SAN DIEGO—Osaka, Japan-based drugmaker Takeda PharmaceuticalCo., maker of the world's top-selling diabetes treatment, will pay as much as$1 billion to San Diego-based Amylin Pharmaceuticals Inc. to co-develop thecompany's obesity treatments, the companies announced in November.
Under the terms of the agreement, Amylin will be responsiblefor executing development activities for potential products through Phase II.Takeda will lead development activities beyond Phase II in the United Statesand all development activities elsewhere. In most instances, Amylin will beresponsible for 20 percent of development costs associated with obtainingapproval for products in the U.S., and Takeda will be responsible for 80percent of such U.S. development costs. Takeda will be responsible for 100percent of development costs associated with obtaining approval for productsoutside the U.S. Amylin will have the option to co-commercialize the first twoapproved products in the U.S. and any follow-on products containing theidentical active ingredients.
Amylin will receive an upfront payment of $75 million fromTakeda and, over the term of the agreement and in relation to the compoundsinvolved in it, is eligible to receive additional payments upon achievingcertain development, commercialization and sales-based milestones that couldexceed $1 billion.
According to Anne Erickson, Amylin's senior director ofcorporate affairs, the agreement involves products to be developed from bothcompanies' obesity pipelines. Specifically, the deal involes Amylin'spramlintide/metreleptin and davalintide, compounds currently in Phase IIdevelopment for treatment of obesity. In the third quarter, Amylin announcedpositive top-line Phase II data from the pramlintide/metreleptin study.
"That study is continuing, and data from the extension willbe announced later this quarter," notes Erickson. "Additionally, Amylin willreport data from a Phase II study of davalintide by the end of the year. Thedevelopment strategy for each program will be determined by the outcome ofthese studies."
Amylin as two products on the market for diabetes—Byetta(exenatide) injection and Symlin (pramlintide acetate) injection—as well as theinvestigational compound exenatide, a once-weekly investigational diabetestherapy injected subcutaneously that is currently in Phase III development.Exenatide is also the active ingredient in twice daily Byetta. The New DrugApplication (NDA) for exenatide once weekly has been accepted by the U.S. Foodand Drug Administration (FDA), with a PDUFA date set for early March.
The agreement marks the first venture between the twocompanies. Erickson says Amylin sees Takeda as a leader in the field ofmetabolic diseases that "shares our philosophical belief that peptides and amulti-hormonal approach has the potential to provide a safe and effective wayto treat obesity."
"This collaboration allows both companies to advance moreprograms for obesity treatments more quickly than either company could doalone," she notes. "It also provides an opportunity for the companies tocombine assets in a way that would not be possible independently. For Amylin,this means that the programs are backed by a partner with the capability todevelop these assets on a global basis. For Takeda, the programs accelerate andcomplement the company's efforts with this important metabolic disease."
Yasuchika Hasegawa, president and CEO of Takeda, says thecompany looks forward to maximizing the potential of the products under theagreement.
"Both Amylin and Takeda have extensive experience in thediabetes and metabolic disease area, and this collaboration should allow us tomore quickly bring promising new treatments to patients in need," Hasegawasays.
According to analysts, the purchase may help Takeda bufferlosses after Actos, a type 2 diabetes drug and its top seller with $4 billiongenerated for the year ended March 31, loses patent protection in January 2011.
"The purchase will surely boost Takeda's product lineup,"Takashi Akahane, a healthcare analyst at Tokai Tokyo Research Center Co. inTokyo, says. "Still, this drug alone won't be enough to make up for the salesdecline in Actos, and the company needs to make more acquisitions."
Leerink Swann Research analyst Dr. Joshua Schimmerreaffirmed a "Market Perform" rating for Amylin, saying the obesity drug dealwill help reduce future expenses. He says Amylin's costs for obesity drugsrepresented about 13 percent of second-quarter research and development costs.
On Oct. 30, Amylin announced that the FDA expanded approvalof Byetta as a stand-alone diabetes treatment. Previously, it was approved foruse in combination with other diabetes drugs. Concerning the Byetta labelextension, Schimmer says he does not see a big change in sales due to theexpanded Byetta approval, since, he notes, "doctors have been already using it asmonotherapy with due caution about pancreatitis."
Cowen & Co. analyst Phil Nadeau agrees, writing in aresearch note that "the monotherapy claim itself is less notable as it isunlikely to change the way in which Byetta is prescribed, and will most likelynot reaccelerate scripts growth."
The FDA also strengthened warning language on Byetta,following more than 60 reports of kidney failure with the drug between April2005 and October 2008. While the previous label mentioned such side effects,the new language specifies that doctors should not prescribe Byetta to patientswith severe kidney problems.
"In our view, these developments are in line withexpectations and we do not expect any impact to Byetta sales, as pancreatitiswas first added as a precaution on the label in October 2007," Lazard CapitalMarkets analyst Michael O'Brien wrote in a note to investors.