February 8, 2007 Notes: Cambrex sells subsidiaries to Lonza, Cobra forms agreement with Pharmexa, more

February 8, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Cambrex, Lonza, EaglePicher, more

Company Notes

East Rutherford, NJ (Feb. 5)-Cambrex Corporation's (www.cambrex.com) shareholders approved the sale of the company's bioproducts and biopharma subsidiaries to Lonza Group AG (Basel, Switzerland, www.lonza.com). The transaction is expected to close within the next two to five business days.

Keele, UK (Feb. 1)-Cobra Biomanufacturing Plc (www.cobrabio.com) formed an agreement with Pharmexa (Hørsholm, Denmark, www.pharmexa.com) for the manufacture of "PX107" protein vaccine for use in Phase I clinical trials for bone disorders. Cobra will manufacture the protein, and Pharmexa will carry out upstream and downstream development of the vaccine.

Toronto, ON, Canada (Jan. 26)-Dalton Pharma Services (www.dalton.com) successfully completed its Health Canada inspection. The receipt of a compliant rating means that the facility can begin to manufacture sterile products and test and ship commercial products to clients in Canada and the Europe.

Inkster, MI (Feb. 1)-EaglePicher Corporation (www.eaglepicher.com) completed the sale of EaglePicher Pharmaceutical Services, LLC to Aptuit, Inc. (Greenwich, CT, www.aptuit.com). Terms of the deal were not disclosed.

Rockville, MD (Feb. 5)-The US Food and Drug Administration (www.fda.gov) missed having a record year for new drug application (NDA) approvals after approving only eight NDAs in December. October saw a surge of approvals, leading some to believe that 2006 would be a record year for NDA approvals, but the dropoff in December meant that FDA ended the year with 13 more approvals than 2005 but 19 fewer than 2004. Overall, FDA approved 93 NDAs, compared with 79 in 2005 but down from 112 in 2004. A total of 123 NDAs were received during 2006. FDA approved 18 new molecular entities (NMEs), the same as in 2005 but down from 31 in 2004. FDA also received fewer submissions for NMEs than in the past.

Gaithersburg, MD (Feb. 1)-GenVec, Inc. (www.genvec.com) signed a three-year contract with the Department of Homeland Security (DHS, Washington, DC, www.dhs.gov) to develop and manufacture vaccines against foot and mouth disease. GenVec will receive as much as $6 million in program funding the first year and as much as $15 million over three years if DHS exercises its annual renewal options under the contract. GenVec will be responsible for the development, production, and regulatory approval of the vaccine, while DHS will conduct animal studies.

Princeton, NJ (Feb. 6)-Laureate Pharma, Inc. (www.laureatepharma.com) formed a partnership wtih Boehringer Ingelheim (Ingelheim, Germany, www.boehringer-ingelheim.com). The partnership gives Laureate's clients access to Boehringer's manufacturing technology platform for biopharmaceutical products produced by mammalian cell culture. Clients also will have access to large-scale commercial production by Boehringer at its facility in Biberach, Germany.

San Diego, CA (Jan. 31)-Ligand Pharmaceuticals Inc. (www.ligand.com) plans to reduce its workforce by approximately 76%, eliminating about 267 positions as part of the company's restructuring. In addition, Ligand's primary operations will be consolidated into one building, and its subsidiary in the United Kingdom will be shut down. Most of the changes are expected to take place in the first quarter of 2007.

Toronto, ON, Canada (Jan. 29)-MDS Inc. (www.mdsinc.com) will acquire Molecular Devices Corporation (Sunnyvale, CA, www.moleculardevices.com) for $615 million. The boards of both companies have unanimously approved the merger, and MDS will commence a cash tender offer for all outsanding shares of Molecular Devices. As a result of the acquisition, MDS plans to create a new business unit that will combine the Molecular Devices and MDS Sciex businesses.

