November 30, 2006 Company and People Notes: AAI Establishes Outsourcing Alliance with Mallinckrodt, Amino GmbH Undergoes Restructuring, more

Company Notes

Wilmington, NC (Nov. 29)-AAIPharma Inc. (www.aaipharma.com) established a pharmaceutical outsourcing alliance with Mallinckrodt Pharmaceuticals Outsourcing (St. Louis, MO, www.pharmaceuticals.mallinckrodt.com/Outsourcing) that will deliver worldwide complementary services from drug development to high-volume commercial manufacturing. Using their scientific and development skills, the companies hope to provide one-stop drug development solutions for the pharmaceutical and biotechnology industries.

Frellstedt, Germany (Nov. 22)-AMINO GmbH (www.aminoactives.com) has undergone restructuring following its leveraged buyout. The company, now under the leadership of managing director Lutz Thomas, will focus on pharma- and infusion-grade amino acids produced under CGMP standards and developed from extraction technology and biotechnology and fermentation. The company hopes to launch new amino acids L-serine and L-phenylalanine in early 2007.

Hoegaarden, Belgium (Nov. 27)-ATMI LifeSciences (www.atmi-lifesciences.com) and Artelis (Brussels, Belgium, www.artelis.be) announced agreements to commercialize and distribute Artelis's disposable mixing technology integrated with ATMI's film technology. In addition, the two companies will jointly develop, test, and manufacture single-use bioreactors and fermentors. The agreements will allow ATMI to use its expertise in advanced ultra-clean film manufacturing and single-use mixing technology in conjunction wtih Artelis's knowledge of the cell-culture process, fermentation applications, and disposable bioreactors for greater purity, precision, and process efficiency in the manufacture of advanced biopharmaceuticals.

Deerfield, IL (Nov. 21)-The Austrian Ministry of Health entered into a three-year preparedness contract with Baxter Healthcare SA (www.baxter.com) that contains an option to purchase 16 million doses of pandemic influenza vaccine. The agreement provies the Ministry with future access to Baxter's cell-based vaccine production capacity. In other news, Baxter announced plans to expand the lyophilization capacity at its Halle, Germany facility to support the future growth of Baxter BioPharma Solutions' cytotoxic contract manufacturing business. The expansion is expected to be completed and validated by mid-2007.

Sainte-Foy, QC (Nov. 21)-Bioxel Pharma Inc. (www.bioxelpharma.com) filled a second international patent application for the semisynthesis of paclitaxel and docetaxel from a common starting material. This patent and an earlier one give the company a proprietary pathway to the docetaxel market. Bioxel expects to have the first pilot lot of docetaxel by the end of 2006.

Heerlen, Netherlands (Nov. 20)-DSM Venturing (www.dsmventuring.com) has taken a 10% share in the advanced materials company Micromuscle (Linkoping, Sweden, www.micromuscle.com). Micromuscle developed electroactive polymers (EAPs) for use in medical devices and life-science product applications, which DSM will now have access to. The two companies plan to explore opportunities for joint development products, especially in the areas of drug delivery and cardiovascular systems.

Rockville, MD (Nov. 28)-The US Food and Drug Administration (FDA, www.fda.gov) will continue its Regulatory Project Management Site tours and Regulatory Interaction Program. The program is designed to promote high performance in its regulatory project management staff and enhance review efficiency and quality by providing the staff with a better understanding of the pharmaceutical industry and its operations through tours of pharmaceutical facilities. Pharmaceutical companies that are interested in participating are invited to submit proposed agendas to the Center for Drug Evaluation and Research (CDER) by Jan. 29, 2007.

Carlsbad, CA (Nov. 27)-Isis Pharmaceuticals, Inc. (www.isispharm.com) and its licensee Alnylam Pharmaceuticals, Inc. (Cambridge, MA, www.alnylam.com) announced that a patent covering certain chemical modifications of oligonucleotides used to introduce drug-like properties in antisense oligonucleotides has been issued by the US Patent and Trademark Office. The patent is owned by Isis and licensed excusively to Alnylam for double-stranded RNAi therapeutic applications.

St. Louis, MO (Oct.)-Jost Chemical Company (www.jostchemical.com) developed a new technology for manufacturing ultra-calcium salts for use in pharmaceutical and clinical nutritional products. The process allows for the manufacture of ultrapure calcium salts with low levels of aluminum and lead such as tricalcium phosphate with aluminum levels less than 1 ppm and lead content less than 0.5 ppm. The company also produced ultrapure forms of dicalcium phosphate, calcium citrate, and calcium hydroxide.

Tokyo (Nov. 10)-Mitsui Chemicals, Inc. (www.mitsui-chem.co.jp) announced plans to open its first research and development center outside of Japan. The new center, known as the Mitsui Chemicals Singapore Technical Centre, will be housed at the Agency of Science, Technology and Research's Institute of Chemical and Engineering Sciences. The center will focus on the areas of catalysis and asymmetrtic synthesis.

Research Triangle Park, NC (Nov. 29)-Quintiles Transnational Corp. (www.quintiles.com) plans to invest $10.1 million over six years in an expansion in Durham County, North Carolina. The expansion will create 1000 new jobs. It was made possible in part by a $2-million award from the One North Carolina Fund, which provides financial assistance to attract business projects to the state, and a Job Development Investment Grant.

Calgary, AB, Canada (Nov. 22)-SemBioSys Genetics Inc. (www.sembiosys.com) completed a technology transfer and manufacturing agreement with Cangene Corporation (Winnipeg, ON, Canada, www.cangene.com) in preparation for SemBioSys's investigational new drug application and the initiation of clinical trials for plant-produced insulin. Under the agreement, Cangene will manufacture the insulin for preclinical and early-stage clinical development.

People Notes

Andover, MA (Nov. 14)-InnoCentive (www.innocentive.com) appointed Dwayne Spradlin president and CEO. Spradlin previously served as president of Hoovers, Inc.

Burlingame, CA (Nov. 29)-Terry M. Nida has been promoted to chief operating officer of UrigenN.A. (www.urigen.com). Nida previously served as vice-president of worldwide sales, marketing, and corporate development. He joined the company after serving as vice-president of VIVUS Inc.