Once A Week Byetta In Jeopardy

Struggling for years to launch a new drug, Eli Lilly and Co. suffered yet another setback when its partners said Tuesday that federal regulators rejected data for a long-acting version of the diabetes drug Byetta.

The move could result in a delay of the drug, several analysts said, putting another crimp in the Indianapolis drugmaker’s late-stage pipeline. That could make it tougher for Lilly to shore up its revenues as its faces a sharp drop-off in sales in coming years when other top-selling drugs become open to generic competition.

Byetta is a popular biotech drug to treat diabetes, used by people who do not yet take insulin. The standard version of the drug, launched three years ago, is a twice-a-day injectable drug to help diabetics control their blood sugar.

Byetta rang up sales of $650.2 million last year, but some analysts have hoped it could become a multibillion-dollar blockbuster if the government approves a new long- acting version. Lilly and its partners have been developing a once-a-week version for patients who do not want daily injections.

Tuesday, Lilly’s partners on Byetta, Amylin Pharmaceuticals and Alkermes, said the Food and Drug Administration rejected data for the long-acting version of the drug, known as Byetta LAR.

What the FDA rejected were studies meant to compare small-scale batches of LAR made by partner Alkermes to large-scale batches made at Amylin’s Ohio facility.

If the biotech companies have to conduct an additional study, it likely would delay their plans to ask for approval by the middle of 2009. Amylin said it is continuing talks with the FDA.

Lilly did not comment on the news.

==============================

Advertisement
Steps to Health Walking Program
The only program that is in use with over 200,000 patients. Reduce your blood sugars for less then 25 dollars and you don’t have to swallow anything. $24.95 with discounts for 2 or more…

https://www.rx4betterhealth.com/ccp51/cgi-bin/cp-app.cgi?pg=prod&ref=sthp&cat=sth&catstr=HOME:sth