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Safety concerns for anti cancer agent
Pharma companies Eli Lilly and Bristol-Myers Squibb have announced that one of their two joint global Phase III trials of necitumumab, an investigational anti cancer agent for the treatment of advanced non-small cell lung cancer (NSCLC) have stopped enrolling patients.
The Inspire trial is looking at the addition of necitumumab – a monoclonal antibody – to two chemotherapy drugs Alimta (pemetrexed) and cisplatin, compared to a control of just cisplatin and Alimta as a first-line treatment for patients with advanced nonsquamous NSCLC.
The decision to stop enrolment came after safety concerns arose relating to blood clots in the experimental arm of the study. Necitumumab is still being studied in a second Phase III trial named Squire in combination with Gemzar (gemcitabine) and cisplatin for the treatment of squamous NSCLC. But no safety concerns for this trial have been raised.
Valeant to acquire rights to Zovirax
Biovail Laboratory International (BLS), subsidiary of multinational pharma company Valeant Pharmaceuticals International, has signed an agreement to acquire US and Canadian rights to non-ophthalmic topical formulations of Zovirax from GlaxoSmithKline (GSK) for $300 million (£186 million).
It is hoped that the deal, which is subject to customary closing conditions, will increase profitability of the brand for BLS. ‘We believe that our sales and marketing organisations in the United States and Canada have the ability to revitalise the brand,’ said BLS chief executive Michael Pearson.
GSK to sell stake in Quest
Pharma giant GSK has announced it has sold all its shares in Quest Diagnostics. GSK originally acquired the shareholding as part of a deal to sell its clinical laboratories business in 1999, and has been gradually reducing its stake in stages since.
In other news, in its fourth quarter financial report, GSK has announced that it will buy back shares again. In 2011, as part of a new long-term share buy-back programme GSK expect to repurchase £1-2 billion of shares, depending on market conditions.
Public rat genome database
Sigma Life Science, the biological products and services business of Sigma Aldrich, has teamed up with Cofactor Genomics in order to sequence six genomes of the most widely used strains of rat.
Cofactor Genomics is set to generate and analyse sequence data using next-generation sequencing techniques, while Sigma will provide the samples and host a new, free public database in late 2011 that will include genomic information and analysis tools.
The Brown Norway is the only strain of rat with a high quality draft sequence available at present, but it does show that the rat has nearly every gene implicated in human disease.
Additional genome sequences provided by this collaboration should therefore develop improved models of human disease for the research community, and a publicly available database will help researchers pinpoint the crucial areas of biological difference between rats and humans.
Solutia to sell rubber chemicals business
Performance materials and speciality chemicals company Solutia has announced that it has sold its dithiocarbamates and tetrabenzylthiuram disulfide businesses to Performance Additives Europe, a subsidiary of Behn Meyer Chemical Holding for $26 million.
Solutia’s products help control the process of manufacturing rubber while improving its durability, flexibility and appearance. ‘These divestitures support our strategy to focus on high value, global market leading performance materials and speciality chemicals,’ said Greta Senn, general manager of Solutia’s technical specialities division.
FDA concern over Contrave
The US Food and Drug Administration (FDA) has raised concerns about Contrave (naltrexone/bupropion) extended-release tablets for the treatment of obesity. The drug developed by Orexigen Therapeutics and Takeda Pharmaceutical was submitted for US regulatory approval in March 2010.
The FDA has noted concern about the cardiovascular safety profile of the combination drug, when used long-term in a population of overweight and obese patients.
Contrave was studied for its ability to help people with obesity initiate and sustain weight loss of at least 5 per cent of their starting body weight in one year. The FDA has told Orexigen and Takeda: ‘Before your application can be approved, you must conduct a randomised, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major cardiovascular events in overweight or obese subjects treated with naltrexone/bupropion does not adversely affect the drug’s benefit-risk profile.’