Company Notes: Crucell Makes Deal With Wyeth, Severin Schwan Becomes CEO of Roche Group, More

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Millipore plans to open Singapore facility, Michael J. Simms joins Alexza Pharmaceuticals, more...

Company Notes

Harbin, China (Feb. 29)-China Sky One Medical, a manufacturer of over-the-counter pharmaceuticals for external use China, signed an agreement to acquire Heilongjiang Tianlong Pharmaceutical, an external-use drug manufacturing specialty pharmaceutical company. Under the terms of the agreement, China Sky One Medical’s wholly owned subsidiary, Harbin Tian Di Ren Medical Science and Technology Company, will acquire 100% of Tianlong’s operations for a cash payment $8.0 million and approximately $300,000 of China Sky One Medical’s common shares. In exchange, China Sky One Medical will obtain Tianlong’s $8.3 million in assets, which include $0.5 million in inventory, land use rights, GMP-certified manufacturing facilities, state-of-the-art production equipment, a research and development center, a portfolio of 69 approved drugs (in 98 forms) and a pipeline of 38 new drugs, all of which have been submitted to the State Food and Drug Administration for approval. The acquisition is expected to close on or before March 31, 2008.

Leiden, The Netherlands (Mar. 3)-Dutch biotechnology company Crucell entered into an exclusive vaccine development agreement with Wyeth Pharmaceuticals, a division of Wyeth (Madison, NJ). Under the terms of the agreement, Crucell will be responsible for the development and manufacture of certain components of a vaccine for use by Wyeth in clinical studies. Crucell will develop the components at its vaccine manufacturing facilities in Bern, Switzerland. Wyeth will be responsible for the clinical development of the vaccine. Financial details were not disclosed.

San Antonio, TX (Feb. 26)-DPT Laboratories added preparation of the chemistry, manufacturing and controls (CMC) documents in the “Common Technical Documents” format as an optional service that can streamline the documentation process for customers applying for approval of new drugs. This new service provides preparation of CMC Modules 2 and 3 documentation for customers throughout formulation and process development in the format established by the International Commission on Harmonization for submitting new drug applications with US Food and Drug Administration, as well as similar regulatory agencies in the European Union and Japan.

Monmouth Junction, NJ (Mar. 3)-MicroDose Technologies entered into a license agreement with Merck & Co. (Whitehouse Station, NJ) for use of MicroDose’s proprietary dry powder inhaler (DPI) with Merck compounds. Under the terms of the agreement, Merck will fund development and commercialization of products that use MicroDose’s DPI technology for the administration of Merck compounds. MicroDose will receive an upfront payment and will be eligible for milestone payments totaling $32 million for successful development of the first product as well as royalties on product revenues.

Billerica, MA (Mar. 3)-Millipore plans to open a new applications and training facility in Singapore. Scheduled to open in early 2009, the Singapore facility will be located in Science Park. Millipore says the facility will be designed to support biopharmaceutical manufacturing.

New York (Mar. 3)-Pfizer entered into an agreement to acquire Serenex (Durham, NC), a privately held biotechnology company with a Phase I clinical candidate and a compound library that targets Heat Shock Protein 90 (Hsp90). Compounds from this library have potential uses in treating cancer as well as inflammatory and neurodegenerative diseases. Under terms of the agreement, Pfizer will acquire the rights to SNX-5422, an oral Hsp90 inhibitor currently in Phase I trials for the potential treatment of solid tumors and hematological malignancies. SNX-1012, another compound in clinical development, is not included in the agreement. The transaction, subject to customary closing conditions, is expected to close in the second quarter of 2008. Financial details were not disclosed.

Sunnyvale, CA (Feb. 28)-Pharmacyclics announced a corporate realignment designed to reduce expenses and focus on advancing its pipeline of new candidates. Mid-stage clinical trials of motexafin gadolinium (Xcytrin) are substantially complete and the company intends to partner or out-license the drug for further development. Pharmacyclics plans to reduce its workforce by approximately 40%. The company expects to make severance payments of approximately $0.4 million in the third quarter of fiscal 2008.

