December 8, 2006 Notes: 3M sells pharmaceutical operations in Asia Pacific Region, Abbott acqures Kos, more

Company Notes

St. Paul, MN (Dec. 5)-3M (www.3M.com) completed the sale of its pharmaceutical operations in the Asia Pacific region, including Australia and South Africa. The $349-million transaction with Archer Capital and Ironbridge Capital establishes a new dedicated pharmaceutical company headquartered in Sydney, Australia. The new company will produce over-the-counter and prescription therapies and will be led by Tony Martin, former general manager of 3M Pharmaceutical’s Asia Pacific operations.

Abbott Park, IL (Dec. 4)-The Federal Trade Commission has cleared the way for Abbott (www.abbott.com) to acquire Kos Pharmaceuticals, Inc. (Cranbury, NJ, www.kospharm.com) by granting early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Abbott made a tender offer on Nov. 14 of $78 per share of outstanding Kos common stock. Unless it is extended, the tender offer is set to expire at 12:00 midnight on Dec. 12.

Reykjavik, Iceland (Nov. 30)?Actavis (www.actavis.com), a generic drug manufacturer, agreed to acquire AbrikaPharmaceuticals (Fort Lauderdale, FL, www.abrika.com), a specialty generics company specializing in controlled-release formulations for an initial gross consideration of $110 million with additional payouts of $125 million during the next three years depending on performance. Claiming 50 controlled-release generic products in its pipeline, Actavis strengthens its position in the US market by complementing its existing controlled-release technology with Abrika?s development expertise and infrastructure.

Shelbyville, KY (Nov. 29)-Global materials company Alcan, Inc. (www.alcan.com) will invest $27.5 million to expand its Pharma Center in Shelbyville, Kentucky. The packaging facility is dedicated to flexible pharmaceutical packaging materials. The company plans to bring the new expansion into operation by February 2008. When completed, the project will employ an additional 40–50 workers and will include a new laminator, eight-color gravure printing press, slitter, cleanroom, finishing and packing complex, warehouse facility, and cure room.

Malvern, PA (Nov. 29)-Auxilum Pharmaceuticals, Inc. (www.auxilium.com) amended its manufacturing agreement with Cobra Biologics Ltd. (Keele, UK, www.cobrabio.com). Cobra will now complete only one biologics license application batch of the active ingredient for AA4500, Auxilium's injectable enzyme for the treatment of Dupuytren's contracture. The amendment is a result of Auxilium's decision to move forward with its facility in Horsham, Pennsylvania to support the BLA submission and supply AA4500. Auxilium will use the materials already produced by Cobra in its current and potential future clinical trials for AA4500.

Chicago, IL (Dec. 4)-Celsis International plc (www.celsis.com) has begun outsourcing its rapid microbial-detection capabilities. The system is based on the company?s ATP bioluminescence technology that detects slow-growing microorganisms, even in the presence of nonmicrobial ATP. Scientists use rapid microbial detection to tests samples for microbial contamination in less time than traditional agar methods.

Leiden, Netherlands (Dec. 1)-Crucell N.V. (www.crucell.com) has been awarded contracts worth more than $230 million for its “Quinvaxem” and “Hepavax-Gene” pediatric vaccines. Covering the next three years, until 2009, the contracts were granted by supranational organizations. The combination vaccine achieved prequalification by the World Health Organization in September 2006. Quinvaxem is a pentavalent vaccine codeveloped by Novartis Vaccines and Diagnostics that combines antigens for protection against five common childhood diseases: diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenza type B. Hepavax-Gene is a recombinant hepatitis B vaccine.

