Week of June 21, 2010: Company and People Notes: Valeant and Biovail to Merge; GPhA Names Interim Director; And More.

June 24, 2010
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Company and People Notes: Valeant and Biovail to Merge; GPhA Names Interim Director; And More.

Company Notes

Bayer Schering Pharma (Berlin) and OncoMed Pharmaceuticals (Redwood City, CA) agreed to discover, develop, and commercialize anticancer stem-cell therapeutics targeting the Wnt signaling pathway. OncoMed is eligible to receive an upfront payment of $40 million and milestone payments of up to $387.5 million for each biotherapeutic drug program and $112 million for each small-molecule drug program.

Diamyd Medical (Stockholm, Sweden) signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, (OMJPI, Raritan, NJ), a Johnson & Johnson company, to develop and commercialize the Diamyd diabetes therapy, a GAD65 antigen-based therapy for the treatment and prevention of Type 1 diabetes and associated conditions. OMJPI will make an upfront payment of $45 million and up to $580 million in milestone payments, as well as tiered royalties on future sales. The transaction is expected to close in the third quarter of 2010.

The biotechnology company Exelixis (South San Francisco, CA) regained full rights to develop and commercialize its oncology compound XL184. Exelixis and Bristol-Myers Squibb (BMS, New York) entered into a global development collaboration for XL184 in December 2008. BMS will make a payment to Exelixis of $17 million in connection with the return of XL184.

Metabolex (Hayward, CA) entered into a development and license agreement with Ortho-McNeil-Janssen Pharmaceuticals (OMJPI, Raritan, NJ) focused on compounds for the treatment of Type 2 diabetes and other disorders. Under the agreement, OMJPI will receive an exclusive worldwide license to develop, manufacture, and commercialize several Metabolex programs that are currently at the preclinical stage. Metabolex is eligible to receive an upfront payment, milestone payments of up to $330 million, and royalties on sales.

After discussions with The US Food and Drug Administration, Pfizer (New York) plans to voluntarily withdraw its new drug application and discontinue commercial availability of Mylotarg (gemtuzumab ozogamicin for Injection), effective Oct. 15, 2010. The drug is used for the treatment ofrelapsed acute myeloid leukemia (AML). The required post-approval study combining chemotherapy and Mylotarg did not demonstrate improved survival compared with chemotherapy alone in patients with previously untreated AML.

Regulus Therapeutics (Carlsbad, CA) and sanofi-aventis (Paris) formed a drug-development pact focused on microRNA therapeutics and their use to treat fibrosis. The deal is valued at potentially over $750 million, which includes a $25-million upfront fee, a $10-million future equity investment subject to mutual agreement on company valuation, and annual research support for three years with the option to extend the research support for two additional years. The companies will collaborate on up to four microRNA targets, including Regulus’s lead fibrosis program targeting microRNA-21. 

Ricerca Biosciences (Concord, OH), a contract research organization, reported that its facility in Lyon, France, recently obtained the ISO 9001:2008 certification for all activities performed at the site.

SCHOTT Pharmaceutical Packaging (Lebanon, PA), a division of SCHOTT North America, announced that its Lebanon, Pennsylvania, facility completed facility and equipment validations of its syringe-production line. The company also announced the product validation for its first ready-to-fill syringe customer, with several others in process.

Specialty pharmaceutical companies Valeant (Aliso Viejo, CA) and Biovail (Toronto) agreed to a merger. The merger, unanimously approved by both boards of directors, would create a combined company known as Valeant Pharmaceuticals International. The new company will focus on four areas: specialty central nervous system, dermatology, Canada, and emerging markets/branded generic drugs.

People Notes

Bausch + Lomb (Rochester, NY), a global eye-health company, appointed Rodney W. Unsworth president of Asia-Pacific, effective July 1, 2010. Unsworth previously served as president of Asia-Pacific, for Schering-Plough from 2004 until its merger with Merck (Whitehouse Station, NJ) in 2009.

DPT Laboratories (San Antonio, TX), a contract development and manufacturing organization, promoted JJ Feik to senior director of business development. Feik previously held the positions of director of marketing and corporate development as well as business-development manager at DPT.

Eisai Inc. (Woodcliff Lake, NJ), a US subsidiary of Eisai Co., Ltd. (Tokyo) appointed Lonnel Coats president and CEO of Eisai Inc. Coats previously held the position of president and chief operating officer. In addition, Coats was appointed senior vice-president of the pharmaceuticals business in the US at Eisai Co. Ltd., where he will be responsible for leading Eisai's Global Medical and Marketing division.

The Generic Pharmaceutical Association (GPhA) named Bob Billings its interim executive director, effective July 1, 2010. Gordon Johnston and Bill Head will also serve on the leadership team, reporting directly to the executive committee. Current CEO and president Kathleen Jaeger will be a senior advisor to GPhA through the end of the year.

Gentris (Morrisville, NC), a developer of applied clinical pharmacogenomics, appointed Rick Williams CEO and a member of the board of directors.

MonoSol Rx (Warren, NJ), a specialty pharmaceutical company, appointed Eric Dadey senior vice-president of pharmaceutical development and Mary Ellen Norvitch to the newly created position of vice-president of regulatory affairs, clinical affairs, and quality assurance. Dadey and Norvitch will report to A. Mark Schobel, the company's president and CEO.

Spencer Pharmaceutical (Boston) appointed Max Arella president and chairman of the company. Spencer focuses on drug-release and absorption systems for the treatment of metabolic diseases such as diabetes and metabolic syndrome.