Cardiome Shares Drop As FDA Does Not Accept Marketing Application From Partner NEW YORK (AP) -- Shares of Cardiome Pharma Corp. dropped Wednesday after the Canadian drug developer said the Food and Drug Administration did not accept a marketing application filed by its partner Astellas Pharma US Inc.

Cardiome shares fell $2.94, or 26.1 percent, to $8.34 in premarket activity on the INET electronic exchange, after closing Tuesday at $11.28 on the Nasdaq. Over the past 52 weeks, the stock has traded between $5.28 and $14.45.

In late March, Astellas filed an application for the heart drug RSD1235 with the FDA, which then had 60 days to decide whether to accept the application or not. Cardiome said that the setback does not mean that RSD1235 is not an approvable drug. The FDA's letter said the application contained inconsistencies and omissions.

Cardiome said it will meet with Astellas and the FDA to discuss ways of making the application acceptable.

The setback also delays a $10 million milestone to Cardiome from Astellas conditioned on the FDA accepting the application.

Shares of Cardiome Pharma (CRME:Nasdaq) were among the worst-performing health-related stocks Wednesday, tumbling 21% after the drug developer said the Food and Drug Administration refused to accept its partner's application for an investigational drug to treat atrial fibrillation. The partner, Astellas Pharma, received a so-called "refusal to file" letter from the FDA. "We are very disappointed to communicate this setback to our stakeholders," Cardiome said in a press release. "Based on the clinical data generated from this program, we had great confidence that the submission would have met the Agency's filing requirements." In its letter to the company, the FDA said there were inconsistencies and omissions in the database that was submitted with the company's new drug application. Cardiome said it would not be deterred by the setback. "Our confidence in this program is in no way affected by this event," it said. "We are reviewing our own efforts in relation to this NDA, and are fully committed to resolving the FDA's concerns as quickly as possible." Shares of Cardiome recently were trading down $2.43 to $8.85. Shares of Connectics (CNCT:Nasdaq) fell 6% after the pharmaceutical company said it received notice from its debt holders warning of a potential default on its convertible notes. The company hasn't complied with the terms of its convertible debt obligation because of its failure to file its quarterly report for the period ending March 31 with the Securities and Exchange Commission in a timely manner. Connectics has 60 days to remedy the situation. "If the company does not cure this breach within this period, an event of default will occur under the indentures, and the trustees or the holders of at least 25% in aggregate outstanding principal amount of each note may accelerate the maturity of that note, causing the outstanding principal amount to be due and payable at that time," Connectics said. The company said that it is "endeavoring" to file the delinquent report within the next 60 days, which would allow it to avoid a default on the notes. Shares were trading down 75 cents to $11.85. Isis Pharmaceuticals (ISIS:Nasdaq) rose 3% after the company said it will sell up to $75 million in stock over the next 18 months as part of an equity financing deal with venture capital firm Azimuth Opportunity. "Isis Pharmaceuticals may at its discretion, from time to time, sell registered shares of its common stock at a small discount to the market price to Azimuth Opportunity," the company said. Isis plans to use proceeds from the financing for research, drug discovery, capital expenditures and general corporate purposes. Shares rose 21 cents to $7.67. Shares of Regeneron Pharmaceuticals (REGN:Nasdaq) rose 8% after the drugmaker said its chronic inflammation treatment received fast-track status from the FDA. "With no medical treatments approved to treat the chronic inflammation generated in people with these rare conditions, we hope the 1L-1 Trap will provide a new option for these patients in the future," the company said. Regeneron said it expects to provide top-line efficacy data from the trial of its treatment by the end of 2006. Shares were up 96 cents to $12.52. Cubist Pharmaceuticals (CBST:Nasdaq) fell 9% after the biopharmaceutical company laid out plans to sell $275 million in convertible subordinated notes due June 15, 2013. The company plans to use a portion of the proceeds to redeem some $165 million of its convertible subordinated notes. The company plans to use the remaining proceeds to increase funding for the commercialization of its Cubicin antibiotic and for working capital and general corporate purposes. Goldman Sachs is leading the underwriting syndicate. Shares were trading down $2.23 to $23.80. Other health care volume movers included Pfizer (PFE:NYSE) , up 3 cents to $23.61; Merck (MRK:NYSE) , up 57 cents to $33.33; Boston Scientific (BSX:NYSE) , up 18 cents to $20.50; UnitedHealth Group (UNH:NYSE) , up 69 cents to $44.02; Amgen (AMGN:Nasdaq) , up 25 cents to $67.08; Elan (ELN:NYSE ADR) , down 8 cents to $18.90; Johnson & Johnson (JNJ:NYSE) , up 16 cents to $60.01; Teva Pharmaceutical (TEVA:Nasdaq) , down 60 cents to $36.47; and Bristol-Myers Squibb (BMY:NYSE) , down 7 cents to $24.49.

Wednesday May 31, 8:37 am ET Biogen Idec Agrees to Buy Swiss Multiple Sclerosis Drug Development Partner Fumapharm CAMBRIDGE, Mass. -- Biotechnology company Biogen Idec Inc. said Wednesday it agreed to buy privately held drug maker Fumapharm AG a day after positive results were released on a multiple sclerosis treatment.

Financial terms of the transaction were not disclosed.

Fumapharm and Biogen have been developing BG-12, a multiple sclerosis treatment that was shown in a mid-stage clinical study Tuesday to significantly reduce the number of brain lesions that cause the debilitating condition. Multiple sclerosis is an incurable disease where the immune system attacks the insulation of nerve fibers by mistake.

The Swiss company also makes the psoriasis treatment Fumaderm, which is sold in Germany.

The boards of both companies have approved the transaction, which is expected to close in two months.

In March, a Food and Drug Administration advisory panel recommended that the agency let Biogen and partner Elan Corp. resume sales of the multiple sclerosis drug Tysabri. However the agency delayed making a final decision until June on the drug, which was pulled from the market because of a link to an often-fatal brain infection.

Biogen also makes the multiple sclerosis drug Avonex.

Soros fund buys 6.8 pct of NPS Pharma

May 31 - Soros Fund Management LLC said on Tuesday it now owns 6.8 percent of NPS Pharmaceuticals Inc. , according to a filing with the U.S. Securities and Exchange Commission.

The fund, controlled by billionaire investor George Soros, acquired more than 3.1 million shares over the past 60 days for a total of about $8.9 million, according the filing.

The Soros group is "concerned about...the past and current decision making and operations," of the company and "may suggest strategic changes," the filing said.

NPS' stock is trading at $5.93 a share in after hours trading after closing at $5.44 on the Nasdaq.

The Food and Drug Administration approved CollaGenex Pharmaceuticals Inc.'s rosacea treatment Monday.

The drug, called Oracea, is now the first FDA-approved, orally administered drug to treat rosacea.

Rosacea is a skin condition that affects an estimated 14 million adults in the United States. It affects primarily the face and is characterized by the appearance of inflammatory lesions, skin redness and spider veins. If allowed to progress to a moderate to severe condition, rosacea can cause itching, pain and thickening of the skin.

Patients spend an estimated $500 million a year on treatments for rosacea.

CollaGenex (NASDAQ CGPI) of Newtown, Pa., plans to launch Oracea to the dermatology community in July.

"Oracea is the first of a series of dermatology products we have in development, and we are very pleased that our (new drug application) was approved by the FDA within 10 months of submission," said Colin Stewart, the company's president and CEO. "Over the past six months, we have built a first-rate specialty sales force to launch Oracea, and all of our representatives were fully trained and in their territories by the end of April. This is an extremely exciting time for CollaGenex, and we look forward to providing dermatologists and their patients with this exciting new therapy to treat rosacea."

Oracea contains doxycycline, the same active ingredient as CollaGenex's gum disease treatment Periostat. The company began focusing on its use in the dermatology market after getting reports from dentists that their patients taking the drug for their gums were surprised to find Periostat was also improving the condition of their skin.

