The Burrill Report


The European Medicines Agency said it has been notified by Merck Serono Europe that it is withdrawing its application for a centralized marketing authorization for its experimental oral multiple sclerosis drug Movectro. Movectro was intended to be used for the treatment of relapsing-remitting multiple sclerosis. In January, the Committee for Medicinal Products for Human Use issued an opinion for a second time that Movectro not be approved. The company stated that its decision to withdraw the application was based on the committee’s opinion that the data available to date did not allow it to adopt a positive opinion recommending the granting of a marketing authorization for Movectro.

Merck said today it was unable to find a buyer for its MSD Organon research and development unit in the Netherlands, M&A Navigator reported. Merck delayed closure of the plant as it considered alternatives including a sale of the unit. Though there were talks with potential buyers, no deal resulted. M&A Navigator said Aspen Pharmacare, Takeda, and Dutch bioscience firm Pantarhei reportedly submitted bids for parts of the unit. The company said Organon’s drugs and biologics business would remain a core part of the group.

The U.S. Food and Drug Administration said that Depomed will need to provide additional information on its newly approved pain drug Gralise before it can grant it orphan drug status. The company announced the development in a filing with the U.S. Securities and Exchange Commission. Gralise is a once-daily formulation of gabapentin for the management of postherpetic neuralgia developed by Depomed and licensed to Abbott Products in the United States, Canada, and Mexico. The FDA previously granted Gralise orphan drug status for the managment of postherpetic neuralgia, but since notified the company that additional submissions or evidence to demonstrate the clinical superiority of Gralise based on improved safety will be required to be provided to the FDA to obtain a seven year period of market exclusivity as a result of the orphan drug designation. G. Steven Burrill, publisher of The Burrill Report, is a member of the Depomed board.

The office of the U.S. Attorney for the District of Massachusetts has served Novo Nordisk with a subpoena calling for the production of documents regarding potential criminal offenses relating to the company's marketing and promotion practices. The company said the office is seeking documents relating to its products NovoLog, Levemir, and Victoza. Novo Nordisk said it will cooperate with the US Attorney in this investigation.

Inspire Pharmaceuticals said it would eliminate 65 positions or more than a quarter of its workforce as part of a restructuring designed to focus its efforts on its eye care business. The job cuts represent a 45 percent cut to non-salesforce positons. The company said the restructuring is estimated to result in a more than $40 million reduction in 2011 non-cost of sales operating expenses, excluding restructuring charges, as compared to 2010.


February 17, 2011
http://www.burrillreport.com/article-merck_serono_withdraws_emea_application_to_market_oral_ms_drug.html