Regulatory "sword of Damocles" dangles over two big AZ drugs

AstraZeneca is bracing itself for big news on two key fronts over the next few days. On Wednesday the FDA will hit its deadline for deciding on Brilinta, its blockbuster anti-clotting hopeful. And tomorrow an expert panel votes on the fate of dapagliflozin, its closely-watched diabetes drug partnered with Bristol-Myers Squibb.

"The next two weeks are make or break," Savvas Neophytou, an analyst at Panmure Gordon, tells The Telegraph. "With two pipeline products at critical junctures and interim results on July 28, the sword of Damocles is hovering. If both events go the company's way, the stock should burn through the £33 ceiling. If only one, it may languish around the £29-31 level and if both are negative then it could be down to £28."

Brilinta is already approved in 38 markets and is an odds-on favorite in the U.S. But some analysts say an approval is not guaranteed, particularly as the drug did not perform as well among Americans as it did in other nationalities enrolled in clinical trials. And as the New York Times' Andrew Pollack notes, FDA experts have to scrutinize the data on cancer, liver damage and infections associated with the diabetes drug, the first of the SGLT2 inhibitors to come up before the FDA.

A number of developers, including J&J, a partnership involving Lilly and Boehringer, Lexicon, Isis and others have similar diabetes therapies in development and will be closely watching the panel discussion tomorrow. The drug lowers blood sugar by spurring the body to excrete it in urine.

- read the story from The Telegraph
- see the NYT article

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