CollaGenex shifted its focus to the dermatology market over the past two years following the approval of generic competition for Periostat.

Shares of CollaGenex Pharmaceuticals (CGPI:Nasdaq) were among the best-performing health-related stocks Tuesday, jumping 11% after the company said the Food and Drug Administration approved its oral treatment for rosacea. The company's Oracea pill will be the first FDA-approved oral treatment for the skin condition. "Oracea is the first of a series of dermatology products we have in development, and we are very pleased that our NDA was approved by the FDA within 10 months of submission," the company said. CollaGenex said that the drug will be ready for distribution in July. CollaGenex shares were trading at $13.01, up $1.33. Vical (VICL:Nasdaq) rose 4% after the company announced a collaborative agreement with AnGes, a Japanese biopharmaceutical firm, to develop Vical's Allovectin-7 cancer treatment. As part of the agreement, AnGes will provide up to $100 million in clinical trial funding and make milestone payments that are tied to sales targets. Through cash and equity investments totaling nearly $23 million, AnGes will fund a Phase III trial of Allovectin-7, which will be conducted in the U.S. AnGes will also pay royalties to Vical that are tied to product sales in specified Asian countries. AnGes will have exclusive marketing rights to Allovectin-7 in the specified Asian countries, while Vical will retain marketing rights in the rest of the world. Vical shares were up 27 cents to $6.35. Applera (ABI:NYSE) fell 2% after the company's Applied Biosystems unit said it plans to acquire privately held Agencourt Personal Genomics for about $120 million in cash. The transaction, which is expected to close during the third quarter, will cut fiscal 2007 and 2008 earnings, Applied Biosystems said. During fiscal 2009, however, the deal is expected to be accretive. "After conducting a thorough evaluation of more than 40 companies and academic research groups, we have concluded that APG's technology is both tested and commercializable," Applied Biosystems said in a press release. Shares of Applied Biosystems were recently trading down 55 cents to $29.31. Shares of Beckman Coulter (BEC:NYSE) , which owns a minority interest in Agencourt, were up 9 cents to $55.42. HealthSpring (HS:NYSE) fell 1% after the managed-care company said it plans to buy America's Health Choice Medical Plans, a privately held Florida-based HMO, for $50 million in cash. HealthSpring, which went public in February, expects the transaction to close late in the third quarter or early fourth quarter. "We are extremely pleased to announce the signing of the agreement to acquire AHC and enter the Florida market," HealthSpring said. Shares were down 22 cents to $16.08. Other health care volume movers included Pfizer (PFE:NYSE) , down 21 cents to $23.79; Elan (ELN:NYSE ADR) , up 53 cents to $19.07; Merck (MRK:NYSE) , down 80 cents to $33.76; Boston Scientific (BSX:NYSE) , down 14 cents to $20.33; UnitedHealth Group (UNH:NYSE) , up 43 cents to $43.55; Medtronic (MDT:NYSE) , unchanged at $50.26; Johnson & Johnson (JNJ:NYSE) , down 63 cents to $60.06; Amgen (AMGN:Nasdaq) , down $1.34 to $67.47; Schering-Plough (SGP:NYSE) , down 14 cents to $19.23; Teva Pharmaceutical (TEVA:Nasdaq) , down 17 cents to $37.01; and Bristol-Myers Squibb (BMY:NYSE) , down 16 cents to $24.79.

SuperGen to Get $20M Dacogen Milestone

SuperGen to Receive $20 Million Milestone Payment From MGI Pharma Following Dacogen Launch

DUBLIN, Calif. -- Drug maker SuperGen Inc. said Friday that its partner MGI Pharma Inc. launched the blood cell disease treatment Dacogen earlier in the week, triggering a $20 million milestone payment.

Under the exclusive worldwide licensing agreement, SuperGen will also receive a 20 percent royalty on Dacogen that can expand to a maximum royalty shares of 30 percent. SuperGen booked $30.2 million in revenue in 2005.

The Food and Drug Administration approved Dacogen in May for the treatment of myelodysplastic syndromes, a group of diseases characterized by poorly functioning and immature blood cells.

Shares of SuperGen rose 23 cents, or 5.4 percent, to $4.50 in premarket activity.

Cyberonics Shares Rise As 4Q Results Beat Street, Analysts Point to Positive Catalysts NEW YORK -- Cyberonics Inc. shares surged Friday after the medical device maker surpassed Wall Street expectations for the fourth-quarter and analysts reiterated Buy-grade ratings based on improved performance and an announced stock buyback.

Cyberonics shares climbed $4.25, or 18.8 percent, to $26.86 in afternoon trading at more than three times their average volume. Shares have traded between $19.84 and $47.77 over the past 52 weeks.

The company, which makes an implantable pacemaker-like device called the Vagus Nerve Stimulator to treat epilepsy and drug-resistant depression, reported a loss of 21 cents per share on sales of $36 million. Analysts surveyed by Thomson Financial expected a wider loss of 30 cents per share on lower revenue of $35.2 million.

Piper Jaffray analyst Thom Gunderson, who rates the company "Outperform," said in a note to clients that Cyberonics is now in a position to have a stable sales force and that productivity will increase as the company's Vagus Nerve Stimulator gains traction, after trimming its sales, general and administrative spending by 17 percent sequentially.

Suntrust analyst Amit Hazan said that he viewed the company's plan to repurchase up to 3 million shares as a positive step. As of April 28, the company had about 25 million shares outstanding.

Cubist Stock Rises on FDA Approval for Antibiotic Cubicin NEW YORK (AP) -- Cubist Pharmaceuticals Inc. stock rose Friday in the first day of trading after the company announced that it received supplemental approval for expanded labeling of Cubicin, an antibiotic treatment for a blood-stream infection.

Shares of Cubist rose $3.91 or 19 percent, to $25.21 in midday trading on the Nasdaq Stock Market.

Based on receipt of the supplemental New Drug Application approval, the Cambridge, Mass.-based biopharmaceutical company confirmed its previously issued U.S. net product revenue forecast for 2006 of between $190 million and $205 million.

Cubist will begin marketing its once-a-day drug Cubicin immediately to acute care infectious disease doctors and specialists who treat Staphylococcus aureus, or S. aureus. The bacterium can spread through human-to-human contact and can cause skin infections and endocarditis, an inflammation of the heart valves. The infections caused by the bacterium are responsible for 30,000 deaths in the United States each year.

"The approval received today provides the clinicians who treat these complicated infections with an alternative therapy backed by prospectively collected, controlled, and comparative clinical data," President and Chief Executive Mike Bonney said.

Analysts said that while it was expected Cubicin would be approved for the bacteremia indication, there was some doubt about endocarditis.

Merrill Lynch analyst David Munno said Cubicin likely will publish its Phase III data in a major medical journal in the future, which will bolster the drug's sales force. Merrill Lynch makes a market in the securities of Cubist.

