Company and People Notes: Amylin, A.P. Pharma, Avigen, and CombinatoRx Announce Staff Reductions; Maccine Appoints Leigh Berryman CEO; More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Patheon opens new European headquarters, Cynvec appoints Frank D. Stonebanks president and CEO, more...

Company Notes

Bangalore, Karnataka, India (Nov. 10)-Advinus Therapeutics, a contract research organization that is part of the TATA group (Mumbai), began its US operations by incorporating a wholly owned subsidiary, Advinus Therapeutics Inc. The US company will operate out of its office in Research Triangle Park, North Carolina. Eric Nelson was appointed global head of business development for marketing and strategy. He will be based out of the US office and will manage its operations.

San Diego (Nov. 10)-Amylin Pharmaceuticals announced restructuring plans that will reduce its San Diego workforce by approximately 25%, or 340 employees, and reduce anticipated 2009 cash expenditures by more than $80 million. These actions are part of the company's business plan to be cash flow positive by the end of 2010. The company remains fully staffed to grow product revenue from “Byetta” (exenatide) injection and “Symlin” (pramlintide acetate) injection and bring a once-weekly formulation of exenatide to market. Amylin's collaboration with Eli Lilly on the development and commercialization of exenatide is unaffected by the restructuring.

Redwood City, CA (Nov. 5)-A.P. Pharma, a specialty pharmaceutical company, reported financial results for its third quarter, ended Sept. 30, 2008. The company also announced additional positive clinical data for its lead product, “APF530,” which has successfully completed a Phase III trial for the treatment of chemotherapy-induced nausea and vomiting (CINV). To focus the company's resources on APF530, the company will place several earlier-stage development programs on hold, and has implemented staff reductions and other cost-saving initiatives. The programs for “APF112” (a Phase II, long-acting local anesthetic) and “APF580” (a seven-day formulation of an undisclosed opioid, which has completed preclinical testing for acute pain with the successful filing of an investigational new drug application in September 2008) will be suspended. Effective earlier this week, A.P. Pharma eliminated 18 positions, approximately 35% of its workforce.

Tustin, CA (Nov. 10)-Avid Bioservices will expand its biomanufacturing capabilities with the installation of two Thermo Scientific HyClone Single-Use Bioreactors (SUB) in Avid's Tustin, California, facility. Avid plans to use the 100 L SUB to produce antibodies and recombinant proteins in multigram quantities for its clients. The smaller unit will also support the scale-up work for the 1000 L SUB, which will be used to produce clinical material under cGMP conditions.

Alameda, CA (Nov. 3)-Avigen, a biopharmaceutical company, announced a significant restructuring of the company aimed at preserving cash and reassessing its strategic opportunities. The plans include a reduction of more than 70% of the company’s workforce. As a result of the restructuring, Avigen expects to have sufficient cash to fund operations for more than four years.

Phoenixville, PA (Nov. 6)-Bilcare Global Clinical Supplies, a provider of clinical trial supplies and services, expanded its early-stage development capabilities by adding fluid bed granulation and enhanced capsule-filling equipment to its research and development center. The company added a fluid bed granulation system equipped with Wurster coating inserts and an "In-Cap" capsule system, capable of filling several thousand capsules per hour in multiple permutations.

Cambridge, MA (Nov. 5)-CombinatoRx, an emerging pharmaceutical firm, reported financial results for the third quarter, ended Sept. 30, 2008. The company announced restructuring plans, effective immediately, which include a reduction of its Cambridge workforce by approximately 45%. This restructuring is expected to allow the company to operate with current cash reserves into 2011. As a result, CombinatoRx expects to incur a restructuring charge of between $1.6 million and $2 million, primarily in the fourth quarter of 2008.

Cambridge, MA (Nov. 4)-Genzyme and Osiris Therapeutics entered a strategic alliance for the development and commercialization of “Prochymal” and “Chondrogen,” two novel, late-stage adult stem cell treatments that could potentially treat a wide range of diseases. These stem-cell products are designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation. Under the terms of the agreement, Osiris will commercialize Prochymal and Chondrogen in the US and Canada, and Genzyme will commercialize the treatments in all other countries. Genzyme will make an up-front payment of $130 million to Osiris, plus potential significant milestone and royalty payments. Osiris is responsible for the clinical development costs for all ongoing trials, as well as future trials for additional indications through completion of Phase II development. Osiris and Genzyme will share the cost of future Phase III–IV clinical trials, with a 60% Osiris/40% Genzyme split.

