The Burrill Report


Pfizer plans to slash an additional $1 billion in annual costs over the billions of dollars already planned for research and development, The Wall Street Journal reported. The newspaper attributed its report to people familiar with the matter. The Journal says Pfizer executives are seeking to cut annual expenses by $500 million this year and a total of $1 billion in 2012. The cuts are expected to come mostly from administrative operations. They are expected to focus on duplication in administrative tasks between the company’s New York headquarters and offices elsewhere. In 2010, Pfizer had selling, informational, and administrative expenses of $19.6 billion.

The U.S. subsidiary of Belgian pharmaceutical manufacturer UCB pleaded guilty to the off-label promotion of its epilepsy drug Keppra and will pay more than $34 million to resolve criminal and civil liability arising from its illegal conduct, the U.S. Department of Justice said. Under the terms of the plea agreement, UCB pleaded guilty to a misdemeanor in connection with the company’s misbranding of Keppra, in violation of the Federal Food, Drug, and Cosmetic Act. Keppra was approved by the FDA as an anti-epileptic drug, for the treatment of seizures in adults and children suffering from epilepsy. The government alleged that UCB promoted the sale of Keppra for off-label use in the treatment of migraine by creating and distributing posters representing that Keppra was safe and effective for treating migraines based on purportedly independent investigator-initiated studies. The posters did not disclose UCB’s sponsorship of these studies or that UCB’s own clinical trial had failed to demonstrate that Keppra was effective in treating migraines.

Danish pharmaceutical manufacturer Novo Nordisk has agreed to pay $25 million to resolve its civil liability arising from the illegal promotion of its hemostasis management drug NovoSeven, the U.S. Department of Justice said. NovoSeven was approved by the U.S. Food and Drug Administration to treat certain bleeding disorders in hemophiliacs. The U.S. subsidiary of Novo Nordisk promoted NovoSeven to healthcare professionals for off-label uses, including as a coagulatory agent for trauma patients, general surgery, cardiac surgery, liver surgery, liver transplants and intra-cerebral hemorrhage, the DOJ said. The settlement resolves a whistleblower lawsuit filed under the False Claims Act.

The U.S. Department of Labor said AstraZeneca resolved a sexual discrimination lawsuit by agreeing to pay $250,000 to 124 women who were subjected to pay discrimination while working at the corporation's Philadelphia Business Center in Wayne, Pennsylvania. The lawsuit, filed in May 2010, alleged that the company discriminated against female sales specialists by paying them salaries that were, on average, $1,700 less than their male counterparts. In addition to making financial restitution, the company has agreed to work with the department to conduct a statistical analysis of the base pay of 415 individuals employed in pharmaceutical sales in several states. If the analysis concludes that female employees continue to be underpaid, the company will adjust salaries accordingly. AstraZeneca has also agreed to develop and annually update its affirmative action plan and keep all supporting documentation as required by law.

Parexel is shutting down four facilities and will shrink staff at five other facilities in its early-phase unit as the company responds to what it has described as irreversible changes in the sector, Outsourcing-Pharma.com reported. Last month the global biopharmaceutical service company said it planned to cut capacity in the unit by 30 percent. As part of the restructuring, the company is expected to eliminate about 300 jobs or 28 percent of its staff.

The U.S. Food and Drug Administration said it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin, because of increased risk of muscle damage. Merck markets simvastatin as Zocor. The agency said simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury. Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug, it said. In addition to these new limitations, FDA is requiring changes to the simvastatin label to add new instructions for when the medicine should not be used and dose limitations for using simvastatin with certain medicines.



June 10, 2011
http://www.burrillreport.com/article-report_says_pfizer_plans_to_cut_another_1_billion_in_annual_spending.html