July 27, 2006: Company and People Notes

July 27, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Albany Molecular Research, Affymax, Antares Pharma, AstraZeneca, Brookwood Pharma, DelSite, Immtech, Nektar, VaxGen, Vical

Company Notes

Albany Molecular Research, Inc. (AMRI, Albany, NY, www.albmolecular.com) announced a multiyear manufacturing agreement with New River Pharmaceuticals Inc. (Radford, VA, www.nrpharma.com). Under the terms of the agreement, AMRI will manufacture the active pharmaceutical ingredient in New River's compound, NRP104, a new treatment for attention deficit hyperactivity disorder.

Antares Pharma, Inc. (Exton, PA, www.antarespharma.com) signed a joint development agreement with the Population Council (New York, NY, www.popcouncil.org), an international, nonprofit research organization. Antares and the Council will develop contraceptive formulation products containing "Nestorone" by using the Council's patented compound and Antares's proprietary, advanced transdermal delivery (ATD), clear gel platform. Under the terms of the joint development agreement, Antares will be responsible for research and development activities as they relate to ATD formulation and manufacturing.

AstraZeneca (Wilmington, DE, www.astrazeneca.com) received FDA approval for its "Symbicort" (budesonide, formoterol) asthma treatment. The pressurized metered-dose inhaler combines an inhaled corticosteroid and a rapid, long-acting beta2-agonist into one inhaler. AstraZeneca plans to launch the therapy in mid-2007.

The Bill & Melinda Gates Foundation (Seattle, WA, www.gatesfoundation.org) announced 16 grants to create international collaborative research consortia to accelerate HIV vaccine development. The grants, which total $287 million, will bring together more than 165 investigators from 19 countries. Eleven consortia will focus on applying new knowledge and research techniques to create and evaluate novel vaccine candidates. These consortia will be linked to five central laboratories and data analysis facilities, enabling investigators to share data and compare results openly.

Biotechnology company CytoDyn, Inc. (Santa Fe, NM, www.cytodyn.com) acquired Advanced Influenza Technologies, Inc. (AIT), a wholly owned subsidiary of UTEK Corp. (Tampa, FL, www.utekcorp.com). AIT holds the license for a DNA-based influenza vaccine candidate developed at the University of Massachusetts Medical School (Worcester, MA, www.umassmed.edu).

DelSite Biotechnologies, Inc. (Irving, TX, www.delsite.com) formed a joint development initiative with Brookwood Pharmaceuticals, Inc. (Birmingham, AL, www.brookwoodpharmaceuticals.com). The goal of this effort is to carry out an expanded evaluation of DelSite's "GelSite" patented drug delivery technology as a matrix for injectable applications and for selected classes of drugs.

Immtech Pharmaceuticals, Inc. (New York, NY, www.immtechpharma.com) was issued a US patent for the manufacturing of its drug candidate compounds. The patent, entitled "Process for the synthesis of bis-aryl diamidoxime compounds," claims a method for making drug candidate compounds such as Immtech's pafuramidine maleate (DB289). The patent names scientists from both the University of North Carolina at Chapel Hill and Georgia State University as inventors.

Momenta Pharmaceuticals, Inc. (Cambridge, MA, www.momentapharma.com), a biotechnology company specializing in the characterization and engineering of complex drugs, announced an exclusive collaboration with Sandoz (Holzkirchen, Germany, www.sandoz.com) to develop four follow-on and complex generic versions of previously approved recombinant biotechnology and complex drugs. Sandoz will make an initial payment of $75 million to Momenta for the purchase of approximately 4.7 million shares at a price of $15.93 per share. Momenta also is eligible to receive as much as $188 million in additional payments if all milestones are achieved for the four product candidates.

Nektar Therapeutics Inc. (San Carlos, CA, www.nektar.com) received a $17.6-million payment under a license agreement with Affymax Inc. (Palo Alto, CA, www.affymax.com). The agreement was established in 2004 to provide technology for Affymax's development of its lead product candidate, "Hematide," an anemia treatment.

Biopharmaceutical contract manufacturing organization Rentschler Biotechnologie GmbH (Laupheim, Germany, www.rentschler.de) will expand its facilities, buildings, and laboratory units at the company's site in Laupheim, Germany. The expansion will increase production capacities for antibodies and mammalian cell culture-derived proteins. The first new production line is planned to go into operation early in 2008.

People Notes

Immtech Pharmaceuticals, Inc. (New York, NY, www.immtechpharma.com) appointed Carol Ann Olson, MD, PhD, as senior vice-president of pharmaceutical development and chief medical officer. Olson will be responsible for Immtech's drug development activities, including drug development, regulatory affairs, and regulatory compliance and quality assurance. She joined Immtech in September 2004 and previously held various pharmaceutical development positions at Abbott Laboratories.

The US Food and Drug Administration (Rockville, MD, www.fda.gov) appointed Mark Goldberger, MD, as medical director for emerging and pandemic threat preparedness in FDA's Center for Biologics Evaluation and Research (CBER). Goldberger will serve as a senior advisor for CBER's pandemic flu program to plan, coordinate, and implement activities related to the development and evaluation of products for emerging and pandemic threats.

VaxGen, Inc. (Brisbane, CA, www.vaxgen.com) announced that Kathrin U. Jansen, PhD, senior vice-president of research and development and chief scientific officer of the company, accepted the position of senior vice-president of vaccine research at Wyeth. She has resigned from VaxGen, effective July 29, 2006.

DNA delivery specialist Vical Inc. (San Diego, CA, www.vical.com) announced that its chief scientific officer, David C. Kaslow, MD, resigned (effective July 31, 2006) to join Merck & Co., Inc.'s vaccine research team. The company is not planning to replace Kaslow.

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