Company and People Notes: Eisai Acquires MGI Pharma, Ceregene Names CEO, More

Company Notes

Toronto (Dec. 5)-Apotex, a generic drug company, acquired Lareq Pharma S.L., a mid-sized generic pharmaceutical company based in Spain for an undisclosed sum from Industria Quimica Y Farmaceutica VIR S.A. (Madrid).

Tustin, CA (Dec. 5)-Avid Bioservices, a contract biologics manufacturer, signed a manufacturing supply and technology transfer agreement with Arius Research (Toronto), a developer of antibody therapeutics. The agreement covers Arius’s lead cancer stem cell antibody, which targets a novel epitope of CD44 found in breast, colon, and prostate cancers. Avid will begin manufacturing drug supply under current good manufacturing practice regulations for human clinical trials that Arius plans to initiate in 2008. In other news, Avid extended its commercial manufacturing supplement agreement with Halozyme Therapeutics (San Diego). Under the agreement Avid could manufacture up to 20 runs per year over the next five years of a recombinant human enzyme that is the active ingredient in Halozyme’s “Hylenex” and “Cumulase” products.

Heerlen, the Netherlands (Dec. 6)-DSM Anti-Infectives, a business group of Royal DSM N.V and supplier of  active pharmaceutical ingredients (APIs) for antiobiotics, and Arch Pharmalabs (Mumbai), a pharmaceutical company manufacturing APIs, have signed a partnership agreement. DSM Anti-Infectives will provide  fermentative technologies and market access to the partnership, and Arch will use its asset base in India and its competences in chemical conversion. DSM Anti-Infectives announced in June 2007 that it is currently rationalizing its portfolio and actively looking for partnerships.

Tokyo (Dec. 10)-The pharmaceutical company Eisai agreed to acquire the biopharmaceutical company MGI Pharma (Bloomington, MN) for $3.9 billion. The deal is subject to customary closing conditions and regulatory approvals and is expected to be completed during the first quarter of 2008. To effect the transaction, Eisai has established an acquisition subsidiary, Jaguar Acquisition Corp., which is wholly-owned by Eisai Corporation of North America (Woodcliff Lake, NJ). The acquisition of MGI Pharma is consistent with Eisai’s strategy to strengthen its position in oncology drugs. In October 2006, Eisai acquired four oncology products and related expertise from Ligand Pharmaceuticals (San Diego) and in April 2007 acquired Morphotek (Exton, PA), a biopharmaceutical company specializing in the development of protein and antibody gene evolution technology. In addition, Eisai is building a new oncology facility for manufacturing and formulation research and development at its North Carolina site.

Rockville, MD (Dec. 3)-The US Food and Drug Administration’s Pediatric Advisory Committee recommended changing the general language in the label of Roche’s (Basel, Switzerland) drug Tamiflu (oseltamivitor) to specify the potential for neuropsychiatric adverse events.

London (Dec. 10)-Hikma Pharmaceuticals, a generic drug company, reports that its October 7, 2007 offer to acquire the pharmaceutical Arab Pharmaceutical Manufacturing (APM) (Amman, Jordan) for JD116.0 million ($163.6 million) was accepted by APM shareholders. Hikma expects to assume control of APM by the end of the year.

Billerica, MA (Dec. 5)-Millipore and Rohm and Haas formed joint development agreement to create new high-performance chromatography products that are used to manufacture biologic drugs. Under the terms of the agreement, Millipore’s bioprocess division and Rohm and Haas’s ion exchange resins group will develop improved ion exchange chromatography products for manufacturing biologic drugs. Millipore will gain exclusive access to new, customized chromatography media developed under the agreement.

Gardner, MA (Nov. 28)-New England Peptide, a contract manufacturer of peptides, opened a 1000-ft² addition to its Gardner, Massachusetts, facility, which houses a dedicated large-scale production suite.

