Shares of Cubist Pharmaceuticals Inc. (NASDAQ:CBST) touched a new 52-week high of $30.02 on Wednesday morning. Optimer Pharmaceuticals Inc. (NASDAQ:OPTR) said it has entered an exclusive two-year co-promotion agreement with Cubist to market Dificid in the U.S.
Dificid, or fidaxomicin, is a novel antibiotic currently being reviewed for market approval by the FDA for the treatment of Clostridium difficile infection, which is also known as Clostridium difficile-associated diarrhea.
Cubist said the FDA is expected to complete its review of Dificid and deliver a decision on market approval by a Prescription Drug User Fee Act goal date of May 30.
Optimer and Cubist will co-promote Dificid to physicians, hospitals, long-term care facilities and other healthcare institutions in the U.S. The agreement expires two years from the first commercial sale of Dificid. As per the deal, Optimer is expected to be responsible for the manufacturing and distribution of Dificid in the US and for recording product revenue.
Cubist will receive quarterly service fees of $3.75 million over the two years beginning with the first commercial sale of Dificid. Cubist is also eligible to receive an additional $5 million in the first year after first commercial sale and $12.5 million in the second year of the agreement.
On Tuesday, shares of Cubist touched a new high of $29.61, after the company granted Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) the license to launch the generic version of its antibiotic Cubicin, thus ending the patent dispute between the two. Cubicin is approved in the U.S. and many non-US markets as therapy for bloodstream infections, including right-sided endocarditis, and complicated skin infections caused by certain Gram-positive bacteria.
Teva may launch its generic daptomycin product in the U.S. on June 24, 2018, if Cubist gets a 6-month extension of marketing exclusivity for Cubicin. But, without the extension Teva will be able to launch its generic version on December 24, 2017. Cubist currently has Orange Book patents that are due to expire on September 24, 2019. Pediatric exclusivity, if granted, would add 6 months to that expiration date.
The agreement also provides that, for the period the license from Cubist to Teva is in effect, Teva will purchase its U.S. requirements of daptomycin exclusively from Cubist. The payments to be made for such supply will be based on the cost-of-goods-sold plus a margin, and on a specified percentage of gross margin from the sale of Teva's generic daptomycin.
Teva admits that the patents asserted in the lawsuit are valid and enforceable against, and would be infringed by, Teva's proposed generic daptomycin for injection product. The claims to be dismissed pursuant to the settlement agreement include Teva's allegation that two of Cubist's patents are unenforceable due to inequitable conduct. As required by law, Cubist and Teva will submit the Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice.
Cubist stock gapped open sharply higher April 6 at $29.23 compared to previous day's close of $29.01. The stock touched a new high of $30.02 on Wednesday morning. The stock traded between $19.65 and $30.02 during the past 52 weeks.
The stock is trading up 2.72 percent at $29.80 on the NASDAQ Stock Market at 11:07 am EDT with a volume of 1.40 million shares.