San Diego-based Amylin Pharmaceuticals, the dark horse in the race to develop a new breed of weight-loss drugs, has struck a partnership with Japan-based Takeda Pharmaceuticals that could be worth more than $1 billion over time if the drug reaches certain goals in development and in the marketplace.
The agreement calls for Amylin (NASDAQ: AMLN) to hand a worldwide exclusive license to Takeda to co-develop Amylin’s experimental obesity drugs, including the combination of pramlintide and metreleptin, and davalintide. In return, Amylin will get $75 million in upfront cash, milestone payments based on clinical and commercial goals that could top $1 billion, and royalty payments worth a double-digit percentage of worldwide sales if the Amylin drugs ever make it onto the market.
This is a big deal for Amylin, which has been toiling in the shadow of three other companies trying to blaze a new trail in the treatment of obesity this year—San Diego’s Arena Pharmaceuticals, San Diego-based Orexigen Therapeutics, and Mountain View, CA-based Vivus. While Amylin has attracted less attention, and it is a little further behind the others in the race to the market (as I pointed out in a September feature story), it may have the most effective drug of all. Amylin is betting it has found a way to breathe new life into one of the most overhyped biotech drugs of the 1990s—Amgen’s leptin—by packaging it in combination with its own pramlintide drug for diabetes. While the Amylin drug needs to be taken by injection and its rivals are oral pills, it has shown some strong promise that it can help people shed pounds in clinical trials, and the market has big potential. About two-thirds of people in the U.S. are considered overweight or obese, according to estimates from the Centers for Disease Control and Prevention.
“Amylin and Takeda are excited about working together to address the significant unmet need for the millions of patients who need better solutions to manage obesity,” said Amylin CEO Dan Bradbury, in a statement.
Data on the Amylin drug combo is still preliminary, but it is encouraging. The company looked at a variety of doses in a study of 608 overweight or obese patients, and has reported preliminary results after a little more than six months of observation. Patients on the highest doses, and who had body-mass indexes of less than 35, lost 11 percent of their body weight on the Amylin drug combo, compared with 1.8 percent average body weight loss in the placebo group.
Still, there are caveats in the data. Patients who are more severely overweight, with a body-mass index of greater than 35, saw some benefit on the Amylin combo, but not as much as less-obese patients. And the Amylin combination still has to be injected twice daily, while other drugs can be taken as oral pills, so it remains to be seen how many injections obese patients will be willing to put up with.
But apparently Takeda liked what it saw enough that it made some big commitments to the Amylin pipeline, which is interesting given that none of the other three biotech companies with weight-loss drugs have yet been able to rope in a Big Pharma partner. Under the terms of the deal, Amylin will be responsible for all development work through Phase II in the U.S., while Takeda will handle pivotal trials in the U.S., and all phases in the rest of the world. Takeda will pay for 80 percent of the development expenses in the U.S., while Amylin picks up the rest in the U.S. and Takeda pays for all development costs outside the U.S. Takeda will pay for all of the commercialization costs worldwide, and Amylin will have an option to co-market the two lead drugs or any follow-ons that contain their active ingredients.
Takeda and Amylin are familiar with each other as contenders in the diabetes drug market. Amylin gets 90 percent of its revenue from exenatide (Byetta) for diabetes, while Takeda’s biggest profit driver is pioglitazone (Actos) for diabetes. Since many diabetic patients also struggle with obesity, both companies have had their eye on expanding into that larger market for some time.
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