Eisai has established a new pharmaceutical sales subsidiary in Mexico City, which will be named Eisai Laboratorios S. de R.L. de C.V. (Eisai Mexico). Eisai Mexico is the company’s second sales subsidiary in Latin America. The company established Eisai Participações Ltda. (Eisai Brazil) in April 2011 in Sao Paulo.
Evonik Industries, a specialty- and fine-chemicals company, will combine its business in custom manufacturing of APIs (exclusive synthesis), pharmaceutical amino acids (the Rexim product line), and pharmaceutical polymers in a new healthcare business line, effective Sept. 1, 2011. The newly formed business line will be part of the Health and Nutrition Business Unit, which is headed by Reiner Beste. Jean-Luc Herbeaux will head the newly formed Health Care Business Line, which will be divided into three product lines: Pharma Polymers under the management of Thomas Riermeier; Exclusive Synthesis under the management of Klaus Stingl; and Rexim under the management of Thomas Hermann.
Mylan has confirmed that the company and its subsidiary, Mylan Pharmaceuticals, have been sued by Endo Pharmaceuticals in connection with the filing of an abbreviated new drug application (ANDA) with FDA for frovatriptan succinate EQ, 2.5-mg base tablets. This product is the generic version of Frova, used for the treatment of acute migraine headaches. Mylan believes it is the first company to have filed a substantially complete ANDA containing a Paragraph-IV certification and expects to qualify for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the US District Court in Delaware.
Nabi Biopharmaceuticals has received a $5-million payment from Fresenius USA Manufacturing, a healthcare provider, that was triggered by the first commercial sale of Phoslyra, a milestone under the agreement governing the company’s 2006 sale of PhosLo (calcium acetate) and related assets to Fresenius. These assets included the rights to a new liquid formulation of PhosLo that Fresenius has commercialized as Phoslyra.
Paladin Labs, a specialty pharmaceutical company, has agreed to acquire the specialty pharmaceutical company Labopharm for $0.2857 per share in cash. The transaction has been approved by Labopharm’s board of directors and subject to regulatory approval.
The CDMO Pharmaceutics International (Pii) has successfully completed a joint European Medicines Agency (EMA) and FDA inspection. The four-day inspection was conducted by representatives of EMA from the Medicines and Healthcare products Regulatory Agency and Medical Products Agency of Sweden and from FDA. The inspection is part of FDA’s and EMA’s joint initiative, which focuses on increasing international regulatory collaboration among the agencies to enhance global drug quality and safety. As part of the inspection, Pii received EMA marketing authorization for a soft-gel product and reauthorization for a tablet product. Both FDA inspections were closed as of June 2011 and indicate that Pii is in substantial compliance with US GMPs.
FDA has approved Roche’s Zelboraf (vemurafenib), a new drug for treating BRAF mutation-positive metastatic melanoma. FDA also approved the cobas 4800 BRAF V600 mutation test, a diagnostic test developed by Roche to identify patients eligible for treatment.
In other news, Roche plans to invest more than $190 million during the next five years in a global pharmaceutical development site in Mississauga, Ontario, Canada. During the next five years, the company plans to bring study-management leadership positions, such as global trial and data management, to Roche Canada’s pharmaceutical development site. The first positions have been filled. It is expected that renovations to house the global site will begin, and several more positions will be filled later this summer and fall. The roles will include global study management, global data management and product development regulatory.
FDA has approved Seattle Genetics’ Adcetris (brentuximab vedotin), a new drug to treat Hodgkin lymphoma and anaplastic large-cell lymphoma. Adcetris is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E.
Valeant Pharmaceuticals International, a specialty pharmaceutical company, has completed its previously announced EUR 314 million ($454 million) acquisition of AB Sanitas, a specialty pharmaceutcial company.
The biopharmaceutical company Addex Pharmaceuticals has named Bharatt Chowrira as CEO. Prior to joining Addex, Chowrira was senior vice-president and CEO of Nektar Theraputics, a biopharmaceutical company.
Astellas has appointed Percival Barretto-Ko to senior vice-president of corporate strategy and government affairs, a new position added to the company’s leadership team. He will report to President and CEO Masao Yoshida and will be responsible for corporate planning, business development, government policy, external affairs, and state-government affairs.
Cangene, a biopharmaceutical company, has named John A. Sedor as president and CEO, effective Sept. 12, 2011. He most recently served as president, CEO, and director of CPEX Pharmaceuticals, a specialty drug-delivery pharmaceutical company, including managing its spinoff from Bentley Pharmaceuticals in 2008. Michael Graham, Cangene’s CFO, who has been interim president and CEO, will continue his role as CFO.
Evonik Industries has appointed Hans-Joseph Ritzert as regional president of the Greater China region, and Jean-Luc Herbeaux as head of the company’s newly formed healthcare business line. Ritzert previously led Evonik’s exclusive synthesis and pharmaceutical amino acids business. Herbeaux previously served as head of the company’s pharmaceutical polymers business.
Paladin Labs has announced President and CEO Jonathan Ross Goodman was involved in an accident and is currently hospitalized with serious injuries, the full extent of which are being assessed. Mark Beaudet, cofounder, director, and vice-president of marketing and sales, has been asked to perform Goodman’s duties on an interim basis.