Monday, January 11, 2010

Notes from JPMorgan: Gilead's Combos

HIV powerhouse Gilead Sciences reminds us of a razor company. Just when you're getting used to a three-drug combination, here comes Mach Four. In Gilead's case, it's the "quad" pill, a combo of four Gilead drugs: Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine) -- marketed as the fixed-dose combination Truvada -- plus the experimental integrase inhibitor elvitegravir and the booster GS9350. Gilead will start advanced trials for the quad this year, which investors here at JP Morgan focused on in the company's Monday morning session.

Gilead COO John Milligan cautioned that if the quad comes to market patients won't switch wholesale from Gilead's current three-in-one pill Atripla, which combines two Gilead drugs and Sustiva (efavirenz) from Bristol-Myers Squibb, the first ever fixed-dose HIV combo with products from two different companies. Gilead of course would prefer to be the sole provider of all the components, or as Milligan put it, "The economics of the 'quad' would flow to us."

In a packed interview room, Milligan did what he reasonably could to prime the pump, highlighting some of the drawbacks of Atripla. ("Less appropriate for women," for example, he said, and the Sustiva portion of it has worrisome central-nervous-system related side effects, especially among African-Americans.)

But Gilead has other fixed-dose partners on the horizon. It's working to combine Truvada (again) with J&J/Tibotec's rilpivirine (TMC 278), a non-nucleoside reverse transcriptase inhibitor. (Tibotec is running a Phase 3 trial.)

Beyond HIV, keep an eye on the company's hepatitis B partnership in Asia with GlaxoSmithKline. Last November the firms said Glaxo would get marketing rights for tenofovir to treat Hep B in China and that a deal for Japan was forthcoming. Prompted by a question from Raymond Schinazi, one of the Emory University researchers who discovered emtracitabine, Milligan said Monday that Gilead and Glaxo were in talks to combine the firms' drugs in Asia. A fixed-dose combination of two companies' products for HBV would be a first, as far as we can tell.

The companies also have adefovir dipivoxil (Gilead) and lamivudine, a.k.a. 3TC (Glaxo), so any combo would presumably come from that pool. When asked to elaborate, a Gilead spokeswoman noted the two companies' HBV portfolios but told the In Vivo Blog that Milligan "wasn't speaking of anything specific."

(Creative commons image courtesy of flickr user Julian Holtom.)

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