Jan. 18, 2007 Notes: Acambis Receives Complete Response Letter from FDA, Baxter Expands Lyophilization Facility, More

January 18, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Acambis, Baxter, NovoNordisk, more

Company Notes

Cambridge, MA (Jan. 17)-Acambis plc (www.acambis.com) received a Complete Response Letter from the USFood and Drug Administration (Rockville, MD, www.fda.gov) following its biologics license application (BLA) for its ACAM2000 smallpox vaccine. FDA has requested additional information to complete its review of the BLA.

Cambridge, MA (Jan. 8)—Alnylam Pharmaceuticals, Inc. (www.alnylam.com) received a worldwide exclusive license to Inex's (Vancouver, BC, Canada, www.inexpharm.com) liposomal delivery formulation technology for the discovery, development, and commercialization of RNAi therapeutics. The companies also expanded their technology research and manufacturing alliance on lipid-based delivery technology. Inex is set to receive three “InterfeRx” license options to develop its own RNAi therapeutic products, and the company also will receive exclusive access to Alnylam's intellectual property to develop oligonucleotide drugs that act through an immune-stimulation mechanism outside the RNAi pathway. Alnylam will give Inex an upfront payment of $8 million in shares of common stock or cash along with $4 million in research and development funding over the next two years. Inex will provide contract manufacturing services on an exclusive basis for Alnylam products in the collaboration and Alnylam will make a $5-million loan available for capital equipment expenditures related to maufacturing.
 
Deerfield, IL (Nov. 20)—Baxter Healthcare Corporation (www.baxter.com) plans to expand the lyophilization capacity at its facility in Halle, Germany. The expansion will support the future growth of Baxter BioPharma Solutions's cytotoxic contract manufacturing business and will add two large-scale lyophilization chambers to freeze-dry cancer therapies. The expansion is expected to be completed and fully validated by mid-2007.

Irving, TX (Jan. 10)-DelSite Biotechnologies, Inc. (www.delsite.com) granted a nonexclusive license to EndoBiologics Inc. (Missoula, MT) to develop and evaluate investigational conjugate vaccines against bacillary dysentery and other bacterial diseases using DelSite's nasal powder vaccine delivery technology. The goal of the program is to develop needle-free vaccines that can be shipped worldwide and stored without refrigeration. DelSite will provide EndoBiologics with its “GelSite” drug-delivery polymer and will assist in the formulation of vaccine powders.

Pompey, France (Jan. 9)-Groupe Novasep (www.novasep.com) was acquired for EUR 425 million by its management and a financial investor group composed of Gilde Buy Out (Utrecht, Netherlands, www.gilde.nl), Banexi Capital Partenaires (Paris, www.banexicapital.com), and BNP Paribas (Paris, www.bnpparibas.com). The acquisition, which was signed Nov. 29, 2006, was completed on Jan. 9, 2007. Novasep will continue to operate through its two complementary divisions: Novasep Synthesis and Novasep Process.

Leverkusen, Germany (Jan. 16)-Lanxess (www.lanxess.com) earmarked EUR 30 million to develop its fine-chemicals subsidiary Saltigo (www.saltigo.com). The money will go toward modernizing Saltigo's plant and introducing new worktime models. A EUR 10-million multipurpose facility also is under construction.

Copenhagen (Jan. 15)-Novo Nordisk A/S (www.novonordisk.com) will focus its research and development efforts on protein-based pharmaceuticals (building on its base in diabetes, hemostasis, and growth disorders) and will out-license its programs in small-molecule products. These include a glucokinase activator in Phase I trials. The decision to halt small-molecule research will eliminate approximately 180 R&D jobs. The company hopes to find positions for about half of those affected.

Oss, Netherlands (Jan. 9)-Organon (www.organon.com) signed a collaboration agreement with HUYA Bioscience International, LLC (San Diego, CA, www.huyabio.com) to search for new proprietary biopharmaceuticals or pharmaceutical compounds. HUYA will support Organon in the sourcing and development of pharmaceutical or biopharmaceutical compounds.

Tustin, CA (Jan. 12)Peregrine Pharmaceuticals, Inc. (www.peregrineinc.com) established a foreign-owned enterprise in the People's Republic of China. The Beijing-based subsidiary will be called Peregrine Beijing Pharmaecuticals Technology Development Ltd.

Saugus, MA (Jan. 16)-A new specialty-services company called Senopsys LLC (www.senopsys.com) was launched in Massachusetts. Senopsys partners with pharmaceutical, biotechnology, and drug-delivery companies and contract research organizations (CROs) to improve the palatability of pharmaceuticals. Using proprietary sensory-assessment tools, Senopsys hopes to identify the critical sensory attributes of drug substances, quantify taste-masking challenges, measure flavor quality or palatability of drug prototypes, and develop target sensory profiles that result in patient-acceptable pharmaceuticals. The company also will assess the suitability of novel dosage forms for specific drug substances and develop new formulation systems for investigational and approved drugs.

