Biotechnology company Amylin Pharmaceuticals Inc. said Tuesday it asked the Food and Drug Administration to approve its highly anticipated once-weekly injectable diabetes treatment exenatide LAR. The drug is an extended version of the twice-daily injectable drug Byetta, a version of a protein found in Gila monster saliva, and is being viewed by Wall Street as a way for Amylin to reinvigorate sales. Byetta sales fell 32 percent in 2008 to $430.2 million because of safety concerns.
Because the drugs are injections, the much lower dosing schedule with exenatide LAR is seen as a commercial advantage.
The drug's competition would likely include Novo Nordisk's once-daily injection liraglutide, which is currently under FDA review.
Drugs that help diabetics control blood sugar are a hot area for developers because the drugs must be taken long-term to control the chronic condition. The U.S. market for diabetes drugs is worth about $5 billion per year.
Meanwhile, San Diego-based Amylin Pharmaceuticals Inc. is cutting about 200 jobs, or more than a third of its sales force, as it combines primary care and specialty drug sales units.
The company's partners on Byetta and exenatide LAR include Indianapolis-based Eli Lilly & Co. and Cambridge, Mass.-based Alkermes Inc.
Denmark-based Novo Nordisk received a split recommendation from its expert panel review at the FDA, with members expressing safety concerns over tumors associated with liraglutide. The FDA is not required to follow its panels' advice, though it normally does.
That recommendation had raised concerns on Wall Street over exenatide LAR, which will also be reviewed by a panel of experts.
The FDA issued new safety guidelines for diabetes treatments last year after concerns about heightened risks of heart attack with GlaxoSmithKline's blockbuster pill Avandia created a storm around the agency and the British drugmaker in 2007.
Both exenatide LAR and liraglutide are part of the same class of diabetes treatments, called GLP-1 analogues. They help increase the body's insulin production.
Amylin shares rose 70 cents, or 6 percent, to $12.28 in morning trading while Alkermes shares jumped $1.46, or 18.6 percent, to $9.31. Eli Lilly shares rose 52 cents to $34.33.
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welcomed many visitors to our booth at the health fair. Women from around the entire state of North Carolina and surrounding areas were able to gain valuable information about the programs and services offered by the nonprofit as well as learn important information pertaining specifically to women with diabetes. Member Polly Anton summed up her experience at TCOYD by saying, “I thoroughly enjoyed the Diabetes Sisters “Meet and Greet” at the end of a long and informative day at the “Taking Control of Your Diabetes” Conference. It was a great opportunity to hear other women’s stories, and to share our own. Brandy and Laura bring such energy to the group—we are lucky to have them as leaders of this community. The Diabetes Sisters reception was truly my favorite part of the day (and I won a great gift bag)!” 
women in attendance about the choices they made and how it affected not only their diabetes care but also other aspects of life. Two years ago, Jacobs decided to compete in a figure body building competition. During that time she learned that she had more discipline that she ever thought she had by realizing that her choices were instrumental in obtaining her goals. "By making conscious, intentional choices we are able to provide good examples to the people we love while at the same time we can also be a catalyst to our own personal growth by choosing to challenge ourselves to do things we may never have thought of before because of AND in spite of diabetes." Founder and executive director, Brandy Barnes tied in Jacobs’ message to the overall mission of DiabetesSisters: to empower women with diabetes through peer support and education. According to Barnes, "As Bianca has shown us all, by making well thought out choices we are all setting ourselves up to be informed and empowered women with diabetes."