It is being reported that GlaxoSmithKline has agreed to pay around $60 million to settle some 700 lawsuits brought by patients who claimed the firm’s diabetes drug Avandia caused heart attacks and strokes.
The company is remaining fairly tight-lipped about an article by Bloomberg which says the company has resolved cases filed by three attorneys. Around 4,000 lawsuits concerning Avandia (rosiglitazone) have been filed so far, and the first trial to go to court is scheduled for July.
GSK spokeswoman Bernadette King reportedly sent an email to the news agency saying that the company is “confident that when courts and juries look at actual clinical data, the manner in which we communicated with the US Food and Drug Administration and physicians and our openness in posting studies on our website, the facts will support our position”. She added that “GSK stands by Avandia and is fully prepared to defend any litigation”. Announcing its first-quarter results recently, GSK noted that it had upped the reserves put aside for various litigation by £210 million.
Avandia has been at the centre of controversy ever since the publication in May 2007 of a meta-analysis in the New England Journal of Medicine which warned of the possible cardiovascular risk of the drug. Apart from the various lawsuits being filed, the FDA has been considering the safety of Avandia and an advisory committee will be held in July.
Some observers, including certain senators in the USA, have called for a withdrawal of the drug, and if that happened, analysts have suggested another raft of lawsuits could follow.
GSK expands in emerging market of South Korea
Meantime GSK has entered into an alliance with Dong-A Pharmaceuticals Co, “the number one pharmaceutical and over-the-counter company in South Korea”.
As part of the deal, the UK drugs major will acquire a 9.9% stake in Dong-A for £73.9 million and the firms will co-promote selected products from their combined portfolio for use in primary care. Last year, Dong-A posted sales of £414 million, compared to GSK Korea’s £225 million; the latter is the country’s fifth biggest drugmaker.
Christophe Weber, regional director of Asia Pacific for GSK said the deal “presents a significant opportunity” for the firm to “extend its commercial footprint and build operational scale in this fast-growing Asian market”. President of Dong-A, Won-Bae Kim, said “we have built an excellent win-win alliance [and] will enable us to accelerate our transformation into a true global player”.
The Korean pharmaceutical market has consistently enjoyed double-digit growth and in 2008, was the 13th largest in the world. IMS data suggest it is forecast to grow by approximately 10% through to 2012.
Cancer theranostic deal with bioMerieux
Finally, GSK is teaming up with France’s bioMerieux to develop a new molecular test, or theranostic to aid oncologists choose the most appropriate treatment for skin cancer.
The Marcy l’Etoile group says that the new assay is intended to detect mutations in the B-Raf gene and will be used on Phase II and III metastatic melanoma patients to test their eligibility for treatment with GSK’s B-Raf or MEK inhibitor compounds.
Noting that mutations in the B-Raf gene are also found in thyroid, ovarian and colon cancers, the two companies say they bring complementary expertise to the project – GSK has “extensive experience in oncology and clinical evaluation” and bioMerieux’ will develop and seek regulatory approval of the test.
The pact could lead to a “companion test that could drive personalised treatment”, said Richard Ding, bioMérieux’s theranostics chief. He added that “what makes this test unique is that it targets a critical part of a tumor growth factor signalling pathway and can be applied to a number of drug candidates in development”.
GSK and bioMerieux have a separate, ongoing collaboration to develop a test for breast cancer patient stratification which they signed in November 2009.
