June 24, 2008
When deciding whether to approve a drug, the FDA only cares whether it's safe and effective. But once the drug hits the market, a third characteristic -- how the drug is taken -- helps determine whether it obtains blockbuster status.
Most type 2 diabetes patients have started out on oral medications like Bristol-Myers Squibb's (NYSE: BMY ) Glucophage -- available as generic metformin -- then progressed to injectable insulin. Newer medications like Merck's (NYSE: MRK ) Januvia sought to put off the inevitable needle pokes by giving patients another oral therapy before heading on to insulin.
Then there's Amylin Pharmaceuticals' (Nasdaq: AMLN ) Byetta. An analog of the hormone GLP-1, this wonder drug improves glucose levels and helps diabetics shed pounds -- but it has one big problem. Byetta aims to help patients avoid using insulin, but still results in two needle pokes a day, which has put a damper on its sales. Novo Nordisk (NYSE: NVO ) has tried to best Byetta by developing a competing GLP-1 analog that only needs to be injected once a day.
If one injection a day is better than two, then one injection per week should be seven times better. That's what Amylin and marketing partner Eli Lilly (NYSE: LLY ) are doing with Byetta. Using Alkermes' (Nasdaq: ALKS ) microsphere technology, the once-weekly Byetta looked good in trials, although it's still more than a year away from being on the market.
Novo Nordisk isn't waiting idly by to be outdone by once-weekly Byetta, though. The diabetes expert announced yesterday that it's taking drug delivery full circle by attempting to make an oral version of GLP-1-like drugs. It won't be easy; if it were, Amylin, Novo Nordisk, and others would have started there in the first place. But Novo Nordisk thinks it can use Emisphere Technologies' (Nasdaq: EMIS ) eligen technology to carry GLP-1 drugs across the membranes of the gut and into the bloodstream.
Hold on to your seat, Fools. The GLP-1 drug wars are going to deliver one bumpy ride.