March 1, 2007 Notes: Royal DSM and Crucell Reach Milestone, Javelin Signs Commercial Supply Agreement with Precision Pharma, more

March 1, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

DSM, Crucell, Genentech, More

Company Notes

Leiden and Groningen, The Netherlands (Feb. 14)-Royal DSM N.V. (www.dsmbiologics.com) and Crucell N.V. (www.crucell.com) have achieved fermentation yields of more than 10 grams per liter for monoclonal antibodies. The achievement is a breakthrough in the development of their PER.C6 technology platform. The higher yield will allow the use of smaller bioreactors and could significantly lower the cost of goods for biopharmaceuticals.

South San Francisco, CA( Feb. 21)-Genentech, Inc. (www.gene.com) received a final office action from the US Patent and Trademark Office (Washington, DC, www.uspto.gov) regarding the reexamination of the Cabilly, et al. US Patent No. 6331415 ('415 patent). The patent covers the company's antibody production technology. The Patent and Tradmark Office has rejected the patentability of the claims of the '415 patent. Genentech plans to respond to the action within the next several months and appeal if necessary.

Gent, Belgium and Hercules, CA (Feb. 22)-Innogenetics (www.innogenetics.com) and Bio-Rad Laboratories, Inc. (www.bio-rad.com) have finalized a non-exclusive licensing agreement for patents in the field of viral diagnostics. According to the terms of the nonexclusive agreement, Innogenetics will get a license from Bio-Rad that has exclusive rights in the field of HIV-2. Bio-Rad will get an option to a non-exclusive license under Innogenetics patents in the field of HCV genotyping.

Cambridge, MA (Feb. 26)-Javelin Pharmaceuticals, Inc. (www.javelinpharmaceuticals.com) signed a commercial supply agreement with Precision Pharma Services, Inc. (Melville, NY, www.precisionpharma.com). Precision will manufacture Javelin's injectable "Dyloject" product for use in anticipated European markets pending regulatory approval.

Bristol, TN (Feb. 21)-King Pharmaceuticals, Inc. (www.kingpharm.com) has received approval for its new manufacturing and production facility in Rochester, MI from the US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov). The facility will be used to manufacture King's "Bicillin" product line, which is used to treat all stages of syphilis.

San Diego, CA (Feb. 26)-Ligand Pharmaceuticals Incorporated (www.ligand.com) completed the sale of its "Avinza" morphine capsules and associated assets to King Pharmaceuticals, Inc. (Bristol, TN, www.kingpharm.com). Ligand received a cash payment of $295 million and will receive a 15% royalty during the first 20 months after the closing of the asset sale.

Covington, KY (Feb. 28)-Omnicare, Inc. (www.omnicare.com) has entered into an agreement with Cardinal Health (Dublin, OH, www.cardinal.com) whereby Cardinal will serve as the contract repackager for pharmaceutical repackaging volumes previously produced at Omnicare's Heartland Repack Services facility. Omnicare ceased repackaging at Heartland in late 2006 after Heartland received a warning letter from the US Food and Drug Administration (Rockville, MD, www.fda.gov) for CGMP violations. The agreement initially extends through October 2010.

Gurgaon, India (Feb. 22)-Terapia Ranbaxy (www.terapia.ro), Ranbaxy's regional hub for European operations, received the manufacturing and import authorization according to the European Union norms and standards. The authorization allows Terapia Ranbaxy to begin batch testing and release activities for products manufactured outside the EU.

Monmouth, NJ (Feb. 26)-TyRx Pharma, Inc. (www.tyrxpharma.com) has entered into a material supply agreement with JFC Technologies (Bound Brook, NJ, www.jfctechnologies.com). JFC's contract manufacturing services will provide TyRx with clinical and commercial supplies of polymer.

Cambridge, MA (Feb. 12)-ViaCell, Inc. (www.viacellinc.com) has entered into an agreement with Invitrogen (www.invitrogen.com) to manufacture its ViaCyte media. ViaCyte is ViaCell's investigational product offering for use during assisted reproductive technology. The media manufactured by Invitrogen will be used in ViaCell's pivotal clinical trial to evaluate the cryopreservation and thawing of human oocytes. Financial terms were not disclosed.

people Notes

Hafnarfjordur, Iceland (Feb. 23)-Actavis (www.actavis.com) has appointed Fearghal Murphy executive vice-president of supply chain and Doug Boothe executive vice-president of commercial activities and administration in the US. Murphy has been with Actavis since 2003, when he joined the company as group logistics manager. Boothe has served as vice-president and chief operating officer for Actavis US since joining the company in 2005.