Rockville, MD (Dec. 5)-The US Food and Drug Administration (www.fda.gov) warned five pharmacies to stop compounding and distributing standardized versions of topical anesthetic creams that have been marketed for general distribution. Triangle Compounding Pharmacy (Cary, NC, www.trianglecompounding.com), University Pharmacy (Salt Lake City, UT), Custom Scripts Pharmacy (Tampa, FL), Hal’s Compounding Pharmacy (San Diego, CA), and New England Compounding Center (Framingham, MA, www.neccrx.com) received warning letters because the creams contain combinations of high doses of local anesthetics, which pose a risk of harm. According to the warning letters, FDA states that although it recognizes the importance of compounded drugs for individual patients, it maintains that these new drugs may not be introduced into interstate commerce without FDA approval.

New York, NY (Dec. 7)-Generex Biotechnology Corporation (www.generex.com) and Inyx (Manati, Puerto Rico, www.inyxgroup.com) signed a letter of intent allowing Inyx to serve as the exclusive manufacturer of Generex’s “Glucose RapidSpray,” a confectionary glucose oral-spray product. The three-year agreement is set to begin during the first quarter of 2007. The spay product delivers a glucose formulation to the inner linings of the mouth without deposition into the lungs. The agreement includes technical transfer, commercial manufacturing, packaging, and supply aspects.

San Diego, CA (Dec. 5)-Halozyme Therapeutics, Inc. (www.halozyme.com) entered into an agreement with Roche (Basel, Switzerland, www.roche.com) to apply Halozyme's "Enhanze" technology to Roche's biological therapeutic compounds. Enhanze is an analogue of a human enzyme that temporarily clears space in the matrix of tissues such as the skin, thus allowing for improved drug delivery by enhancing the entry of therapeutic molecules through the space. Roche will make an initial upfront payment of $20 million to apply Enhanze to three biologic targets. The agreement allows Roche to exclusively develop and commercialize the Enhanze technology with an additional 10 targets over the next decade. Roche may pay Halozyme further milestones which could reach a value of $111 million.

London, UK (Dec. 4)-The oil, chemical, and agricultural division of Intertek Group plc (www.intertek.com) acquired Alta Analytical Laboratory Inc. (www.altalab.com) a pharmaceutical testing laboratory. Alta provides immunochemistry and LC–MS–MS bioanalytical services from its California-based facilities. The firm also provides inspection, research and development, method development, and process services. Terms of the acquisition were not disclosed.

Foxboro, MA (Dec. 4)-Invensys Process Systems (www.invensys.com) signed a sales and marketing agreement with Cutler Technology Corp. (CTC, San Antonio, TX. www.cutler-tech.com) in which Invensys will resell and implement CTC’s “Adaptive Dynamic Matrix Controller (ADMC) technology. ADMC is an “Adaptive Multivariable Controller” that uses an open loop (all valve) model of processes. The technology is designed to eliminate the need for proportional integral derivative process controllers and allow controllers to operate with valves fully open.

Cleveland, OH (Dec. 5)-IQS (www.iqs.com) was awarded a multiyear contract by the US Food and Drug Administration (Rockville, MD, www.fda.gov) to expand the application of quality-management principles at the Center for Biological Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). IQS will provide the information-management systems to allow the centers to comply with ISO 17025.

New York, NY (Dec. 2)-Pfizer Inc. (www.pfizer.com) has stopped all clinical trials involving its cardiovascular therapy torcetrapib. The decision was made on the basis of a recommendation of an independent data safety monitoring board (DSMB) citing an “imbalance of mortality and cardiovascular events.” The company has notified the US Food and Drug Administration and is currently notifying all clinical investigators and other regulatory agencies. While acknowledging the board’s recommendation as “surprising and disappointing,” Pfizer CEO Jeffrey Kindler said the company will focus on core research and development, manufacturing, and commercial operations.

Brisbane, Australia (Nov. 29)-Progen Industries (www.progen.com.au) has been cleared by the US Food and Drug Administration to manufacture its PI-88 anticancer drug for Phase III clinical trials. The first step of the process will be manufactured at Progen's facility in Darra, Australia, and a large US-based contract manufacturing company will produce the final active ingredient. Altogether, up to 150,000 doses of PI-88 will be manufactured for the trial, which is scheduled to begin in mid-2007.

