Company and People Notes: KV Pharmaceutical Restructures; Otsuka America Appoints Mark Altmeyer President and CEO; More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Sandoz received approval for its third biosimilar from the EU, WuXi PharmaTech's CFO Benson Tsang to leave at month's end; more...

Company notes

Berlin, Germany (Feb. 12)-Bayer Schering Pharma AG, the pharmaceutical division of Bayer HealthCare (BHC), will invest EUR 100 million ($126 million) during the next five years in a research and development center in Beijing, China. Additionally, Bayer Schering Pharma announced it is in advanced discussions with Tsinghua University on entering into a strategic partnership to pursue research collaborations for the discovery of new disease-related targets.

Frankfurt, Germany (Feb. 2)-International Chemical Investors Group (ICIG) acquired 100% of the shares of the Miteni (Milan, Italy), a fine-chemical producer of fluorine-based intermediates, from Mitsubishi (Tokyo, Japan), and other shareholders. Terms of the transaction were not disclosed.

St. Louis, MO (Feb. 9)-As part of a restructuring plan, KV Pharmaceutical will reduce its workforce by approximately 700 jobs. The action is part of a cost-cutting program as the company works toward resuming full operation after its voluntary suspension of product manufacturing and shipment, as well as voluntary recalls of its products. The KV workforce reduction includes a combination of terminations and layoffs. The company expects to recall some employees when production and shipment of approved products resume. Additionally, the company is working with Lachman Consulting to enhance KV’s current good manufacturing practices (CGMP) processes and quality systems.

Whitehouse Station, NJ (Feb. 12)-Merck & Co., Inc. will acquire Insmed’s (Richmond, VA) portfolio of follow-on biologic therapeutic candidates and its commercial manufacturing facilities located in Boulder, Colorado, for $130 million in cash. The agreement provides for initial payments of up to $10 million for “INS-19,” an investigational recombinant granulocyte-colony stimulating factor (G-CSF) that will be evaluated in Phase III clinical trials for its ability to prevent infections in patients with cancer receiving chemotherapy and “INS-20,” a pegylated recombinant G-CSF designed to allow for less frequent dosing, which is currently in Phase I clinical trials. Merck will pay Insmed the remaining balance upon closing of the transaction, without any further milestone or royalty obligations. Merck plans to offer positions to the staff at the Boulder facilities.

Billerica, MA (Feb. 16)-Millipore opened its Biomanufacturing Sciences and Training Center (BSTC) in Singapore. The 8,000-ft2 facility is located in Science Park and is designed to support biopharmaceutical manufacturing. The company plans to offer training courses beginning in March 2009.

Ballerup, Denmark (Feb. 17)-NeuroSearch signed a three-year drug discovery and development alliance with Eli Lilly to investigate a defined number of undisclosed ion channel targets for their potential in treating various central nervous system (CNS) disorders. Under the terms of the agreement, NeuroSearch is eligible to receive up to $13 million (DKK 75.9 million) from Lilly in upfront fees and research funding over the next three years, of which $5 million (DKK 29.2 million) will be paid up front. Lilly will also make a $17-million (DKK 99.2-million) equity investment in NeuroSearch. Additionally, NeuroSearch may be entitled to milestone payments of up to $320 million (DKK 1,868.2 million) plus royalties on sales of commercialized products resulting from the agreement.

Basel, Switzerland (Feb. 12)-Novartis and Portola Pharmaceuticals (South San Francisco, CA) signed a drug-development pact for elinogrel, an anti-clotting agent in Phase II clinical trials. Under the terms of the agreement, Novartis will have responsibility for the Phase III development, manufacturing and commercialization of elinogrel. Portola will receive an upfront cash payment of $75 million and is eligible to receive additional cash milestone payments totaling up to $500 million. Portola will also receive royalties on worldwide net sales of elinogrel.

Waltham, MA (Feb. 11)-Oscient Pharmaceuticals announced a restructuring plan that includes the reduction of approximately 32% of its 305 employees across the United States. The company is also eliminating approximately 25 positions that have been vacant. Following the staff reductions, the company will have approximately 35 employees at its offices in Waltham, Massachusetts, and Skillman, New Jersey; and approximately 170 field employees across the US. In addition, Oscient has engaged Broadpoint Capital to advise the company on strategic options, including the potential sale of the company.

Leiden, The Netherlands (Feb. 12)-OctoPlus, a drug-delivery company, signed a pharmaceutical development contract with Galapagos (Mechelen, Belgium). Under the contract terms, OctoPlus will manufacture clinical trial material for Galapagos’ Phase II study of “Nanocort,” a liposome formulation of prednisolone. Financial details of the agreement were not disclosed.


Holzkirchen, Germany (Feb. 13)-Sandoz has received final approval for its third biosimilar, filgrastim, in the European Union. Filgrastim is indicated for the treatment of neutropenia, a condition characterized by a lack of neutrophils, one of the most common types of white blood cells, whose role is to fight infection in the body. Sandoz is the only company with marketing authorization for more than one biosimilar medicine, according to a company press release.

Ashland, OH (Feb. 13)-The contract research organization WIL Research Laboratories, LLC, part of WIL Research Holding Company, Inc., acquired Midwest BioResearch (Skokie, IL), a contract research organization focused on drug disposition and toxicology services. WIL Research Laboratories provides services in nonclinical toxicology, pharmacology, metabolism, and both clinical and nonclinical bioanalytical services.

People Notes

Portland, OR (Feb. 12)-AVI BioPharma, a developer of RNA-based drugs, appointed Stephen B. Shrewsbury chief medical officer (CMO) and senior vice-president of clinical and regulatory affairs. Shrewsbury previously served as CMO and senior vice-president clinical development and regulatory affairs for Adamas Pharmaceuticals.

Rockville, MD (Feb. 12)-Otsuka America Pharmaceutical appointed Mark Altmeyer president and CEO. Altmeyer succeeds Interim President and CEO Dean R. Haubrich, who has been leading the company since August 1, 2008, and has been named Chairman of the company’s board of directors.

Watertown, MA (Feb. 11)-Panacos Pharmaceuticals announced that the company’s chief medical officer, Scott McCallister, and the vice-president of manufacturing operations, John Richards, will leave the company effective Feb. 13, 2009. These positions were eliminated after Panacos sold its HIV/AIDS drug "bevirimat" last month, and the company has refocused its efforts on its early stage programs.

Newton, MA (Feb. 17)-Pro-Pharmaceuticals named Theodore D. Zucconi CEO and president. Zucconi is a member of the company's board of directors and former president. Zucconi replaces David Platt, who will become CEO and chief technology officer of Medi-Pharmaceuticals, a company that is 10% owned by Pro-Pharmaceuticals that is focused on developing cardiovascular treatments. The company also announced that Anatole Klyosov has returned to Pro-Pharmaceuticals as chief scientist.

East Brunswick, NJ (Feb. 12)-Savient Pharmaceuticals, a biopharmaceutical company, appointed David G. Gionco vice-president, chief financial officer, and treasurer. Gionco replaces Brian Hayden, who was terminated as Savient's CFO.

Shanghai (Feb. 17)-WuXi PharmaTech announced that Benson Tsang, chief financial officer, will leave the company for personal reasons at the end of February. Tsang has agreed to provide transition services and to assist in recruiting his successor. Edward Hu, chief operating officer, will serve as acting CFO until a replacement is found. In the interim, Christine Lu-Wong, vice-president of finance, will serve as the company's principal accounting officer.