Rockville, MD (Jan. 11)-The US Food and Drug Administration (FDA, www.fda.gov) issued a warning letter to Omnicare's (Covington, KY, www.omnicare.com) drug-repackaging facility, Heartland Repack Services, citing violations of current good manufacturing (CGMP) practices. This letter marks the fifth time in 11 years that Omnicare has received a warning from FDA. Although the firm has taken corrective action, including recalling affected products and closing its facility for an extended period of time, the letter was issued because the actions have not been completed and because of past documented CGMP deficiencies. The CGMP violations included failure to completely separate penicillin and nonpenicillin products during repacking, failure to maintain separate or defined areas for the storage of in-process materials to prevent contamination or mix-ups, failure to exercise controle over drug-product labeling operations, failure to use appropriate equipment for the manufacture, processing, packing, or holding of drug products, and failure to properly test drug products or reject those that do not meet established specifications and quality-control criteria. The company intends to relocate its repackaging operations to a new facility, which will open once the company meets safety and compliance requirements.

Rockville, MD (Feb. 8)-Under a new guidance issued by the US Food and Drug Administration (www.fda.gov), user fees will be waived for certain applications for FDA and copackaged versions of previously approved drugs for the treatment of HIV. Certain applications whose user fees will not be waived will still be eligible for a public health or a barrier-to-innovation waiver. In addition, treatments that use an active ingredient that has already been approved or applications that do not require clinical data for approval could qualify for fee exemptions or could be assessed a half fee.

New York, NY (Feb. 1)-Pfizer Inc. (www.pfizer.com) plans to acquire BioRexis Pharmaceutical Corporation (King of Prussia, PA, www.biorexis.com). Financial terms were not disclosed. The deal is expected to close in the first or second quarter of 2007.

Basel, Switzerland (Feb. 5)-Roche (www.roche.com) plans to introduce a new operating model for its global research and development activities that is organized around disease biology areas (DBA). Managed by disease biology area leadership teams (DBLT), they will be located in Basel; Nutley, New Jersey; and Palo Alto, California. Each DBLT will manage compounds from drug discovery through proof of concept, with oversight through to the market.

People Notes

San Diego, CA (Jan. 30)-Amylin Pharmaceuticals, Inc. (www.amylin.com) appointed Daniel M. Bradbury president and chief executive officer. Bradbury joined Amylin in 1994 and most recently served as president and COO. He succeeds Ginger L. Graham, who has led the company since 2003.

Oxford, UK (Jan. 31)-Cobra Biomanufacturing Plc (www.cobrabio.com) appointed Tony Mulcahy general manager of the Oxford facility. Mulcahy has been with the company for12 years, most recently as director of customer relations and marketing.

Lake Forest, IL (Feb. 1)-Following its acquisition of Mayne Pharma Limited (Melbourne, Australia, www.maynepharma.com), Hospira, Inc. (www.hospira.com) announced several new leadership appointments. Chris Kolber was promoted to president of global devices. Thomas Moore was promoted to president of global pharmaceuticals. Alejandro Infate was appointed president for the Americas. Michael Kotsanis, formerly president for Asia-Pacific for Mayne Pharma, will serve as president for Europe, the Middle East, and Africa. Tim Oldham, PhD, will take over as president for Asia-Pacific, and Ron Squarer will serve as corporate vice president of global strategy and business development. 

Pittsburgh, PA (Jan. 31)-Mylan Laboratories Inc. (www.mylan.com) announced several new appointments as part of its strategic global reorganization following its acquisition of Matrix Laboratories (Secunderabad, India, www.matrixlabsindia.com). Rajiv Maliks, CEO of Matrix, will be head of global technical operations for Mylan. S. Srinivasan was promoted to chief operating officer for Matrix, and Heather Bresch was named head of North American operations for Mylan. Terry Stewart was promoted to head of global manufacturing for Mylan. In addition, John P. O'Donnell, Mylan's chief scientific officer, will retire onA pril 1, 2007 and take on the new role of strategic scientific advisor.

Bridgewater, NJ (Feb. 6)-Sanofi-Aventis (www.sanofi-aventis.us) named Tim Rothwell chairman of the Sanofi-Aventis Group US Pharmaceutical Activities. Rothwell previoiusly served as president and CEO of US pharmaceutical operations, a position that will be assumed by Greg Irace, the company's chief financial officer and senior vice-president of finance and administration.