The medicine Amylin Pharmaceuticals makes in West Chester Twp. received its first regulatory approval in Europe while approval of the diabetes drug has been delayed at least a year in the United States.
Bydureon, the proposed trade name, would be the first drug for Type 2 diabetes to come in a once-a-week dose. It’s pending approval from the U.S. Food and Drug Administration, which made two requests for more information last year. An application was also recently submitted in Japan, said Alice Izzo, an Amylin spokeswoman.
The approval by the European Commission in June means the 300 employees Amylin has at its manufacturing facility on Trade Port Drive will switch gears from making the drugs for clinical trials to making the drugs for market. They have the capacity to take the drugs to shelves in the United Kingdom and Germany by October, Izzo said. How quickly more jobs are added depends on how quickly demand builds for the product, she said.
“It’s the first approval anywhere around the world, so it’s great progress for us and the facility in West Chester,” she said.
Amylin is a San Diego, Calif.-based pharmaceutical company that focuses on diabetes and other metabolic issues. It was a big deal when the company purchased in 2005 a facility in West Chester Twp. because bioscience firms are seen as a critical future growing industry and it was a significant investment.
The company was welcomed with tax incentives from the township and funding from Ohio Third Frontier.
Soon after its initial purchase, it was announced the building would be expanded to make room for a packaging facility, so far a total $700 million investment for land, building, construction and equipment, Izzo said. The plant started operating in 2009, according to the company.
The local facility is the only manufacturing facility Amylin owns, designed for the production of Bydureon. The injection drug is a once-weekly version of its twice-daily formulation Byetta, its biggest selling drug, to lower blood sugar.
Bydureon has three companies at the table: Eli Lilly and Co., a global pharmaceutical company responsible for marketing and selling the drug internationally; Alkermes, a company responsible for the drug delivery technology to make it last longer; and Amylin, the manufacturer and developer of the active ingredient, Izzo said.
An application was submitted to U.S. FDA in 2009, she said. Some of the additional information the FDA asked about was related to impact on the heart.
Just Thursday, Amylin released results of its study on how Bydureon impacts heart rhythm, saying the drug at various concentrations in the blood stream didn’t prolong the time between heart beats. Amylin said it plans to submit the results of the study with a full response to the FDA this quarter.
Diabetes affects an estimated 160,000 people in Greater Cincinnati, said Randy Seeley, professor of medicine for University of Cincinnati and director of the Cincinnati Diabetes and Obesity Center. He studies how the stomach and intestine talks to your brain and other organs to control what you eat and how it’s processed and has received research funding and consulting fees from Amylin and its competitors, he said.
There are two strategies diabetes drugs take in this class to take advantage of the system that says when to stop eating and to process food, Seeley said. One is a drug that copies the system, GLP-1, but lasts longer. The other strategy is to inhibit an enzyme the breaks down GLP-1.
Bydureon takes the first approach.
So the success of the drug will depend on the tradeoffs for customers of costs, side effects and the convenience of taking it once a week versus once or twice daily medications available now, he said.
“The market’s very large, so there’s money to be made. But who’s going to win in the long run in terms of the market share...it’s not clear,” he said.
Contact this reporter at (513) 705-2551 or email@example.com.
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