Each week, "The Pink Sheet" presents commentary on some of the week's most interesting business deals, contributed by the editors of the In Vivo blog. Visit the blog at ¹ http://invivoblog.blogspot.com/ .

GlaxoSmithKline/Cellzome: GSK has entered into an option agreement with Anglo-German biotech Cellzome around seven kinase inhibitor programs in the area of inflammation, the companies announced Sept. 10. Though the deal generated several hyperbolic wire story headlines, the guaranteed payments (about $25 million in equity purchases and cash, split undisclosed) were rather more pedestrian. More importantly, the deal has some interesting features and further underscores the externalization of R&D at GSK under new chief Andrew Witty.

Cellzome is essentially becoming GSK's center of excellence in kinase drug discovery, at least in the inflammation space, Cellzome CEO Tim Edwards told In Vivo Blog Sept. 11. GSK has an option to license - at clinical proof-of-concept or earlier - drug candidates from programs in four target areas (which very likely are the previously announced programs for mTOR, Zap-70, PI3K delta and JAK3) and an additional three targets.

Edwards noted the deal does not include Cellzome's lead PI3K gamma program, for which the company hopes to file an IND in 12-18 months. Until such time as GSK opts into a project, Cellzome is footing the R&D bill. However the biotech can earn milestone payments along the way that will cover those costs, and keeps rights to programs that GSK declines. "We have day-to-day control," explains Edwards. "They're sponsoring us, as it were, and as we make achievements we bring in additional dollars."

Cellzome previously inked a handful of deals around its proteomics mapping platform and out-licensed Alzheimer's programs to J&J, but this deal is the first for its Kinobeads technology. That platform allows the firm to screen for kinase inhibitors in a "physiological setting." Edwards claims this means it can identify very selective inhibitors of individual kinases. "In oncology you can hit four or five targets" without compromising the safety/efficacy profile of a kinase inhibitor. "But that isn't okay in inflammatory disease, and the solution is to have very selective inhibitors. It's amazing how you can change a molecule in a very small way and change its selectivity profile in a profound way," he says.

Optioning nearly all its programs to one partner in its chosen (and crowded) field of kinase discovery suggests that GSK is the private firm's only potential suitor, however, significantly limiting Cellzome investors' exit options (the company has raised at least €73 million [$104 million]) since 2000 from a variety of venture capital firms). "Today that may be the case," says Edwards, but perhaps not for long. Cellzome aims to reconfigure its screening platform for other target classes and is diversifying out of inflammatory disease and potentially into other central nervous system therapeutic spaces. And then there is the PI3K gamma program. For now, Edwards is keeping the details of that program under wraps.

Alfama/hemoCORM: Alfama and hemoCORM, two companies pursuing the use of carbon monoxide releasing molecules (CORMs) in a variety of chronic and acute diseases, merged last week. Terms were undisclosed. Both Alfama and hemoCORM are investigating metal carbonyls, one of the first types of compounds identified as a potential CO-carrier. hemoCORM initially is focused on ischemic perfusion injury, while Alfama is working primarily on treatments for inflammatory and auto-immune disease. Alfama chief Nuno Arantes-Oliveira will lead the combined group.

CV Therapeutics/Menarini: CV Therapeutics licensed European, CIS and certain South and Central American rights (27 countries in all) to its recently approved Renaxa (ranolazide) to Menarini. The Italian pharma will pay CV $70 million in upfront payments plus a potential $315 million in milestone payments and investments linked to European label extensions and sales figures. The angina treatment has been marketed in the U.S. by CV since January 2006; the firm currently aims to secure approval in a first-line angina setting.

Amgen/potential denosumab partner: Amgen CEO Kevin Sharer says that a U.S. partnership around denosumab is unlikely (though things might be different overseas). "It is very hard for me to imagine what another company would bring to us," in North America, Dow Jones reports Sharer saying at the Morgan Stanley health care conference Sept. 9. Maybe Sharer needs to watch a little Sesame Street to get those imaginative juices flowing.

Let us help out: a worldwide or U.S. partner on denosumab would not only bring Amgen a significant upfront payment, primary care expertise, and drug reps, but also a big hedge against the risk that the product will be delayed or even fail. Doctors who are worried about denosumab getting inadequate reimbursement are asking Amgen for assurance of financial protection in the event Medicare does not cover the full cost of the drug (² Also see "Denosumab Uptake Could Depend On Abating Physicians’ Financial Risk" - Pink Sheet, 8 September, 2008., p. 23).

- Windhover Biopharma Team

GSK Continues R&D Externalization With Option To License Kinase Inhibitors

More from Archive

More from Pink Sheet