Dec. 15, 2006 Notes: Abbott Enters Development and Commercialization Agreement with Enanta, Celgene Acquires API Manufacturing Facility from Siegfried, More

December 15, 2006
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Abbott, Enanta, BASF, Celgene, More

Company Notes

Abbott Park, IL (Dec. 12)-Abbott (www.abbott.com) entered into an agreement with Enanta Pharmaceuticals (Watertown, MA, www.enanta.com) to develop and commercialize hepatitis C virus NS3 and NS3/4A protease inhibitors. Under the terms of the agreement, Abbott will gain access to Enanta’s intellectual property position for a variety of compounds. Enanta will receive an upfront payment of $57 million. If clinical and regulatory milestones are met, Enanta will receive additional payments of up to $250 million.

Ludwigshafen, Germany (Dec. 12)-BASF Corporation (www.basf.com) chose Mutchler Inc. (Harrington Park, NJ, www.mutchlerchem.com) to serve as an authorized distributor of pharmaceutical excipients in the United States. Mutchler has served as BASF’s distributor for pharmaceutical excipients in Puerto Rico for the past five years.

Summit, NJ (Dec. 11)-Celgene Corporation (www.celgene.com) acquired an active pharmaceutical ingredient manufacturing facility from Siegfried Ltd. (Zofingen, Switzerland, www.siegfried.ch) for US $46.5 million. The facility is capable of producing multiple drug substances, and Celgene plans to use it intiially to produce “Revlimid” for the global market. The facility may also be used to produce drug substances for future Celgene drugs and drug candidates.

Leiden, Netherlands (Dec. 8)-Crucell N.V. (www.crucell.com) was awarded an additional contract of more than $20 million for its “Quinvaxem” pediatric vaccine. The contract was awarded by a supranational organization for Latin America and covers sales in 2007.

New York, NY (Dec. 14)-Forest Laboratories, Inc. (www.frx.com) will acquire biopharmaceutical company Cerexa (Alameda, CA, www.cerexa.com) for $480 million. The acquisition will give Forest worldwide develoment and marketing rights (excluding Japan) to two injectable antibiotics and an option to a third, early-stage injectable antibiotic.

Rockville, MD (Dec. 1)-The US Food and Drug Administration (www.fda.gov) issued warning letters to two more compounding pharmacies, telling them to cease compounding certain drugs. Spoonamore Drug Co., Inc. (Louisville, KY) and Health Dimensions, Inc. (Farmington Hills, MI, www.healthdimensionspharmacy.com) were told to cease producing domperidone capsules, which is commonly prescribed to patients with gastroparesis. FDA contends that domperidone is not an active ingredient contained in any FDA-approved drug products, and it poses public health risks. In addition, Spoonamore was told to cease compounding and distributing progesterone capsules and testosterone HPC 5% gel products because neither product is significantly different from FDA-approved competitors.

Spokane, WA (Dec. 13)-HollisterStier Contract Manufacturing (www.hollisterstier.com) signed a manufacturing contract with GeneraMedix Inc. (Liberty Corner, NJ, www.generamedix.com) to develop a process for compouding and lyophilizing multiple generic drug products. GeneraMedix plans to use Hollister’s Project Management System to meet certain timelines and project specifications.

Scottsdale, AZ (Dec. 13)-Holmes Biopharma, Inc. (www.holmesbiopharma.com) announced its intention to purchase an existing pharmaceutical development, clinical manufacture, biotechnology, and analytical laboratory business in the eastern United States. The name of the company and the terms of the acquisition will be disclosed after the completion of a formal purchase agreement.

Lexington, MA (Dec. 12)-Indevus Pharmaceuticals, Inc. (www.indevus.com) will acquire specialty pharmaceutical company Valera Pharmaceuticals, Inc. (Cranbury, NJ, www.valerapharma.com) in a stock transaction for $7.75 per share, for a total of approximately $120 million. Subject to approval by the boards of directors of both companies, the deal is expected to be completed on or around April 30, 2007.

Pasadena, CA (Dec. 12)-Jacobs Engineering Group Inc. (www.jacobs.com) received a contract from Schwarz Pharma (Monheim, Germany, www.schwarzpharma.com) to provide engineering and procurement for the development of a new active pharmaceutical ingredient manufacturing facility at Schwarz’s manufacturing site in Shannon, County Clare, Ireland. Jacobs will modify the existing process equipment and procure new equipment for the existing building and for a planned extension to the north side of the production building.

