Company and People Notes: Schering-Plough and Merck Withdraw NDA and Terminate Respiratory Joint Venture, Cell Biosciences Names Management Team, More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Covance and WuXi PharmaTech to form contract research joint venture in China, Covidien makes appointments to its Pharmaceutical Products and Imaging Solutions businesses, more...

Company Notes

West Lafayette, IN (June 30)-Bioanalytical Systems (BASi) sold its Baltimore Clinical Pharmacology Research Unit to a subsidiary of Algorithme Pharma Holdings for a cash payment of $850,000. As a result, BASi will exit the Phase I clinical-study market. On June 24, BASi formed an alliance with the drug-development services company Swiftwater Group (Tucson, AZ) in which BASi will offer a preferred provider arrangement for Swiftwater clients, and BASi’s clients will have access to Swiftwater’s consultancy services.

Princeton, NJ (June 24)-Covance and WuXi PharmaTech (Shanghai, China) will form a 50-50 joint venture that will provide preclinical contract-research services in China. Operations will be located in a 323,450-ft2 facility in Suzhou, China, which is currently being constructed by WuXi. This facility, expected to be completed in 2009 and designed to meet the worldwide regulatory standards, will provide GLP toxicology, drug-metabolism and bioanalytical chemistry services. Financial and structural details of the joint venture are expected to be disclosed once definitive terms are agreed upon later this year.

Heerlen, The Netherlands (June 25)-DSM Biologics and Crucell (Leiden, The Netherlands) entered into an agreement with the contract manufacturer Avid Bioservices (Tustin, CA) to join their vendor network. Avid will be a preapproved contract manufacturer for licensees of the “PER.C6” cell line located in the western United States. Avid is the first US-based contract manufacturer to be awarded this status. The “PER.C6” technology platform is used for the large-scale manufacture of biopharmaceutical products such as recombinant proteins and monoclonal antibodies.

London, UK (June 12)-GlaxoSmithKline announced last month that it will cut 350 jobs in its research and development departments, which represents about 2% of its total research workforce. The move is part of the company’s restructuring plans that began in October 2007 to increase productivity.

Bedford, MA (June 9)-The diagnostics company Hologic will acquire Third Wave Technologies, a company focused on molecular diagnostics, for $11.25 per share, or approximately $580 million. Hologic will gain Third Wave’s molecular diagnostic reagents for various DNA and RNA analysis applications based on its proprietary “Invader” chemistry. The boards of directors of both companies unanimously approved the transaction in which Hologic is to acquire 100% of Third Wave’s stock in a cash tender offer to be followed by a merger to acquire any untendered shares. The companies expect the transaction to be completed in the third quarter of 2008.

Basel, Switzerland (July 1)-Lonza formed a clinical and commercial manufacturing agreement with the biotechnology company Osiris Therapeutics for the production of “Prochymal,” its leading adult stem-cell therapy. Terms of this agreement were not disclosed. Lonza also announced plans to build a new commercial-scale allogeneic CGMP manufacturing facility at its site in Walkersville, Maryland. The facility will feature additional capacity to manufacture CGMP-grade cell culture media for therapeutic applications.

Shanghai, China (June 13)-NovaMed Pharmaceuticals, a provider of outsourced drug-development and commercialization services, and Pfizer China formed a partnership in the oncology area. Under the terms of the agreement, NovaMed will serve as Pfizer China's sole distributional and promotional partner for six of its oncology products throughout mainland China starting June 2008. This is the first alliance of its kind for Pfizer China's oncology portfolio. NovaMed has a similar ongoing deal with Baxter China for three of its oncology products.

Val de Reuil, France (June 25)-Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, opened its new €100-million ($158-million) vaccine-production facility located in Val de Reuil (France). The facility is highly automated and is scaled to fill 200 million syringes and vials per year, increasing by twofold the current capacity at this site. The facility is expected to be operational by the end of 2008, upon certification by health authorities.

