One Step Closer

One Step Closer

This morning Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS) announced; “that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of exenatide 2 mg powder and solvent for prolonged release suspension for injection  (proposed trade name BYDUREON™) in the European Union for the treatment of type 2 diabetes in combination with certain oral therapies.”  The companies expect a final decision sometime in the next three months.

While this is obviously good news for the Bydureon™ Trio (Amylin, Lilly and Alkermes), it also reinforces something Diabetic Investor has been stating since the FDA became an overly conservative agency who’s afraid of their own shadow, in that, patients overseas are now more likely to see advanced diabetes drugs and devices as the FDA continues to drag their feet.  The simple fact is there is no logical reason that the FDA has not approved Bydureon™ and their most recent request for additional information proves to Diabetic Investor that the agency remains in fear mode in spite of all the talk of supposed reform at the agency.

Diabetic Investor remains convinced that the FDA will eventually wake up and approve Bydureon™ without any adverse labeling. With this day fast approach insulin companies, in particular Sanofi-Aventis (NYSE:SNY), should be very worried about future sales as Bydureon is not just an effective therapy option for type 2 patients, it’s the biggest threat to future insulin sales.  Although Sanofi does have a GLP-1 in development, it’s unlikely that no matter how good this drug may be, that any drug who’s third to market will achieve much in the way of market penetration.  The stark reality is while everyone wants to be a player in the GLP-1 arena, right now that arena belongs to two players Novo Nordisk (NYSE:NVO) and Amylin, Lilly and Alkermes. 

As we have noted before, this fight between two heavyweights will at times get ugly as there is just too much at stake here, GLP-1 therapy is gaining traction. While Bydureon trumps Victoza in terms of fewer injections, once weekly versus once daily, this fact alone does not guarantee sales superiority.  The Bydureon Trio must execute better than they did when Byetta first came to market.  The clock is ticking towards zero hour, get ready, and fasten your seat belts as the ride is sure to be bumpy from here.