AstraZeneca to Ax 8,000 More Workers: Biotech's Latest Mishaps

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Includes: AZN, GSK, INVA, PFE, SEPR, SPPI
by: The Burrill Report

AstraZeneca (NYSE:AZN) said it will eliminate an additional 8,000 jobs or about 12 percent of its workforce as it seeks to cut costs in the face of declining revenue and lowered its forecast for 2010. The announcement came as the company reported earnings that fell short of expectation. The company said the next five years will be difficult as key products come off-patent. AstraZeneca expects to save $1.8 billion a year as a result of the cuts by 2014, but would take a $2 billion restructuring charge. It also announced it would buy back up to $1 billion worth of its own stock.

Pfizer (NYSE:PFE) said it has withdrawn its application with the U.S. Food and Drug Administration to expand indications for its pain drug Lyrica to include the adjunctive treatment of generalized anxiety disorder. Lyrica is approved to treat epileptic seizures, fibromyalgia and nerve pain. The decision came as part of an overhaul of Pfizer’s product pipeline in the wake of its acquisition of Wyeth. The company announced it was discontinuing 100 development programs. Click here for more.
Spectrum Pharmaceuticals (NASDAQ:SPPI) said that it has met with the U.S. Food and Drug Administration regarding its supplemental application to market its experimental injectible drug for colorectal cancer that has spread. The FDA in October told the company it wanted more data on Fusilev (levoleucovorin) before it would approve the drug. The Irvine, California-based company expects to submit the data in the third quarter of 2010. The FDA did not request any additional efficacy studies.
Spectrum Pharmaceuticals said it has terminated its development program for Ozarelix, an experimental drug to treat benign prostate hypertrophy or BPH. The company said the decision will allow it to save $40 million in clinical trials and other related costs. The company said those funds will be used to advance other programs that have the greatest likelihood of commercial success in providing patients with more effective treatment options. Spectrum said the move was part of an effort to streamline and prioritize its portfolio. Ozarelix, a luteinizing hormone-releasing hormone antagonist, was in late stage trials for the treatment of benign prostatic hypertrophy. However, the mixed results of the company's earlier mid-stage study and the recently announced failure of AEterna Zentaris's (NASDAQ:AEZS) large, late-stage, registrational trial of cetrorelix (another LHRH antagonist) in BPH did not support continued development in this indication.
Sepracor (SEPR) said the U.S. Food and Drug Administration now anticipates completing its review of its application to market its experimental drug Stedesa (eslicarbazepine acetate) on April 30, three-months later than originally expected. The delay follows additional data the Marlborough, Massachusetts-based company’s submitted in response to a request from the agency in November. Stedesa is a novel, voltage-gated sodium channel blocker to treat patients who suffer from epileptic seizures.
A study by researchers at Pfizer is raising questions about rival GlaxoSmithKline’s (NYSE:GSK) anti-aging drugs in development, Forbes reported. In the Journal of Biological Chemistry, Pfizer scientists say that resveratrol and other drugs developed by Sirtris Pharmaceuticals, GSK’s $720 million acquisition in 2008, fail to hit their intended SIRT1 enzyme. They say earlier findings may be due to “an experimental artifact.” Researchers at Amgen (NASDAQ:AMGN) announced similar findings in 2009. In 2007 Sirtris reported that its compound SRT1720 lowered blood sugar in diabetic mice. But Forbes says when Pfizer researchers tried to repeat the experiment, low doses of the experimental drug had no effect on blood sugar and the mice gained weight. High doses of the drug, they say, killed three of eight mice.
Theravance (THRX) said the U.S. Food and Drug Administration notified it that the company’s response to the agency’s request for additional data for its application to market telavancin as a treatment for nosocomial pneumonia is still incomplete. In November 2009, the agency requested additional data on telavancin, a bactericidal, once-daily injectable investigational antibiotic for the treatment of NP caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus or MRSA. The drug, marketed as Vibativ, is approved in the United States and in Canada for the treatment of adult patients with certain complicated skin and skin structure infections. The FDA letter noted that, "While we acknowledge that additional mortality data and analyses have been provided to support pooling the two phase 3 clinical trials, even if this is acceptable, the two pooled studies would equate to only one adequate and well-controlled trial and would not constitute substantial evidence of efficacy. The adequacy and similarity of populations across studies for the purposes of pooling has not yet been determined, and is a review issue." The FDA encouraged Theravance to request a meeting to discuss the issues. However, there was no guidance provided regarding the primary clinical efficacy endpoint suitable for approval, the size or number of additional studies required, or statistical methods for evaluation of clinical results.