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ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Genzyme to build R&D center in Beijing, Noven Pharmaceuticals appoints Peter C. Brandt president and CEO, more...
Sulzbach, Germany (Apr. 18)-Archimica sold its 5-fluorouracil production facility at Humacao, Puerto Rico, to a subsidiary of Teva Pharmaceutical Industries (Jerusalem, Israel). Financial details of the transaction were not disclosed.
Somerset, NJ (Apr. 23)-Catalent Pharma Solutions, a provider of outsourcing services, will more than double its bioreactor capacity, adding a 1000-L bioreactor train in its Middleton, Wisconsin, facility by 2009. The expansion is in response to increased client demand for production to support clinical trials across Asia, Australia, Europe and now the United States. Catalent supplies biotechnology companies with proteins made by its “GPEx” system, which produces stable, high-yielding mammalian cell lines for protein production.
Kingsport, TN (Apr. 10)-Eastman Chemical will close its manufacturing site located in Wales, UK, and will cease production of EASTMAN Vitamin E TPGS, which is currently manufactured at the site. TPGS is used as a pharmaceutical excipient, and Eastman will provide transition supply inventory to customers based on historical purchases. The company expects to close the site later this year.
London, UK (Apr. 22)-GlaxoSmithKline (GSK) and Sirtris Pharmaceuticals (Cambridge, MA) entered into a definitive agreement in which GSK will acquire Sirtris for approximately $720 million through a cash tender offer of $22.50 per share. Through this acquisition, GSK will establish a presence in the field of sirtuins. Sirtris has established a drug discovery capability to exploit sirtuin modulation for the treatment of human disease. Their focus to date has been on the development of SIRT1 activators for the treatment of Type 2 diabetes mellitus (T2DM).
Cambridge, MA (Apr. 22)-Genzyme will build a major new research and development center in Beijing, as part of the company’s global expansion and commitment to establishing a long-term presence in China. The new facility will be used for research and development in areas such as orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease. The facility, which will feature an innovative green design, will also include laboratory-scale operations for the “MACI” (matrix-induced autologous chondrocyte implantation) cell therapy and polyclonal antibody operations.
Genzyme also announced last week that FDA informed the company of its opinion that “Myozyme” (alglucosidase alfa) produced at the 160 L-bioreactor scale and Myozyme produced at the 2000 L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. Currently, Genzyme has US approval to sell Myozyme manufactured at the 160 L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000 L scale. Production at this larger scale has already been approved in more than 40 countries. The FDA will require Genzyme to submit a separate biologics license application (BLA) to gain approval for Myozyme produced at the 2000 L scale. The company expects to begin providing US patients with commercial 2000 L Myozyme during the first quarter of 2009.
Mumbai, India (Apr. 15)-Nicholas Piramal India Limited (NPIL) and Khandelwal Laboratories (K-Lab) signed a definitive agreement for purchase of Anafortan and CEFI Brand Groups by NPIL for a total consideration of Rs. 1,160 million ($28.7 million). As a part of the agreement, K-Lab has agreed to provide NPIL with certain patents’ use and noncompete assurances for Cefixime- and Camylofin-based drugs. Anafortan and CEFI Groups had revenues of Rs. 491 million ($12.1 million) for the financial year ended March 31, 2008.
Gurgaon, India (Apr. 22)-Ranbaxy Laboratories and Orchid Chemicals & Pharmaceuticals (Chennai, India) entered into an agreement involving multiple geographies and therapies for both finished dosage formulations and active pharmaceutical ingredients. This agreement would establish a framework for enhanced future cooperation between the two companies.
Fairfield, NJ (Apr. 23)-Unigene Laboratories broke ground for new facilities for its joint venture in China. The joint venture, named Unigene Biotechnology Co. Ltd., will operate facilities for research, development, formulation and manufacturing that will occupy more than 215,000 ft2 of space. The joint venture is currently owned 55% by the Shijiazhuang Pharmaceutical Group and its subsidiaries, the China Pharmaceutical Group, a publicly traded company based in Hong Kong, and NBP Pharmaceutical, and 45% by Unigene. The first phase of construction will be completed this year and validation activities will begin in 2009. Initial research and manufacturing will focus on salmon calcitonin, parathyroid hormone, and related products for China and possibly other global markets. The location of the park is in the Shijiazhuang Economic and Technology Development Zone of Hebei Province.
Somerset, NJ (Apr. 28)-Alfacell announced that Kuslima Shogen, the company’s chief executive officer and scientific founder, will retire on or before March 31, 2009. Lawrence A. Kenyon has been named president. Kenyon joined Alfacell in January 2007 as executive vice-president, chief financial officer, and corporate secretary. He was promoted to chief operating officer and elected to the board of directors in November 2007.
Reinach, Switzerland (Apr. 25)-Arpida, a biopharmaceutical company, announced that Jurgen Raths will succeed Khalid Islam as chief executive officer. Islam will work closely with Raths for a seamless transition and will continue as a consultant for the coming years. Raths, a member of the Arpida board since 2006, will assume his responsibilities as CEO on May 1, 2008. The board of directors will propose to appoint Islam as a member at the annual general meeting on May 7, 2008.
Alameda, CA (Apr. 23)-InSite Vision, an ophthalmic company, appointed Surendra Patel to the newly created position of vice-president of operations. Patel will be responsible for the direction of operational activities, including the expansion of commercial contract manufacturing for international sales of “AzaSite;” the on-site production of clinical supplies for testing product candidates; and the planning of commercial capability for future products.
Miami, FL (Apr. 29)-The board of directors of specialty pharmaceutical company Noven Pharmaceuticals appointed former Pfizer executive Peter C. Brandt president, chief executive officer and to the Noven board of directors. These appointments are effective immediately.
Petaluma, CA (Apr. 23)-Oculus Innovative Sciences, a biopharmaceutical company, appointed Michelle Carpenter to the position of vice-president of regulatory affairs and quality. Carpenter will lead the company’s regulatory and quality activities including key negotiations with the FDA regarding clinical development initiatives.
Madison, NJ (Apr. 24)-Wyeth announced that its chairman, Robert Essner, has decided to retire from the company, effective June 27, 2008. Essner held the position since January 2003 and served as Wyeth's chief executive officer from 2001 to 2007. The board of directors elected Bernard Poussot, Wyeth’s president and chief executive officer, to the additional position of chairman, effective June 27, 2008.