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Company and People Notes: FDA Warns Puerto Rico-Based Compounder Farmacia La Salud, Chemokine Names Walter Korz President and CEO, More

Company notes

Windsor, Canada (Apr. 18)Accucaps Industries, a company focused on soft gelatin encapsulation products, converted its newest facility in Strathroy, Ontario, to focus on the production of health, nutritionals, and cosmetic products. Effectively doubling the total manufacturing and production capacity for Accucaps, the 125,000-ft2, GMP facility will become the ‘center of excellence’ for the manufacturing and production of health and nutritionals in North America. The new facility features product compounding, 16 encapsulation machines capable of producing 4 billion doses, a large temperature-controlled warehouse, and capabilities for blistering, bottling, and distribution.

Toronto, Canada (Mar. 26)Clairvest Group Inc. and Clairvest Equity Partners III Limited Partnership announced a combined $20-million minority investment in Lyophilization Services of New England (LSNE, Manchester, NH). LSNE is a contract manufacturing organization focused on providing lyophilization services to biotech, pharmaceutical, and medical device manufacturers and operates two facilities: one in Manchester, New Hampshire, the other in nearby Bedford.

Düsseldorf, Germany (Apr. 16)—German pharmaceutical packaging company Gerresheimer announced that The Blackstone Group will sell its approximately 25% stake in Gerresheimer, held by BCP Murano II S.à.r.l., with immediate effect. In this transaction, led by Credit Suisse, 7.8 million shares will be sold to a variety of institutional investors. Blackstone has thus decided to exit its Gerresheimer investment after Gerresheimer’s initial public offering in June 2007. 

Dungarvan, Ireland (Apr. 18)GlaxoSmithKline (GSK, London) will invest a further €30 million ($47.7 million) in the expansion of its existing over-the-counter pharmaceutical manufacturing facility in Dungarvan, Ireland. The investment will create 50 new jobs over three years in the production of a product to aid smoking cessation, for supply to all markets outside of North America. GSK employs 1450 people in Ireland and first established operations there in 1975. Two manufacturing operations in Dungarvan make GSK the largest employer in the town with almost 700 employees; in Cork GSK has a third manufacturing operation, where it develops and produces bulk pharmaceuticals, together with research and development and European trading operations. Sales and marketing functions take place in Dublin.

Princeton, NJ (Apr. 10)Laureate Pharma, a contract manufacturing company, entered into a contract manufacturing agreement with Alopexx Pharmaceuticals (Cambridge, MA). According to the agreement, Laureate will produce Alopexx’s mAb F598 antibody under CGMP conditions. This antibody is planned for use in clinical trials, and later for commercial production for the treatment and prevention of Staphylococcus aureus infections. Terms of the agreement were not disclosed.

Rockland, MA (Apr. 16)Merck Serono and its US affiliate EMD Serono, Inc., both part of Merck KGaA (Darmstadt, Germany), announced an investment of $50 million at EMD Serono’s Billerica facility northwest of Boston, Massachusetts. The company anticipates that this investment will create more than 100 new jobs in Massachusetts. Once complete, the new site will accommodate approximately 200 scientists with expertise in cancer biology, cancer immunotherapy, oncogene signaling, manufacturing cell lines, medicinal chemistry, molecular modeling, protein engineering, and therapeutic antibodies, across the research areas of cancer and fertility, as well as approximately 50 employees in technical operations who specialize in process development and protein production. The company’s protein production facility in Billerica, which manufactures products for early-stage clinical testing, is a significant reason why the site was selected for expansion. Construction at the new site will begin early next year and is expected to be complete in 2010. Upon completion, the total square footage of the Billerica Campus will be approximately 210,000 ft2, including more than 160,000 ft2 of lab space.

Tredegar, UK (Apr. 14)—Welsh contract manufacturing organization Penn Pharmaceuticals will expand its storage and distribution services with a new facility. The temperature-controlled warehouse, located at Pen-y-Fan Industrial Estate in Crumlin, Wales, will support Penn’s existing clinical and commercial storage and distribution services. The new warehouse will create an additional 2400 pallet locations and will be able to hold several hundred thousand patient drug packs, which increases Penn's storage and distribution capacity sevenfold.  

Toronto, Ontario (Apr. 15)Sanofi Pasteur, the vaccines division of Sanofi-Aventis (Lyon, France), will invest Can$100 million (US$99.4 million) in a research and development facility in Canada. The investment includes the construction of a Can$80-million (US$79.5-million) facility, the purchase of specialized R&D equipment, and the support of jobs over the next five years. Construction of the 165,000-ft2 facility will begin in 2008 and is projected to be ready for occupancy in 2010. Research targets will include pediatric combination vaccines, pneumococcal protein vaccines, and cancer vaccines. 

Rockville, MD (Apr. 24)—The US Food and Drug Administration issued a warning letter to Puerto Rico-based Farmacia La Salud (FLS, Caguas, PR), a pharmacy compounder, for going beyond what FDA considers “traditional extemporaneous compounding” and manufacturing large volumes of inhalation solution products, including some that are copies of FDA-approved solutions, without the consent of FDA. FLS was also cited for nine violations of CGMP regulations. The letter was dated March 26, 2008, and posted on FDA’s website last week.

People Notes

Portland, OR (Apr. 16)AVI BioPharma appointed Ryszard ‘Richard’ Kole, PhD, as senior vice-president of discovery research. Kole has a successful track record of research and discovery in directed alternative splicing and was a company founder of Ercole Biotech, Inc. AVI’s acquisition of Ercole closed on March 20, 2008. Patrick L. Iversen, PhD, who had served AVI as senior vice-president of research and development, will assume a new role as senior vice-president of strategic alliances.

Vancouver, Canada (Apr. 16)Chemokine Therapeutics, a biotechnology company, appointed Walter Korz as its new president and chief executive officer. Korz succeeds Bashir Jaffer who held the position as CEO on an interim basis since December 2007. Jaffer will continue to serve the company as chief financial officer.

Valencia, CA (Apr. 16)MannKind announced that Matthew J. Pfeffer will join the company as corporate vice-president and chief financial officer, effective April 21, 2008. Pfeffer will report to Hakan Edstrom, president and chief operating officer. Pfeffer’s appointment follows the previously announced retirement of Dick Anderson, who has now transitioned to the role of corporate vice-president, office of the chairman.

Emeryville, CA (Apr. 17)ProGenTech, a life sciences company based in Shanghai, China, and Emeryville, California, made several executive management appointments: Paul Richardson joined ProGenTech as vice-president for R&D; Jesus Ching was appointed chief scientist; Sarah Wenning joined ProGenTech as vice-president of US operations; Dylan Bird joined the company as director of business development; and David Hu joined ProGenTech as vice-president of engineering. All will be based in Emeryville, except Hu, who will be based in Shanghai.

Research Triangle Park, NC (Apr. 16)Quintiles Transnational named Oren Cohen senior vice-president of clinical research strategies. Most recently, Cohen held the position of chief medical and scientific officer. Also, Cohen will continue to serve as managing director of Quintiles Public Health and Government Services.

Source:  ePT--the Electronic Newsletter of Pharmaceutical Technology, Company and People Notes: FDA Warns Puerto Rico-Based Compounder Farmacia La Salud, Chemokine Names Walter Korz President and CEO, More,

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