Shares of Cubist Pharmaceuticals (CBST:Nasdaq) were among the best-performing health-related stocks Friday, jumping 21% after the biopharmaceutical company received an expanded approval from the Food and Drug Administration for Cubicin. In addition to treating skin infections with the treatment, Cubicin can now be marketed for treating bloodstream and heart infections as well. "The approval received today provides the clinicians who treat these complicated infections with an alternative therapy backed by prospectively collected, controlled, and comparative clinical data," the company said. "Based on the expanded label approved today, we are very comfortable confirming our previously issued U.S. net product revenue guidance for 2006 of between $190 million and $205 million." Shares were trading up $4.62 to $25.87. NWH (NWIR:Nasdaq) soared 32% after the health information company agreed to be acquired by a unit of UnitedHealth (UNH:NYSE) for about $54 million in cash. The unit, Ingenix, will pay $18.24 a share for NWH, which represents a 35% premium over the Thursday closing price of $13.51. The deal is expected to close during the third quarter. Shares of NWH were trading up $4.29 to $17.80. Shares of SuperGen (SUPG:Nasdaq) fell 2%, even though the company said it would receive a $20 million milestone payment, which was triggered by the first commercial shipment of Dacogen. SuperGen said that its partner, MGI Pharma (MOGN:Nasdaq) , released the first shipment of Dacogen, a treatment of myelodysplastic syndromes, to wholesale drug distributors earlier this week. In addition to receiving the milestone payment, SuperGen will also be eligible to receive royalties tied to specific sales targets. Shares of SuperGen were down 7 cents to $4.20. Cyberonics (CYBX:Nasdaq) jumped 19% after the medical-device maker posted better-than-expected fourth-quarter results. For the quarter ended April 28, the company reported a loss of $5.2 million, or 21 cents a share, on revenue of $36 million. Analysts polled by Thomson First Call expected a wider loss of 30 cents a share and revenue of $35.2 million. A year earlier, the company's loss totaled $6.5 million, or 26 cents a share, on revenue of $26.7 million. Cyberonics said it expects to return to profitability, excluding stock-based compensation costs, during the second quarter of fiscal 2007. Meanwhile, the company continues to project quarterly sales of more than $50 million by the fourth quarter of fiscal 2007. Cyberonics also said its board authorized the repurchase of about 3 million shares. The company's shares were recently up $4.22 to $26.83. Shares of Weight Watchers International (WTW:NYSE) rose 3% after the company announced an expanded share repurchase plan and declared a quarterly dividend. The company will repurchase an additional $250 million in stock as part of its ongoing stock buyback plan, the company said. As for the dividend, Weight Watchers will pay 17.5 cents on July 14 to shareholders of record on June 30. Shares were trading at $42.37, up $1.35. Other health care volume movers included Pfizer (PFE:NYSE) , up 11 cents to $23.96; Elan (ELN:NYSE ADR) , up 42 cents to $18.55; UnitedHealth, up 82 cents to $43.24; Boston Scientific (BSX:NYSE) , up 27 cents to $20.16; Omnicare (OCR:NYSE) , up $1.63 to $46.09; Medtronic (MDT:NYSE) , down 35 cents to $50.25; Johnson & Johnson (JNJ:NYSE) , up 16 cents to $60.61; Amgen (AMGN:Nasdaq) , up 56 cents to $68.72; Schering-Plough (SGP:NYSE) , up 6 cents to $19.36; Teva Pharmaceutical (TEVA:Nasdaq) , up 62 cents to $37.27; and Bristol-Myers Squibb (BMY:NYSE) , up 33 cents to $24.94.

FDA approves Merck vaccine to prevent shingles
Fri May 26, 2006 10:15 AM ET

May 26 - U.S. health regulators on Friday approved the first vaccine to prevent shingles, a painful disease characterized by a blistering rash, the vaccine's developer, Merck & Co. , said.

Shingles is caused by the reactivation of the virus that causes chickenpox, and treatments generally only relieve pain and shorten the duration of the disease. The virus can lie dormant after childhood and strike again when the immune system weakens with age or illness.

The U.S. Food and Drug Administration approved the vaccine, Zostavax, for people aged 60 and older. The company also plans to seek approval for those as young as 50.

Everyone who has been infected with chickenpox -- about 90 percent of American adults -- is at risk of developing shingles, Merck said.

"This is going to be one of our important products," said Christine Fanelle, a Merck spokeswoman. "We have a lot of plans to make it a big success."

The vaccine is given as a single dose by injection, and Merck plans to charge $145.35 per dose.

There are roughly 50 million Americans over the age of 60, the vast majority of whom would be eligible for the vaccine, Merck said.

Cowen and Co. analysts in a March report had estimated sales of Zostavax could reach $900 million by 2010.

An FDA advisory panel in December had recommended approval of the vaccine for those 60 and over, but did not recommend it for younger adults because there was no data on the vaccine for adults aged 50 to 59.

"We'll be working with the FDA to talk about an indication beginning at age 50 and what it is specifically the FDA would like to see in addition," said Dr. Jeffrey Silber, Merck's senior director of clinical research, in an interview.

Symptoms of the disease can begin with a pain or tingling on one side of the body, followed by a blistering rash that can last several weeks. Treatment often involves use of antiviral drugs to relieve pain and shorten the duration of the disease.

In some cases the rash is followed by nerve pain known as postherpetic neuralgia that can last weeks or even months and years.

Of the roughly 1 million cases of shingles that occur in the United States each year, 40 percent to 50 percent affect people over the age of 60, the company said.

Merck studied the vaccine in more than 40,000 people, of whom about 21,000 received the vaccine. Zostavax reduced the risk of developing shingles by 51 percent, compared with placebo.

In those people who did develop shingles, the incidence of postherpetic neuralgia was cut by 39 percent, Merck said.

Merck's shares rose 28 cents, or nearly 1 percent to $34.67 in early trading on the New York Stock Exchange.

Shares of Encysive Pharmaceuticals soared on Thursday after the company announced it had filed a reply to an approvable letter issued by the Food and Drug Administration for its drug candidate Thelin, a treatment for pulmonary arterial hypertension.

Encysive (ENCY) closed up 17% at $4.45 after earlier hitting a session high of $4.63.

Earlier Thursday, Encysive said it had submitted additional information to support its market application for Thelin. In late March, the FDA had issued Thelin an approvable letter, meaning that it believed the drug could be approved if certain conditions were met.

"Encysive and the FDA have come to the mutual agreement that the company's approach to responding to the items outlined in the approvable letter with our existing data set is reasonable, making possible the submission of a complete response," said Encysive chief executive officer Bruce Given, in a statement.

Pulmonary arterial hypertension is a serious cardiovascular condition caused by unusually high blood pressure in the main artery of the lungs, which can lead to heart failure.

The company said it expects to hear from the agency within 30 days as to whether information submitted is sufficient, thereby alleviating the need for the company to run any additional studies in order to win approval for the drug.

Encysive shares lost almost 50% of their value after it reported on March 24 that it had received an approvable letter for Thelin. Investors had expected the FDA to grant full approval for the drug.

Analysts on Thursday remained cautious about Thelin's prospects.

"Encysive has not provided any insight about what course of action will be necessary before the FDA grants Thelin approval," wrote Needham & Co. analyst Mark Monane in his note Thursday. "However, we anticipate that this development signals a significant delay in Thelin's development, from 2 to 3 months at the least, up to 1 to 2 years."

"We believe that this longer delay period is more realistic. Owing to the current uncertainty surrounding the Thelin development schedule, we reiterate our hold rating," Monane added.

"The key downside risk obviously remains further worldwide regulatory delay on Thelin," wrote Deutsche Bank analyst Jennifer Chao. "Upside risks to our hold rating include faster than anticipated FDA approval for Thelin, and potential acquisition on recently discounted valuation".

