Company and People Notes: Pfizer and Graceway Form Deal; GeoVax Labs Leader Resigns; More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Lundbeck acquired LifeHealth; FDA is seeking a director of its new tobacco regulation branch; Charles River Labs announces personnel changes; more...

Company Notes

Azopharma Product Development Group (Hollywood, FL), completed its expansion of its current good manufacturing practices (CGMP) cytotoxic and highly potent compound facilities at its Hollywood, Florida, location. The expansion adds 7,000 ft2 of space to Azopharma’s current capacity and includes three manufacturing suites with dedicated equipment, analytical instrumentation, and staff.

Graceway Pharmaceuticals (New York), a portfolio company of GTCR Golder Rauner, acquired the commercial rights for three investigational dermatological molecules from Pfizer (New York) and the related transferred or licensed intellectual properties. Two molecules that target the treatment of oily skin and acne-an early stage stearoyl CoA desaturase 1 (SCD1) inhibitor and a cholesterol-acyltransferase (ACAT) inhibitor-are currently in Phase II development. In addition, Graceway will acquire an activin-like kinase 5 (ALK-5) inhibitor, currently in early preclinical development, designed to reduce surgical and traumatic scar formation. The companies also signed a master services and supply agreement under which Pfizer agreed to perform developmental and clinical services for these three molecules. Terms of the transaction were not disclosed.

Johnson & Johnson (New Brunswick, NJ) announced that approximately 84.4% of shares of common stock of Cougar Biotechnology (Los Angeles, CA) were tendered during the initial offering period, which ended July 2. 2009. The company also said it received commitments to tender roughly 2 million additional shares. A subsequent offering period will expire on July 9, 2009. The offer was conducted through a wholly owned subsidiary of Johnson & Johnson named Kite Merger Sub.

Lundbeck (Copenhagen, Denmark) will acquire the biotechnology firm LifeHealth (Berkshire, UK). The deal is an all-cash transaction valuing LifeHealth at $147 million. The boards of both companies unanimously approved the transaction.

Novasep (Pompey, France), a provider of active pharmaceutical ingredients and purification technologies, acquired the contract manufacturing organization Henogen (Charleroi, Belgium). Financial terms of the transaction were not disclosed.

Novavax (Rockville, MD) agreed to license its recombinant virus-like-particle (VLP) vaccine technology to the specialty pharmaceutical company ROVI Pharmaceuticals (Madrid, Spain). ROVI will use the VLP technology to create an influenza vaccine solution for the Spanish government under a new EUR 60 million ($83.4 million) program led by the Spanish Ministry of Health and other government groups to develop flu vaccines and establish the country’s only in-border facility.

The European Commission granted marketing authorization for Novo Nordisk’s (Bagsværd, Denmark) Victoza (liraglutide) for the treatment of Type 2 diabetes in adults. Victoza is the first once-daily human glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of Type 2 diabetes, according to a company press release.

Pfizer (New York) will invest more than EUR 11 million ($15 million) for a process research and development and kilo technology laboratory at its Ringaskiddy, Cork, Ireland site. The project has the support of the Irish government through IDA Ireland, the country’s inward investment promotion agency. Pfizer intends to use continuous processing involving chemistry in a pipe and continuous extraction, according to an IDA Ireland press release.

Rottapharm Ireland, part of the Rottapharm/Madaus Group (Monza, Italy), expanded its manufacturing operations at its Dublin site. The EUR 7 million ($9.7 million) investment in the facility is expected to create 35 new jobs.

The US Food and Drug Administration approved sanofi-aventis’s (Paris) anti-arrhythmic drug Multaq (dronedarone). Multaq is designed to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter. The drug is under review by the European Medicines Agency.

Regulatory Roundup


The Royal Pharmaceutical Society of Great Britain (RPSGB) warned the publicabout the risks of buying online medicines for swine flu such as Tamiflu (oseltamivir phosphate, Roche, Basel) or Relenza (zanamivir, GlaxoSmithKline, London). David Pruce, RPSGB director of policy said in a press release, “This is a golden opportunity for counterfeiters to offer fake supplies of these drugs. People can be at real risk if they buy medicines from unknown sources.”

The US Food and Drug Administration posted ajob listing for the director of its newly created Center for Tobacco Products. The position will “lead the designand implementation of a science-based set of strategies to reducethe disease and death caused by tobacco products in the UnitedStates,” according to the job listing. The application period ends July 9, 2009. More information can be found on USAJOBS, the official job site for the US Federal Government.

FDA signed a three-year maintenance and support agreement with GlobalSubmit (Philadelphia, PA), a developer of software designed exclusively for the review and validation of electronic Common Technical Document (eCTD) global submissions. Under the agreement, GlobalSubmit will enhance and/or upgrade the GlobalSubmit Review and Validate software products already in use at the agency. The organizations previously had a similar agreement that ended in June 2009. GlobalSubmit’s Review and Validate products are used by reviewers at the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and by reviewers at life-sciences companies worldwide, according to a GlobalSubmit press release.

FDA posted on its website a question and answer document on current good manufacturing practices for drugs that focuses on penicillin. The Level 2 guidance document outlines cross-contamination issues and special manufacturing requirements for penicillin drugs.

People Notes

Charles River Laboratories International (Wilmington, MA) announced a succession plan for Research Models and Services (RMS) and enhancements to the Preclinical Services (PCS) and Sales organizations. Real H. Renaud, corporate executive vice-president and president of RMS, will retire by the end of 2010. Davide Molho was appointed corporate senior vice-president of North American and European RMS. For more about the reorganization see the company press release.

GeoVax Labs (Atlanta, GA), an HIV/AIDS vaccine-development company, announced that Andrew Kandalepas has resigned from his positions as senior vice-president and director of the company. Kandalepas was chairman of the board, president and chief executive officer of Dauphin Technology from 1995 until the merger with GeoVax in September 2006, at which time he assumed the position of senior vice-president and remained a director of the company.

International Stem Cell (ISCO, Oceanside, CA) expanded its senior management team. Andrei Semetchkine, who is already a director and officer of the company, will assume the duties of executive vice-president of ISCO; Jeffrey Janus will continue as CEO and president of Lifeline Cell Technology, a subsidiary of ISCO, and will also serve as senior vice-president of operations for the parent company, ISCO; Ray Wood was promoted to vice-president of finance and principal financial officer; William Adams, a founder of the company, stepped down as chief financial officer on June 30, 2009.

NeoStem (New York) a company focused on adult stem-cell storage, named Alan G. Harris as the company's vice-president of drug development and regulatory affairs. In addition to overseeing the company's regulatory activities, Harris will advance NeoStem's intellectual property portfolio and licensed technologies, assist in the development of a chronic wound care program, and develop a regulatory pathway for commercializing stem cell therapy.

OncoMed Pharmaceuticals (Redwood City, CA), a clinical-stage company developing novel antibody therapeutics that target cancer stem cells, appointed Sunil Patel senior vice-president of corporate development. Patel will have primary responsibility for corporate business development activities and will report to Paul Hastings, OncoMed's president and CEO.

Sundia MediTech (Shanghai), a pharmaceutical and biotechnology research and development outsourcing company, appointed Chen Chen senior vice-president of chemistry services. Chen previously worked at Neurocrine Biosciences (San Diego, CA) for 15 years.