The Zacks Analyst Blog Highlights: Celgene, Onyx Pharmaceuticals, Medivation, Targacept and Eli Lilly

Feb 12, 2013, 09:30 ET from Zacks Investment Research, Inc.

CHICAGO, Feb. 12, 2013 /PRNewswire/ -- 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 Celgene Corporation (Nasdaq:CELG), Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX), Medivation, Inc. (Nasdaq:MDVN), Targacept, Inc. (Nasdaq:TRGT) and Eli Lilly and Company (NYSE: LLY).


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Here are highlights from Monday's Analyst Blog:

U.S. Approval for Celgene's Pomalyst

The US Food and Drug Administration (FDA) recently delivered encouraging news to Celgene Corporation (Nasdaq:CELG) by approving the company's oncology drug, Pomalyst.

Pomalyst was approved in the US in combination with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma (MM) patients, who have received at least 2 prior therapies. Pomalyst has been approved to treat patients whose cancer has worsened on or within 60 days of the last medication.

We remind investors that Celgene had filed a new drug application (NDA) with the FDA seeking approval for Pomalyst last year. The FDA had granted standard review (10 month review period) to the NDA for Pomalyst for the MM indication. The US regulatory body cleared the drug a couple of days before the assigned target date of Feb 10, 2013.

The FDA approval for Pomalyst came on the back of encouraging data from a phase II study (MM-002) on the candidate. Furthermore, in Dec 2012, the company announced encouraging data from the international phase III study (MM-003), which evaluated Pomalyst as a combination therapy in relapsed refractory multiple myeloma patients. The patients did not respond favorably to Takeda's Velcade and Celgene's Revlimid, administered either as a monotherapy or in conjunction with other therapy/ies. Data revealed that there was significant improvement in progression-free survival and overall survival in patients in the Pomalyst arm.

The approval of Pomalyst has further boosted Celgene's already strong oncology product portfolio and should augment its top line as the MM market offers significant commercial potential. We remind investors that the FDA had approved another drug in the MM space last year – Onyx Pharmaceuticals, Inc.'s (Nasdaq:ONXX) Kyprolis.

Celgene, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Biopharma stocks, such as Medivation, Inc. (Nasdaq:MDVN) and Targacept, Inc. (Nasdaq:TRGT) presently appear to be more attractive. While Medivation carries a Zacks Rank #2 (Buy), Targacept carries a Zacks Rank #1 (Strong Buy).

Update on Lilly's Tabalumab

Eli Lilly and Company (NYSE: LLY) recently provided an update on its rheumatoid arthritis candidate, tabalumab. The company said that it intends to discontinue its phase III rheumatoid arthritis program for the candidate.

However, Eli Lilly will continue developing tabalumab for systemic lupus erythematosus. ILLUMINATE, the phase III program for the lupus indication, will continue as planned.

We note Eli Lilly had scrapped a pivotal phase III study being conducted with tabalumab in Dec 2012. Tabalumab, an anti-BAFF monoclonal antibody, was being evaluated in the FLEX-M study for the treatment of moderate-to-severe rheumatoid arthritis in patients who have not responded adequately to methotrexate therapy.

The company's decision to halt the study was based on a planned interim futility analysis which showed insufficient efficacy.

Given the disappointing FLEX-M findings, Eli Lilly conducted an interim futility analysis of FLEX-V, another study being conducted with tabalumab on patients suffering from moderate-to-severe rheumatoid arthritis who did not respond sufficiently to one or more tumor necrosis factor (TNF) inhibitors.

Based on the interim futility analyses of these studies, Eli Lilly decided to discontinue the development of tabalumab in the ongoing rheumatoid arthritis program.

Eli Lilly expects to record a charge of about $50 million in the first quarter of 2013 due to the discontinuation of the rheumatoid arthritis program.

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