September 7, 2006: Company and People Notes

September 7, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Genzyme Corporation, Luitpold Pharmaceuticals, Kemwell Pvt. Ltd.

Company Notes

Cambridge, MA (Aug. 30)-Genzyme Corporation (www.genzyme.com) plans to initiate a tender offer to acquire AnorMED, Inc. (Vancouver, BC, Canada, www.anormed.com). The offer will be in the form of an all-cash transaction valued at US $8.55 per outstanding share, which totals about $380 million. Acquiring AnorMED will give Genzyme a late-stage product candidate in development for hematopoietic stem cell transplantation.

Shirley, NY (Aug. 25)-Luitpold Pharmaceuticals (ABL, www.luitpold.com), working with the US Food and Drug Administration (Rockville, MD, www.fda.gov) issued a voluntary recall of its “Hydralazine HCL” injection because the product may contain particulates. Early in August, Luitpold recalled a batch of hydralazine with the expiration date of December 2006. The new recall reaches further, asking that batches with expiration dates in September and November 2006 and January, February, June, and December 2007 be returned to the company.

Bangalore, India (Aug. 28)-In accordance with agreements signed by Kemwell Pvt. Ltd. (www.kemwellindia.com) and Pfizer, Inc. (New York, NY, www.pfizer.com) in February 2006, Pfizer handed over their manufacturing unit located in Uppsala, Sweden to Kemwell. The new facility manufactures both API and finished drugs, mainly the “Salazopyrine” drug to treat arthritis and irritable bowel syndrome. The production unit, which will be called Kemwell AB, will continue to manufacture this drug for Pfizer. In addition to acquring the Uppsala facility, Kemwell recently completed the construction of its new tablet facility in Bangalore, which has the capacity to produce as many as 5 billion tablets for exports to the United States and Europe.

Deerfield, IL and Dublin, OH (Sept. 6)-OVATION Pharmaceuticals, Inc.(www.ovationpharma.com) and Cardinal Health, Inc. (www.cardinalhealth.com) have received approval from the Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) to begin manufacturing “Panhematin” therapy. Panhematin, which is produced by Ovation, is used to treat acute porphyria. It will be manufactured at Cardinal Health's new sterile facility in North Raleigh, North Carolina.

Pittsburgh, PA (Aug. 30)-The University of Pittsburgh School of Medicine (www.medschool.pitt.edu) has been awarded a $1.3-million grant from the National Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD, www3.niaid.nih.gov) and the National Institutes of Health (NIH, Bethesda, MD, www.nih.gov) to produce an avian flu vaccine for Phase I and Phase II clinical trials. The vaccine, which contains components of the H5N1 virus but does not cause the disease, has been found to protect mice and chickens from infection after exposure to the wild form of the virus. The grant will be used to begin scale-up of vaccine production.

Waltham, MA and Hampton, NH (Aug. 30)-Stockholders for Thermo Electron Corporation (www.thermo.com) and Fisher Scientific International Inc. (www.fisherscientific.com) voted to approve the companies' merger. More than 99% of the Fisher shares represented and 98% of the Thermo shares represented voted in favor of the move. As part of the agreement, the number of shares of Thermo's common stock will be increaed to 1.2 billion, and the new company will be named Thermo Fisher Scientific Inc. The transaction is expected to close in the fourth quarter of 2006.

Milford, MA (Aug. 28)-Waters Corporation (www.waters.com) acquired all the outstanding capital stock of Thermometric AB (Jarfalla, Sweden, www.thermometric.se) for approximately $2.5 million. Waters plans to merge Thermometric's business into its TA Instruments Inc. operation in New Castle, Delaware.

People Notes

Foster City, CA (Sept. 6)-APT Pharmaceuticals Inc. appointed Stephen G. Dilly, PhD, as chief executive officer. Dilly previously served as senior vice-president, head of development, and chief medical officer for Chiron BioPharmaceuticals. In addition, he held positions with SmithKline Beecham and Pfizer.

Glen Rock, PA (Aug. 28)-ARx, LLC, a subsidiary of Adhesives Research (www.adhesivesresearch.com), appointed Richard Tumbusch quality director and Michael Stanley quality systems manager. Tumbusch will be responsible for ensuring that all products are manufactured in compliance with 21 CFR 11, other applicable regulations, and the ARx facility's quality and validation master plan. In addition, he will ensure that the quality department maintains facilities according to FDA standards. Stanley will be responsible for leading the development and implementation of quality systems in support of pharmaceutical products in the ARx division as well as supporting new product and process developments and maintenance of current products.

Baltimore, MD (Sept. 5)-Mark McClellan, head of the Centers for Medicare and Medicaid Services (CMS, www.cms.hhs.gov) announced that he will be resigning in early October. McClellan, who was confirmed administrator of CMS in March 2004 after two years as an FDA commissioner, says he does not know who his successor will be and did not recommend anyone for the position.

Binzen, Germany (Aug. 17)-Bill Bundenthal joined Glatt Pharmaceutical Services (www.glattpharmaceuticals.com) as vice-president of operations. In this role, Bundenthal will oversee the completion of a multimillion-dollar facility expansion to increase capacity. In addition, he is responsible for Glatt’s commercial manufacturing operations, warehousing, and facility engineering. Glatt also announced the appointment of Robert Femia, PhD, as vice-president of R&D. Femia will manage Glatt’s pharmaceutical R&D services and product-development efforts.

Vancouver, BC, Canada (Sept. 1)-InNexus Biotechnology Inc. (www.innexusbiotech.com) promoted Jeff Morhet to the position of CEO and president. Morhet previously served as COO of InNexus and has held positions at Baxter Healthcare, Merck, and AstraZeneca.

Albany, OR (Sept. 5)-Gregory Hahn has been appointed president and chief operating officer of Sythetech, Inc (www.synthetech.com). He will assume his new position on Sept. 11, 2006. Hahn previously worked with FMC Corporation, Sigma Aldrich Fine Chemicals, and Koch Chemical Company.

Corona, CA (Sept. 5)-Watson Pharmaceuticals, Inc. (www.watsonpharm.com) appointed Thomas R. Russillo executive vice-president of the corporation and president, US generics division. In this capacity, he will have overall responsibility for the business, ensuring its continued growth and success. Russillo previously served as president of Ben Venue Laboratories. In addition, Andrew S. Boyer was promoted to senior vice-president, sales and marketing.

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