Week of Oct. 5, 2009: Merck and CSL Sign Flu Vaccine Pact; Cardinal Health Names VP; More...

October 8, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Company and People Notes: GSK forms joint venture with China-based Jiangsu Walvax Biotech; Sigma-Aldrich appoints VP and board member; more...

The contract manufacturing organization Almac (Craigavon, Northern Ireland) is planning an expansion that could potentially create more than 500 jobs during the next five years, according to a company press release. The company acquired a 5.4-acre site adjacent to its Craigavon, Northern Ireland, headquarters and will soon begin the first phase of development there. This phase includes the construction of a three-story office unit to accommodate over 220 employees, and the second phase will include a new research facility and distribution unit.

Caraco Pharmaceutical Laboratories (Detroit, MI) entered into a consent decree with the US Food and Drug Administration regarding the company's drug-manufacturing operations. The decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Detroit area facilities, and the company is working to satisfy those requirements.

GlaxoSmithKline (GSK, London) issued a statement about the death of a 14-year-old girl who was vaccinated with its cervical cancer vaccine, Cervarix. GSK said it was notified by the UK’s Department of Health on Sept. 28, 2009, that the girl, Natalie Morton, had died after receiving Cervarix as part of the national human papillomavirus immunization program. Pim Kon, medical director for GlaxoSmithKline UK said, “Our deepest sympathies are with the family and friends of the young girl. At this stage the cause of this tragic death is unknown. Following immediate quarantine of the batch involved last night, we have taken the decision to voluntarily recall this batch as a further precautionary measure while the investigation into the circumstances surrounding Natalie’s death is conducted.” GSK recalled the batch number AHPVA043BB, and it will be tested as part of the investigation. Other batches of the vaccine remain available and are not affected by this recall.

In a separate announcement, GSK said it formed a long-term joint venture (JV) with Jiangsu Walvax Biotech (Taizhou, Jiangsu, China) to develop and manufacture pediatric vaccines for use in China. The JV will produce vaccines for measles, mumps, rubella, and potentially other pediatric vaccines. GSK will transfer the technology to enable the JV to manufacture the vaccines locally over time. In addition to the technology transfer, the JV will build a new manufacturing facility for GSK’s pediatric vaccine Priorix and once the facility is operational, the JV will supply the vaccines to China’s public vaccine market, according to a company press release.  

Hospira (Lake Forest, IL), a specialty pharmaceutical company, acquired the worldwide rights to a biogeneric version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska (Zagreb, Croatia) located in Croatia. Hospira will now have full global rights to the biogeneric filgrastim that had previously been part of a strategic collaboration between Hospira and PLIVA/Barr, the latter two companies now owned by Teva Pharmaceutical Industries (Petach Tikva, Israel). Financial terms of the agreement were not disclosed.

Merck & Co. (Whitehouse Station, NJ) entered into an agreement with CSL Biotherapies, a subsidiary of CSL Limited (Melbourne, Australia), to market and distribute Afluria (influenza virus vaccine), CSL's seasonal flu vaccine, in the United States for the 2010/2011–2015/2016 flu seasons. CSL and Merck have been partners in vaccine development and marketing since 1980. Under the terms of the agreement, Merck will assume responsibility for all aspects of commercialization of Afluria in the U.S, and CSL will supply the vaccine to Merck. Financial details of the agreement were not disclosed. 

OctoPlus (Leiden, the Netherlands), a drug-delivery company, will reduce its workforce by approximately 25%. Reductions will occur across all areas of the company and have taken place in consultation with the company’s works council. The reduced headcount will not impact the company’s targeted revenues for 2009, according to a company press release.

Pharmatek Laboratories (San Diego, CA), a contract development and manufacturing organization, announced it acquired the Xcelodose system. The Xcelodose, manufactured by Capsugel, a division of Pfizer (New York), is a precision powder microdoser and automated encapsulator that has the ability to accurately fill formulations or active pharmaceutical ingredient directly into capsules. Pharmatek Laboratories will install the Xcelodose unit in its solid-dose manufacturing facility located in San Diego, California.