Princeton, NJ (Feb. 20)-Johane Boucher-Champagne has been promoted to president and chief executive officer of Anapharm, Inc., a subsidiary of PharmaNet Development Group, Inc. (www.pharmanet.com). The promotion is effective March 18, 2007.

Greenwich, CT (Feb. 20)-Aptuit, Inc. (www.aptuit.com) announced several promotions and changes to its senior management team. Frank J. Wright, former chief operating officer, will assume the role of vice-chairman, and Scott L. Houlton will take on the role of chief operating officer. Michael J. Butler, PhD, president of scientific operations, will take responsibility for the company's technology and innovation investment activities. Robert G. Burford, PhD, the company's managing director, will also serve as chairman of the management committee of Aptuit Consulting. Ann W. Newman, PhD, has been promoted to vice-president of research and development, and Stuart E. Needleman has been promoted to vice-president of sales and marketing. Vice-president of scientific development, Paul F. Skultety, PhD, will join the technology development committee. Paul E. Kennedy, PhD, a company director, has been named interim head of pharmaceutics in Kansas City, and Jane Fraser, PhD, has been promoted to senior manager and named interim head of pharmaceutics in Riccarton. Charles D. Nardi has been appointed vice-president of Aptuit Informatics, Vikram Marla has been promoted to chief technology officer of Aptuit Informatics, and John M. Morrison, director of clinical packaging and logistics, has accepted interim management responsibility for all North American clinical packaging operations. Panos T. Boudovas,Frank J. Manzella, and Kunal Khattar have all been appointed directors of clinical management. In addition, Aptuit cofounder Jon E. Tropsa is transitioning from his full-time role as chief financial officer to a part-time position as vice-president of special projects.

Gif-Sur-Yvettte, France (Feb. 26)-Cytomics Systems (www.cytomics.fr) has appointed Bernard Cambou, PhD, chief executive officer. Cambou joins Cytomics from StageMark Inc., where he served as chief executive officer. He was also a venture capital partner with Birchmere Ventures, a Pittsburgh, PA-based life sciences investment firm.

Princeton, NJ (Feb. 28)-Laureate Pharma, Inc. (www.laureatepharma.com) has elected Tracy Ken Tsuetaki chairman of its board of directors. Tsuetaki is currently president of medical communications and consulting at Quintiles Transnational.

Darmstadt, Germany (Feb. 21)-Karl-Ludwig Kley has been appointed chairman of the executive board of Merck KGaA (www.merck.de). Kley has served as vice-chairman of the executive board of Merck KGaA and general partner of E. Merck OHG since Sept. 1, 2006.

Flemington, NJ (Feb. 26)-NovaDel Pharma Inc. (www.novadel.com) appointed Deni M. Zodda, PhD, senior vice-president and chief business officer. NovaDel also promoted Frank Blondino, PhD, to executive director of formulation and process development. Zodda previously served as senior vice-president of business development at Discovery Laboratories, Inc. Blondino has served as director of formulations at NovaDel since 2004.

Tarrytown, NY (Feb. 26)-Regeneron Pharmaceuticals, Inc. (www.regeneron.com) has named Robert J. Terifay senior vice-president, commercial and Alain Thibault, MD, vice-president of clinical sciences-oncology. In addition, Stuart Kolinski has been promoted to senior vice-president, general counsel and secretary, Kremena Simitchieva has been promoted to vice-president of marketing, and Douglas McCorkle was appointed vice-president, controller and assistant treasurer.

San Diego, CA (Feb. 26)-Jeffrey Stein, PhD, has been appointed president and chief executive officer of Trius Therapeutics, Inc. (www.rx3pharma.com). Stein previously served as chairman of the company.

Collegeville, PA (Feb. 22)-Wyeth Pharmaceuticals (www.wyeth.com) has named Geno Germano president-US and general manager. Germano joined Wyeth in 1984 as a sales representative.

Berkeley, CA (Feb. 26)-Jack Castello, president, chief executive officer, and chairman of the board of XOMA Ltd. (www.xoma.com) plans to retire. He will continue to serve in his present capacities until a suitable replacement can be found.