The newsflow on diabetes drugs is at a rapid-fire this week.
An estimated 20 million or so Americans have the disease, which many experts call an epidemic. It costs this country tens of billions of dollars a year to deal with it. And several biopharma and monitoring device companies are racing to grab a bigger piece of this fast-growing, sugar-free pie.
Tuesday, Eli Lilly (NYSE:LLY), Amylin (AMLN) and Alkermes (NASDAQ:ALKS) announced that once-a-week Byetta, which is in late-stage testing, lowered blood sugar more than pills—Merck's (NYSE:MRK) Januvia and Takeda's (OTCPK:TKPHF) Actos. Yesterday, an FDA advisory committee is looking at a potential competitor to the MRK drug from Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) called Onglyza. It's what's referred to as a "me-too" product in the industry because it's really not all that different from Januvia.
Today, though, the same FDA panel takes up a first-ever one-a-day injection called Victoza from diabetes drug kingpin Novo Nordisk (NYSE:NVO). Shares of NVO bounced back yesterday after falling Tuesday on investor jitters following the release of the agency briefing documents for Thursday's meeting. Many analysts cited the FDA's concern over a very small number of cases of thyroid tumors in people and lab rats that got Victoza. David Kliff, a type-2 diabetic who writes "The Diabetic Investor" newsletter says, "It wouldn't surprise Diabetic Investor at all if the FDA asked the company (NVO) to conduct another pre-approval study."
But it's important to point out that handicapping FDA panel votes is very risky business.
It ain't over until the fat lady sings. And remember that advisory committees simply make recommendations to the FDA and the agency doesn't always follow their outside experts' advice. The outcome of the Novo vote could have an impact on GlaxoSmithKline (NYSE:GSK) and Roche (OTCQX:RHHBY), which are both working on similar drugs. But the nearest-term potential competitor is once-a-week Byetta, which if it's safe and effective, some analysts think would trump NVO's one-a-day.
The global diabetes market pie is big and getting bigger by the day. The brewing battle over which companies will get the biggest piece is going to be a sweet story to cover.