Sanofi aventis agreed to acquire Fovea Pharmaceuticals, biopharmaceutical company focused on the treatment of ocular diseases. Fovea has a portfolio of three clinical compounds, a proprietary technology platform, and several discovery programs dedicated to eye diseases. Under the terms of the agreement, sanofi aventis agreed to purchase Fovea for up to EUR 370 million ($544 million), including an upfront payment and subsequent milestone payments related to the three clinical compounds.

In a separate announcement, sanofi aventis said it signed an agreement with Merrimack Pharmaceuticals, to develop and commercialize MM-121, a fully human monoclonal antibody designed to block signaling of the ErbB3 receptor. The the ErbB3 receptor is a member of the epidermal growth factor receptor family (also known as ErbB family) that plays a role in the development and evolution of cancer. MM-121 is currently in Phase I clinical testing. Sanofi aventis will pay Merrimack an upfront cash payment of $60 million, milestone payments of up to $410 million, and sales-based royalties of up to $60 million.

Sigma-Aldrich (St. Louis, MO) and Sangamo BioSciences (Richmond, CA) expanded their existing license agreement to include the exclusive rights to develop and distribute zinc finger DNA binding protein (ZFP)-modified cell lines for commercial production of protein pharmaceuticals. Additionally, Sigma-Aldrich licensed rights to certain ZFP-engineered transgenic animals for commercial applications.

West Pharmaceutical Services, (Lionville, PA), a company focused on injectable drug administration, announced the formal opening of its injection-molding factory in the Shanghai Qingpu Industrial Zone (SQIZ) in China. The Qingpu plant features advanced injection-molding technologies where West will manufacture TrimTec and InsoCap closures for intravenous solution bottles. The plant is approximately 129,000-ft2 on 7.8 acres. It currently employs 52 people and is ISO:9001 certified.

Xcellerex (Marlborough, MA) and Itero Biopharmaceuticals (San Mateo, CA) entered a collaboration for the production of Itero’s lead product, an undisclosed commercially differentiated therapeutic protein. Itero will initiate technology transfer for the product to Xcellerex, and Xcellerex will provide development expertise and product manufacturing for global clinical and commercialization supplies under the terms of a Master Services Agreement to be executed as soon as is reasonably practicable. The companies anticipate that this will be a multiproduct collaboration, and for the first product, Xcellerex will manufacture Itero’s Phase III clinical materials in 2010/2011.

People Notes

Algos Therapeutics (St. Paul, MN), a contract research organization, appointed Ganesh Iyer as its president and CEO. Iyer previously was director of strategic analysis and business operations at MDS Pharma Services (King of Prussia, PA).

Cardinal Health (Dublin, OH) named Mark Blake executive vice-president of strategy and corporate development, effective Oct. 19. Blake will be responsible for company-wide strategic planning and business development, and will report to George Barrett, the company’s chairman and CEO.

Clinsys Clinical Research (Bedminster, NJ), a clinical research organization, appointed Karen Lewis vice-president of global clinical operations. Lewis has more than 20 years of clinical research experience in multiple therapeutic areas, including infectious disease, gastrointestinal diseases, cardiovascular, central nervous system, ophthalmology, dermatology, and women’s health.

GTC Biotherapeutics (Framingham, MA), a developer of therapeutic proteins produced through transgenic animal technology, appointed Evelyne Nguyen, Jean-François Prost, Bertrand Merot, and William Heiden as directors. These appointments replace the following directors who have resigned: Robert Baldridge, Kenneth Bauer, Mary Ann Gray, and Marvin Miller.

Sigma-Aldrich (St. Louis, MO) appointed George Miller senior vice-president, general counsel and secretary. He will report to Jai Nagarkatti, chairman, president and CEO. Additionally, George M. Church was elected by the board as a director of the company. Church is a professor of genetics at the Harvard Medical School and director of the Center for Computational Genetics in Cambridge, Massachusetts.

Sinobiopharma (Nantong City, Jiangsu, China) appointed Xinjie (James) Mu as its chief financial officer and as a director of the board. Mu replaces Lequn Huang, who resigned as CFO.