All eyes are on the US Food and Drug Administration advisory panel meeting later today which will go some way to determining the future of Avandia but in the meantime, GlaxoSmithKline has signed a deal worth over $1.5 billion with the USA’s Targacept which will develop drugs for central nervous system disorders.
Specifically the two companies are hoping to discover treatments that selectively target neuronal nicotinic receptors (NNRs), using Targacept’s Pentad technology, and will focus on five therapeutic areas – pain, smoking cessation, obesity, addiction, and Parkinson’s disease. The alliance includes TC-2696, which is currently in a Phase II trial for acute post-operative pain and TC-6499, a preclinical candidate for neuropathic pain.
On the financial side, GSK will make an initial upfront payment of $35 million, $15 million of which will be used to buy nearly 1.28 million Targacept shares. The US biotechnology firm will receive up to $1.5 billion depending on development, regulatory and commercial milestones across the five therapeutic areas, as well as “tiered double-digit royalties dependent on sales achieved”.
Shares in Targacept, which was spun out of RJ Reynolds Tobacco Co in 2000, leapt almost 20% to $10.79 after the pact was announced, and chief executive Donald deBethizy said that it “validates the importance of NNRs in the potential treatment of a broad range of CNS-related disorders and diseases”. He added that through “this uniquely structured deal”, Targacept, which also has a deal with AstraZeneca for AZD3489 (formerly TC-1734), a compound in Phase IIb for Alzheimer’s disease, has retained a co-promotion option for the pain products.
FDA meeting on Avandia hours away
GSK’s shares, meanwhile, fell again ahead of the FDA committee meeting today which will discuss the thiazolidinedione class of antidiabetic drugs, and Avandia (rosiglitazone) in particular, as briefing documents from agency staff raised questions over the conflicting data relating to cardiovascular events.
The FDA will ask its advisory panel to consider whether the drug's prescribing information should be updated and whether new warnings should be added to Avandia's labelling, though some groups have been calling for a complete withdrawal of the product, a step which is highly unlikely.
Avandia’s safety profile took another bashing on Friday from new research from the UK which suggests that the GSK as well as Eli Lilly/Takeda’s Actos (pioglitazone) double the risk of heart failure, with fluid retention caused by the drugs providing the trigger. Those findings are based on a meta-analysis of more than 78,000 patients, which estimates that one in every 50 patients taking the drugs over a 26-month period will require hospital admission due to heart failure.
GSK, which has been stoutly defending Avandia ever since the now infamous article published in May in the New England Journal of Medicine which said that Avandia users run a higher risk of heart attack, claimed that the analysis “provides no new information on the risk of heart failure associated with the thiazolinediones class”.