GlaxoSmithKline (GSK) and Denmark-based Genmab received some good news with the US Food and Drug Administration’s (FDA) approval for Arzerra (ofatumumab), a monoclonal antibody for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.  Arzerra is approved for cancer patients who are no longer responding to the current available treatment options using fludarabine and alemtuzumab. Following the approval, Genmab has become eligible to receive a milestone payment of DKK 116 million (approximately $23 million) from Glaxo.  Earlier, in May 2009, Arzerra had received a positive recommendation from the FDA's Oncologic Drugs Advisory Committee (ODAC) in which the panel had voted 10-3 in favor of the drug. They had found that Arzerra provided some clinical benefit to patients with CLL whose disease was refractory to fludarabine and alemtuzumab.  Arzerra has been approved by the FDA under the accelerated approval process ...

For Immediate Release

Chicago, IL – October 14, 2009 – Zacks Equity Research highlights VimpelCom (VIP) as the Bull of the Day and Rite Aid Corporation (RAD) the Bear of the Day. In addition, Zacks Equity Research provides analysis on Johnson & Johnson (JNJ), Elan Pharmaceuticals (ELN) and Gilead Sciences, Inc. (GILD).

Full analysis of all these stocks is available at http://at.zacks.com/?id=2676

Here is a synopsis of all five stocks:

Bull of the Day:

We reaffirm our Outperform recommendation for VimpelCom (VIP), Russia's second largest cellular carrier with over 25% market share. Reported earnings in the last quarter outpaced the Zacks Consensus Estimate, driven by foreign exchange gains.

We continue to be intrigued by VimpelCom's successful sales growth trend and its ability to retain subscribers on a recurring basis, even as overall economic factors remain weak. The company is also progressing

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Johnson & Johnson’s (JNJ) third quarter earnings of $1.20 surpassed the Zacks Consensus Estimate by 7 cents and by 3 cents from the year-ago period. However, the company reported revenues of $15.1 billion, a decline of 5.3% compared to the third quarter of 2008. While 2.8% of the decline in revenue was due to operational factors, foreign exchange movement was responsible for the remaining 2.5% decline. Sales in both domestic and international markets recorded declines of 8.1% and 2.5%, respectively. Johnson & Johnson’s diversified business model is helping the company pave its way through tough situations. For the second quarter in a row, the company’s medical devices segment posted higher revenues than the pharmaceuticals. While medical devices recorded an increase of 2.3% compared to the year-ago period, consumer products and pharmaceuticals recorded a year-over-year decline of 2.7% and 14.1%, respectively. While generic competition was primarily ...

The pharmaceutical industry is entering a period of substantial change in 2009. Most of the names in the industry are facing significant patent challenges in the years to come. U.S.-based firms are facing foreign exchange headwinds, as well. Revenue growth is non-existent, and earnings growth is being driven primarily by mergers, cost-cutting and share buybacks. Knowing that investors rarely pay-up for this type of manufactured earnings growth, we struggle to see a broad-based out-performance for the large-cap pharmaceutical sector in 2009.Valuations, however, are attractive, with several of the largest players trading at PEs below 10x, including: Pfizer (PFE, 7.5x), Eli Lilly (LLY, 8.1x), Merck (MRK, 8.3x), Sanofi (SNY, 7.5x), AstraZeneca (AZN, 7.6x) and GlaxoSmithKline (gsk, 9.3x) based on our fiscal 2009 estimates. Attractive valuations, along with big dividend yields, should protect investors against significant downside risk even if the economy continues ...

This morning, Acorda Therapeutics (ACOR) received a "refuse to file" (RTF) letter from the U.S. FDA regarding its new drug application (NDA) for Fampridine-SR, the company's novel therapy designed to improve walking ability in people with multiple sclerosis (MS).According to management on the conference call this morning, the FDA raised 3 issues in the RTF letter. The first issue raised by the FDA notes a "format issue" regarding the electronic common technical document (eCTD) submission and requested that some of the data in the filing be reformatted.This could be as simple as font or margin issues to as tedious as re-working a data presentation. On the conference call, CEO Ron Cohen noted the issue pertained to only a part of the filing.The FDA also asked Acorda for additional data relating to a fed/fasting study and some analytical information from the clinical program ...