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Also, Sanofi-aventis acquires Medley and Laboratorios Kendrick; Eli Lilly's Cook to retire from board; more...
BioAlliance Pharma (Paris), a specialty pharmaceutical company, said it will work with the US Food and Drug Administration on its new drug application (NDA) for Loramyc (miconazole) mucoadhesive buccal tablet (MBT), which was not accepted based on the lack of a tablet imprint code. Loramyc was approved in Europe in 2007 and is currently marketed in several European Union territories. While the EU does not require a unique tablet identifier, FDA does require a tablet imprint code for drug identification purposes. BioAlliance said in a company press release that it will work closely with FDA on the introduction of a debossed tablet and will resubmit the application.
The contract research organization Covance (Princeton, NJ) opened new clinical-development offices in Santiago, Chile, and Lima, Peru. The company also announced the expansion of the company's Buenos Aires, Argentina office. In a separate announcement, Covance said that the company's Shanghai, China, central laboratory has achieved accreditation by the College of American Pathologists.
Genentech (South San Francisco, CA) announced on Apr. 8, 2009, a voluntary withdrawal of its psoriasis drug Raptiva (efalizumab) because it is associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. As the company press release states, “Effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives.” Raptiva will no longer be available after June 8, 2009.
Merck & Co. (Whitehouse Station, NJ), and Cardiome Pharma (Vancouver, Canada) formed an agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation. Under the terms of the agreement, Merck will pay Cardiome an initial fee of $60 million. In addition, Cardiome is eligible to receive up to $640 million in development and sales milestone payments and royalties.
MonoSol Rx (Warren, NJ), a drug-delivery company specializing in dissolving thin-film products, was granted US Patent No. 7,500,984 from the United States Patent and Trademark Office. The patent relates to the delivery of an active ingredient contained in a thin film that is attached or placed inside of a pacifier or porous nipple member, such as the tip of a baby bottle.
Royal DSM (Heerlen, The Netherlands), the life-sciences and materials-sciences company, entered into a multimillion-dollar manufacturing and supply contract with Shire US Manufacturing (Owings Mills, MD). During the next three years, Shire will transition several products, including Carbatrol (carbamezepine), Intuniv (guanfacine extended-release), Lialda (mesalamine), Pentasa (mesalamine), and Vyvanse (lisdexamfetamine dimesylate), from its Owings Mills, Maryland, facility to DSM’s facility in Greenville, North Carolina. There is an initial term of five years for commercial manufacturing upon completion of a successful transition. DSM will continue to manufacture Adderall XR (mixed salts of a single-entity amphetamine product) and Fosrenol (lanthanum carbonate) for Shire and will provide Shire with technical services.
Sanofi-aventis agreed to acquire generic-drug maker Medley (Campinas, Brazil) in a deal that values the company at €500 million ($659 million). Medley has a generic-drug portfolio of 127 products, which accounted for 68% of the total revenues of the company in 2008. Sanofi-aventis also announced that its subsidiary, sanofi-aventis Mexico, acquired the generic-drug maker Laboratorios Kendrick (Mexico City). Sales in 2008 amounted to about 500 million Mexican pesos ($38 million). Kendrick’s portfolio incorporates more than 50 active ingredients in the areas of analgesics, antihistamines, anti-infectives, antirheumatics, cardiovascular, and central-nervous-system drugs.
Seattle Genetics (Bothell, WA) signed a licensing agreement with Millennium: The Takeda Oncology Company (Cambridge, MA), for the development of antibody-drug conjugates (ADCs). Under the terms of the agreement, Millennium will pay a $4 million upfront fee for an exclusive ADC license to an initial antigen expressed on solid tumors, and has the option for licenses to two other antigens upon payment of additional fees. Millennium is responsible for research, product development, manufacturing, and commercialization of the ADC products. Seattle Genetics will receive milestone, royalty, and research-support payments, as well as material-supply and annual maintenance fees.
Sigma-Tau Pharmaceuticals (Gaithersburg, MD), and Danisco BioActives (Madison, WI) signed a partnering agreement for the development of a new biologic drug candidate designed to prevent necrotizing enterocolitis (NEC). NEC is a rare, life-threatening gastrointestinal disorder in infants that affects very low birth weight premature infants (babies less than 1,500 grams or 3 pounds, five ounces). Under the terms of the agreement, Sigma-Tau and Danisco will develop STP-206, a biologic agent comprised of live bacteria, which may be effective in preventing NEC. Sigma Tau will manage the clinical development of the product and will seek regulatory approval from the US Food and Drug Administration and the European Medicines Agency. Human clinical trials are scheduled to start later this year.
Vetter (Ravensburg, Germany), a contract manufacturing organization, launched a quality-assurance program for its project managers, which the company expects will lead to their certification by the International Project Management Association (IPMA). Vetter expects the program to boost its efficiency, according to a company press release.
Cohera Medical (Pittsburgh, PA), a biotechnology company, named William M. Cotter to the newly created position of vice-president of manufacturing. The company is preparing to enter the clinical stage of development with its lead surgical adhesive product, TissuGlu.
Dionex (Sunnyvale, CA), a manufacturer and marketer of chromatography systems, announced that Frank Witney will become its president, chief executive officer, and a member of its board of directors, effective Apr. 30, 2009. Lukas Braunschweiler, who served as president and CEO since 2002, resigned.
The board of directors of Eli Lilly announced that J. Michael Cook will retire from the board, effective Apr. 20, 2009. Cook, the retired chairman and chief executive officer of Deloitte & Touche, has been a director on the board since 2005. Michael Eskew will replace Cook as chair of the audit committee.
Pfizer appointed Martine J. George vice-president of medical affairs for its Oncology Business Unit. George will be responsible for managing external relationships with cancer agencies, organizations, and specialists around the world. Pfizer also announced senior staffing changes last week, pending the closure of the Wyeth deal, and a summary of those personnel changes can be found on the company’s press release.
The biotechnology company Seattle Genetics (Bothell, WA) appointed Vaughn B. Himes executive vice-president of technical operations and promoted Morris Z. Rosenberg to executive vice-president of process sciences. Additionally, the company has recognized Peter D. Senter, vice-president of chemistry, as the company's first Distinguished Fellow.
Sigma-Aldrich (St. Louis, MO) appointed Michael Kanan as vice-president and corporate controller. Kanan succeeds Karen Miller, who was recently promoted to vice-president of strategy and corporate development. He will report to Rakesh Sachdev, vice-president and chief financial officer.