Shares of Encysive Pharmaceuticals (ENCY:Nasdaq) were among the best-performing health-related stocks Thursday, jumping 15% after the company submitted a complete response to the Food and Drug Administration for its pulmonary arterial hypertension drug. "Encysive and the FDA have come to a mutual agreement that the company's approach to responding to the items outlined in the approvable letter with our existing data set is reasonable, making possible the submission of a complete response," the company said. In March, shares in Encysive were hammered after the company received an approvable letter from the FDA requesting more information about the drug, Thelin. The company said it expects to hear within 30 days whether the FDA will accept its latest submission for review. Shares were trading up 57 cents to $4.39. Shares of Angiotech Pharmaceuticals (ANPI:Nasdaq) rose 2% after the medical device company narrowed its 2006 earnings forecast and announced an acquisition. The company now sees full-year adjusted earnings of 79 cents to 81 cents a share. Previously, the company forecast a profit of 76 cents to 81 cents a share. Angiotech predicts revenue of $325 million to $335 million. The updated guidance is better than the earnings of 78 cents a share and revenue of $312 million that analysts project. For 2007, Angiotech anticipates adjusted earnings of 90 cents to 95 cents a share on revenue of $400 million to $425 million. Analysts project earnings of $1 a share on revenue of $400.7 million. Separately, Angiotech said it signed a definitive agreement to buy privately held Quill Medical for $40 million. Quill makes aesthetic surgery and wound-closure products. The deal is expected to close in the third quarter. Angiotech shares recently changed hands at $13.97, up 24 cents. Shares of United Natural Foods (UNFI:Nasdaq) jumped 9% after the distributor of natural and organic foods posted third-quarter results that topped forecasts. For the quarter ended April 30, the company earned $12.3 million, or 29 cents a share, up from $10.7 million, or 26 cents a share, a year earlier. Sales rose to $637.1 million from $534.3 million. Analysts polled by Thomson First Call expected earnings of 28 cents a share on sales of $622 million. "These results reflect the continued strong consumer demand for natural and organic products as well as the underlying strength of our sales channels across all regions in the country," the company said. United Natural Foods now sees full-year earnings of $1.08 to $1.10 a share, narrowed from a prior forecast of $1.05 to $1.10. The company raised its sales projection to a range of $2.42 billion to $2.45 billion from its previous estimate of $2.38 billion to $2.42 billion. Shares were trading up $2.79 to $33.20. Shares of Patterson (PDCO:Nasdaq) fell 4% after the supplier of dental products posted in-line fourth-quarter earnings but warned that first-quarter earnings would be lower than Wall Street's current targets. For the quarter ended April 29, the company earned $56.8 million, or 41 cents a share, on revenue of $695.2 million. The earnings matched analysts' mean estimate, while revenue topped Wall Street's projection of $689.1 million. Last year, Patterson earned $50.2 million, or 36 cents a share, on revenue of $627.3 million. Patterson sees first-quarter earnings of 31 cents to 33 cents a share, below the 35 cents that analysts project. For all of fiscal 2007, the company sees earning of $1.61 to $1.64 a share, in line with analysts' forecast of $1.63. Shares fell $1.27 to $34.22. Shares of PSS World Medical (PSSI:Nasdaq) fell 5% after the distributor of specialty pharmaceutical products posted mixed fourth-quarter results. The company earned $12.9 million, or 19 cents a share, up from $10.2 million, or 16 cents a share, a year earlier. Revenue rose to $422.7 million from $401.3 million. Analysts expected earnings of 19 cents a share on revenue of $430.8 million. PSS shares were down 88 cents to $17.42. Other health care volume movers included Pfizer (PFE:NYSE) , down 9 cents to $23.75; Omnicare (OCR:NYSE) , down $3.78 to $44.22; UnitedHealth Group (UNH:NYSE) , up 20 cents to $42.29; Boston Scientific (BSX:NYSE) , down 18 cents to $19.85; Medtronic (MDT:NYSE) , up 90 cents to $51.07; Elan (ELN:NYSE ADR) , up 67 cents to $17.98; Johnson & Johnson (JNJ:NYSE) , down 7 cents to $60.34; Amgen (AMGN:Nasdaq) , down 42 cents to $67.65; Schering-Plough (SGP:NYSE) , up 6 cents to $19.18; Teva Pharmaceutical (TEVA:Nasdaq) , up 89 cents to $36.45; and Bristol-Myers Squibb (BMY:NYSE) , up 60 cents to $24.57.

Shares of Novavax (NVAX) and other biotechs such as BioCryst (BCRX) and Gilead (GILD), whose products might be used to fight the bird flu virus, were seen higher Wednesday on news from Indonesia of possible human-to-human transmission of the disease.

New drug may hold promise for stutterers - trial
May 25, 2006 2:35 PM ET
BOSTON, May 24 (Reuters) - When Dr. Gerald Maguire was a child, he resolved every New Year's eve to stop stuttering. The resolution usually lasted less than two hours.

Now Maguire is helping investigate an experimental new drug that he believes could offer hope to the more than 3 million Americans who suffer from the speech disorder.

The drug, pagoclone, is being developed by Indevus Pharmaceuticals Inc. . Results of a 132-patient trial released on Wednesday showed that 55 percent of patients taking pagoclone showed a significant improvement in symptoms compared to 36 percent who took a placebo.

Shares of Lexington, Massachusetts-based Indevus rose as much as 10 percent on Wednesday on the news.

Maguire, who is an associate professor of psychiatry at the University of California Irvine School of Medicine, said pagoclone, if approved, would be the first drug specifically designed to treat stuttering.

Today, patients are either not treated, or are treated with drugs that are not approved for the disorder such as the benzodiazepine class of anti-anxiety drugs or antipsychotics such as Zyprexa and Risperdal.

Maguire believes pagoclone may help stutterers without causing the kind of dependence linked to benzodiazepines or the weight gain often associated with the newer antipsychotics.

Pagoclone is designed to heighten activity of the brain chemical GABA, which is thought in turn to block the chemical dopamine. Dopamine, which is responsible for motion and movement, is often too high in people who stutter, Maguire said.

"Stuttering is a neurological disorder that has psychological consequences," he said.

For four years, Maguire did not talk on the phone, as his anxiety overwhelmed his ability to speak. He said the antipsychotic Zyprexa helps.

The disorder, which affects about 1 percent of the adult population, normally begins in childhood. About half of children who develop it grow out of it.

That could be because an area of the brain called the striatum, which acts as the timer and initiator of speech, does not fully develop until later in life. Pagoclone is designed to enhance the functioning of the striatum, Maguire said.

The drug, which was tested in patients for eight weeks, was not associated with any serious complications, Indevus said.

Indevus said it will meet with the U.S. Food and Drug Administration to discuss the findings and plans for further development. By mid-afternoon trading, the company's shares were up 3.8 percent at $4.61 on Nasdaq.

Amgen Shares Look Cheap Ahead Of ASCO

Wachovia Securities upgraded shares of Amgen ahead of one of the biggest medical meetings of the year, as the biotech giant is expected to report positive data for one of its most promising drugs in development.

Analyst George Farmer said denosumab, an experimental osteoporosis treatment formerly known as AMG-162, could receive accelerated approval should pending Phase II data prove positive.

"Based on compelling biology, there is good reason, in our view, why a positive outcome could be expected from the denosumab Phase II trials to be presented at ASCO this June," Farmer wrote in a note to clients Monday.

The mid-stage clinical trials are designed to determine the efficacy of the drug for the treatment of metastatic bone disease.

"We believe one or more of these trials could support an accelerated approval plan if positive," he added. "Should Amgen pursue such a strategy, we believe a BLA [biologics license application] for denosumab as treatment for bone metastases could be filed in the first half 2007 and perhaps face market entry in 2008 -- one year ahead of Street expectations."

Farmer forecasts a 13% revenue compound annual growth rate for Amgen through 2008, relative to the median combined growth rate of peers Biogen Idec, Gilead Sciences and Genentech. The Wachovia analyst values Amgen in a range of $75 to $82 per share.

"We believe the potentially early filing of denosumab justifies buying Amgen stock ahead of ASCO, especially now that most of the negativity, in our view, has been played out," the analyst noted.

"With $3 billion of stock already repurchased this year and another $3.2 billion remaining, Amgen management has signaled, from our perspective, that it believes its stock to be cheap."

Pharmacopeia Partners With Cephalon
Tuesday May 23, 9:14 am ET Pharmacopeia to Form Drug-Discovery Partnership With Cephalon

PRINCETON, N.J. (AP) -- Pharmacopeia Inc., which provides services to pharmaceutical and biotechnology companies, on Tuesday said it will form a drug-discovery partnership with biopharmaceutical company Cephalon Inc. for an up-front fee of $15 million.

Under terms of the deal, Cephalon will be responsible for identifying promising compounds. Both companies will then work to develop the compounds into clinical candidates. Pharmacopeia will be responsible for medicinal chemistry and primary biology, while Cephalon will provide biology support as needed.

Cephalon will then be responsible for the development and commercialization of clinical candidates, while Pharmacopeia will retain an option to develop candidates from the collaboration.

