Company and People Notes: Pfizer Forms Licensing Agreements; Malvinder Mohan Singh Steps Down at Ranbaxy, More...

Company notes

Asymchem Laboratories (Tianjin, China), a contract manufacturer of active pharmaceutical ingredients (APIs) and intermediates, opened a high-potency API manufacturing facility in Tianjin, China. The facility provides containment for production of potent APIs at an occupational exposure level (OEL) of < 0.1mg/m³/8hrs, validated by an expert independent assessor. The facility features two separate API manufacturing trains of 50 and 100L, and contains four independent breathing air lines per suite. The space will allow for the future addition of smaller-scale research and production of oral dosage forms, tablets and capsules, and manufacturing that incorporates potent ingredients.

Dr. Reddy’s (Hyderabad, Andhra Pradesh, India) announced that effective July 1, 2009, its drug-discovery operations at Hyderabad will be absorbed into Aurigene, a wholly owned independent subsidiary of the company. Aurigene is a partnership-based drug discovery biotech entity headquartered in Bangalore, Karnataka, India. The discovery research resources such as employees, facility, and infrastructure will transition into being resources of Aurigene, which will now operate out of Bangalore and Hyderabad.

Genzyme (Cambridge, MA) announced that it submitted documentation to address all items in FDA’s complete response letter for Lumizyme (alglucosidase alfa), produced at the 2000-L bioreactor scale. Genzyme also completed all of the measures required to respond to the FDA warning letter regarding the company’s Allston, Massachusetts, manufacturing facility. FDA has begun the inspection process at the plant to determine if the deficiencies cited in its warning letter have been satisfactorily addressed. Genzyme and FDA are also in discussions regarding the submission of a supplemental biologics license application for the 4000-L scale manufacturing process. Genzyme anticipates filing its submission later this quarter.

The biopharmaceutical company Human Genome Sciences (HGS, Rockville, MD) and Novozymes Biopharma (Nottingham, UK), a part of Novozymes, amended their existing license agreement relating to albumin fusion technology. Under the amended agreement, HGS and Novozymes each have the opportunity to exclusively license and/or sublicense a number of albumin fusion proteins in exchange for royalties and other consideration. Financial or other terms of the agreement were not disclosed.

Johnson & Johnson (New Brunswick, NJ) will acquire Cougar Biotechnology (Los Angeles, CA), a biopharmaceutical company with a focus on oncology, in a $1-billion cash tender offer. Cougar Biotechnology, which has compounds in development for the treatment of prostate cancer, breast cancer, and multiple myeloma, will work with Ortho Biotech Oncology Research & Development, a unit of Centocor Research & Development, a Johnson & Johnson company.

Morphotek (Exton, PA), a subsidiary of Eisai Corporation of North America, and Lonza Group (Basel) signed a manufacturing pact for a subset of antibodies in Morphotek’s therapeutic antibody pipeline. The agreement will reserve capacity for commercial manufacturing of Morphotek’s lead compound farletuzumab (also known as MORAb-003), which recently entered Phase III clinical trials for ovarian cancer under a special protocol assessment agreement with the US Food and Drug Administration. The collaboration between both parties already encompasses several other monoclonal antibodies currently in clinical or preclinical development.

Novartis (Basel) agreed to acquire the specialty generic injectables business of EBEWE Pharma (Unterach, Austria) for EUR 925 million ($1.2 billion) in cash. Excluded from this transaction is EBEWE Pharma's separate injectable neurological products business.

Novartis (Basel) and Schering Plough restructured their fixed-dose combination respiratory therapy pact. Novartis has assumed exclusive worldwide rights to develop and commercialize QMF149, a fixed-combination of its investigational drug QAB149 (indacaterol) with Schering-Plough’s inhaled corticosteroid mometasone. QMF149 is being developed for chronic obstructive pulmonary disease and asthma. A Novartis press release says the agreement is a step toward a potential innovative respiratory portfolio centered around QAB149.

Onyx Pharmaceuticals (Emeryville, CA) filed a complaint in the United States District Court for the Northern District of California asserting its rights to a Phase II anticancer compound discovered during joint research between Onyx and Bayer. In its complaint, Onyx seeks a declaration that fluorosorafenib is a jointly owned collaboration compound under the Bayer/Onyx collaboration agreement, together with other remedies. The defendants in the complaint are Bayer Corporation (Leverkusen, Germany) and Bayer AG. Onyx said that it continues to collaborate with Bayer in the development and commercialization of Nexavar, according to a press release.

Patheon (Research Triangle Park, NC), a provider of drug-development and manufacturing services, introduced cell-based assay services to support biopharmaceutical product development. Biological potency analytics and the required supporting capabilities for tissue culture, such as assessment of cell viability and production of master and working cell banks, will take place at Patheon’s Swindon, UK, facility.

Peru’s National Center for Quality Control (the Centro Nacional de Control de Calidad, or CNCC) has attained internationally recognized ISO/IEC 17025:2005 accreditation for testing and calibration laboratories. The US Agency for International Development (USAID) and the US Pharmacopeial (USP) Convention assisted the laboratory in achieving the accreditation.

