of another partnership with PDL to develop the drug to treat asthma.

PDL said it will provide an update on the expected financial impact of the move with its 2006 financial results, expected to be released in February.

Shares of PDL rose 17 cents to close at $22.67 on the Nasdaq, but lost $1, or 4.4 percent, to $21.67 in aftermarket activity. The shares have ranged between $16.39 and $33.30 over the past year.

2006-11-21T07:37:00.000-08:00

Drug makers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Tuesday that European regulators approved their Type 2 diabetes treatment Byetta for sale.

The companies plan to launch the drug in Europe in 2007. Byetta was given a positive recommendation by a panel advising European regulators in September. The drug, which is derived from the saliva of the Gila monster, was launched in the U.S. in June 2005.

Lilly and Amylin ran into difficulties in April when the companies asked doctors to limit the number of patients started on the drug because cartridges had fallen into short supply. In August, the companies lifted the restriction when supplies caught up with demand again.

2006-11-20T16:46:00.000-08:00

Shares of Omrix Biopharmaceuticals Inc. rose Monday after Brean Murray Carret initiated coverage on the company with a "Buy" rating, citing the market potential for the company's products and speculating on the possibility of a buyout.

The biotech stock gained 49 cents to $29.35 in afternoon trading on the Nasdaq, after setting a fresh 52-week high of $30.49 earlier in the session. The stock's previous year high of $29 was set on Friday.

The biotech company's lead products include Evicel and Crosseal, both of which are used to stem bleeding, or for homeostasis, during liver surgery. The products, called fibrin sealants, promote clot formation. Evecel is also undergoing two additional clinical trials as part of a move by the company to get it approved for use in general surgery.

Analyst Jonathan Aschoff initiated coverage with a "Buy" rating and a $35 price target. He cited the company's marketing partnership on Evicel and Crosseal with Johnson & Johnson as a key reason for the rating, saying Omrix could be a possible buyout target.

"Since we view Omrix's business as relatively low-risk and on the brink of such robust revenue growth, it therefore makes for a very rational acquisition by J&J," he wrote.

Johnson & Johnson already made an offer for the company before it went public in April.

Evicel is superior to products currently on the market, he wrote, and it is poised to gain more market share with additional FDA approvals.

The company's immunotherapy business, which included developing treatments for West Nile virus, smallpox and hepatitis B-related liver transplants, is another positive, the analyst wrote.

2006-11-20T08:24:00.000-08:00

Dyadic International Inc., a biotechnology company, said it has agreed to privately place stock and warrants with institutional investors, raising net proceeds of $12.3 million.

The company placed 2.79 million common shares at $4.68 per share and warrants to purchase up to 557,400 shares with an exercise price of $6.33 each.

Dyadic said it will use proceeds to expand its development program, strengthen its product pipeline and accelerate the commercial launch of new products.

Cowen and Co. LLC acted as the exclusive placement agent for the offering. The closing of the private placement is subject to the approval of the listing of the shares and the shares underlying the warrants by the American Stock Exchange and other customary closing conditions.

Dyadic shares added 7 cents to $5.31 in morning trading. The stock has traded between $1.50 and $9.06 over the past 52 weeks.

2006-11-20T07:26:00.000-08:00

Biotech drug developer Oragenics Inc. said Monday that it bought privately held iviGene Corp. in an all-stock transaction.

Oragenics issued just over 185,000 shares for iviGene, which holds two patents for identifying gene and protein biomarkers that can be used for a better diagnosis and treatment of a wide range of infectious diseases and cancers. Oragenics has about 21 million shares outstanding.

Oragenics had an exclusive license to specific applications of iviGene's patented IVIAT technology since February 2004. With this transaction Oragenics now has all of iviGene's assets, including issued and pending patents to two broad-based platform technologies.

The transaction was approved by the boards of both companies. Oragenics is required to file a resale registration statement for its newly issued shares within 90 days.

Shares of Oragenics rose 2 cents at $1.27 in morning trading on the American Stock Exchange.

2006-11-19T16:11:00.000-08:00

The AMEX BIOTECHNOLOGY INDEX recently broke through technical resistance and now trades at a 5 year high. This one year chart of the Index shows that the biotech sector has made a very impressive move off of the July lows. Both the biotech index and sector are in a very bullish pattern. Many analysts expect biotech to continue to rally well into 2007.