The company developing a clinical candidate that goes forward will then make clinical, regulatory and sales milestone payments to the non-developing company. Further, the company commercializing each resulting product will pay the other company up to double-digit royalties based on sales.

Shares of Pharmacopeia (PCOP:Nasdaq) were among the best-performing health-related stocks Tuesday, soaring 33% after the biotech company announced a drug discovery alliance with Cephalon (CEPH:Nasdaq) . As part of the pact, Pharmacopeia will receive an upfront fee of $15 million from Cephalon. "The primary objective of the alliance is to identify active molecules and bring them forward to clinical proof of concept, yielding novel candidates for drug development in various therapeutic areas," Pharmacopeia said. Cephalon will be in charge of identifying promising compounds. Once a compound is identified, Pharmacopeia will be responsible for medicinal chemistry and primary biology and Cephalon will provide biology support. "Cephalon has been very successful at producing proprietary lead series against novel targets, so we are excited to be able to establish this alliance with Pharmacopeia," Cephalon said. Shares of Pharmacopeia recently were trading up $1.29 to $5.25, while shares of Cephalon rose 11 cents to $57.22. Varian Medical Systems (VAR:NYSE) rose 1% after the medical device company's Trilogy linear accelerators received Food and Drug Administration marketing clearance for an expanded range of medical conditions. "With this new clearance, physicians can begin to provide Trilogy treatments for functional lesions like trigeminal neuralgia and other non-cancerous conditions," the company said. "The prior FDA clearance for the Trilogy device was limited to benign and malignant cancers, and arteriovenous malformations." Shares were up 55 cents to $46.88. Shares of Abaxis (ABAX:Nasdaq) slipped 2% after the company said it agreed to end its distribution pact with Henry Schein (HSIC:Nasdaq) . The split is effective immediately. Distribution of Abaxis' veterinary products through Henry Schein accounted for about 14% of Abaxis' total business during fiscal 2006, the company said. "We believe that the loss of sales from the Schein organization will be principally offset with increased sales in our other domestic sectors, as well as increased international sales," Abaxis said. "We expect to meet our internal quarterly and annual financial targets." Shares were trading down 44 cents to $17.28. Vertex Pharmaceuticals (VRTX:Nasdaq) rose 7% after the biotech company said it launched a phase II trial of VX-950, an investigational oral hepatitis C protease inhibitor. The company said it expects to initiate a second trial in June. The studies are being conducted to evaluate sustained viral response rates in 580 patients who have not received the treatment before and who suffer from the genotype 1 hepatitis C virus. Shares were trading up $2.03 to $31.48. Other health care volume movers included Pfizer (PFE:NYSE) , up 18 cents to $23.90; Boston Scientific (BSX:NYSE) , down 26 cents to $19.70; Elan (ELN:NYSE ADR) , up 43 cents to $17.80; UnitedHealth Group (UNH:NYSE) , down 33 cents to $43.19; Johnson & Johnson (JNJ:NYSE) , up 55 cents to $60.41; Amgen (AMGN:Nasdaq) , down 15 cents to $67.64; Schering-Plough (SGP:NYSE) , up 5 cents to $19.07; Teva Pharmaceutical (TEVA:Nasdaq) , up 30 cents to $36.90; Medtronic (MDT:NYSE) , down 48 cents to $48.09; and Bristol-Myers Squibb (BMY:NYSE) , up 16 cents to $24.02.

Shares of Exact Sciences (EXAS:Nasdaq) were among the best-performing health-related stocks Monday, jumping 12% after the biotech company said its DNA-based colon-cancer screening technology performed well in a study. The company said its stool DNA-testing technology was able to demonstrate an 88% sensitivity for cancer, with an 82% specificity. "Colonoscopy is the gold standard for colorectal cancer screening and is usually our first screening recommendation to patients," the study's lead investigator said. "However, many people are reluctant to undergo a colonoscopy. This study shows that very high sensitivity can be achieved with noninvasive, stool DNA testing." The data were presented at the annual Digestive Disease Week conference on Sunday. "With sensitivity for colorectal cancer approaching 90%, we believe that stool DNA testing and colonoscopy could be a powerful one-two punch in the quest to get more people screened and to reduce colon cancer mortality," Exact Sciences said. Shares were trading up 24 cents to $2.48. Quest Diagnostics (DGX:NYSE) fell 1% after the company said it received a subpoena from the California attorney general's office. The subpoena, the company said, requests documents relating to billings to MediCal, the state's Medicaid program. The subpoena covers documents over three to 10 years. The company said it plans to cooperate with the attorney general's office. Shares were down 55 cents to $56.98. Shares of Adventrx Pharmaceuticals (ANX:AMEX) rose 6% after the company withdrew a secondary stock offering and said it received clearance to initiate a Phase III trial for CoFactor, a drug designed to improve the efficacy and safety of a widely used chemotherapy agent. The company said that market conditions forced it to shelf its stock offering. The company had planned to sell some 15.5 million shares of stock. As for the Phase III trial of CoFactor, Adventrx said it reached an agreement with the Food and Drug Administration over the design of the trial's protocol. The agreement means that Adventrx remains on track to launch the trial during the second quarter, the company said. Shares were trading up 17 cents to $4.37. Oscient Pharmaceuticals (OSCI:Nasdaq) rose 8% after the company named Philippe Maitre as its new chief financial officer. Maitre will replace Stephen Cohen, who is retiring after five years as CFO. "A veteran of the pharmaceutical industry, Philippe was the CFO of a leading publicly-traded contract research organization and deputy CFO for a large pharmaceutical company," Oscient said in a statement. Shares were trading up 10 cents to $1.35. Other health care volume movers included Pfizer (PFE:NYSE) , up 24 cents to $24.06; Boston Scientific (BSX:NYSE) , down 53 cents to $19.62; Elan (ELN:NYSE ADR) , down 36 cents to $17.61; UnitedHealth Group (UNH:NYSE) , down 72 cents to $43.70; Johnson & Johnson (JNJ:NYSE) , unchanged at $59.90; Amgen (AMGN:Nasdaq) , up 34 cents to $68.03; Schering-Plough (SGP:NYSE) , down 16 cents to $19.07; Teva Pharmaceutical (TEVA:Nasdaq) , down 40 cents to $36.56; Medtronic (MDT:NYSE) , down 72 cents to $48.58; and Aetna (AET:NYSE) , down 55 cents to $39.70.

Drug stocks finished in the red Monday while Amgen gained on an analyst upgrade.
The Amex Pharmaceutical Index edged down 0.4% to close at 325.12 and the Amex Biotechnology Index was down 1% at 626.15 following an unusually placid trading morning for the sectors on Wall Street.
Amgen advanced after analysts at Wachovia upgraded the stock to outperform. Amgen closed up modestly at $67.79 after hitting a session high of $68.59.
Forest Labs rose 2 % after analysts at UBS upgraded their rating on the stock to buy, only to reverse direction later in the day. The stock closed down 1% at $37.69.
ViroPharma (VPHM)
climbed 2% to $9.45. The vaccine developer unveiled positive Phase I data for its hepatitis C treatment HCV-796 this weekend at the annual scientific meeting Digestive Disease Week. The drug is being co-developed with Wyeth.

AVI BioPharma Shares Drop on Early Data From Hepatitis C Drug Trial NEW YORK (AP) -- Shares of AVI BioPharma Inc. dropped Wednesday after early reported results from a clinical trial for the biotech drug maker's hepatitis C treatment were not as robust as some investors expected.

AVI shares fell $2.23, or 30.7 percent, to $5.03 in midday trading on the Nasdaq at more than four times their average volume. Over the past 52 weeks, shares have risen from a low of $2.05 during the summer to hit a high of $9.20 in February.

Hepatitis C virus concentrations in the blood, known as viral loads, fell only slightly on average based on early data gathered on five patients taking the company's antisense compound AVI-4065 for 14 days. Antisense drugs interfere with genetic processes to stop the manufacture of harmful proteins.