Houston, TX (Jan. 15)-Tanox, Inc.'s (www.tanox.com) stockholders voted to approve the merger with Genentech, Inc. (South San Francisco, CA, www.gene.com). Approximately 34.2 million shares of common stock, representing about 75.5% of Tanox's total outstanding shares, voted at the meeting. Under the terms of the agreement, Tanox stockholders will receive $20.00 per share in cash, which is a 47% premium over the last trading day before the proposed merger was announced on Nov. 9, 2006. The transaction is expected to close in the first quarter of 2007.

Waltham, MA (Jan. 15)-Thermo Fisher Scientific Inc. (www.thermofisher.com) acquired SwissAnalytic Group AG (Basel, Switzerland). Swiss Analytic owns Spectronex AG, a supplier of mass spectormetry, chromatography, and surface-science instrumentation, and Flux instruments, which manufactures high-performance liquid chromatography pumps and software.

Boston, MA (Jan. 16)-The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) released a study showing that approval times for new products in both the European Union and the United States were nearly identical, but many medicines are available in the US before they are available in the EU. The study found that the European Medicines Agency (EMEA, London, www.emea.eu.int) takes an average of 15.8 months to approve a new product, while the USFood and Drug Administration (Rockville, MD, www.fda.gov) took an average of 15.7 months to approve a new product. Out of 71 products submitted to both FDA and EMEA for approval, FDA acted faster in 47 of the cases; however, there was greater variability in FDA approval review times than in those of EMEA.

Rockville, MD (Jan. 16)-United States Pharmacopeia (USP, www.usp.org) is collaborating with Therapeutic Research Center (Stockton, CA, www.therapeuticresearch.net) and Consumer Reports (Yonkers, NY, www.consumerreports.org) to include its USP Verified Mark in their online health databases Natural Medicines Comprehensive Database and ConsumerReportsMedicalGuide.org. The mark will appear next to the dietary supplement products that have passed USP's verification process. Inclusion of the mark will provide health professionals and consumers with an additional means of identifying supplements that have USP's testing requirements for purity, potency, and quality.

Redmond, WA (Feb. 1)—Univar USA (www.univarusa.com) will be named the exclusive US distributor for SPI's (New Castle, DE, www.spipharma.com) “Mannogem,” “Barcroft,” “Advantose,” “Effer Soda,” and “Sorbitol Special” product lines for over-the-counter and prescription applications. Univar also willcontinue to offer “Sorbogem” liquid sorbitol and “Maltisweet” on a nonexclusive basis.

People Notes

Tarrytown, NY (Jan. 16)Michael M. Goldberg was terminated as CEO and chairman of the board of Emisphere Technologies, Inc. (www.emisphere.com). The company's board of directors has begun the search for a permanent replacement for Goldberg. Meanwhile, Lewis H. Bender, senior vice-president of business development, will act as the interim CEO.

Arlington, VA (Jan. 11)-The International Pharmaceutical Excipients Council of the Americas (IPEC, www.ipecamericas.org) announced the results of its recent executive committee elections. Janeen Skutnik of Pfizer, Inc. was elected chair, and Eli Lilly's Robert E. Wiens was elected vice-chair of science and regulatory policy. Eunice M. Cuirle of FMC Biopolymer and Edward G. Malawer, PhD, of International Specialty Products were elected executive committee members. They will all serve through Dec. 31, 2008.


New York, NY (Jan. 16)-

IRX Therapeutics

(

www.irxtherapeutics.com

) appointed

John W. Hadden II

president and chief executive officer. Hadden joined IRX in 1998 as chief financial officer. He was most recently chief operating officer.
 

San Diego, CA (Jan. 16)

John L. Higgins

was made chief executive officer, president, and a member of the board of directors of

Ligand Pharmaceuticals Incorporated

(

www.ligand.com

). Higgins previously served as chief financial officer and executive vice-president of finance, administration, and corporate development of Connetics Corporation.

Princeton, NJ (Jan. 16)-Pharmacopeia's (www.pharmacopeia.com) president and chief executive officer Leslie J. Browne, PhD, was appointed chairman of New Jersey Technology Council (NJTC, Mt. Laurel, NJ, www.njtc.org). Browne has served as a member of the NJTC's board of directors since 2005.

Liberty Corner, NJ (Jan. 16)-Reliant Pharmaceuticals, Inc. (www.reliantrx.com) appointed Bradley T. Sheares, PhD, chief executive officer. Sheares joins the company from Merck & Co., Inc., where he was president of US human health.

Karlsruhe, Germany (Jan. 18)-Thomas Luken was appointed president of the Romaco Business Unit (www.romaco.com). Luken will be responsible for the company's worldwide operations, including sales activities and production sites for liquid and powder packaging, solids packaging, and solids and semisolids processing equipment in Italy, Germany, and Switzerland.