2006-11-17T08:06:00.000-08:00

Biotechnology company Genentech Inc. said late Thursday the Food and Drug Administration approved cancer drug Herceptin as part of a combination treatment for women who have had initial breast cancer therapy, with the goal of reducing the risk of recurrence.

The drug was originally approved in 1998 to treat metastatic breast cancer.

Studies showed that adding the drug to chemotherapy early in breast cancer treatment reduced the relative risk of recurrence by half.

Shares of the biotecg giant rose 41 cents to $81.43 on the New York Stock Exchange.

2006-11-16T09:53:00.000-08:00

Biotechnology company Dendreon Corp. said Thursday it agreed to sell about 9.9 million of its common shares to institutional investors for gross proceeds of $45 million, before deducting offering fees and expenses.

The total proceeds imply a per-share offering price of about $4.54, representing a 15 percent discount to the stock's Wednesday closing price of $5.35.

Credit Suisse Securities (USA) LLC and Lazard Capital Markets LLC acted as joint lead placement agents for the offering, which is expected to close on Nov. 21, subject to customary closing conditions.

The company currently has about 71.9 million shares outstanding.

Shares tumbled 69 cents, or 12.9 percent, to $4.68 in morning trading on the Nasdaq, where the stock has ranged between $3.68 and $6.22 over the past year.

2006-11-16T09:50:00.000-08:00

Biotech company Millennium Pharmaceuticals Inc. has successfully raised $250 million to help fuel potential acquisitions and general corporate activity.

The Cambridge, Mass. company (Nasdaq MLNM) raised the amount by selling convertible senior notes due Nov. 15, 2011. Morgan Stanley & Co. Inc. and J.P. Morgan Securities Inc. acted as joint book-running managers.

It's not as if Millennium needs the cash. The company reported more than $635 million in cash and equivalents on hand as of Sept. 30. But the move to raise more funds comes after Millennium lost a bid to buy cancer drug developer AnorMed Inc. earlier this fall.

After a fierce bidding war, biotech giant Genzyme Corp. in Cambridge won out, agreeing to pay $580 million for the Canadian company. Millennium had bid $515 million, which trumped an earlier Genzyme bid.

Millennium announced in late October that it would lay-off 150 employees, outsource some drug discovery functions and consolidate space in Cambridge.

2006-11-15T08:01:00.000-08:00

Acorda Therapeutics, Inc. (Nasdaq ACOR) today announced that it has been selected for addition to the Nasdaq Biotechnology Index, which will be effective at the market's opening on Monday, November 20, 2006. "We are very pleased to be included in the NASDAQ Biotechnology Index and believe that our selection to this index is recognition of Acorda's consistent progress and achievements," said Ron Cohen, M.D., President and CEO of Acorda. "We are committed to delivering on our mission to develop therapies to restore neurological function to people with spinal cord injury, multiple sclerosis and other disorders of the nervous system."

The NASDAQ Biotechnology Index was launched in 1993 and includes contains securities of NASDAQ-listed companies that meet minimum requirements, including market value, average daily share volume, and seasoning as a public company, among other criteria. The index is ranked on a semi-annual basis in May and November and serves as the basis for the iShares NASDAQ Biotechnology Index Fund (Amex IBB).

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda's lead clinical stage product, Fampridine-SR, recently completed a Phase 3 study in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

2006-11-15T06:31:00.000-08:00

Biopharmaceutical company StemCells Inc (NASDAQ STEM) said Wednesday it transplanted a human neural stem cell as part of an early stage clinical trial to combat a rare neurodegenerative disorder.

The disorder, called Batten Disease, affects infants and young children and is brought on by inherited genetic mutations. That mutation causes the lack of a lysosomal enzyme, which leads to loss of motor skills, seizures and other symptoms. Eventually, the patient becomes blind, bedridden and unable to communicate, the company said.

The disease is fatal.

The company's human neural stem cell is transplanted into the brain of the patient, with the goal of producing the missing enzyme. The intention is for the enzyme to increase and continuing increasing over time, providing long-term delivery.

The Phase I clinical trial is designed to primarily study the safety of the treatment, but will also look at effectiveness. In all, six patients are expected to undergo the treatment over the next 12 months.

The beginning of human studies for the treatment gave biotech company StemCells a boost in premarket trading, raising shares 36 cents, or 11.3 percent, to $3.53 on the INET electronic exchange.

2006-11-14T18:59:00.000-08:00

The 6 month chart of the BIOTECH HOLDERS TRUST (AMEX:BBH) shows the index testing support at the 50 day moving average. The next few trading sessions will be critical in determining the direction of the market.