Montreal, Canada (Dec. 4)-ProMetic Biosciences, Ltd. (PBL, www.prometic.com), a subsidiary of ProMetic Life Sciences, and Novartis Vaccines and Diagnostics GmbH & Co. (Basel, Switzerland, www.novartis.com) have agreed to develop a synthetic ligand affinity adsorbent for the purification of a recombinant protein vaccine. PBL will screen Novartis’s “Chemical Combinatorial Libraries” for ligands suitable for the processable purification of a new vaccine product developed by Novartis and currently undergoing clinical trials.

Gurgaon, India (Dec. 1)-Ranbaxy Laboratories Ltd. (www.ranbaxy.com) has acquired Be-Tabs Pharmaceuticals Ltd. (Johannesburg, South Africa), the fifth largest generics player in South Africa and the country’s largest manufacturer of penicillin formulations. The $70 million transaction is pending approval from South Africa’s Competition Council authority. The acquisition further strengthens Ranbaxy’s position in the largest pharmaceutical market in Africa, valued at $2 billion.

People Notes

Thousand Oaks, CA (Dec. 1)?Amgen (www.amgen.com) named Yuji Orihara president and representative director of Amgen KK. Orihara will assume responsibility for Amgen?s commercial efforts in Japan and will work at the Amgen KK headquarters in Tokyo. Orihara recently served at Novartis Pharma as senior managing director in charge of the oncology, transplantation/immunology/infectious diseases, and ophthalmic business units. Amgen KK was formed in Japan in 1992 as a wholly owned subsidiary of Amgen Inc.

Rockville, MD (Dec. 1)?The US Food and Drug Administration (www.fda.gov) appointed Susan C. Winckler its acting chief of staff. In this role, she will supervise staff activities in the Office of the Commissioner and be the principal liaison to the US Department of Health and Human Services. Winckler will succeed Patrick Ronan, who resigned last week, in early January 2007.

Bristol, TN. (Dec. 4)-The board of directors at King Pharmaceuticals (http://kingpharm.com) chose Brian A. Markison to succeed Ted G. Wood as its chairman. The appointment will be effective at the close of the company’s May 2007 annual shareholders’ meeting. Markison will keep his positions as president and chief executive officer of King. Wood will remain a member of King's board and will act as lead independentdirector.

Gaithersburg, MD (Dec. 5)-MedImmune (www.medimmune.com) promoted Cynthia N. Oliver, PhD, to vice-president of process biochemistry and formulation sciences; Kripa Ram, PhD, to vice-president of bioprocess and manufacturing sciences; and Mark A. Schenerman, PhD, to vice-president of analytical biochemistry. The company also hired Jessie R. Groothuis, MD, as vice-president and head of medical and scientific affairs, infectious disease. Oliver, Ram, and Schenerman will report to Gail Folena-Wasserman, PhD, senior vice-president of development. Groothuis will report to Frank J. Malinoski, MD, PhD, senior vice-president of medical and scientific affairs.

San Francisco (Dec. 5)-Medivation (www.medivation.net) named Sue Wollowitz, PhD, vice-president for chemistry and manufacturing. Wollowitz has more than 20 years of experience in drug discovery and development and becomes a part of Medivation’s senior management team. Wollowitz previously was president of Wollowitz Associates, a consulting business that assists small and emerging pharmaceutical companies in process scale-up, outsourcing, in-licensing, and regulatory approvals.

Osaka, Japan (Dec. 5)-Giacomo Di Nepi joined Takeda Pharmaceutical Company Limited (www.takeda.com) as CEO of Takeda Pharmaceuticals Europe Limited (TPEU). TPEU is Takeda’s wholly owned subsidiary for European operations that was established in August and is now beginning operation. TPEU leads the business activities of Takeda’s six European subsidiaries.