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Company and People Notes: ISP to raise prices, Patheon appoints CEO, more.
Buffalo Grove, IL (Nov. 27)-Akorn, a pharmaceutical company and contract manufacturers and the pharmaceutical manufacturer Cipla (Mumbai) signed an exclusive 10-year manufacturing and supply agreement for an inhalation product. Under the agreement, Cipla will be responsible for the development, manufacturing, and supply of the drug product. Akorn will be responsible for the regulatory submission with the US Food and Drug Administration and for marketing and distribution of the drug product in the United States and Puerto Rico. Akorn expects to launch the inhalation drug product in 2010.
Tokyo (Nov. 27)-Astellas Pharma’s US subsidiary Astellas US Holding (Deerfield, IL) agreed to acquire Agensys (Santa Monica, CA), a biotechnology company specializing in antibody research and development, for $387 million upfront and an additional $150 million to Agensys shareholders, conditioned on Agensys achieving certain milestones. Agensys applies differential gene expression technology to human tissues and has identified 30 proprietary targets in 14 cancer types, uses an optimized hybridoma method to generate fully human monoclonal antibodies, and has a GMP manufacturing facility for producing investigational antibodies for clinical trial material supply for Phase I and early Phase II trials. The deal is expected to close by the end of December 2007.
Ingelheim, Germany (Nov. 20)-Boehringer Ingelheim received US Food and Drug Administration approval at the end of October 2007 for the manufacture of a biological drug in prefilled syringes. The European Medicines Agency granted approval in July 2007. The product had been produced in a lyophilized form by Boehringer Ingelheim as a contract manufacturer, and now the product will also be available in glass prefilled syringes. The product is the first biopharmaceutical offered by the company in prefilled syringes. The company has a new filling and packaging line with annual capacity of 25 million syringes
Princeton, NJ (Nov. 20)-Covance, a drug-development services company, agreed to purchase a partially constructed manufacturing facility in Prince William County, Virginia from Eli Lilly (Indianapolis, IN). Eli Lilly had announced earlier this year (see Jan. 18 ePT, “Eli Lilly Announces Strategic Changes to its Manufacturing Operations,” that it was stopping construction of its insulin manufacturing facility in Prince William County. Covance plans to convert the 410,000-ft2 into an early drug-development laboratory offering safety testing and chemistry analysis services. Covance will relocate approximately 450 employees from its existing operations in Vienna, Virginia, and Chantilly, Virginia, to the Prince William County facility by 2011, and plans to hire an additional 100 employees by 2014. The total planned investment for the project is $175 million.
Montreal (Nov. 27)-Draxis Health has begun construction of a 77,000-ft2 secondary packaging and warehousing facility in St-Anne-de-Bellevue near Montreal to help fulfill a recently announced contract to product multiple nonsterile specialty semisolid products for Johnson & Johnson Consumer Companies (New Brunswick, NJ). The facility is expected to be completed in mid-2008, after which equipment will be installed and validated. Broccolini Construction (Kirkland, Canada) is designing and building the facility, and the Broccolini Group of Companies will own the facility and lease it to Draxis under a seven-year agreement with an option to renew.
Hyderabad, India (Nov. 26)-Dr. Reddy’s Laboratories signed an exclusive 10-year agreement with the pharmaceutical company Sygnis Pharma (Heidelberg, Germany) for the supply of the active ingredient in AX200, a biological molecule in development by Sygnis for treating stroke and other neurodegenerative disorders. Sygnis completed a Phase IIa clinical trial of AX200 in September 2007.
Wayne, NJ (Nov. 26)-International Specialty Products will increase prices for all its pharmaceutical excipients, including “Plasdone,” “Polyplasdone” binders and disintegrants, “Pharmasolve” solubilizers, cyclodextrins, and pharmaceutical-grade hydrocolloids and biogums, up to 10%, effective immediately or as contracts allow.
Carlow Town, Ireland (Nov. 27)-Merck & Co. (Whitehouse Station, NJ) plans to build a new EUR 200 million ($280 million) vaccine facility in Carlow Town, Ireland, according to IDA Ireland, the economic development agency of Ireland. Merck acquired the 65-acre IDA Business and Technology Park for the facility, which will support Merck’s human vaccines and biologics business. The facility will house formulation and sterile-filling operations and a research and development ream.
Cleveland, OH (Nov. 20)-Oakwood Laboratories, a specialty pharmaceutical company, reports that Santen Pharmaceutical (Osaka, Japan), a pharmaceutical company developing ophthalmic and anti-rheumatic pharmaceuticals is using Oakwood’s “Chroniject” sustained-release delivery technology for Santen’s DE-102, a drug to treat macular edema in Phase I/IIa clinical development. The product’s microsphere formulation and sterile filling was completed at Oakwood’s Cleveland manufacturing facility.
Monterey, CA (Nov. 26)-PARI Pharma, a drug delivery company focused on aerosol technology, reports that its “eFlow” electronic nebulizer was included in Gilead Sciences (Foster City, CA) recent new drug application for aztreonam lysine for inhalation (75 mg three times daily). Aztreonam lysine for inhalation is an investigational therapy for treating patients with cystic fibrosis who have pulmonary Pseudomonas aeruginosa infection.
Lyon, France (Nov. 26)-Rhodia Organics will increase prices by 10 to 15% for its salicylic product range, effective January 2008. The product range includes salicylic acid, “Rhodine” aspirin, methyl salicylate, and salicylate derivatives used in pharmaceutical, flavor and fragrance, and other industrial applications.
Schamburg, IL (Nov. 27)-Sagent Pharmaceuticals, a privately held specialty pharmaceutical company, and Astral Pharmaceutical (Mumbai), a manufacturer and exporter of pharmaceuticals, formed an agreement under which Astral will develop, manufacture, and supply injectable products for which Sagent will obtain US regulatory approval and market in the United States.
Stockholm, Sweden (Nov. 26)-Orexo appointed a new executive management team following its acquisition of Biolipox. The team consists of Torbjörn Bjerke as president and CEO, Claes Wenthzel as executive vice-president and CFO, Thomas Lundqvist as executive vice-president and executive advisor, Göran Smedegärd as vice-president of business development and commercial development, and Göran Tornling as executive vice-president of research and development. Orexo focuses on developing efficient delivery methods for existing products.
Columbia, MD (Nov. 23)-Osiris Therapeutics announced that Cary J. Claiborne left his position as CFO, effective immediately. Phil Jacoby, corporate controller and assistant secretary will serve as interim CFO and corporate secretary until a successor is named. Osiris is a stem-cell therapeutics company.
Toronto, Canada (Nov. 21)-Patheon, a global service provider, appointed Wesley P. Wheeler as CEO, effective Dec. 10. Wheeler brings 29 years of pharmaceutical industry experience, most recently at Valeant Pharmaceuticals International where he served as president of research and development and global manufacturing.
Cost Mesa, CA (Nov. 20)-Synthetic Blood International announced restructuring of its financial, management, and board positions. Following the resignation of Robert Nicora as CEO, Robert Larsen, company founder, will assume the interim CEO responsibilities. In addition, the company appointed Chris J. Stern, PhD, and Richard Kiral, PhD, as members of its board of directors and named Bruce Spiess, MD, and Ross Bullock, MD, to its new scientific advisory board. Synthetic Blood International is a biopharmaceutical company focused on the commercialization of pharmaceuticals and medical devices in oxygen therapeutics and continuous substrate monitoring.