In a major disappointment for Spectrum Pharmaceuticals (SPPI), the US Food and Drug Administration (FDA) last week refused to approve the company’s supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) in its current form. The company was seeking approval for the treatment of patients with advanced metastatic colorectal cancer. Following the news, the shares plummeted 18% on Friday.

Spectrum received a Complete Response Letter (CRL) from the FDA, in which the agency stated that the Fusilev data did not confirm the drug’s non-inferiority to leucovorin. Spectrum Pharmaceuticals plans to request a meeting with the agency to discuss the future course of action. The drug is currently approved by the FDA as a treatment option after high dose of methotrexate therapy in patients with osteosarcoma, a type of bone cancer.

Earlier in September, the company raised $50 million in a registered direct offering of shares and warrants priced at $7.55. We believe

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In a major breakthrough, Allos Therapeutics (ALTH) received FDA-accelerated approval for Folotyn (pralatrexate injection) last week.

The company was seeking approval of the drug for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn becomes Allos' first drug to receive FDA approval.

While the drug will be available to patients within a month, the commercial launch is scheduled for January 2010. Allos is increasing its sales force from the current level of 25 to 50, and doing the necessary preparations for its launch.

Allos has agreed to conduct additional clinical trials to further verify the benefit of Folotyn. The requirement of additional trials comes with accelerated FDA approval as the agency requires further studies after the launch to confirm the drug's benefits to patients.

Earlier this month, Folotyn received a favorable recommendation from the FDA advisory panel, which voted 10-4 in favor of the drug along with stating

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We are awaiting the US Food and Drug Administration’s (FDA) decision regarding Allos Therapeutics’ (ALTH) lymphoma drug Folotyn. The company, which is seeking approval of Folotyn for the treatment of relapsed or refractory peripheral T-Cell lymphoma (PTCL), was assigned a Prescription Drug User Fee Act (PDUFA) date of Sept. 24.

We are optimistic about the approval of Folotyn based on the FDA advisory panel’s favorable recommendation earlier this month. The board voted 10-4 in favor of the drug and said that new treatments were required for the disease.

However, we are still wary as the studies conducted by Allos did not record robust data. The number of patients who responded to the treatment was rather low (27% of 115 patients) with the majority of them responding only partially. Moreover, effect of the treatment lasted for less than 14 weeks in more than half of these patients. The panel

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Yesterday, the US Food and Drug Administration’s (FDA) panel came out with a favorable recommendation regarding the approval of Allos Therapeutics’ (ALTH) lymphoma drug Folotyn (pralatrexate). The company is seeking approval of Folotyn for the treatment of relapsed or refractory peripheral T-Cell lymphoma (PTCL). Although the FDA is not required to follow the panel’s advice, it generally does so. The agency is supposed to take a final decision on the drug by Sept 24.

The FDA panel voted 10-4 in favor of the drug along with stating that new treatments are required for the disease. Studies conducted by the company did not record robust data. The number of patients who responded to the treatment was quite less (27% of 115 patients) with majority of them responding only partially. Benefit of the treatment lasted for less than 14 weeks for more than half of the responding patients. The panel voted in

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On Friday, Trubion Pharmaceuticals, Inc. (TRBN) agreed to jointly develop and commercialize TRU-016 globally with Facet Biotech Corp. (FACT).  TRU-016 is undergoing early-stage studies for chronic lymphocytic leukemia (CLL).   The deal requires Facet to make a $20 million upfront payment to Trubion coupled with an additional $176.5 million on the achievement of certain milestones. Further, Facet has agreed to buy 2.24 million shares of newly issued Trubion common stock for $10 million. The companies have agreed to contribute equally towards costs related to development, commercialization and promotional activities. All global operating profits will be shared equally.   The TRU-016 program is focused on the development of a novel CD37-targeted therapy for B-cell malignancies, such as Non-Hodgkin's lymphoma (NHL) and CLL. CD37 is a clinically validated target for the treatment of B-cell malignancies and TRU-016 has been designed for a desired therapeutic label surrounding B-cell depletion in these

