Take the Diabetes Health Pump Survey
See What's Inside
Read this FREE issue now
For healthcare professionals only
  • 12 Tips for Traveling With Diabetes
See the entire table of contents here!

You can view the current or previous issues of Diabetes Health online, in their entirety, anytime you want.
Click Here To View

See if you qualify for our free healthcare professional magazines. Click here to start your application for Pre-Diabetes Health, Diabetes Health Pharmacist and Diabetes Health Professional.

Learn More About the Professional Subscription

Free Diabetes Health e-Newsletter
Latest
Popular
Top Rated
Diabetes Health Reference Charts
Insulin Archives
Print | Email | Share | Comments (1)

Amylin Cuts Workforce, Asks FDA to Approve Once-Weekly Byetta

May 11, 2009

The FDA has intensified its scrutiny of diabetes drugs ever since GlaxoSmithKline’s popular Avandia was associated with an increased risk of heart attack in 2007

It has been an interesting month for San Diego-based Amylin Pharmaceuticals Inc., the co-manufacturer of Byetta (exenatide) with Eli Lilly & Co., and Alkermes Inc. First, the company announced that it will reduce its sales force by 35 percent-200 employees-in hope of saving $20 million this year and $45 million annually starting in 2010. The company plans to retain 325 representatives to sell its diabetes products to doctors and endocrinologists. At the same time, Amylin has petitioned the FDA to approve the marketing of Byetta LAR, a form of the type 2 drug that requires injection only once a week.

The employee cutback was not unexpected. Large pharmaceutical companies across the board are trimming their sales staffs in the wake of lagging drug sales. Amylin, however, has also been hit with a notable drop in Byetta sales since 2008, when the FDA began questioning whether the drug might be a causative factor in several deaths from severe pancreatitis.

The agency's concerns about the drug's safety caused a 32 percent drop in sales last year, from $635 million to $430 million. Amylin is hoping that Byetta LAR will rejuvenate the market for the drug, especially given the attraction of injecting the drug once a week instead of twice daily. The U.S. market for diabetes drugs is estimated at $5 billion per year, and some analysts say that Byetta LAR, which would be the first long-acting diabetes drug on the market, could push Byetta sales past the $1 billion mark.
The fly in the ointment for Amylin and its partners is that the FDA has intensified its scrutiny of diabetes drugs ever since GlaxoSmithKline's popular Avandia was associated with an increased risk of heart attack in 2007. Since then, the agency has been slower to approve drugs and has added new performance benchmarks to its requirements.


Categories: Byetta, Diabetes, Diabetes, Insulin, Type 1 Issues, Type 2 Issues



You May Also Be Interested In...


Comments

Posted by Anonymous on 20 May 2009

Bring on the LAR, Byetta has been the answer to my problems with control. Once in control and mentaly able to function better because of it I am doing more on my own to be under control. I only need the injection 1 time per day and one 800MG metformin. Last A1C was 5.7 one before that 5.9 and one before that 6.5...one prior to Byetta was 7.1. I shoot it in my butt cheek to keep the nausea down. A once a week shot would be great!!


Add your comments about this article below. You can add comments as a registered user or anonymously. If you choose to post anonymously your comments will be sent to our moderator for approval before they appear on this page. If you choose to post as a registered user your comments will appear instantly.

When voicing your views via the comment feature, please respect the Diabetes Health community by refraining from comments that could be considered offensive to other people. Diabetes Health reserves the right to remove comments when necessary to maintain the cordial voice of the diabetes community.

For your privacy and protection, we ask that you do not include personal details such as address or telephone number in any comments posted.

Don't have your Diabetes Health Username? Register now and add your comments to all our content.

Have Your Say...


Username: Password:
Comment:
©1991-2014 Diabetes Health | Home | Privacy | Press | Advertising | Help | Contact Us | Donate | Sitemap

Diabetes Health Medical Disclaimer

The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images, and information, contained on or available through this website is for general information purposes only. Opinions expressed here are the opinions of writers, contributors, and commentators, and are not necessarily those of Diabetes Health. Never disregard professional medical advice or delay seeking medical treatment because of something you have read on or accessed through this website.