Is Acomplia the first Avandia causality?
Yesterday by a unanimous vote an FDA panel rejected Sanofi-Aventis (NYSE:SNY) diet/diabetes drug Acomplia. It’s difficult to asses what role, if any, the controversy over Avandia played in the panel’s decision as there were several concerns with Acomplia. While this news is a blow to Sanofi, Amylin (NASDAQ:AMLN) shareholders are likely to gain from the news.
With Avandia prescriptions in a free fall, physicians are exploring alternative treatments options for their type 2 patient population. Early reports indicate that Actos, from Takeda, appears to be the favorite replacement drug for Avandia, a situation which may change dramatically when another FDA panel meets July 30th to review Avandia. It should be noted that back on June 6th Takeda changed the label for Actos with a revised warning related to congestive heart failure. While it is unknown what action the FDA will take after the July 30th meeting, the pressure is on and it is possible the agency could pull the drug from the market. Which begs the question can the FDA take action against Avandia without also raising concerns over Actos which is from the same family of drugs?
Looking over the most recent prescription data it appears physicians are taking their time in deciding what to do with their Avandia patients. The number of prescriptions for Avandia fell to 151,807 in the week ended June 1, down from 172,644 the previous week and 208,533 the week before the May 21 report in the New England Journal of Medicine, according to Wolters Kluwer. For Actos, prescriptions rose to 265,723 the last week of the month, up from 227,478 a week earlier and 235,355 before the Avandia news. Even with this increase in Actos prescriptions Takeda is not revising their Actos sales forecast, perhaps realizing this increase in Actos could be short lived.
With the American Diabetes Association Scientific Sessions set to begin next week in Chicago, a clearer picture will likely emerge on which direction physicians will ultimately decide upon. Diabetic Investor believes Byetta, from Amylin, will win out in the long run. Januvia from Merck (NYSE:MRK) after getting off to a record start is already falling out favor with physicians who are less than impressed with the drugs performance. Januvia prescriptions which were leveling off prior to the Avandia situation would have begun to show signs of weakening had there been no controversy. The fact of the matter is for all the hype over Januvia the drug really isn’t that great.
This leaves Byetta standing by itself as the most effective replacement. Many continue to see the fact that Byetta is injected twice daily as a negative, something Diabetic Investor has never seen as a problem. Besides being extremely effective at control glucose levels and lowering A1C, Byetta has the added benefit of producing progressive weight loss. Physicians are using the weight loss factor as their primary selling point to overcome the so-called fear of injections. These same physicians also know that the long-acting once-a-week version of Byetta is coming, a drug that will change the paradigm for treating type 2 diabetes. With concerns surrounding Avandia and the negative vote on Acomplia, Byetta stands alone as the only drug that effectively controls diabetes and produces the added benefit of weight loss.
The bottom line here is when the dust settles and all the meetings are over Amylin stands to gain the most. The train is getting set to leave the station and it would be wise for investors to jump on board before someone else comes along and buys the most valuable asset in diabetes; Amylin.