Ebb & Flow

The 2004 merger of Fujisawa Pharmaceutical Co. Ltd. and Yamanouchi Pharmaceutical Co. Ltd. to form Astellas Pharma Inc. (Tokyo:4503) has led to big payoffs in the last two weeks for Calixa Therapeutics Inc. and Gloucester Pharmaceuticals Inc., which both were formed around compounds that Astellas chose to out-license.

Calixa was founded in 2007 based on ex-Asian rights to CXA-101, after Astellas decided to drop discovery and early development of antibiotics. The biotech raised a single $30 million venture round and last week agreed to be acquired by Cubist Pharmaceuticals Inc. (NASDAQ:CBST) for $92.5 million in cash and up to $310 million in development, regulatory and sales milestones.

The prior week, oncology company Gloucester was acquired by Celgene Corp. (NASDAQ:CELG) for $340 million in cash and $300 million in milestones in a deal built around Gloucester's Istodax romidepsin, which FDA approved in November to treat cutaneous T cell lymphoma (CTCL). Gloucester in-licensed Istodax from Fujisawa, which needed to off-load the compound just prior to the Japanese merger (see BioCentury, Dec. 14).

Gram negative is positive

The investors in Calixa, including Domain Associates; Canaan Partners; and Frazier Healthcare Ventures, are looking at anywhere from a 3X-plus return up to almost a 13.5X return.

CXA-101 is a cephalosporin antibiotic in Phase II testing for complicated urinary tract infection (cUTI). The company also is developing CXA-201, a combination of CXA-101 and the generic beta lactamase (LACTB) inhibitor tazobactam, which is expected to begin Phase II testing for complicated intra-abdominal infections and cUTI in 1H10 and nosocomial pneumonia in 2H10.

CXA-301, an inhaled formulation of CXA-101 to treat infections in cystic fibrosis patients, is in preclinical development.

According to Cubist SVP and CSO Steven Gilman, the company is most interested in the combination formulation CXA-201. While CXA-101 is most active against Pseudomonas aeruginosa and in multi-drug resistant Pseudomonas, in combination with tazobactam it also hits other Gram-negatives including E. coli and Klebsiella, and ESBL versions of Klebsiella.

Cubist is targeting an NDA submission in 2H13.

"It's very important to all of us that CXA-201 reaches market;

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