Company and People Notes: FDA Issues Final Guidance on Genetically Engineered Animals; Bob Myers to Retire from PDA; More...

Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, UCB will divest certain business in emerging markets to GSK; the KineMatik Group named Michael G. Jarjour president and CEO; more...

Company Notes

Singapore (Jan. 20)-Abbott opened a new pharmaceutical analytical research laboratory in Singapore's Biopolis research park. The new facility will conduct stability studies to support global regulatory requirements for new pharmaceutical products. It is Abbott's first pharmaceutical research and development site in Southeast Asia.

Tokyo (Jan. 27)-Astellas Pharma submitted a proposal to the board of directors of CV Therapeutics (Palo Alto, CA) to acquire all outstanding common shares of CV Therapeutics for $16 per share in cash. The proposal is not subject to any financing conditions and represents a total equity value of $1 billion on a fully diluted basis. CV Therapeutics previously rejected the same unsolicited offer in November 2008. CV Therapeutics said in a statement that it would review the proposal and advise its shareholders.

Basel, Switzerland (Jan. 27)-Basilea Pharmaceutica plans to expand its worldwide organization and add more than 100 positions in order to focus on “Toctino” (alitretinoin) and “Zeftera/Zevtera” (ceftobiprole medocaril), two drugs it says are high-priority programs, according to a press release. The company will reduce approximately 30 positions at its headquarters that are mainly involved in research programs of lower priority, and it will create 17 new positions in Switzerland and a total of approximately 100 new positions worldwide.

Tokyo (Jan. 19)-Daiichi Sankyo will make an open offer for the acquisition of up to 20% of the common stock of Zenotech Laboratories, a unit of Ranbaxy (Mumbai, India). Daiichi acquired a 63.9% stake in Ranbaxy in 2008.

Cambridge, UK (Jan. 26)-Intercytex Group, a biotechnology company, announced a restructuring plan to reduce cash burn. The company is considering a reduction of headcount at its facilities in Manchester, United Kingdom, and Boston, Massachussetts, of around 50% from the current level of 76 employees, which could take effect in March 2009.

Walkersville, MD (Jan. 15)-Lonza Bioscience will expand with a $26-million new building and 80 new associates, the Frederick News Post reports. The 44,000-ft2 building will accommodate three Class 10,000 cell-production sites and office space. The company expects construction to be completed in the fall of 2009.

Stockholm, Sweden (Jan. 27)-Orexo and NovaMed Pharmaceuticals (Shanghai, China) signed a licensing and distribution agreement that grants NovaMed rights to seek approval to market Orexo’s product for treatment of cancer pain,“Abstral” (rapinyl), in China. The terms of the agreement includes an upfront payment, regulatory milestones and sales milestones. The total value of the deal, which includes an upfront payment and milestones, is $4.75 million.

Brussels, Belgium (Jan. 23)-UCB will divest certain business and affiliates in emerging markets to GlaxoSmithKline (GSK) for a cash compensation of €515 million upon closing of the transaction, which is expected in late March 2009. The commercial operations and product distribution rights to be acquired by GSK represent approximately 3–4% of UCB's 2008 expected revenue of at least €3.3 billion.

Rockville, MD (Jan. 15)-The US Food and Drug Administration issued a final guidance on regulating genetically engineered animals. The guidance, titled The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs, is a followup to the draft released in September 2008. The draft guidance received about 28,000 comments during its 60-day public comment period.

Tampa, FL (Jan. 27)-Xcelience, a contract research organization, recently expanded its GMP manufacturing capabilities with the purchase of three new pieces of equipment: a low-volume feeder, a Diosna P1-6 High Shear Granulator, and a Vector LD CS.

People Notes

Amsterdam (Jan. 22)-Amsterdam Molecular Therapeutics (AMT), a company focused on human gene therapy, announced Ronald H.W. Lorijn will retire as chief executive officer, effective Feb. 1, 2009. Sander van Deventer, AMT's chief scientific officer and co-founder of the company, will serve as interim CEO.

Basel, Switzerland (Jan. 27)-Basilea Pharmaceutica named Laurenz Kellenberger chief scientific officer and member of the executive committee. Kellenberger will succeed Jutta Heim, who is leaving the company.

Palo Alto, CA (Jan. 22)-Genencor, a division of Danisco focused on biotechnology and enzyme manufacturing, appointed Soonhee Jang vice-president of intellectual property strategy and chief intellectual property counsel, effective Jan. 19, 2009. Jang will report to Genencor CEO Tjerk de Ruiter and will be a member of the company’s senior management team.

South San Francisco, CA (Jan. 21)-Genentech appointed Jennifer A. Doudna vice-president of discovery research. Doudna will report to Richard Scheller, executive vice-president of research and chief scientific officer.

Cork, Ireland (Jan. 21)-The KineMatik Group, providers of software solutions for R&D operations, appointed Michael G. Jarjour president and CEO. Jarjour has more than 18 years of experience in the pharmaceutical research and healthcare technology industries.

Florence, KY (Jan. 22)-KMPT USA, Inc., an affiliate of the equipment manufacturer KMPT AG, appointed Patrick McCarty president, effective Jan. 1, 2009. McCarty joined KMPT in 1981 and has served the company in several key roles, including project engineer, product manager, and general manager of sales and marketing.

Liege, Belgium (Jan. 23)-The biotechnology company OncoMethylome Sciences appointed Gert-Jan Renardel de Lavalette chief operating officer, effective Feb. 2, 2009. In this newly created management position, he will focus on the development and commercialization OncoMethylome’s products.

Bethesda, MD (Jan. 29)-Bob Myers, president of the Parenteral Drug Association (PDA), will retire in mid-2009. The organization formed a search committee to hire its next president. Applicants can view the job description here.

London (Jan. 26)-Quanticate, a clinical research organization, appointed Andrew MacGarvey as president of its US operations, headquartered in Cambridge, Massachussetts. MacGarvey will work to expand the company’s clinical trial service capabilities and will direct its global sales efforts.

Sydney, Australia (Jan. 22)-QRxPharma, a specialty pharmaceutical company named Jesus Soriano executive vice-president. Soriano brings more than 17 years of experience in healthcare management, research, regulatory compliance, licensing, and business development.