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On July 7, 2009, Celgene International Sàrl, the Swiss unit of biopharmaceutical company Celgene Corp. (CELG) filed  a New Drug Application (NDA) with the Japanese Ministry of Health, Labor and Welfare (MHLW) for Revlimid in combination with dexamethasone for the treatment of multiple myeloma (MM) patients with at least one prior therapy. The filing was based on the safety and efficacy results of two late-stage trials – the North American trial MM-009 and the International trial MM-010 which evaluated Revlimid plus dexamethasone in MM patients with at least one prior therapy. The studies were published in the New England Journal of Medicine in November 2007. The Revlimid–dexamethasone combination for the treatment of MM patients with at least one prior therapy is already approved in nearly 50 countries worldwide. Revlimid was granted orphan drug status in Japan in February 2008 for deletion 5q myelodysplastic syndromes (MDS) as ...

Sanofi-Aventis (SNY) posted EPS of e5.36 in 2008, an increase of just 2% from 2007. Revenue fell 1% in 2008 as a number of products experienced significantly declining sales including Ambien, Tritace and Copaxone.For 2009 we expect revenue growth to return, as generic erosion is more than offset by strong growth of Taxotere, Lantus, Avapro and the vaccines business. We expect revenue growth of 6% in 2009 and EPS of e5.93 ($4.10), up 11% from 2008. EPS should continue to benefit from strong contributions to royalty income from U.S. Plavix sales and operating margin improvement as a result of cost-cutting. We also expect foreign exchange to benefit both revenue and EPS in 2009 as the U.S. dollar strengthens against the Euro.Generic competition will continue to be a concern, however. While we expect new product launches to make significant revenue contributions in the ...

Surge of CTIC on PIX301 Trial Data: Sustainable?Pixantrone is more efficacious than comparators but with safety concernsYesterday afternoon (June 1), Cell Therapeutics, Inc. (CTIC) presented updated final results of its pivotal phase III EXTEND (PIX301) trial of Pixantrone in relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) at the 2009 American Society for Clinical Oncology (ASCO) Annual Meeting held in Orlando, Florida.The PIX 301 EXTEND trial was a phase III single-agent trial of Pixantrone for patients with relapsed or refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either Pixantrone (N=70) or another single-agent drug (N=70) currently used for the treatment of this patient population and selected by the physician.Efficacy data encouragingThe efficacy data were encouraging. Patients treated with ...

We highlight Sanofi-Aventis SA (SNY) and Biogen Idec Inc. (BIIB).Sanofi-Aventis SA (SNY) posted EPS of EUR5.36 in 2008, an increase of just 2% from 2007. Revenue fell 1% in 2008 as a number of products experienced a significant decline in sales including: Ambien, Tritace and Copaxone.However, for 2009 we expect revenue growth to return as generic erosion is more than offset by strong growth of Taxotere, Lantus, Avapro and the vaccines business. We expect revenue growth of 6% in 2009 and EPS of EUR5.89 ($3.90), up 10% from 2008.EPS should continue to benefit from strong contribution to royalty income from U.S. Plavix sales and operating margin improvement as a result of cost-cutting. We also expect foreign exchange to benefit both revenue and EPS in 2009 as the U.S. dollar strengthens against the Euro.Generic competition will continue to be a ...

For Immediate Release

Chicago, IL - April 28, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Dynavax Technologies Corp. (DVAX),Skyworks Solutions, Inc. (SWKS), Wilmington Trust Corp. (WL), Micromet Inc. (MITI) and Embraer (ERJ).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Monday's Analyst Blog:

Dynavax Surge Not Warranted

In early morning trading, Dynavax Technologies Corp. (NASDAQ: DVAX) shares shot up dramatically (36%). However, we don't see a clear reason for that.

The surge may be related to two pieces of news: phase III Heplisav data and the swine

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