LEXINGTON, Mass.& TOKYO—Cubist Pharmaceuticals Inc. andAstellas Pharma Inc. announced march 11 that they had entered intoan agreement under which Cubist obtains the rights to ceftolozane incertain Asia-Pacific and Middle East territories from Astellas, for an upfrontpayment of $25 million. Ceftolozane, in combination with tazobactam (ceftolozane/tazobactam orCXA 201), is currently being studied in two pivotal Phase III trials as apotential first-line intravenous therapy for the treatment ofcomplicated intra-abdominal infections (cIAI) and complicated urinarytract infections (cUTI) caused by certain Gram-negative bacteria,including those caused by multi-drug resistant Pseudomonas aeruginosa.
Also under the terms of the agreement, sales of ceftolozane/tazobactam made in thenewly-obtained territories will be counted toward the existingcommercial milestone and royalty terms of the original agreement. Cubistwill fund the upfront payment with cash on hand. With theattainment of these rights, Cubist now owns worldwide rights todevelop, manufacture, and commercialize ceftolozane/tazobactam.
Top-line data readouts from the two Phase III clinical trials are expected inthe second half of 2013. Cubist anticipates filing a New DrugApplication (NDA) for ceftolozane/tazobactam in cUTI and cIAIapproximately six months after announcing top-line results from those trials.
In addition, Cubist plans to begin Phase III studies for the drug in nosocomialpneumonia around mid-year 2013.
The FDA had already granted a Qualified InfectiousDisease Products (QIDP) designation for all three indications andgranted Fast Track status for ceftolozane/tazobactam in cIAI. As aresult of the QIDP designation, if ceftolozane/tazobactam is ultimatelyapproved by the FDA, it would also receive a five-year extension ofHatch-Waxman exclusivity.
Cubist previously obtained the rights, outside of these Asia-Pacific andMiddle East territories, to develop and commercializeceftolozane/tazobactam through its acquisition of Calixa TherapeuticsInc. in December 2009.
"Today's agreement underscores our belief that ceftolozane/tazobactamhas the potential to be an important therapy to combat certain seriousGram-negative bacterial infections," said Michael Bonney, CEO of Cubist. "With ownership of the global rights toceftolozane/tazobactam, Cubist is well-positioned to continue advancingthis promising product candidate and capture the drug's full potentialaround the world, if it is approved."
