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TRIALS AND TRIBULATIONS

Novartis Threatens to Pull R&D from the U.K.

The weekly round-up of failed trials, missed targets, and other business mishaps.

The Burrill Report

Novartis told U.K.’s National Health Service that it needs to improve the process in the United Kingdom for approving and adopting the use of new medicines or the company will decrease investments and cut jobs in the country. Novartis CFO Jon Symonds delivered the message at a meeting where he urged the NHS to move faster in helping to arrange clinical trials and granting approvals. “One of the characteristics of the U.K. is a very low up-take on innovation,” said Symonds told The Daily Telegraph. “If we don’t see the up-take in the UK resources will be allocated elsewhere…the placement of research is increasingly globally competitive; we can and must make choices over where we invest.”

Just three weeks after Ranbaxy Pharmaceuticals recalled more than three-dozen lots of generic Lipitor found to contain small glass particles, the company is now halting all production of the drug until it completes a thorough investigation of why the contamination occurred. The company has said that it has already taken steps to remedy the contamination and the U.S. Food and Drug Administration believes the chance of patient harm due to the contamination to be low. “Based on the information from Ranbaxy and from the FDA’s initial assessment, the possibility for adverse events related to the recalled produce appear to be low, and if any adverse events are experienced, they would be temporary,” the FDA says in a statement. The news comes at a difficult time for Ranbaxy, as it is dealing with a consent decree for a permanent injunction that prevents the company from making medicines for the U.S. market until its facilities meets U.S. standards.

The U.S. Federal Trade Commission has filed a brief supporting Mylan Laboratories and its lawsuit charging Warner Chilcott with illegally interfering with Mylan’s attempts to sell a generic version of Chilcott’s antibacterial drug Doryx. Mylan initially filed the suit in July, alleging that Warner Chilcott utilized a concept called product switching or product hopping to delay Mylan’s entrant in the market. Product hopping is when a brand-name drugmaker makes modest reformulations that effectively offer little or no therapeutic advantages, but causes competing generic drugmakers to reformulate their copycat versions. In the FTC’s brief the commission said that “a brand name company can interfere with the mechanism by which generic drugs compete by making modest non-therapeutic changes to its product, and effectively prevent generic competition, not because the reformulated product is preferred by consumers, but simply because it is different.”

GlaxoSmithKline said it is planning a change in the focus and organizational structure of its Melbourne, Australia pharmaceutical division. The restructuring will result in the reduction of about 90 positions from its pharmaceuticals business, but will not impact manufacturing. Geoff McDonald, GSK’s general manager of pharmaceuticals, said the job cuts came as a result of difficult conditions in the Australian market. “Funding for medicines is currently very challenging in Australia,” said McDonald.

A U.S. Food and Drug Administration panel voted 9-6 against recommending approval of a new indication for hospital-acquired pneumonia for the skin infection drug, Vibativ. FDA reviewers raised serious questions about the drug’s toxic effect on the kidneys. One of the two late-stage clinical trials found a substantially higher risk for death in the Vibativ group compared with the group that took Vancomycin, an active comparator in the study. But, despite the worries, most panelists on FDA’s Anti-Infective Drugs Advisory Committee agreed that Vibativ should be approved, with the significant caveat that it only be used in hospital-acquired pneumonia patients with methicillin-resistant staphylococcus who have creatinine clearance.


November 29, 2012
http://www.burrillreport.com/article-novartis_threatens_to_pull_rd_from_the_u_k_.html

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