2006-11-14T07:23:00.001-08:00

Biotechnology company Gilead Sciences Inc. said Tuesday it completed its cash tender offer for shares of Myogen Inc.

Gilead said preliminary results show about 40.1 million shares, or more than 91.3 percent of outstanding stock, were validly tendered and not withdrawn prior to the expiration of the tender offer on Monday.

All shares have been accepted for payment.

In October, Gilead said it planned to buy Westminster, Colo.-based drug company Myogen for $52.50 cash per share, or about $2.5 billion.

Shares of Gilead rose 23 cents to $67.30 during premarket electronic trading on the INET.

2006-11-14T07:23:00.000-08:00

Biopharmaceutical company Novavax Inc. said Tuesday its third-quarter loss widened on higher costs for developing its flu vaccine program.

The company lost $5 million, or 8 cents per share, compared with a loss of $2.7 million, or 6 cents per share, a year ago. Analysts polled by Thomson Financial expected a loss of 11 cents per share.

Revenue dipped to $1.2 million from $1.9 million a year ago, while analysts expected revenue of $700,000.

Costs rose to $6.9 million from $4.1 million. The increase came as the company ramped up development of its VLP, or virus-like particle-based, flu vaccines. In July, the company received positive news from researchers that the developing vaccine could protect from influenza after only one dose. The results were part of preclinical trials.

The company is working with the Food and Drug Administration to design studies to test the vaccine in humans.

Shares of Novavax rose 7 cents to $5.02 in premarket trading on the INET electronic exchange.

2006-11-13T14:11:00.000-08:00

Biotechnology company ZymoGenetics Inc. said Monday data from early-stage clinical trial show its lupus treatment atacicept was safe and tolerable.

The drug, being developed with Swiss-based biotechnology company Serono, was tolerated across all dose levels in the Phase Ib study. Seattle-based ZymoGenetics said the companies hope to start a Phase II clinical trial before the end of the year.

The study involved 49 patients with systemic lupus erythematosus, the most common form of the immune system disorder. The key goal of the study was to test the drug for safety. Secondary goals measured biologic activity, or impact of the drug on disease symptoms. Results varied based on the dose.

The results were released at the American College of Rheumatology's annual meeting.

Shares of ZymoGenetics rose 57 cents, or 3.7 percent, to $16.06 on the Nasdaq in midday trading. The stock has traded between $15.02 and $25 over the last 52 weeks. American depositary shares of Serono fell 12 cents to $21.79 on the New York Stock Exchange.

2006-11-13T11:02:00.000-08:00

Biopharmaceutical company Samaritan Pharmaceuticals Inc. on Monday said it got a notice from the American Stock Exchange Inc. saying it did not meet listing standards

Samaritan said it did not comply with Amex rules requiring companies to have shareholder equity of not less than $4 million and losses from continuing operations, or net losses, in three out of four of its most recent fiscal years -- as well as a rule requiring shareholder equity of not less than $6 million and net losses in the five most recent fiscal years.

If it wants to stay listed, Samaritan Pharmaceuticals must submit a plan by Dec. 6 describing how it will be back in compliance within 18 months. The company said it will come up with a plan.

"If we fail to timely submit this plan, AMEX does not accept the plan, or we fail to perform in accordance with the plan, we will be subject to delisting procedures," the company said.

Shares of Samaritan Pharmaceuticals dipped 2 cents to 28 cents in midday trading on the AMEX.

2006-11-13T08:06:00.000-08:00

Biotechnology company Amgen Inc. said Monday an ongoing study of its drug Enbrel showed patients with a spine inflammation condition had positive results, consistent with a previous late-stage study.

The drug was approved by the Food and Drug Administration in 2003 to treat ankylosing spondylitis, a chronic inflammation of the spine and joints at either side of the spine. The ongoing open study showed that after a period between 148 and 160 weeks, patients maintained improvement in spinal mobility. The condition is known for impeding movement and flexibility.

In all, 59 patients received the drug in the ongoing study, and 78 percent of them improved based on a clinical scale measuring back pain, physical function and inflammation. The drug appeared to be safe and tolerable in the long-term study.

The results from the ongoing study reflect those seen in late-stage clinical trials, in which patients improved over a 24-week period.

The drug was approved in 1998 to treat inflammation associated with rheumatoid arthritis.

Shares of Amgen fell 46 cents to $73 on the Nasdaq in morning trading.

