Biotech's Latest Failed Trials, Mishaps and Missed Targets

by: The Burrill Report

The European Commission has contacted Pfizer (NYSE:PFE) as part of its antitrust investigation into patent settlements between pharmaceutical firms and generic drugmakers, according to various press accounts. Pfizer acknowledged it was among the companies involved in the probe and said it was cooperating and confident it complied with applicable laws. AstraZeneca (NYSE:AZN), GlaxoSmithKline (NYSE:GSK), Sanofi-aventis (NYSE:SNY), Novartis (NYSE:NVS), Roche (OTCQX:RHHBY), and Boehringer Ingelheim have also said they have been contacted by the Commission about drug patent settlements. The investigation is part of an effort by the EU to fight anticompetitive actions by drugmakers that it says cost healthcare providers $4.4 billion between 2007 and 2008, according to Reuters.

Charles River Laboratories (NYSE:CRL) said that it will suspend operations at its Preclinical Services facility in Shrewsbury, Massachusetts by mid-2010 and lay off 300 employees. Suspension of operations at the facility is expected to reduce operating costs by about $25 million a year. The company expects to record charges of approximately $7 million, primarily in the first quarter of 2010. The company said it intends to resume operations when global preclinical market conditions improve and the company requires additional capacity.

The Medicines Company (NASDAQ:MDCO) said it has cut 31 employees or about 10 percent of its centralized office jobs to cut costs and improve efficiency. In a filing with the U.S. Securities and Exchange Commission, the company said the reductions do not affect its customer-facing functions. As a result of the workforce reduction, the company expects to record, in the aggregate, one-time charges of approximately $4 million associated with the workforce reduction, about $3 million of which is related to employee severance and about $1 million related to the closure and consolidation of its Indianapolis site. Charges will be recognized in the first quarter of 2010. The company expects to realize estimated annualized cost savings from the workforce reduction in the range of $6.5 to $7.5 million starting in the first quarter of 2010.

The Lonza Group (OTCPK:LZAGF) said it is will eliminate 175 jobs as it shuts three manufacturing sites as part of an ongoing restructuring announced in October. The sites being closed are ones in the United States, Canada, and the United Kingdom. At the same time, the company said it is strengthening its platform in Asia as there is economic pressure on the pharmaceutical industry to reduce costs. The company said it will shut its Riverside plant in Pennsylvania in the fourth quarter of 2010 and its Shawinigan plant in Canada by the end of March. Work at the Wokingham plant in the United Kingdom will be closed and the activities will be transferred to Verviers, Belgium. The closings are part of an effort to cut nearly $60 million in costs within the next two years.

The U.S. Food and Drug Administration staff is questioning a study by the Italian pharmaceutical Recordati (OTC:RCDTF) for its experimental drug Carbaglu, a treatment of NAGS, an inherited disorder that causes ammonia to build up in the blood, Reuters reported. FDA staff noted problems with the study’s design including a lack of controls and said that clear conclusions about the effectiveness cannot be made because of the limited amount and quality of the data. The FDA will have an advisory panel review the data.