San Diego-based Optimer Pharmaceuticals has found a partner to help market its most important drug candidate outside the U.S.
Optimer (NASDAQ: OPTR) is announcing today it has struck a deal with Japan-based Astellas Pharma in which Astellas gets exclusive rights to market fidaxomicin in Europe, plus parts of the Middle East, Africa, and the Commonwealth of Independent States. Astellas agreed to pay $68 million upfront, another $156 million in milestone payments, plus a tiered double-digit percentage royalty on sales in the territory. Astellas will pay all the development expenses in its territory, and handle the fidaxomicin application for approval with European regulators.
The deal is the latest boon for Optimer, which has had some wind in its sails lately. The company filed for FDA approval of fidaxomicin in late November, asking U.S. regulators to clear its drug as a new option for treating potentially deadly infections with “C.difficile” bacteria. The company sought, and the FDA has granted, a faster than usual six-month regulatory review, which the agency sometimes offers to treatments with lifesaving potential. Last week, Optimer got the attention of a key physician audience, when results from one of its pivotal clinical trials for fidaxomicin were published in the New England Journal of Medicine. Since “C.diff” doesn’t often make headlines, getting that attention was critical for Optimer, as it lays the groundwork to market the drug on its own in the U.S.
If the drug wins regulatory clearance, it will be Optimer’s first marketed product.
“We expect the Astellas collaboration will help Optimer realize the full potential of fidaxomicin,” said Lichtinger said in a statement.
The next big step for Optimer comes on April 5, as it is scheduled to appear before an FDA advisory panel, to make its case in favor of the new antibiotic. The FDA then has a deadline of May 30 to complete its review, and determine whether to allow the product on the U.S. market.
Optimer plans to hold a webcast conference call at 9 am Eastern/6 am Pacific to discuss the new Astellas collaboration.