Amylin and Alkermes Waiting for FDA Verdict on Once-Weekly Diabetes Drug

• Date: March 11, 2010
• Source: admin

Amylin and Alkermes are now sitting in suspense as the FDA deadline of approving their blood sugar controlling date is nearing. The drug manufactured by Amylin and Alkermes is coming with a revolutionary promise of transforming diabetes treatment with the first-one weekly injectable drug to control blood sugar.

Gone are the Days of Monitoring through Pinpricks

There was a time, when the diabetics used to take two shots a day and used to worry as much about the peaks and valleys of drug concentration in their bloodstream that they had to monitor through pinpricks.

Amylin with its top-selling drug, exenatide (Byetta) and biodegradable polymer from Alkermes, promised to produce a one-of-a kind drug which last longer in the blood thereby treating diabetes in a more efficient way. The drug has shown in clinical trials it can control blood sugar more effectively with just one shot a week, compared with the existing drug, which requires two shots per day.

Impact of the Drug

With FDA approval, the drug can potentially become Amylin’s (NASDAQ: AMLN) biggest sales driver for years to come. Alkermes (NASDAQ: ALKS), which has developed the technology to make the drug last an entire week in the bloodstream, has a 7.5 percent royalty on worldwide sales, without spending a penny on manufacturing or marketing.

The drug also has the potential of creating a deep impact on the on the diabetes epidemic. In a discussion that took place in January with Luke Timmerman, Amylin CEO Dan Bradbury told that he believes an estimated 25 million people in the U.S. have diabetes, and as the obesity epidemic rages on, the incidence of diabetes is expected to double over the next 25 years,

Moreover, according to the JP Morgan analyst Cory Kasimov, the drug has about an 85 percent chance of winning regulatory approval sooner or later, and could generate worldwide peak sales of $2 billion by 2017.

FDA Approval - Points to Note:

According to Luke Timmerman, whose opinion has come up on March 10, 2010 in Xconomy, there are four possible scenarios

—First, with a standard warning about risk of patients getting pancreatitis, the FDA could approve the drug.

—Second, the FDA may approve the drug but can issue a severe Black Box warning on the prescribing information that tells doctors about a risk that patients might get thyroid cancer.

—Third, according to Kasimov, with a “complete response” letter, the FDA can delay the exenatide once-weekly application. In that case, FDA will ask for a “minor” data from clinical trials that have already been done. However, for such minor request, companies can re-submit their application by the end of June, and has the chance of winning clearance for the U.S. market by the end of 2010.  

—Fourth, instead of minor “complete response”, the FDA can also issue a painful “complete response” letter saying that the drug needs additional data from an ongoing clinical trial, or that the drug needs to wait for long-term follow up to prove that exenatide has a beneficial effect on cardiovascular health of diabetes patients.

 Source:

http://www.xconomy.com/