Ravensburg, Germany (Feb. 27)-Vetter Pharma-Fertigung was granted approval by the US Food and Drug Administration for the production of a new client drug. Vetter, which provides contract-manufacturing services for pharmaceutical and biotech companies, will now begin filling the drug at its Ravensburg Vetter South (RVS) facility. This approval underscores the competence of Vetter’s aseptically prefilled injection systems used in the production of biotechnological and complex medications.

People Notes

Mountain View, CA (Feb. 27)-Michael J. Simms joined Alexza Pharmaceuticals as senior vice-president of operations and manufacturing. Simms was most recently senior vice-president of manufacturing operations at Nektar Therapeutics (San Carlos, CA).

Pune, India (Feb. 26)-Bilcare Global Clinical Supplies appointed Vito Mangiardi, a 30-year industry veteran, as its new chief executive officer. Mangiardi recently served as president of North American operations for AAI Pharma (Wilmington, NC), and previously worked at Quintiles Transnational (Research Triangle Park, NC).

Concord, CA (Mar. 3)-Laurence M. Corash, was promoted to senior vice-president and chief medical officer at Cerus, a biopharmaceutical company. Corash is a cofounder and board member of Cerus, and has been a member of the senior management team at Cerus since 1994.

Hayward, CA (Feb. 28)-Kosan Biosciences announced that Robert G. Johnson, Jr., PhD, resigned as president, chief executive officer, and a member of the board of directors. Helen S. Kim, who joined the company in January 2008 as senior vice-president and chief business officer, has been appointed president of Kosan.

Pittsburgh, PA (Feb. 27)-Mylan appointed Jagdish Viswanath Dore as chief executive officer and managing director of Matrix Laboratories (Secunderabad, India), a majority owned subsidiary of Mylan. Dore will assume the responsibilities of Rajiv Malik, who became executive vice-president and head of global technical operations in October 2007 and has been serving as interim CEO for Matrix. Malik will relocate to the United States in connection with his employment by Mylan.

New York (Mar. 3)-Pfizer named William Ringo senior vice-president of strategy and business development. He will join Pfizer’s executive leadership team and report to chairman and chief executive officer Jeff Kindler.

Basel, Switzerland (Mar. 4)-Severin Schwan succeeded Franz B. Humer as CEO of the Roche Group, and made his first address as CEO at the company’s annual general meeting. Schwan will take over as CEO from Humer, who will remain chairman of the board.

Kenilworth, NJ (Feb. 29)-Ian McInnes, PhD, was promoted to senior vice-president and president of the global supply chain at Schering-Plough. McInnes is responsible for more than 60 manufacturing sites worldwide. The company’s global supply chain strategy now includes operations from Organon BioSciences, which was acquired in November 2007.

Coral Gables, FL (Feb. 29)-Stiefel Laboratories promoted William D. Humphries to president of the privately held dermatology company. This move marks the first time in the organization’s 160-year history that a non-family member held the position of president. Humphries will lead all sales, marketing, communications, public relations and commercial aspects of Stiefel’s global business, and he will assume responsibility for Glades Pharmaceuticals, a wholly owned subsidiary of Stiefel specializing in the sales and marketing of generic pharmaceutical products.

Exton, PA (Feb. 26)-ViroPharma announced that, effective March 31, 2008, Vincent J. Milano will succeed Michel de Rosen as president and chief executive officer of the company and has been elected to its board of directors. De Rosen will continue as nonexecutive chairman of the board of directors. Daniel B. Soland will become chief operating officer, also effective March 31, 2008.

Fremont, CA (Mar. 3)-WaferGen Biosystems, a biotechnology company, promoted two members of the company’s management team: Kumar Kastury, PhD, director of assay development, has been promoted to vice-president of assay development; and John McEntee, director of engineering, has been promoted to associate vice-president of engineering. The company announced that Terry W. Osborn, PhD, chief operating officer, is leaving to pursue other interests.