Pfizer (New York) entered into licensing agreements with two pharmaceutical companies based in India (Aurobindo Pharma and Claris Lifesciences) in a move designed to expand its portfolio of generic medicines in its Established Products Business Unit. Under its deal with Aurobindo, Pfizer acquired the rights to 55 solid oral dose products and five sterile injectable products. Under its deal with Claris Lifesciences, Pfizer acquired the rights to 15 injectable products. As a result of the deals, 60 products will be available in more than 70 countries throughout Asia, Latin America, Africa and the Middle East, and more than 100 products will be available across North America, Europe, Australia, and New Zealand.

Takeda Pharmaceutical's (Osaka, Japan) subsidiary Takeda America Holdings will acquire IDM Pharma (Irvine, CA). Takeda America will purchase all of IDM Pharma's outstanding shares for $2.64 per share in an all-cash tender offer followed by a merger. Millennium: The Takeda Oncology Company, Takeda’s business unit responsible for oncology strategy and development, will have development responsibility for Mepact (mifamurtide), a therapy indicated for the treatment of non-metastatic osteosarcoma, and Takeda Pharmaceuticals Europe will be responsible for commercializing Mepact in Europe. The European Commission granted a centralized marketing authorization for the drug on March 6, 2009.

Takeda Pharmaceutical (Osaka, Japan) signed a deal with Novartis (Basel) for a vaccine for the prevention of infection caused by Haemophilus influrnzae Type B (Hib). Novartis developed the vaccine, known as Vaxem Hib, by combining it with the detoxified diphtheria toxin to increase immunogenicity, assuring the potential to induce the production of antibody in infants. Under the agreement with Novartis, Takeda obtains an exclusive right for the development and commercialization of Hib vaccine in Japan, and also the right for development, manufacture and commercialization of combination vaccines, including Hib vaccine, outside Japan. If Takeda decides to commercialize such combination vaccines outside Japan jointly with other companies, Novartis has the prioritized right as a partner. Takeda will pay to Novartis an upfront payment of 100 million yen ($1 million) plus milestone and royalty payments.

Regulatory Roundup

The National Institutes of Health (NIH) launched a program to develop drugs for rare and neglected diseases. The $24-million program begins a trans-NIH initiative called the Therapeutics for Rare and Neglected Diseases program (TRND), which creates a drug-development pipeline within NIH and is designed to stimulate research collaborations with academic scientists working on rare illnesses. The NIH Office of Rare Diseases Research (ORDR) will oversee the program, and TRND’s laboratory operations will be administered by the National Human Genome Research Institute (NHGRI), which also operates the NIH Chemical Genomics Center (NCGC), a principal collaborator in TRND. Other NIH components will also participate in the initiative.

The New Molecular Purification Technology for Pharmaceutical Production (NEMOPUR) project, which is focused on developing technologies for removing organic impurities from the production of active pharmaceutical ingredients (APIs), was awarded 3 million euro ($4.1 million) by the European Commission (EC) as part of the EC’s 7th Framework Program of the Marie Curie Initial Training Network (TIN). TIN awards funding to researchers to strengthen the scientific and technology base of the European industry. The NEMOPUR project will develop new solvent-resistant membranes with improved chemical stability and better controlled cut-off properties, molecularly imprinted polymers with scaleable production chemistries, and composite molecularly imprinted films. The project is led by a consortium of three universities-Imperial College London, the Institute on Membrane Technology, and the Technical University of Dortmund-and industrial partners, GlaxoSmithKline (London), UCB (Brussels), and Hovione (Lisbon, Portugual). Experts from Membrane Extraction Technology (Wembley, England), a company focused a separation process development, and MIP Technologies (Lund, Sweden), a company developing molecularly imprinted polymers, will also contribute.

People Notes

Daiichi Sankyo (Tokyo) and Ranbaxy Laboratories (Gurgaon, Haryana, India) announced that Malvinder Mohan Singh has stepped down from the positions of chairman, CEO, and managing director of Ranbaxy, effective May 26, 2009. Atul Sobti, currently Ranbaxy's chief operating officer, was appointed CEO and managing director. Tsutomu Une, non-executive director of Ranbaxy, was elected as chairman of the board.

GeoVax Labs (Atlanta, GA), a biopharmaceutical company developing vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, announced today that Chuck Panozzo, founder of the rock band Styx, has joined the GeoVax Labs awareness campaign as an advocate of the company's HIV/AIDS vaccine, currently in Phase IIa human trials.

Keryx Biopharmaceuticals (New York) appointed Ron Bentsur chief executive officer of the company. Bentsur is expected to join the company's board of directors at the annual meeting of the board on June 16, 2009.

The contract research organization PPD (Wilmington, NC) promoted Fredric N. Eshelman, vice-chairman and CEO, to the newly created position of executive chairman of the board of directors. Ernest Mario, who has served as the non-executive chairman of the board since 1993, was appointed lead independent director. Brig. Gen. David L. Grange (retired), a member of PPD’s board of directors since 2003, was named PPD’s new CEO. Grange will report to Eshelman in his new capacity as executive chairman. These appointments will be effective July 1, 2009.

Simcere Pharmaceutical Group (Nanjing, China), a manufacturer of branded generic and innovative pharmaceuticals, appointed Peng Wang chief scientific officer. Wang has two decades of experience in pharmaceutical research and development, most recently serving as vice-president of discovery biology at WuXi PharmaTech (Shanghai).

Xention (Cambridge, UK), a biopharmaceutical company, appointed Calum Graham as director of business development. For the last six years, he served as director of scientific licensing in worldwide business development at GlaxoSmithKline (London).