2006-11-10T12:11:00.000-08:00

A study released Friday suggests that an immunotherapy drug being developed by Dendreon Corp. may prolong the lives of prostate cancer patients who also undergo chemotherapy, the company announced.

The findings were released at a New York symposium by Dr. Daniel Petrylak, an associate professor of medicine with Columbia University Medical Center, Dendreon said in a press release.

The study examined the effects of Provenge, a drug that is designed to stimulate a patient's immune system. Seattle-based Dendreon (NASDAQ DNDN) is developing Provenge as an initial treatment for men with prostate cancer who later receive docetaxel chemotherapy for their illness.

Petrylak tracked 82 prostate cancer patients who were administered either Provenge or a placebo before undergoing chemotherapy.

The median survival period for patients treated with Provenge was 34.5 months, while the median survival period for patients treated with a placebo was 25.4 months, the company said.

Provenge is in late-stage clinical development.

2006-11-10T06:45:00.000-08:00

Drug developer Adventrx Pharmaceuticals Inc. said Friday it completed the sale of 14.5 million shares for $2.75 each.

The offering, announced on Nov. 3, generated roughly $40 million in gross proceeds, and $37.3 million in net proceeds. All shares were sold by the company.

Shares of Adventrx were unchanged in premarket trading from Thursday's closing price of $2.69 on the American Stock Exchange.

2006-11-09T13:04:00.001-08:00

One-time charges relating to a merger created much higher net losses during Epix Pharmaceuticals Inc.'s fiscal 2006 third quarter.

The Lexington, Mass., biotech company (Nasdaq EPIX) lost $133.1 million during the quarter ending Sept. 30, compared to a $5.7 million loss in its fiscal 2005 third quarter. The number jumped because of a one-time charge of $123.5 million recorded for ongoing research and development connected to Epix's merger with Predix Pharmaceutical Holdings Inc. in August.

Company revenue reached $1.3 million during the third quarter, down from $2.3 million in the same quarter last year.

Epix pursued its $125 million merger with Predix in an effort to diversify its product line after repeated delays in U.S. regulatory approval for its Vasovist imaging agent, which has received approval in Australia, Canada, the European Union, Norway, Iceland and Switzerland.

The merger transaction includes a $35 million milestone payment based on Predix's strategic collaboration with Amgen Inc., for which the merger triggered the extra money.

The combined company focuses on imaging agents and treatments for hypertension, anxiety and depression, and pulmonary disease.

2006-11-09T13:04:00.000-08:00

MedImmune has filed an investigational new drug application with the Food and Drug Administration to start human studies of its cell culture-based flu vaccine as part of a five-year, $170 million contract with the U.S. Department of Health and Human Services.

This flu vaccine would be produced through cell culture manufacturing techniques, replacing the decades-old method of using chicken eggs. Cell culture-based production would allow the Gaithersburg company to scale up its manufacturing without worrying about chickens getting infected.

With the new manufacturing technology, MedImmune estimates that by 2012 it will be able to produce 300 million bulk doses of a pandemic flu vaccine each year, beefing up the national stockpile of vaccines fighting that disease.

In July, MedImmune (NASDAQ MEDI) got FDA approval to turn to reverse genetics technology to develop seasonal and pandemic flu vaccines -- another method that the company says will speed up the manufacturing process.

On the other side of the Potomac River, Innocoll has filed an investigational new drug application to further test an antibiotic for diabetic foot ulcers.

The Ashburn company is developing a topical treatment version of CollaRx Gentamicin, already approved and being sold outside of the United States as a surgical implant.

Innocoll had purchased the rights to the drug from Essex Chemis, an affiliate of Schering-Plough, and has since won approval to sell the surgical-implant product in Central and South America. In August, the company joined its sales and marketing arm with BurnsAdler Pharmaceuticals to market the treatment in Mexico, Argentina, Chile, Colombia and parts of the Caribbean.

2006-11-09T08:56:00.000-08:00

Shares of EntreMed Inc. jumped Thursday after the drug developer said its experimental cancer drug showed activity against tumors in preclinical studies.

EntreMed shares rose 8 cents, or 3.9 percent, to $2.15 in morning trading on the Nasdaq. Shares have traded between $1.43 and $2.99 over the past 52 weeks.

The company said preclinical results for its cell cycle inhibitor MKC-1 showed that the compound interfered with tumor cells in models of lung cancer and pancreatic cancer when used by itself and with the cancer drug Tarceva.

Data showed that MKC-1 binded to tumor cells and destabilized structural components within the cells.