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Also, Quintiles Transnational to acquire Eidetics, ChemAxon appoints Alex Drijver CEO, more...
Santa Clara, CA (May 7)-Agilent Technologies is expanding its nucleic acid active pharmaceutical ingredient (API) manufacturing facility in Boulder, Colorado. Agilent's Nucleic Acids Solutions Division is adding large-scale nucleic acid synthesis, purification and drying capacity that will come on stream by the end of 2008. As a part of this expansion, Agilent has purchased from Dowpharma (Midland, MI) all of the assets of its Nucleic Acid Medicines business. The financial terms of the purchase were not disclosed. This is the second manufacturing expansion for the Boulder facility since Agilent purchased the business in 2006. Agilent’s capacity expansion features the addition of a 200–1,000 mmole synthesizer capable of producing kilo quantities of API per synthesis batch, a 30-liter-per-min chromatography system, two multikilo lyophilization units, as well as infrastructure and reaction vessels for custom conjugation chemistries and duplex annealing of siRNAs.
Baton Rouge, LA (May 5)-Albemarle, a provider of custom pharmaceutical manufacturing services, was selected by SIGA Technologies, a company focused on the development of pharmaceutical agents to fight biowarfare pathogens, to provide scale-up and manufacturing services for ST-246, SIGA’s leading smallpox antiviral candidate. Caused by the variola virus, smallpox is no longer found generally in the environment, but it is considered a formidable bio-warfare threat. SIGA’s ST-246 has shown evidence of safety and high levels of efficacy against poxvirus disease in multiple animal trials, as well as continued success in human safety studies. As a result of success in early trials and in one emergency compassionate use case, FDA has designated ST-246 for "fast track" status. Activities supporting a new drug application are currently in process. Under its existing manufacturing agreement with SIGA, Albemarle's Fine Chemistry Services division will scale up the manufacturing process for SIGA's active pharmaceutical ingredient to produce three CGMP registration batches at Albemarle's facility in South Haven, Michigan.
Toronto, Canada (May 8)-To improve operating efficiencies, Biovail is taking steps to close its two Puerto Rico manufacturing facilities and transfer certain manufacturing processes to its Steinbach, Manitoba, facility. Biovail believes these closures, which are expected to take 18–24 months to complete, should not result in any supply disruptions, and are intended to reduce costs.
Bridgewater, NJ (May 7)-Enzon Pharmaceuticals will spin-off its novel biotechnology business from Enzon resulting in two independent public companies. Upon completion of the spin-off, Jeffrey H. Buchalter will serve as chairman, president and chief executive officer of the new biotechnology company and Craig Tooman, the current chief financial officer of Enzon, will assume the role of president and CEO of Enzon. Each company will operate with independent management teams, the details of which be disclosed at a later time.
Uttar Pradesh, India (May 8)-Jubilant Organosys, a custom research and manufacturing services company, acquired Speciality Molecules (Ambarnath, India), a niche manufacturer with manufacturing facilities, for Rs. 199.5 million ($4.7 million) on a debt free, cash free basis. Speciality Molecules is engaged in developing, manufacturing and selling intermediates, which include primarily pyridine derivatives used in the pharmaceutical and other life science industries.
Whitehouse Station, NJ (May 5)-Merck plans to reduce the size of its US sales force by 1200 positions. Affected employees, who are located throughout the US, will be notified by the end of May; separations will be completed by the end of July. Eligible employees will receive benefits and other services to assist them.
Research Triangle Park, NC (May 7)-Quintiles Transnational signed an agreement to acquire Eidetics (Boston, MA), a privately held decision-analytics and market research consulting firm as part of its expanding Quintiles Consulting business. Eidetics has provided research-based market insights and data analytics to support business decision making in drug development and commercialization for the past 20 years and has worked with 18 of the top 20 pharmaceutical companies.
Guragaon, India (May 12)-Ranbaxy Laboratories and Merck (Whitehouse Station, NJ) signed a product development agreement for a drug discovery and clinical development collaboration for new products in the anti-infective field. Under the terms of the agreement, Ranbaxy will handle drug discovery and clinical development through Phase IIa clinical trials, with Merck conducting development and commercialization of drug candidates thereafter. The collaboration will begin this year with an initial term of five years and can be extended mutually thereafter by the parties. Ranbaxy will be paid an undisclosed upfront sum, with the potential to receive payments totaling more than $100 million in milestone payments. Ranbaxy is also eligible to receive royalties on worldwide net sales of any products commercialized under the agreement.
Princeton, NJ (May 9)-Celator Pharmaceuticals, a biopharmaceutical company, appointed Scott Jackson chief executive officer. Jackson joined Celator in October 2007 as head of commercial development. He succeeds Andrew Janoff.
Budapest, Hungary (May 12)-ChemAxon, a software solutions provider for cheminformatics, appointed Alex Drijver as chief executive officer (CEO). Ferenc Csizmadia, founder and former CEO, will assume the positions of chairman and head of research and development.
Taian City, China (May 13)-China Biologic Products, a plasma-based pharmaceutical company, announced that Stanley Wong resigned as president and chief executive officer (CEO), effective June 1, 2008, for personal reasons. Chao Ming Zhao resigned from his position as chief financial officer (CFO) in order to take over the role of president and CEO, and Y. Tristan Kuo, the current vice-president of finance, will take Zhao’s place as CFO, effective June 1, 2008.
Foster City, CA (May 7)-Gilead Sciences, a biopharmaceutical company, appointed John C. Martin, PhD, chairman of the board of directors, and John F. Milligan, PhD, was appointed president. Martin will continue to serve as Gilead’s chief executive officer. Milligan will continue to serve as chief operating officer, in addition to his new role of president.
Cincinnati, OH (May 6)-Kendle, a clinical research organization, appointed Patricia Williams to the position of vice-president of commercial operations. Williams will provide leadership for global contract execution and negotiation with the company’s biopharmaceutical customers, including master service agreements and changes in scope. Williams will be based in Kendle’s European headquarters in Crowthorne, England, and will report directly to Chris Bergen, chief operating officer.
Quebec City, Quebec (May 7)-Medicago, a biopharmaceutical company, appointed Brigitte Barbeau vice-president of manufacturing, and will join the company on May 26, 2008. In this newly created position, Barbeau will lead the company's manufacturing functions to accelerate the development of its H5N1 pandemic influenza vaccine and other vaccine candidates.
Gaithersburg, MD (May 6)-MedImmune, a subsidiary of AstraZeneca (London), made appointments to its executive team: Jacqueline Hall was appointed global vice-president of product development team leadership; Lorin Roskos, PhD, was appointed vice-president and global head of pharmacokinetics, pharmacodynamics, and bioanalysis in translational sciences; and Beth Wensley was appointed vice-president of project management. In addition, Erik-Jan Dekker, PhD, joined MedImmune as vice-president of international regulatory affairs for vaccines, and Reginald Seeto joins as vice-president of global strategic marketing and portfolio management.
Berkeley, CA (May 8)-Nile Therapeutics, a biopharmaceutical company, appointed Jane Moffitt vice-president of regulatory affairs. Moffitt has more than 30 years of experience in regulatory affairs for pharmaceutical, device and biotechnology companies. This experience includes developing clinical regulatory strategies and leading teams responsible for preparing and maintaining investigational new drug applications, new drug applications, biologic license applications and global product launches. Her drug product expertise includes natriuretic peptides, small molecules and biologics.