The Burrill Report


DNA sequencing instrument maker Pacific Biosciences is laying off 130 employees, 28 percent of its workforce, the company said in a regulatory filing. The company cited “uncertainties associated with the economic environment” for its decision and said that its current infrastructure was staffed to support a faster adoption rate for its products. Although the cuts were across the organization, the company’s operations and research and development functions were most affected. As a result of the reductions, the company expects to record a restructuring charge, comprised mainly of compensation and benefits afforded to terminated employees, of approximately $5.2 million during the third quarter of fiscal 2011. The company anticipates that the actions associated with the reductions will be substantially completed during September 2011. All cash expenditures for restructuring related charges are expected to be substantially completed during 2011.

The founder and head of Servier laboratories is under investigation as authorities in France respond to public outcry over the lack of regulation in the wake of at least 500 deaths attributed to the diabetes drug Mediator, Reuters reported. Jacques Servier, president of the company, is being investigated on suspicion of dishonest practices, deception over the drug's quality, and of falsely obtaining authorization, Reuters said. Mediator, introduced in 1976, was pulled from the market in France in 2009, long after it was pulled from markets in Spain and Italy. Servier has denied wrongdoing.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended restricting use of Sanofi’s arrhythmia drug Multaq because of concerns about the safety of the drug. The agency said the drug should only be prescribed for maintaining heart rhythm in patients with paroxysmal or persistent atrial fibrillation for the maintenance of sinus rhythm after successful cardioversion. CHMP said because of an increased risk of liver, lung and cardiovascular adverse events, Multaq should only be prescribed after alternative treatment options have been considered. The agency advised patients currently taking Multaq to have their treatment evaluated by their doctor at their next scheduled appointment.

The U.S. Food and Drug Administration has notified the Indian manufacturer of active pharmaceutical ingredients Yag-Mag Labs Private Limited that because of its failure to adequately take corrective actions to problems at its manufacturing facility the agency will keep the firm under an FDA Import Alert and will continue to refuse admission of all articles manufactured by it into the United States. “Among the areas needing global attention include but are not limited to facility improvements, process validation, complete and accurate manufacturing procedures, training programs, quality unit effectiveness, and an overall effective quality system,” the agency told the firm. It has also failed to register certain products in distribution in the United States as required. The FDA told the company a previous response from it failed to correct the problems and that until the agency confirms the company is in compliance with current good manufacturing practices it may withhold approval of any new applications or supplements listing the firm as an API manufacturer.

Enzon Pharmaceuticals said that it is cutting its staff by 48 percent as part of a reorganization to cut operating costs. The company will reduce the number of its employees to a total of 47 effective June 2012. Enzon expects the reduction in force to cut its annual operating expenses by $6 million once the plan is fully implemented. The company said it expects to incur a charge in the third quarter of 2011 of approximately $3 million related to the reduction.

The U.S. Food and Drug Administration notified Immunomedics that a partial clinical hold has been placed on the company's phase 1b/2 clinical trial of clivatuzumab tetraxetan in patients with advanced pancreatic cancer because an incorrect dose had been given to a patient enrolled at one of its trial sites. The decision by the FDA was not due to safety issues of the product, but was based on a single incident in which a patient undergoing retreatment following a prior successful therapy cycle was inadvertently administered a yttrium-90 (Y-90) dose higher than prescribed, the company said. After the error was discovered, no further doses were given to the patient, who remains in the study with no critical toxicity. The company said it is preparing the requested remediation documents for the agency to ensure that the “single error by the radiopharmacy will not reoccur.”


September 23, 2011
http://www.burrillreport.com/article-pac_bio_slashes_staff_fearing_slower_than_expected_adoption_because_of_the_bad_economy.html