Week of Sept. 26, 2011: BMS Collaborates With Ambryx; Merck & Co. Opens New R&D Center; Teva Acquires Joint Venture Interest; and More.

Company Notes

Boehringer Ingelheim plans to establish a new and separate business for the development and commercialization of its own biosimilars. The company made the announcement in a Sept. 26, 2011, press statement and did not offer further details.

Bristol-Myers Squibb (BMS) and the biopharmaceutical company Ambrx have formed a collaboration under which BMS will receive exclusive worldwide rights to research, develop, and commercialize biologics based on Ambrx’s research surrounding the fibroblast growth factor 21 (FGF-21) protein for treating Type II diabetes and the hormone Relaxin for treating heart failure. Derivatives of FGF-21 and Relaxin were developed using Ambrx’s ReCODE platform technology, which is used to modify native proteins with nonnatural amino acids. Under the agreement, BMS will make an upfront payment of $24 million to Ambrx and will make potential milestone payments and royalty payments on worldwide sales for both programs.

GlaxoSmithKline (GSK) has received a Complete Response letter from FDA for its biologics license application for the candidate meningococcal and Hib combination vaccine, MenHibrix (Hib-MenCY-TT). This is the second response letter GSK has received for Hib-MenCY-TT. GSK said it will respond to the questions posed by FDA.

Illinois Governor Pat Quinn has signed of a memorandum of cooperation between the Illinois Science & Technology Coalition, an Illinois-based association that represents research universities and technology companies, iBIO, an Illinois-based life sciences industry association, and China-based Shanghai Bio Pharmaceutics Association to increase economic opportunities for both regions in biotechnology.

Isis Pharmaceuticals, a pharmaceutical specializing in antisense drug technology, has filed a patent-infringement lawsuit against the biopharmaceutical company Santaris Pharma in the US District Court of the Southern District of California. Isis' infringement suit against Santaris is based upon Santaris' activities providing antisense drugs and antisense drug-discovery services to several pharmaceutical companies. In other news, Isis has completed a new 176,000-ft² corporate and research facility in Carlsbad, California.

Merck KGaA has acquired from the biopharmaceutical company Peptimmune worldwide exclusive rights to PI-2301, a second-generation peptide copolymer, which is being developed for multiple sclerosis.

Merck & Co. has opened a new EUR 100 million ($136 million) R&D Center in Ballydine, Ireland. Construction on the new R&D facility at the existing Ballydine site began in September 2007. An additional EUR 6 million ($8.1 million) investment is in the planning phase to extend the new facility and add extra capacity, according to a press release by IDA Ireland, the economic development board of Ireland.

The biopharmaeutical company RXi Pharmaceuticals will separate its programs into two publicly traded companies: Galena Biopharma, which will focus on the development of targeted cancer therapies, and RXi Pharmaceuticals, which will focus on the development of RNAi-based therapeutics. In connection with these transactions, the company has changed its name to Galena Biopharma.

Sanofi reported that the US District Court of New Jersey has ruled against Sun Pharmaceutical in favor of Sanofi US with respect to a contractual dispute arising from the resolution of patent litigation of the anticancer drug Eloxatin (oxaliplatin). The ruling maintains Eloxatin’s marketing exclusivity through Aug. 9, 2012.

In other news, Sanofi Pasteur, the vaccines division of Sanofi, has formed a R&D collaboration with the University of California, San Diego on immunological approach to acne prevention and treatment. 

Silence Therapeutics, a RNA interference (RNAi) therapeutics company, formed an agreement with an undisclosed global pharmaceutical companies to investigate the application of Silence’s proprietary lipid delivery system, DACC, for intravenous delivery of short interfering RNA sequences (siRNAs) to the pulmonary vascular endothelium. Under the agreement, Silence’s partner will provide Silence with specific siRNAs, which Silence will formulate with its DACC delivery system. Silence and its partner will undertake in vitro and in vivo studies of the DACC formulated siRNAs developed under the agreement and select lead candidates for further evaluation. Financial terms were not disclosed.

Teva Pharmaceutical Industries has agreed to acquire the 50% interest formerly held by Kowa in Teva's Japanese joint venture for $150 million. With this acquisition, Teva will own 100% of the former joint venture.

Unigene Laboratories, a provider of drug-delivery and manufacturing technologies for peptides, has divested its Site Directed Bone Growth (SDBG) business by assigning seven patent applications to Kieran Murphy, a development-stage company. In addition, Unigene terminated an exclusive license agreement and consulting agreement with Kieran Murphy as well as a license option agreement and research agreement with Yale University. In exchange for the assignment of the patents, Unigene will receive sales royalties in excess of 7%, 40% of any future licensing revenue, and/or 40% of all considerations received upon the subsequent sale of the SDBG patent portfolio by Kieran Murphy.

People Notes

Merck & Co. has appointed Cuong Viet Do as chief strategy officer, effective Oct. 3, 2011. He will be responsible for developing and executing enterprise-wide strategy and further building connections between the current and future business plans of Merck's franchises, divisions, and functions. He will report to Kenneth C. Frazier, Merck's president and CEO, and will serve on the company's executive committee. He succeeds Mervyn Turner, who retired from the company this summer. Do was formerly senior vice-president of corporate strategy and business development at TE Connectivity, formerly Tyco Electronics. He currently sits on the board of WuXi AppTec, a pharmaceutical R&D outsourcing company.

The CDMO NextPharma announced that Bill Wedlake, CEO of NextPharma Chief Executive Officer will step down effective Sept. 30, 2011. Franck Latrille will become new CEO, effective. Oct. 3, 2011. The rest of the NextPharma executive management team remains unchanged.