Best of the Blog: IN VIVO, December 2008
The best posts from the In Vivo Blog in December include: Is biotech running GSK? And the FDA's internal advisory meeting: what Avandia, Vioxx, Ketek, Elidel and Palladone have in common.
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When FDA reviewers need help on a tricky regulatory question, they get advice from top-level officials at an internal meeting called a regulatory briefing. Many sponsors don't even know they exist. But at a time of change in review procedures and staff, companies need to learn how FDA's "internal advisory committees" work.
GSK paid a very large upfront fee ($148mm) for access to Actelion's Phase III insomnia candidate almorexant, but still some were disappointed; the Big Pharma is only paying 40% of the costs of the Phase III program. The truth is that even late-stage primary care assets--especially those with novel mechanisms of action--are under intense regulatory scrutiny and licensors are having to take on more risk.
Following similar moves by many of its Big Pharma peers, GSK is buying into large molecules, big time. In December 2006, it paid $454 million in cash for next-generation antibody specialist Domantis. Later that month, the pharmaceutical firm committed over $2 billion in up-fronts, milestones, and equity for an antibody program from Genmab AS. For investors in privately held Domantis, whose most advanced drug candidate is preclinical, the acquisition was a much earlier than-anticipated exit.