Best of the Blog: IN VIVO, December 2008
Executive Summary
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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Regulatory Briefings: FDA's "Internal Advisory Committees"
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/Actelion: Phase III Value Is in the Eye of the Beholder
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.
GlaxoSmithKline Breaks Out of Its Small-Molecule Mind-Set
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.