The Portland, Ore.-based company stressed that the data was preliminary and that formal results would be out by the end of the year. The study is expected to test the drug in about 40 patients.

AVI said that a longer treatment period could be the key to reducing viral loads further.

Rodman & Renshaw analyst Ren Benjamin, who rates AVI "Market Outperform," said in an interview that investors sold on a combination of lower-than-expected efficacy results and the "news mentality" of the release.

"It's still pretty early," Benjamin said. "There's a lot of expectation built into the stock. Primarily, investors expected a bigger load decrease."

Benjamin said he is currently reviewing his price target on the stock.

AVI BioPharma Shares Drop on Early Data From Hepatitis C Drug Trial NEW YORK (AP) -- Shares of AVI BioPharma Inc. dropped Wednesday after early reported results from a clinical trial for the biotech drug maker's hepatitis C treatment were not as robust as some investors expected.

AVI shares fell $2.23, or 30.7 percent, to $5.03 in midday trading on the Nasdaq at more than four times their average volume. Over the past 52 weeks, shares have risen from a low of $2.05 during the summer to hit a high of $9.20 in February.

Hepatitis C virus concentrations in the blood, known as viral loads, fell only slightly on average based on early data gathered on five patients taking the company's antisense compound AVI-4065 for 14 days. Antisense drugs interfere with genetic processes to stop the manufacture of harmful proteins.

The Portland, Ore.-based company stressed that the data was preliminary and that formal results would be out by the end of the year. The study is expected to test the drug in about 40 patients.

AVI said that a longer treatment period could be the key to reducing viral loads further.

Rodman & Renshaw analyst Ren Benjamin, who rates AVI "Market Outperform," said in an interview that investors sold on a combination of lower-than-expected efficacy results and the "news mentality" of the release.

"It's still pretty early," Benjamin said. "There's a lot of expectation built into the stock. Primarily, investors expected a bigger load decrease."

Benjamin said he is currently reviewing his price target on the stock.

Anadys Pharmaceuticals Reports First Quarter 2006 Financial Results

SAN DIEGO, May 09, 2006 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. , a biopharmaceutical company committed to the discovery, development and commercialization of novel small molecule medicines for the treatment of hepatitis, other serious infections, and cancer, today reported its operational highlights and financial results for the quarter ended March 31, 2006.

"During the first quarter we initiated dosing of ANA975, a Toll-Like Receptor-7 oral prodrug, in chronic hepatitis C virus patients in our 28-day placebo-controlled, multiple-dose Phase Ib clinical trial to evaluate safety, tolerability and viral load reduction," said Kleanthis G. Xanthopoulos, Ph.D., Anadys' President and Chief Executive Officer. "Based on progress in this trial, we and our partner Novartis anticipate the initiation of a Phase II study in HCV patients later this year."

Financial Results

Anadys reported revenues of $1.5 million for the first quarter of 2006, compared to $563,000 for the first quarter of 2005. Revenues for the quarter were primarily derived from the Company's collaboration with Novartis. Operating expenses were $8.4 million for the quarter, compared to $9.1 million for the first quarter of 2005. This decrease was primarily attributable to the recording of a $845,000 offset in research and development expense, which represents an estimate of the net reimbursement by Novartis of ANA975 research and development costs.

Net loss was $5.8 million for the first quarter of 2006, compared to $8.4 million for the first quarter of 2005. Basic and diluted net loss per common share was $0.20 in the first quarter of 2006, compared to $0.38 for the same period in 2005. The adoption of Financial Accounting Standards Board Statement 123R "Share-Based Payment" resulted in non-cash operating expenses of approximately $1.4 million for the first quarter of 2006 or approximately $0.05 effect on basic and diluted net loss per common share.

As of March 31, 2006, the Company's cash, cash equivalents and securities available-for-sale totaled $99.8 million.

Recent Highlights
* Reported Viral Load Reduction Achieved in Phase II Clinical Trial of
ANA380 in Lamivudine-Resistant, Hepatitis B Patients. In February,
2006 Anadys and LG Life Sciences announced principal findings from an
open label, multi-center, dose-escalation Phase II clinical trial,
evaluating the safety and antiviral activity of ANA380 in patients
with lamivudine-resistant hepatitis B virus (HBV) infection. These
findings and more recent data were presented in April 2006 at the 41st
Annual Meeting of the European Association for the Study of the Liver
(EASL), where Anadys and LG Life Sciences announced updated results
from this Phase II clinical trial, based on an analysis of data from
12 weeks of dosing in 62 patients in five cohorts. Patients treated
with ANA380 at 90 mg, 150 mg and 240 mg dose levels experienced
reduction in plasma HBV viral DNA at 12 weeks of 3.9 log10, 3.9 log10,
and 4.1 log10 units, respectively (greater than 99.9% clearance of the
virus in plasma).
* Appointed Two Executives to Senior Management Positions. Anadys hired
Michael Adam, Ph.D., as Senior Vice President, Development Operations.
Dr. Adam, who has 20 years of experience in drug development, is
responsible for regulatory affairs, quality assurance, pharmaceutical
development and manufacturing. Anadys also hired Carol G. Gallagher,
Pharm. D., as Vice President, Commercial Affairs. Dr. Gallagher is
responsible for commercial affairs, including business development,
market planning and strategic planning.
* Appointed Two Scientists to Clinical and Scientific Advisory Board.
Anadys appointed Francis V. Chisari, M.D., to its Clinical and
Scientific Advisory Board. Dr. Chisari is a Professor in the
Department of Molecular and Experimental Medicine and Head of the
Division of Experimental Virology at Scripps Research Institute, La
Jolla, California. Anadys also appointed Robert "Chip" Schooley,
M.D., to its Clinical and Scientific Advisory Board. Dr. Schooley is
Professor and Head of the Division of Infectious Diseases of the
University of California, San Diego.

Panacos Up on Speculation of Takeover
Monday May 8, 2:55 pm ET Panacos Pharma Shares Rise on Analyst Note Speculating on Acquisition by Gilead Sciences

NEW YORK (AP) -- Panacos Pharmaceuticals Inc. shares jumped Monday that after an analyst speculated in a research note that Gilead Sciences Inc. could potentially acquire the biotech company in 2007.

Shares of Panacos climbed 73 cents, or 13 percent, to $6.24 in afternoon trading on the New York Stock Exchange. Shares have traded between $2.64 and $12 over the past 52 weeks.

Yaron Werber, an analyst for Citigroup who covers Gilead, suggested in a research note that Gilead could leverage its HIV treatment holdings with the acquisition of Panacos for a promising new treatment called PA-457. Gilead makes the antiretrovirals Viread and Truvada, which combines the company's antiretroviral Emtriva along with Viread into a single daily tablet.

According to Werber's scenario, Gilead buys Panacos for about $620 million cash after the release of positive mid-stage clinical trial data for PA-457. With positive results, decisive late-stage clinical trials could be launched for the treatment in HIV patients who had received other treatments.

Werber estimates that an acquisition of Panacos would shave 4 cents per share and 3 cents per share off Gilead's 2007 and 2008 earnings, respectively, but add 16 cents per share in 2009 if PA-457 were launched and approved.

Separately, a filing with the Securities and Exchange Commission on Monday showed that Panacos President and Chief Executive Samuel K. Ackerman bought 10,000 shares of common stock at $5.62 per share, and Chief Financial Officer Peyton J. Marshall bought 10,000 shares at $5.61 per share. Shares of Panacos closed at $5.51 on Friday.

Supply seen assuring Bristol arthritis drug sales
Mon May 8, 2006 4:02 PM ET

NEW YORK, May 8 (Reuters) - Bristol-Myers Squibb Co's recently launched arthritis drug Orencia is more likely to achieve its promise as a big seller, thanks to federal approval of a new manufacturer of the product, industry analysts said on Monday.

The New York-based drugmaker in December won U.S. approval for the treatment of rheumatoid arthritis, the less common but potentially crippling form of arthritis caused by an overactive immune system.