Kenilworth and Whitehouse Station, NJ (June 27)-Schering-Plough and Merck & Co., Inc. announced the withdrawal of their new drug application for the loratadine/montelukast combination tablet. The companies also terminated the respiratory joint venture that was formed in May 2000 to develop and market a fixed-combination product that would combine loratadine and montelukast. The US Food and Drug Administration issued a not-approvable letter for the proposed fixed-dose combination of loratadine and montelukast on April 25, 2008. The decision to terminate the respiratory joint venture has no impact on the business of the Merck/Schering-Plough cholesterol joint venture.

People Notes


San Diego, CA (June 30)-Akesis Pharmaceuticals, an emerging diabetes drug-development company, named Carl LeBel, PhD, as president and chief operating officer. LeBel has been a member of the company’s board of directors since December 2007. The current president, Jay Lichter, PhD, will retain the position of chief executive officer and add the title of chairman of the board of directors.

London (June 26)-Dave Mott, president and chief executive officer of AstraZeneca's biologics business unit, MedImmune, will leave the company at the end of July. Tony Zook, CEO of AstraZeneca’s North American business and executive vice-president of global marketing, was appointed as head of MedImmune on an interim basis.

Ingelheim, Germany (June 26)-Boehringer Ingelheim announced the following changes to its board of managing directors: Alessandro Banchi, chairman of the board and responsible for marketing and sales, will retire at the end of 2008 after more than 35 years with the corporation. His successor will be the vice-chairman of the board of managing directors, Andreas Barner, who is currently responsible for research, development and medicine. Bert Tjeenk Willink will be the new board member responsible for marketing and sales. Two more board members retiring at the end of the year are Hans-Jürgen Leuchs, responsible for operations and animal health, and Marbod Muff, responsible for finance and human resources. Wolfram Carius will be responsible for operations and human resources, and Hubertus von Baumbach will oversee the areas of finance and animal health as members of the board.

Palo Alto, CA (June 25)-Cell Biosciences, a provider of ultrasensitive protein detection and characterization systems to life science researchers, today announced three important additions to its management team: Tim Harkness was named president and chief executive officer, Richard Lussier was named vice-president of sales and international operations, and Walter Ausserer, PhD, was appointed vice-president of marketing.

St. Louis, MO (June 30)-Covidien, a provider of healthcare products, announced appointments to its research and development (R&D) leadership team for its Pharmaceutical Products and Imaging Solutions businesses. Michael J. Giuliani joined Covidien as vice-president of R&D for Pharmaceutical Products and Imaging Solutions. James L. Young, PhD, joined the company as vice-president of R&D operations for Pharmaceutical Products and Imaging Solutions. Ralph A. Heasley, PhD, joined the company as vice-president of Global R&D Technology, Pharmaceutical Products. Randel Frazier will continue as vice-president of Global R&D, Imaging Solutions.

Clinton, NJ (July 1)-Ikaria Holdings, a biotherapeutics company, appointed two executives to its research and development division: Deborah Petrowsky was named vice-president of medical affairs and Steven Knapp was appointed vice-president of regulatory affairs. Both will report to Ralf Rosskamp, executive vice-president for research and development.

King of Prussia, PA (June 26)-MDS Pharma Services, a contract research organization, appointed Lori McDonald vice-president of quality and compliance. McDonald will be direct the company’s program to build and manage quality and regulatory compliance systems across its global business platforms.

Burnaby, Canada (June 27)-Welichem Biotech, a publicly traded biotechnology company, appointed Genhui Chen as president and chief executive officer, effective immediately. Chen is a long-time director and one of the founders of the company. York Yingping Guo resigned as president and CEO for personal and family reasons.

Collegeville, PA (June 26)-Wyeth Pharmaceuticals, a division of Wyeth, appointed Andreas Krebs president, Europe/Middle East/Africa and Canada, effective immediately.  Krebs will report to Joseph M. Mahady, president of Wyeth Pharmaceuticals and senior vice-president of Wyeth.