March 8, 2007 Notes: Dalton to Manufacture Tox Material for Affectis, Celgene and Novartis File Suit Against Abrika, Eli Lilly Acquires Hypnion, more

March 8, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Affectis, Dalton, Celgene, Novartis, GSK, More

Company Notes

Munich (March 1)-Affectis Pharmaceuticals AG (www.affectis.com) has contracted Dalton Pharma Services (Toronto, ON, Canada, www.dalton.com) to manufacture preclinical tox material with potential for CGMP production. The agreement follows Dalton's recent receipt of an establishment license from Health Canada, which allows Dalton to manufacture sterile products and test and ship commercial products. Dalton will be manufacturing Affectis' novel antidepressant candidate.

Summit, NJ and Basel, Switzerland (Feb. 27)-Celgene (www.celgene.com) and Novartis (www.novartis.com) filed suit against Abrika Pharmaceuticals (Sunrise, FL, www.abrika.com) for patent infringement after Abrika filed an abbreviated new drug application with a paragraph IV certification to market generic methylphenidate hydrochloride, the active ingredient in Ritalin. Celgene and Novartis filed complaints in the US District Court for the District of New Jersey and in the US District Court of the District of Delaware. Abrika has argued that its product does not infringe on any patents held by Novartis, and the company is seeking a declaratory judgement from the Delaware court on the matter.

Indianapolis, IN (March 5)-Eli Lilly and Co. (www.lilly.com) has agreed to acquire neuroscience drug discovery and development company Hypnion, Inc. (Lexington, MA, www.hypnion.com). The deal is expected to close in the first quarter of 2007.

London (March 7)-GlaxoSmithKline (GSK, www.gsk.com) is ramping up drug production at its manufacturing site in Poznan, Poland in preparation to more than double the number of markets the plant will supply. The Poznan plant currently performs finished dosage manufacturing and packaging of mature tablet-form products for 30 global markets. GSK is transferring production of several drugs from its manufacturing site in Hertfordshire, UK to Poznan and, as a result, the Poznan site will be serving 72 markets by 2009. The company already has begun the transfer process and has hired 70 new staff for the Poznan site.

Basel, Switzerland (Feb. 27)-Lonza (www.lonza.com) has completed master cell bank and dose production runs for Athersys, Inc. (Cleveland, OH, www.athersys.com). The cell bank and product doses will support Athersys' clinical trial activity in 2007 and 2008.

Malvern, UK (March 1)-Malvern Instruments Limited (www.malvern.com) concluded an agreement giving the company exclusive distribution rights in the United States, South and Central America for Farfield Scientific Limited's (Crewe, UK, www.farfield-scientific.com) analytical instruments. The instruments give insight into the struction and functional behavior of biomolecules and nanoscale materials. The agreement was effective from March 1.

Oss, The Netherlands (March 1)-Organon (www.organon.com) signed an agreement with Acrux (Melbourne, Australia, www.acrux.com.au) to develop and commercialize contraceptives delivered through the skin using Acrux's spray technology. Under the terms of the agreement, Acrux will develop formulations of selected contraceptive compounds for use with the spray technology. Organon will undertake and fund clinical trials, regulatory submissions, manufacturing, and marketing.

Toronto, ON, Canada (March 2)-Patheon, Inc. (www.patheon.com) entered into an agreement with JLL Partners (New York, NY, www.jllpartners.com) whereby JLL will purchase $150 million of convertible preferred shares of Patheon. Patheon hopes the investment will allow the company to focus on manufacturing excellence and client service.

Allegan, MI (March 6)-The Perrigo Company (www.perrigo.com) will acquire nine generic prescription dermatological products and four pipeline products from Glades Pharmaceuticals, Inc. (Duluth, GA, www.glades.com). The transaction totals $56 million in cash plus other consideration for future R&D collaborations. The deal is expected to close by the end of March.

New York, NY (Feb. 27)- A federal court in the western district of Pennsylvania has upheld Pfizer, Inc.'s (www.pfizer.com) patent covering the active ingredient in "Norvasc." The patent had been challenged by generic manufacturer Mylan (Canonsburg, PA, www.mylan.com). The ruling prohibits Mylan from launching a generic version of amlodipine until September 2007.

Lyon, France (Feb. 27)-Sanofi Pasteur's (www.sanofipasteur.com) H5N1 bird flu vaccine has been unanimously recommended for approval by a US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) advisory panel. The panel agreed that there is sufficient data to support the vaccine's effectiveness during a pandemic or during situations of potential high-risk exposure.

People Notes

Baltimore, MD (March 5)-Alba Therapeutics Corporation (www.albatherapeutics.com) has appointed Linda M. Arterburn, PhD, senior director of in-vivo pharmacology and toxicology. Arterburn previously served as executive director of discovery research at Martek Biosciences.

Cambridge, MA (March 5)-David A. Broecker has been promoted to president and chief executive officer of Alkermes, Inc. (www.alkermes.com). Broecker has served as Alkermes' president since 2001 and was appointed chief operating officer in 2002.

Cranbury, NJ (March 5)-John F. Crowley has returned to his position as president and chief executive officer of Amicus Therapeutics (www.amicustherapeutics.com). Crowley took a leave of absence in order to complete a six-month tour of duty with the US Navy.

Vancouver, BC, Canada (March 7)-Victor Diaz has been appointed senior vice-president of global manufacturing and supply chain management for Angiotech Pharmaceuticals, Inc. (www.angiotech.com). Diaz previously served as vice-president of global operations at Teleflex Medical.

San Francisco. CA (March 1)-Bridge Pharmaceuticals (www.bridgecro.com) has appointed James Carignan vice-president of quality assurance and regulatory compliance for its Beijing operations. Carignan was formerly responsible for directing the quality assurance program at Novartis.

Cambridge, MA (March 6)-ImmunoGen, Inc. (www.immunogen.com) announced the departure of executive vice-president of science and technology Walter Blattler, PhD. Until a replacement is found, Blattler's responsibilities will be handled by John Lambert, PhD, senior vice-president of pharmaceutical development; Pauline Ryan, senior vice-president of corporate development and operations; and Mitchel Sayare, PhD, chairman and CEO of ImmunoGen.

Mississauga, ON, Canada (March 7)-Vasogen Inc. (www.vasogen.com) appointed board member Terrance H. Gregg president and chief executive officer. Gregg, formerly the president and chief operating officer of MiniMed Inc., succeeds David G. Elsley.