Gurgaon, Haryana, India (Nov. 7)-Ranbaxy Laboratories and Daiichi Sankyo (Tokyo) completed their merger deal and Daiichi now owns 63.92% of the equity share capital of Ranbaxy. Continuing to operate as an autonomous company, Ranbaxy will work closely with Daiichi to explore opportunities for growth.

Toronto, Canada (Nov. 6)-Patheon, a drug development and manufacturing service provider, announced the opening of its new headquarters for its European operations in Zug, Switzerland. The new headquarters will manage the company’s sales, marketing, and customer support activities in Europe. 

New York (Nov. 5)-Pfizer will terminate the Phase III development program for its investigational anti-obesity compound, “CP-945,598,” a selective antagonist of the cannabinoid type 1 (CB1) receptor. Pfizer says the compound has the potential to be a safe and effective treatment for weight management, but that the development program is discontinued based on changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval, according to a company press release.


People Notes

Tustin, CA (Nov. 6)-AMDL, a biopharmaceutical company, announced the promotion of its chief financial officer, Akio Ariura, to chief operating officer and CFO. Additionally, Raymond Gatchalian was appointed director of compliance and information technology.

Cheshire, CT (Nov. 11)-Alexion Pharmaceuticals, a biopharmaceutical company,
announced that David W. Keiser, the company's chief operating officer since 1992 and president since 2002, will retire by the end of 2008. He will remain on the board of directors at least through his current term, which ends in 2009. Keiser's responsibilities will be distributed among current members of Alexion's senior management will assume Keiser’s responsibilities, and will report to the company’s CEO, Leonard Bell.

New York (Nov. 11)-Cynvec, a privately held biopharmaceutical company, appointed Frank D. Stonebanks president and chief executive officer, effective immediately. Stonebanks will serve on Cynvec's board of directors.

Salt Lake City, UT (Nov. 11)-Great Basin Scientific, a life sciences company developing molecular diagnostic solutions, named Laurence Rea vice-president of operations. Rea will be responsible for creating the company’s regulatory, manufacturing and quality control systems, and he will oversee the set up of the company's manufacturing facilities in Longmont, Colorado.

Alameda, CA (Nov. 6)-InSite Vision, an ophthalmic products company, announced that S. Kumar Chandrasekaran will step down as chief executive officer, effective immediately. Louis Drapeau, the company’s vice-president and chief financial officer, has been appointed interim CEO. An active CEO search has been initiated.

Singapore (Nov. 7)-Maccine, a preclinical contract research organization, appointed Leigh Berryman CEO of Maccine and subsidiary companies, effective December 1, 2008. Berryman is an accredited toxicologist and certified GLP professional with more than 32 years experience in the industry; 24 years in the biotechnology contract research industry.

Groningen, The Netherlands (Nov. 6)-Mucosis, a biotechnology company developing mucosal vaccines that can be applied via the nose or mouth, appointed Govert Schouten chief executive officer. Schouten formerly served as vice-president of business development at Crucell (Leiden, The Netherlands).

San Diego (Nov. 10)-Orexigen Therapeutics, a biopharmaceutical company focused on the treatment of obesity and central nervous system-related disorders, announced that Gary Tollefson, the company's chief executive officer and president, is taking a leave of absence. He is expected to remain a member of the board of directors during his leave.  Eckard Weber, the current nonexecutive chairman of the board, will serve as executive chairman and interim chief executive officer of the company, effective immediately.

Durham, NC (Nov. 11)-The biopharmaceutical company Regado Biosciences appointed Alexander R. Giaquinto, to the newly created position of senior vice-president of regulatory affairs and quality assurance, effective immediately. Giaquinto will report to David J. Mazzo, Regado's president and CEO, and will be based in the company's office in Basking Ridge, New Jersey.

Seattle, WA (Nov. 10)-Targeted Genetics, a biotechnology company, announced that President and Chief Executive Officer H. Stewart Parker and Executive Vice-President and Chief Scientific Officer Barrie J. Carter, have resigned, effective November 6, 2008. Parker remains on the board of directors. B.G. Susan Robinson will take over as president and CEO.