August 24, 2006: Company and People Notes

August 24, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Air Products, Althea Technologies, Inc., Bradley Pharmaceuticals, Bristol-Myers Squibb, Crucell N.V., Emergent Biosolutions

Company Notes

Allentown, PA (Aug. 23)-Air Products (www.airproducts.com) agreed to sell its amines business to Taminco (Gent, Belgium, www.taminco.com), a company that produces methylamines and methylamine derivatives for the pharmaceutical and chemical industries. The sale includes production facilities located in Pace, Florida; St. Gabriel, Louisiana; and Camacari, Brazil. The transaction is expected to be completed by the end of September.

San Diego, CA (Aug. 22)-Althea Technologies, Inc. (www.altheatech.com) has been awarded a contract from Altus Pharmaceuticals Inc. (Cambridge, MA, www.altus.com) to produce Altus’s “ALTU-238” product candidate, a crystallized formulation of human growth hormone. The Phase III clinical trial material of the ALTU-238 formulation will be produced at Althea’s San Diego manufacturing facility.

Fairfield, NJ (Aug. 18)-Bradley Pharmaceuticals, Inc. (www.bradpharm.com)has formed a development agreement with Polymer Science, Inc. (Monticello, IN, www.polymerscience.org). Under the terms of the agreement, Polymer will develop delivery sytems for future products to be commercialized by Bradley’s Doak Dermatologics and Kenwood Therapeutics operating units.The product launches are expected to begin in 2007. Bradley agreed to an initial financial commitment of $760,000. It will pay $190,000 in the fourth quarter of 2006, another $190,000 in the first quarter of 2007, and the remaining $380,000 during the first three years of product production.

New York, NY (Aug. 17)-Bristol-Myers Squibb (www.bms.com) and Otsuka Pharmaceutical Company (Tokyo, Japan, www.otsuka.com) launched “ABILIFY DISCMELT” orally disintegrating tablets. The tablets are a new form of the antipsychotic medication ABILIFY that disintegrates rapidly upon contact with saliva.The tablets were approved by the US Food and Drug Administration (Rockvlle, MD, www.fda.gov) in June 2006.

Leiden, Netherlands (Aug. 17)-Crucell N.V.(www.crucell.com)and DSM Biologics (Groningen, Netherlands, www.dsmbiologics.com) signed a second “PER.C6” license agreement with MorphoSys AG (Planegg, Germany, www.morphosys.com). The agreement will allow MorphoSys to use the PER.C6 cell line in the production of clinical-grade material for the development of its MOR103 therapeutic antibody program. In additon, MorphoSys signed a biopharmaceutical manufacturing agreement with DSM Biologics to produce the material in DSM’s facilities in Groningen, Netherlands.

Gaithersburg, MD (Aug. 15)-Emergent BioSolutions Inc. (www.emergentbiosolutions.com) filed a registration with the US Securities and Exchange Commission related to the proposed initial public offering of its common stock. J.P. Morgan Securities Inc. will serve as the book-running manager for the offering, with Cowen and Company, LLC serving as joint lead manager and HSBC Securities acting as comanager. The number of shares to be offered and the price range for the offering have not yet been determined.

San Diego, CA (Aug. 22)-Lpath, Inc. (www.lpath.com) and Laureate Pharma, Inc. (Princeton, NJ, www.laureatepharma.com) have entered into an agreement to produce Lpath’s “Sphingomab” recombinant. Sphingomab is a monoclonal antibody specific for sphingosine-1-phosphate that is desiged for use as a therapy for diseases such as cancer and various ocular and cardiovascular conditions. Laureate will provide cell-line, optimization, and upstream and downstream process development, followed by CGMP manufacture of the product for use in clinical trials.

Keene, NH (Aug. 16)-Markem Corporation (www.markem.com) will be acquired by Dover Corporation (New York, NY, www.dovercorporation.com). Markem will retain its company name and its current management team and remain at its Keene, New Hampshire location.

Basel, Swizerland (Aug. 16)-Novartis(www.novartis.com) has delivered and released its first shipments of "Fluvirin” influenza vaccine to the United States for the 2006–2007 influenza season. Novartis plans to deliver the majority of its influenza vaccine production by the end of October, with additional shipments through the end of 2006.

