Suffice to say that diabetes is a huge and fast-growing problem and represents a huge and fast-growing drug and device market.
Novo Nordisk recently won FDA approval of Victoza, a one-a-day injection of a new type of diabetes medication. Lilly, Amylin and Alkermes are hoping the FDA will approve their similar once-a-week drug on or before the scheduled decision day of March 5th. Meantime, GlaxoSmithKline, Sanofi-Aventis and Roche are in various stages of developing potential competitors.
So, this morning Roche (which now goes by Genentech in the U.S.) announced that five late-stage studies of its experimental once-a-week diabetes shot met the main goals of lowering blood sugar. By how much; patients, investors and competitors might ask?
Well, Roche ain't tellin'.
At least, not yet.
A spokesman said the company is simply holding back the detailed data for presumably a high-profile presentation at the upcoming American Diabetes Associationmeeting in Orlando. One big late-stage drug study is usually enough to get prestigious late-breaker status at a scientific meeting like ADA. But five of 'em all at once? I'd say Roche's results are a lock. Roche spokesman Terry Hurley said the ADA doesn't require that every single datapoint be kept under wraps, but that the company decided not to release any numbers at all on its own.
In its earnings press release last weekRoche said the market potential of taspoglutide--the Street calls it taspo, for short--is "best in class." After my interview with Roche CEO Severin Schwan last Friday I asked him off camera how he could make that bold prediction. He replied that Roche wouldn't be pursuing the drug if he didn't think it's going to be number one.
AMLN, LLY and ALKS didn't seem to have any issues disclosing the amount of blood sugar reduction in previous studies of its once-a-week version of the current twice-a-day injectable Byetta. And those results were later presented at scientific meetings, including ADA, and/or published in peer-reviewed medical journals. The same can be said for NVO when it was still developing Victoza. The amount that a diabetes drug lowers blood sugar levels is the key measure of its efficacy.
David Kliff, a type-2 diabetic who writes a newsletter called, "The Diabetic Investor," has been closely following this burgeoning drug field for years. He's frustrated that he can't even begin to try to handicap the race with the amount of information Roche is releasing. "They've been building this (taspo) up as if it's the greatest thing since sliced bread and soft soap," he told me over the phone. "To me it's a little disingenuous what they're doing. They're playing a game here and it's a dangerous game," Kliff said.
If Roche is so confident that taspo is going to be "best in class" you'd think it wouldn't be afraid to show it. But to give the company the benefit of the doubt, maybe it just wants to make a big, headline-grabbing splash at the ADA meeting in late June.
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