Saborg, Denmark(Dec. 11)-NNE Pharmaplan was selected by Pronova BioPharma (Lysaker, Norway) a company involved in the research, development and manufacturing of marine-originated, omega-3 fatty acids derived pharmaceutical products, to establish Pronova’s new pharmaceutical production facility in Kalundborg, Denmark. Under the contract, NNE Pharmaplan will be responsible for engineering, procurement, construction management, validation and automation integration. The new facility will be approved according to good manufacturing practice. Pronova BioPharma plans to invest between NOK 1.45 and 1.70 billion ($268–314 million) in the new facility, which is expected to be operational and approved by the relevant regulatory authorities by the first half of 2010. The new facility in Kalundborg is expected to double Pronova BioPharma's current production capacity of the active pharmaceutical ingredient used in the company’s lead product, marketed as “Omacor” in Europe and “Lovaza” in the United States.

Toronto (Dec. 6)- Patheon agreed to sell its Niagara-Burlington commercial manufacturing business for $5.75 million plus working capital to Pharmetics (Laval, Quebec, Canada), a privately owned contract manufacturer of vitamins, herbal products, supplements and over-the-counter (OTC) pharmaceutical products. Under the agreement, Pharmetics will acquire the assets, including equipment, facilities and land, at Patheon’s facilities in Fort Erie and Burlington (Gateway Drive) in Ontario. Pharmetics will provide employment to the entire active workforce of about 250 commercial manufacturing employees at the two sites and, subject to assignment of third-party contracts, will continue to manufacture and supply all of the products currently manufactured at these sites. Collectively, the two sites currently serve 14 clients, manufacturing and packaging on their behalf about 60 OTC pharmaceutical products in a range of dosage forms, including tablets, liquids and powders. The deal is expected to close by the end of January 2008.

London (Dec. 10)-Reckitt Benckiser, a provider of household, personal care, and health products, agreed to acquire the specialty pharmaceutical company Adams Respiratory Therapeutics (Chester, NJ) for $2.3 billion. Adams is currently active in the United States only and markets two brands: “Mucinex,” an adult cough expectorants and “Delsym,” a cough suppressant.

Ravensburg, Germany (Nov. 28)-Vetter Pharma-Fertigung, a contract manufacturer for aseptic filling of prefilled injection systems, has received accreditation by Japan’s Ministry for Health, Labor and Welfare as a foreign manufacturer for the Japanese pharmaceutical market. Vetter received certification in the categories of “drug, sterile product,” drug, packaging, labeling and storage,” and “medical device, sterilized medical device.” Approval by Japanese regulatory authorities is needed by companies looking for partnerships as a contract manufacturer with Japanese pharmaceutical and biotech companies seeking to sell drugs in the local market.

In another development, Vetter began construction of a new facility for visual inspection and secondary packaging near its Ravensburg Vetter South facility. Vetter is investing EUR 20 million in the project, which will create more than 200 jobs. The new facility is being created to meet demand in the growing market for homecare applications, including dual chamber syringes and cartridges for pen- and autoinjectors, and to meet new international requirements, such as the adoption of safety systems for anti-counterfeiting. The facility will be operational by the end of 2008.

People Notes

San Diego, CA (Dec. 6)-Ceregene promoted Raymond T. Bartus, PhD, to executive vice-president of clinical and preclinical research and development and chief operating officer. Bartus has been with the company since 2002, most recently as a leader of the preclinical and clinical development programs for the company’s “CERE-120” and “CERE-110” therapeutic candidates for Parkinson’s disease and Alzheimer’s disease, respectively.

Seattle, WA (Dec. 7)-Dendreon has promoted Mark Frohlich, MD, to senior vice-president of clinical affairs and chief medical officer. The company credits Frohlich as a key contributor to its biologics license application filing for the “Provenge” (sipuleucel-T) prostate-cancer therapeutic and the monitoring of its related Phase III trials. Frohlich was previously the company’s vice-president of clinical affairs.

San Carlos, CA (Dec. 11)-Nektar Therapeutics promoted John Nicholson to senior vice-president and chief financial officer. Nicholson has served in the pharmaceutical industry for more than 25 years, most recently as the company’s senior vice-president of corporate development and business operations.

San Diego, CA (Dec. 7)-Somaxon Pharmaceuticals appointed David F. Hale executive chairman of the board, effective immediately, and interim CEO, effective Jan. 1, 2008. Hale replaces Kenneth M. Cohen, who remains a member of the company’s board of directors. The company’s board is currently seeking a new CEO and expects to name a permanent CEO at its 2008 meeting of stockholders. Somaxan is a pharmaceutical company focusing on therapeutic products for insomnia and movement disorders.