- 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.