New Brunswick, NJ (Dec. 12)-The US Federal Trade Commission cleared Johnson & Johnson’s (www.jnj.com) proposed acquisition of Pfizer Consumer Healthcare (Morris Plains, NJ, www.pfizerch.com). The $16.6-billion all-cash acquisition, which has already received clearance from the European Commission, was announced in June 2006. The transaction is expected to close by the end of the year.

Whitehouse Station, NJ (Dec. 11)-Merck & Co. (www.merck.com) formed a broad collaboration with Idera Pharmaceuticals (Cambridge, MA, www.iderapharma.com) to research, develop, and commercialize Idera’s toll-like receptor (TLR) agonists by incorporating them into vaccines being developed by Merck for oncology and the treatment of infectious diseases and Alzheimer’s disease. Merck will receive exclusive rights to a number of Idera’s agonist compounds and the companies will engage in a two-year research and development collaboration to generate novel agonists. Merck agreed to pay a $20-million license fee and will purchase $10 million worth of Idera common stock. Merck will also fund the research and development collaboration. Idera could receive milestone payments of up to $165 million.

Kalamazoo, MI (Dec. 11)-ScinoPharm Taiwan Ltd. (www.scinopharm.com) entered into an agreement with Pfizer CentreSource (www.pfizercentresource.com) to manufacture and supply selected steroid active pharmaceutical ingredients and intermediates. The agreement, which is part of a new phase in the four-year-old business relationship between ScinoPharm and Pfizer CentreSource, is expected to propel ScinoPharm into the position of leading global API source for steroid drugs.

Washington, DC (Dec. 11)-The Synthetic Organic Chemical Manufacturers Association (SOCMA, www.socma.org) announced the winners of its 2006 Performance Improvement Awards at its annual dinner. The awards recognize manufacturing facilities that demonstrate outstanding commitment to continuous improvement in environmental, health, safety, and security (EHS&S). The winners are: Isochem, Inc. (Lockport, NY, www.isochem.fr), SACHEM, Inc. (Cleburne, TX, http://216.70.124.175/), and BASF Corporation (Florham Park, NJ, www.basf.com). In addition, 42 SOCMA member facilities were honored wtih the Achievement Award, which is presented to facilities that maintain strong EHS&S programs.

Brussels, Belgium (Dec. 13)-ThromboGenetics is licensing its "THR-100" thrombolytic to Bharat Biotech International Ltd. (Hyderabad, India, www.bharatbiotech.com). The deal covers manufacturing, clinical development, and commercialization of the product in developing countries and certain industrialized countries. Bharat will develop the commercial manufacturing process, implement a clinical development plan for Phase III trials, and gain marketing authorization to commercialize THR-100, intially in India.

New Haven, CT (Dec. 13)-Vion Pharmaceuticals, Inc. (www.vionpharm.com) entered into a manufacturing agreement with Ben Venue Laboratories (Bedford, OH, www.benvenue.com) for its lead anticancer agent “Cloretazine.” Ben Venue will manufacture Cloretazine finished drug product for Vion.

People Notes

Santa Clara, CA (Dec. 12)-Ilypsa, Inc. (www.ilypsa.com) promoted Gerrit Klaerner, PhD, to the postiition of senior vice-president and chief business officer. Klaerner cofounded Ilypsa in 2003 while serving as a staff scientist at Symyx Technologies.

Boston, MA (Dec. 11)-PAREXEL International Corp. (www.parexel.com) appointed Christopher Rieder to the newly created role of chief information officer. In this capacity, he will manage the company’s global information technology (IT) initiatives and provide leadership for the IT staff worldwide. He also will be responsible for accelerating the integration of technology solutions, information management, and business processes. He previously served as vice-president of IT at Kos Pharmaceuticals.

Monheim, Germany (Dec. 13)-SCHWARZ Pharma (www.schwarzpharma.com) announced that Patrick Schwarz-Schutte will resign as CEO and member of the company’s executive board on Dec. 31, 2006. Klaus Veitinger, president and CEO of Schwarz Pharma Inc., USA also will resign, effective Dec. 31. Jurgen Baumann will resign his responsibilities for the European business as of April 30, 2007. The supervisory board appointed Detlef Thielgen, chief financial officer, to replace Schwarz-Schutte. Peter Moller and Martin Schnieder will take Veitinger’s and Baumann’s places on the executive board, effective Jan. 1, 2007.

Chelmsford, MA (Dec. 12)-Donald S. Masters was appointed president and CEO of Triton BioSystems, Inc. (www.tritonbiosystems.com). Masters brings more than 27 years of experience to the role; he most recently served as CEO of Esperance Pharmaceuticals. At Triton, Masters will be responsible for the strategic direction of the company, which includes the completion of preclinical testing, expanding its investor base, initiating human clinical trials, and forming global partnerships.