Although Bristol-Myers makes Orencia, which is given by periodic infusions, the company had cautioned that its factory in Syracuse, New York, would be unable by itself to meet potential demand for the new medicine.

Analysts said uncertainty about adequate supplies was allayed late on Friday after U.S. regulators approved use of Swiss specialty chemicals and biotechnology group Lonza to make batches of Orencia for Bristol.

As a result, Bear Stearns analyst John Boris said he now expects sales of Orencia to hit $900 million by 2010, up from his earlier projection of $750 million.

The drug was approved for treating patients that have failed to benefit from older treatments -- including Amgen Inc's Enbrel and Johnson & Johnson's Remicade, which both work by blocking a protein called tumor necrosis factor (TNF) linked to inflammation.

Boris said in an interview that even his raised Orencia sales forecast could prove "conservative" in view of how many patients are not getting adequate relief.

"You have 20 percent to 40 percent of patients with rheumatoid arthritis that actually don't benefit from TNF drugs, even when they are used with methotrexate," another widely used treatment, he said.

UBS Securities analyst Roopesh Patel on Monday said approval of Lonza as a supplier "removes an uncertainty," and should assure that Orencia achieves annual sales of $1.3 billion by 2010.

With the manufacturing issue resolved, Patel said Bristol-Myers will now increase its focus on also competing with Rituxan, a rheumatoid arthritis sold by Biogen Idec that is also used to treat patients that fail to benefit from anti-TNF drugs


Drug stocks closed mixed Wednesday while shares of Vertex Pharmaceuticals slid in the wake of a weakened first-quarter earnings report.
The Amex Pharmaceutical Index edged up 0.4% to close at 325.47 and the Amex Biotechnology Index fell 1.8% to 666.50.

Biotech index component Vertex slid 7% to $34.82. After market close Tuesday, the anti-viral drug developer reported a quarterly net loss of $50.1 million, or 47 cents a share. This compared to a net loss of $44.7 million, or 56 cents a share, last year.

Biogen Idec dipped as low as $42.52 before closing down marginally at $44.07.

Discovery Laboratories was on the rebound, after sinking over 50% on Tuesday on news that manufacturing problems were delaying approval of its pediatric respiratory treatment Surfaxin.
Shares of Discovery shot up 17% to close at $2.58.

Also climbing was German drugmaker Bayer AG up 3% at $43.70. The FDA awarded its drug candidate Nexavar orphan drug status in the treatment of liver cancer, meaning that if it receives approval, it will enjoy seven years of market exclusivity for that condition. Nexavar is already approved in the U.S. for the treatment of kidney cancer.
Gilead Sciences (GILD) fell 7% to close at $57.31. The HIV drug developer announced on Tuesday that it had closed on a $1.3 billion sale of convertible senior notes

US clears Genzyme drug for Pompe disease

WASHINGTON (Reuters) - The first drug to treat a rare, debilitating muscle disease that can kill infants within a year won U.S. approval on Friday, health officials said.

Genzyme Corp. (Nasdaq GENZ) developed the drug, Myozyme, to treat Pompe disease, which afflicts fewer than 10,000 people worldwide. It causes severe muscle weakness and breathing trouble that can be fatal, but the progression can vary.

If the disease emerges in infancy, it usually causes an enlarged heart and kills within a baby's first year of life. In other cases symptoms appear during childhood, adolescence or adulthood, causing progressive respiratory failure.

Pompe disease is caused by an inherited enzyme deficiency that leads to a build-up of carbohydrates in muscles. Myozyme replaces that enzyme, known as acid alpha-glucosidase.

The Food and Drug Administration said it approved Myozyme after reviewing studies of 39 patients who received their first dose at ages ranging from one month to 3.5 years. The drug was given intravenously every two weeks for up to two years.

In one test of 18 children, all survived a year and only three needed ventilators to help them breathe. One died after 14 months of treatment and another after 25 months.

Without treatment, infants are expected to live with Pompe disease 18 months at most.

FDA officials said the children's progress was substantially better than would be expected without treatment, but the drug did not return them to normal health. Their long-term prognosis is unknown.

"There are improvements in motor function, but the children still remain behind in terms of developmental milestones," said Dr. Julie Beitz, head of the FDA office that reviewed Myozyme.

The drug's label will include a boxed warning, the strongest type for prescription drugs, about the possibility of life-threatening allergic reactions, the FDA said. Three percent of 280 patients who have received Myozyme treatment have experienced significant allergic reactions, Genzyme said.

The company is studying the drug's effects in people with late-onset Pompe disease.

Genzyme's chief executive has said Myozyme could become as big a seller as the company's Cerezyme drug, which is expected to generate more than $1 billion in sales this year. Cerezyme treats a rare condition called Gaucher disease, a painful build-up of fatty deposits in certain organs and bones.

Myozyme's price will be similar to that of the company's other enzyme replacement therapies, which cost about $200,000 a year, Genzyme spokesman Bo Piela said. The drug will be shipped to pharmacies in two weeks.

The shares of Cambridge, Massachusetts-based Genzyme fell 3 cents to close at $61.16 on Nasdaq.

ITC to look at Amgen complaint on Roche drug
Tue May 9, 2006 4:14 PM ET

NEW YORK, May 9 (Reuters) - The U.S. International Trade Commission said on Tuesday it has agreed to look into a request by Amgen Inc. to prohibit Swiss drug maker Roche Holding AG from importing its experimental anemia drug Cera into the United States.

Amgen, the world's largest biotechnology company, claims that Roche's pegylated recombinant human erythropoietin (peg-EPO), which is used to boost red blood cells, violates U.S. patents Amgen holds on its anemia drug Epogen.

Amgen asked the ITC to issue a permanent exclusion order to prohibit importation of Roche's peg-EPO drug Cera into the United States.

The ITC, a federal agency that protects U.S. companies and industries from unfair trade practices, said it voted to launch the investigation based on Amgen's complaint.

The ITC said in a statement that by instituting the investigation it "has not yet made any decision on the merits of the case."

The agency said within 45 days it will set a target date for completing the investigation.

The case will be referred to an ITC administrative law judge, who will make the initial determination on whether Roche has committed a violation. The judge's finding will be subject to review by the Commission.

Cera has not yet been approved for sale in the United States or Europe. The complaint filed with the ITC was the second preemptive strike launched by Amgen, which last November filed a patent infringement lawsuit against Roche seeking an injunction preventing the manufacture or sale of recombinant human erythropoietin in the United States.

Roche has argued that its pegylated version of EPO does not infringe Amgen's patents because it is linked to a chemical that makes it last longer in the body than Epogen.

Amgen also sells Aranesp, a longer-lasting version of Epogen used to treat anemia in kidney dialysis patients and cancer patients undergoing chemotherapy.

Amgen's combined sales of Epogen and Aranesp reached nearly $6 billion last year.

Thermo Electron, Fisher Scientific in Deal
Monday May 8, 4:32 pm ET

Thermo Electron Agrees to Pay $10.6 Billion in Stock for Fisher Scientific BOSTON (AP) -- Thermo Electron Corp. said Monday it will acquire the larger Fisher Scientific International Inc. for $10.6 billion in stock, in a deal to carve out a bigger share of the laboratory supplies business by offering the market's broadest range of products.

While analysts said the 7 percent premium Thermo is offering Fisher's investors on the price of their shares is relatively skimpy, the companies said the combination will create far stronger growth prospects than either partner could expect by continuing to go it alone.

The deal pairs Thermo Electron's core business making reusable scientific instruments with Fisher's strengths in producing single-use chemical agents and other lab equipment such as glass beakers and tubing.

"If you were to use a kitchen analogy, Thermo would be supplying the appliances, and Fisher would be the supermarket," said Quintin Lai, an analyst with Robert W. Baird & Co. "Right now in the life sciences tool space, we don't have anybody that has all this under one roof."