Montreal, QC, Canada (Aug. 21)-ProMetic Life Sciences(www.prometic.com) signed a strategic license agreement and associated services and supply agreements with Nabi Pharmaceuticals (Boca Raton, FL, www.nabi.com) to allow Nabi to use ProMetic’s mimetic ligands technology to manufacture selected plasma-derived hyperimmune products. Nabi Biopharmaceuticals will pay ProMetic milestone payments once a biologic license application has been filed and hyperimmune products made using ProMetic’s technology have been licensed. Nabi also will pay royalties on the sale of these products.

San Diego, CA (Aug. 22)-Vical Inc.(www.vical.com) announced the initiation of a National Institutes of Health-sponsored Phase I clinical trial of a prime-boost vaccine approach to prevent or control disease in HIV-positive patients. The vaccine, developed by scientists at the Dale and Betty Bumpers Vaccine Research Center and manufactured by Vical, incorporates HIV genetic material from the most globally important HIV subtypes, clades A, B, and C, which are involved in about 85% of all HIV infections around the world.


People Notes

Basel, Switzerland (Aug. 21)-4-Antibody(www.4-antibody.com) appointed Sijmen de Vries to the position of CEO. Before joining 4-Antibody, de Vries was CEO of Morphochem AG. He has also held senior management positions at Novartis Pharma AG and SmithKline Beecham.

Wilmington, NC, (Aug. 23)-AAIPharma (www.aaipharma.com) has hired Lee Karras as senior vice-president of nonclinical services and Anne Wiles as senior vice-president of data systems and processes. Karras will build the company’s North American nonclinical business infrastructure. He has worked as a consultant and served as vice-president of contract services for Baxter Healthcare Corp. Wiles will advance AAIPharma’s clinical processes and technologies worldwide. She previously was president of INC DataSpectrum, the data services subsidiary of INC Research

Cambridge, MA (Aug. 17)-Altus Pharmaceuticals Inc.(www.altus.com) announced that Renato Fuchs, PhD, has been appointed senior vice-president of manufacturing and technical operations. Previously, Fuchs held the position of senior vice-president of manufacturing and operations at Shire HGT.

Milan, Italy (Aug. 23)-John Fraherhas been promoted to chief commercial officer with Eurand (www.eurand.com). In this position, he will lead the company's commercial and public relations activities. He previously acted as president of Eurand's North American business and vice-president of operations at the company’s manufacturing facility in Vandalia, Ohio.

Horsholm, Denmark (Aug. 15)-LifeCycle Pharma (www.lcpharma.com) appointed Flemming Ornskov, PhD, president and CEO. Before joining LifeCycle, Ornskov was the president and CEO of Ikaria, Inc. He has also served as the president of Novartis’s Opthalmics.

Cambridge, MA (Aug. 22)-Craig A. Wheeler has been appointed chief executive officer of Momenta Pharmaceuticals (www.momentapharma.com). He will assume his new duties beginning Sept. 12, 2006. Before joining Momenta, Wheeler was president of Chiron BioPharmaceuticals, the biotechnology division of Chiron Corporation.

Radford, VA (Aug. 17)-Samir Roy, PhD, joined New River Pharmaceuticals (www.nrpharma.com) as vice-president, formulation and manufacturing. Roy has worked in the pharmaceutical industry for nearly 20 years. Before joining New River, he served as the executive director of product research at Watson Pharmaceuticals, Inc.

Washington, DC (Aug. 22)-Prestwick Pharmaceuticals, Inc. (www.prestwickpharma.com) named George F. Horner III president and chief executive officer. Horner previously held positions at Vicuron Pharmaceuticals, Inc., Ligand Pharmaceuticals, and Abbot Laboratories.

King of Prussia, PA (Aug. 21)-Tunnell Consulting, Inc. (www.tunnellconsulting.com) announced that Sherry Hanafin joined the firm as a principal for its life sciences practice. Hanafin previously served as director of sourcing for Quintiles Consulting.

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