Week of Dec. 28, 2009: Company and People Notes: Ambit Biosciences And Astellas Pharma Form Agreement; Merck Discontinues Development of MK-1903; and More.

December 31, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

BioNanomatrix (Philadelphia) names Edward Erickson president and CEO; and More.

Company notes

Ambit Biosciences (San Diego, CA) and Astellas Pharma (Tokyo) formed a worldwide agreement to jointly develop and commercialize FLT3 kinase inhibitors in oncology and nononcology indications. This partnership includes AC220, Ambit's lead clinical-stage investigational drug in Phase II clinical development and other undisclosed FLT3 kinase inhibitors. The companies will share equally in the responsibilities and expenses for the development of AC220 and any additional products in the US and Europe; Astellas will have sole responsibility to fund development in all other territories. Under the terms of the agreement, Ambit will receive an up-front cash payment of $40 million and will be eligible to receive precommercialization payments of as much as $350 million.

Merck & Co. (Whitehouse Station, NJ) decided to discontinue its research collaboration with biopharmaceutical company Arena Pharmaceuticals (San Diego). One aim of the collaboration was to develop MK-1903, an investigational niacin-receptor agonist to treat atherosclerosis. Merck decided to discontinue development of MK-1903 following evaluation of the results of a recently completed Phase IIa clinical trial.

AstraZeneca (London) agreed to acquire the pharmaceutical research company Novexel (Romainville, France) and will collaborate with Forest Laboratories (New York) on the future codevelopment and commercialization of two late-stage antibiotics, ceftazidime/NXL-104 (CAZ104) and ceftaroline/NXL-104 (CEF104). These antibiotic combinations use Novexel’s investigational beta-lactamase inhibitor NXL-104 to overcome antibiotic resistance. Under the terms of the deal, AstraZeneca will acquire 100% of Novexel’s shares for $350 million in cash, will pay as much as $75 million if specified development milestones are reached, and will pay an additional $80 million upon closing of the deal. Under a separate agreement following closing of the Novexel deal, Forest will pay AstraZeneca a sum equal to half of the acquisition costs of Novexel and half of any such specified development milestone payments in return for rights to CAZ104 in North America and the buy-down of payment obligations in relation to CEF104 from previous existing license arrangements. In January 2008, Novexel granted Forest rights to develop CEF104 in North America. AstraZeneca secured the rights to commercialize ceftaroline outside North America and Japan from Forest in August 2009.

In other news, AstraZeneca acquired the rights to Biovitrum’s (Stockholm) leptin-modulator program for treating obesity in exchange for an up-front payment of EUR 6 million ($8.6 million) and milestone payments of as much as EUR 186 million ($267 million) contingent on development progress and sales. The leptin-modulator program is currently in preclinical development.

DSM (Heerlen, The Netherlands) successfully completed process development and commenced manufacture under current good manufacturing practices of a lipase compound for preclinical and Phase I clinical needs for the pharmaceutical company Mayoly Spindler (Chatou, France). DSM manufactures the lipase compound at its microbial fermentation facility in Capua, Italy.

Durata Therapeutics (New York) acquired Vicuron Pharmaceuticals from Pfizer (New York). Durata is a biopharmaceutical company created by a five-member venture-capital syndicate to pursue late-stage clinical development of novel antibiotic programs. The acquisition was funded through a stock purchase by New Leaf Venture Partners, Domain Associates, Aisling Capital, Sofinnova Ventures, and Canaan Partners. Durata is focused primarily on Vicuron’s antibiotic drug candidate dalbavancin, a long-acting, injectable, lipoglycopeptide antibiotic in late-stage clinical development. Durata’s product portfolio also includes two preclinical antibiotic programs. Pfizer will retain the marketed antifungal agent, Eraxis (anidulafungin), which was formerly owned by Vicuron.

The US Food and Drug Administration issued a complete response letter regarding Pfizer’s (New York) new drug application (NDA) for Lyrica (pregabalin) capsules CV as a monotherapy treatment for generalized anxiety disorder (GAD). FDA determined that the data contained in the NDA were insufficient to support approval. The application was a resubmission in response to FDA’s “not-approvable” letter of August 2004. FDA continues to review a separate application for Lyrica as adjunctive therapy for the treatment of GAD.

The biopharmaceutical company Seattle Genetics (Bothell, WA) formed a collaboration with GlaxoSmithKline (GSK, London) under which GSK will pay an up-front fee of $12 million for rights to use Seattle Genetics's antibody drug conjugate (ADC) technology with multiple antigens to be named by GSK. Under the agreement, GSK is responsible for research, product development, manufacturing, and commercialization of all ADC products under the collaboration. Seattle Genetics is eligible to receive as much as $390 million in milestone payments if all ADCs in the collaboration are commercialized, as well as royalties on worldwide net sales of any resulting ADC products. Seattle Genetics also will receive material-supply and annual maintenance fees as well as research support payments for assistance provided to GSK under the collaboration.

 

People notes

BioNanomatrix (Philadelphia), a developer of single-molecule genomic analysis technology, has named Edward Erickson president and CEO. He succeeds Michael Boyce-Jacino, who recently stepped down as president, CEO, and from the board. Erickson has been a consultant to entrepreneurial and venture capital firms. He has served as a president, CEO, or director of more than 12 such companies. In 2004, Erickson was received Small Times magazine's "Best of Small Tech, Business Leader" Award in nanotechnology.