Rivals of Hampton, N.H.-based Fisher include Becton, Dickinson & Co., Corning Inc. and VWR International, with Waltham-based Thermo competing against Agilent Technologies Inc., Beckman Coulter Inc. and Wellesley-based PerkinElmer Inc.

The pairing of Thermo and Fisher is expected to create the largest global provider of research supplies and instruments, catering to industrial customers as well as labs in faster-growing markets in the health care, pharmaceutical, and drug- and environmental testing industries.

If the companies' shareholders and U.S. and European regulators approve the deal, the combined company would have more than $9 billion in annual revenue and 30,000 employees.

Thermo -- with $2.63 billion in revenue last year to Fisher's $5.58 billion -- will assume $2.2 billion in Fisher's debt in addition to paying $10.6 billion to buy the larger company.

Marijn Dekkers, Thermo's president and chief executive, will keep both those roles as head of the combined company, which will be named Thermo Fisher Scientific Inc. after the deal's expected closure late this year. Paul Montrone, chairman and CEO of Fisher, will step down to concentrate on new business opportunities while also advising the combined company.

Paul Meister, vice chairman of Fisher, will become chairman of the new company's board, which will consist of five members nominated by Thermo and three chosen by Fisher.

The combined company will be headquartered at Thermo's offices in Waltham and maintain an office 60 miles northeast at Fisher's headquarters in Hampton.

Dekkers said in a phone interview that the deal is expected to lead to "minimal job reductions," but he declined to be more specific.

"This is all about growth," Dekkers said.

Some analysts said the companies were not overreaching with their projections that the deal will yield 20 percent earnings growth over three years and $200 million in annual cost savings within that time.

The companies expect to streamline manufacturing, sales, delivery and administrative operations. They also expect gains from cross-promoting one another's products to 350,000 customers in 150 countries, especially in emerging markets like China.

"With complementary product portfolios and strong distribution channels, we believe the combined entity will be a formidable competitor," John Sullivan, an analyst with Leerink Swann & Co., said in a research report.

Deutsche Bank's Ross Muken said the deal will create "a health care behemoth with an attractive growth profile."

Allen Michel, a Boston University professor and expert in mergers and acquisitions, said the 7 percent premium Thermo is offering Fisher's investors to convert their shares into Thermo stock pales in comparison to the 15 to 20 percent premiums typically offered in acquisitions.

While Fisher shareholders ultimately could benefit if the combined company's growth projections pan out, some may not want that risk, Michel said.

"If I were a Fisher shareholder, I'd be concerned that I'm not going to see a rate of return that is reasonable for an acquisition of this sort," he said.

Fisher shareholders will receive two shares of Thermo common stock for each Fisher share. Based on Thermo's closing price of $39.45 per share on Friday, the offer represents a value of $78.90 per Fisher share -- a 7 percent premium over Fisher's closing price of $73.73 on Friday.

Thermo's shareholders would own about 39 percent of the combined company, and Fisher shareholders about 61 percent.

Fisher's shares rose $2.22, or 3 percent, to close at $75.95 on the New York Stock Exchange after reaching a new 52-week high of $82.05 earlier in the session. Thermo's shares fell 91 cents, or 2.3 percent, to $38.54 after rising to a 52-week high of $41.85 earlier in the day.

Both companies have bought up smaller lab supply companies in recent years, and executives said the merger would leave them with enough cash to continue making acquisitions.

Meister said some of the two companies' smaller business units have discussed partnerships for years, but it was only recently that the companies discussed a merger.

Elan Reports Smaller 1Q Loss of $33.3M
Thursday May 4, 5:51 pm ET

Elan Posts Smaller 1st-Quarter Loss of $33.3M; Company Forecasts Possible Return to Profitability DUBLIN, Ireland (AP) -- Elan Corp. PLC, the Irish biopharmaceutical company whose hopes are tied to a suspended multiple-sclerosis drug, reported a smaller first-quarter loss Thursday and forecast a return to profitability if U.S. sales of Tysabri resume.

Elan said it lost $33.3 million inl;uding stock compensation expenses in the January-March quarter versus a loss of $115.6 million in the same quarter a year ago. It said sales rose 31 percent to $134.3 million from $102.7 million a year earlier.

On the Irish Stock Exchange, Elan's shares initially rose but fell back in a broadly negative market, closing down 8 euro cents (10 cents) at 11.32 euros ($14.26). The company's U.S. shares fell 20 cents, or 1.4 percent, to finish at $14.48 on the New York Stock Exchange.

Analysts say the future of the Dublin-based company depends on the return of Tysabri, a drug withdrawn from sale in the United States early last year after being linked to a rare, often fatal brain disease. The U.S. Food and Drug Administration is expected to announce by June 28 whether Tysabri sales can resume.

Both company officials and market analysts said they expect Tysabri to get the green light.

"We remain committed to making Tysabri available for patients in the U.S. and Europe and are confident that, with the financial leverage we've created over the year, revenues from Tysabri will accelerate our return to profitability," said Elan's chief financial officer, Shane Cooke.

"Once Tysabri is back on the market, momentum will return to the stock," said Ian Hunter, an analyst for Goodbody Stockbrokers in Dublin.

In November 2004 the FDA approved Tysabri for sale to the approximately 350,000 people in the United States who suffer from MS, an incurable disease of the central nervous system. Elan and Biogen Idec Inc., its U.S. partner in developing Tysabri, withdrew the drug three months later when three people taking Tysabri in clinical trials contracted the brain disease PML; two died. Both companies subsequently said they found no additional PML cases among other Tysabri users.

The suspension of Tysabri hammered Elan's shares, which fell from above 20 euros to as little as 3 pounds before mounting a gradual recovery over the past year.

On March 9, an advisory panel to the FDA voted unanimously to recommend that the agency should permit Tysabri to be sold again in the U.S., subject to new restrictions. The panel cited the drug's strong ability to help MS sufferers block the recurrence of key effects, such as sudden partial paralysis.

Cytogen Corporation has entered into a royalty buyout agreement with Berlex for Quadramet, an oncology product indicated for pain relief.

Cytogen will no longer pay Berlex a royalty on Quadramet sales in exchange for an upfront cash payment of $6 million and the issuance of 623,441 shares of Cytogen common stock at a price of $3.21 per share to Berlex.

In addition, Cytogen will also pay Berlex, sales-based milestone payments of $3.34 million and $5.01 million the first time net sales of Quadramet in the US territory reach $20 million and $30 million, respectively, in any 12-month period.

"By eliminating the previous Berlex royalty structure, this transaction will increase our gross margin for Quadramet and provide additional strategic and financial value for Cytogen and our stockholders," said Michael Becker, president and CEO of Cytogen. "The agreement also underscores our conviction in the long-term prospects for this novel therapeutic agent, which is currently being evaluated for new indications in numerous clinical studies at prestigious institutions."

Indevus Pharma credits healthier drug sales for Q2 boost
Monday May 8, 4:37 pm ET Sales for two drugs helped boost Indevus Pharmaceuticals Inc.'s sales by 55 percent in the second quarter of 2006.

The Lexington, Mass.-based pharmaceutical company said revenue was $14.4 million, up from $9.3 million in the second quarter of 2005, primarily driven by sales and royalties of Sanctura, a treatment for overactive bladder, and by sales of Delatestryl, a testosterone replacement therapy.

Indevus (Nasdaq stock symbol IDEV) received $4.3 million on product sales of Sanctura to the company's partner, Esprit Pharma. Indevus received $1 million from product sales of Delatestryl and $2.2 million in sales-force subsidy.

"We are in the midst of one of the most active periods in the history of Indevus," said Glenn Cooper, Indevus chairman, CEO and president. The company completed enrollment in both Phase III clinical trials for Sanctura XR as well as our Phase II pagoclone trial for stuttering among other trials.

The company announced it has filed a new patent application with the U.S. Patent Office covering the use of pagoclone as a treatment for premature ejaculation and intends to initiate a proof-of-concept study during the summer.