• Active Pass Pharmaceuticals Inc., of Vancouver, British Columbia, received a grant of C$3.6 million (US$2.8 million) for the development of a treatment for secretory diarrhea. The award was made by the National Institute of Allergy and Infectious Diseases branch of the National Institutes of Health in Bethesda, Md. The company is focused on exploiting the ABC transporter gene family as pharmacological targets.

• Altus Pharmaceuticals Inc., of Cambridge, Mass., and Dr. Falk Pharma GmbH, of Freiburg, Germany, said TheraClec was granted orphan drug designation by the European Medicines Evaluation Agency. The compound was granted the designation for the treatment of malabsorption due to exocrine pancreatic insufficiency, a condition most often found in patients with cystic fibrosis, chronic pancreatitis, pancreatic cancer and other diseases related to the pancreas. TheraClec, which is in Phase II testing, received orphan drug status from the FDA in January 2002.

• Amarin Corp. plc, of London, closed the acquisition of Laxdale Ltd., of Stirling, Scotland, a private neuroscience development company. The acquisition provides Amarin with a neuroscience pipeline in clinical development for central nervous system disorders and neuroscience development capability. The most advanced candidate, Miraxion, for which Amarin originally licensed U.S. rights in November 2000, is in Phase III development for Huntington's disease. (See BioWorld Today, Aug. 25, 2004.)

• Cardiome Pharma Corp., of Vancouver, British Columbia, completed patient enrolment in its Phase III atrial fibrillation trial, ACT 1. It is designed to measure intravenous RSD1235's safety and efficacy in 420 patients with atrial fibrillation or flutter. The primary efficacy endpoint is acute conversion of atrial arrhythmia to normal heart rhythm in the recent-onset patients. Safety observations focus on sensory and cardiovascular effects of the drug, with particular emphasis on the lack of side effect arrhythmias. Cardiome said it expects to release top-line results before the end of the year.

• Dyax Corp., of Cambridge, Mass., and Genzyme Corp., also of Cambridge, said DX-88 was named a fast-track product by the FDA for the treatment of hereditary angioedema. In Phase II development, the recombinant small protein was discovered by Dyax and is a specific inhibitor of human plasma kallikrein. Through their joint venture, Dyax-Genzyme LLC, the companies are developing and plan to commercialize DX-88 for hereditary angioedema and other non-surgical indications. In related news, Dyax said the FDA noted that toxicology issues raised by the agency in May, which resulted in a partial clinical hold on DX-88 trials and related to findings in preclinical animal studies, are fully resolved. The company said it would meet with the FDA before the end of the year for guidance on requirements for filing DX-88's biologics license application.

• Dynogen Pharmaceuticals Inc., of Boston, gained exclusive worldwide rights to certain compounds from Newron SpA, of Milan, Italy, in order to explore their potential for genitourinary and gastrointestinal disorders. Newron granted Dynogen a license to a number of ion channel modulators, including preclinical data packages and related intellectual property. Dynogen will apply its predictive pharmacology platform to identify those with the greatest potential for clinical efficacy. Financial terms were not disclosed.

• Elite Pharmaceuticals Inc., of Northvale, N.J., conducted a private placement of about $4.7 million to a group of institutional and other private investors through the issuance of 379,121 shares of its Series A preferred stock at $12.30 a share, each share initially convertible into 10 shares of common stock, or an aggregate of about 3.8 million shares of common stock. Each purchaser will receive two common stock purchase warrants for each share of Series A preferred stock acquired. Each warrant represents the right to purchase five shares of common stock, or an aggregate of about 3.8 million shares of stock for both warrants at $1.54 a share. Elite Pharmaceuticals focuses on oral, controlled-release products.

• Endovasc Inc., of Montgomery, Texas, reported plans to create a new subsidiary to showcase its ProStent technology. ProStent is Endovasc's stent coating comprised of a polymer and prostaglandin E1 (PGE1). Endovasc recently signed a material-transfer agreement with a major medical company for research on the stent coating project. The coating slowly releases the hormone PGE1.

• Generex Biotechnology Corp., of Toronto, said the founder of its Antigen Express immunomedicines subsidiary, Robert Humphreys, made a presentation at the Euroconference Vaccines 3 meeting of the Pasteur Institute in Paris, which summarized work in a special mouse model for melanoma vaccines. The transgenic mice used in the model contain the human HLA-DR molecules, which present the vaccine peptides to mouse T-helper cells.

• Gloucester Pharmaceuticals Inc., of Cambridge, Mass., said the FDA granted fast-track designation for FK228 (depsipeptide) as monotherapy treatment of cutaneous T-cell lymphoma (CTCL) in patients who have become refractory to, or relapsed following, one other systemic therapy. FK228, Gloucester's lead product, is being evaluated in CTCL and other hematologic and solid-tumor indications in Phase II trials sponsored by Gloucester, as well as the National Cancer Institute, under a Cooperative Research and Development Agreement.

• Karo Bio AB, of Huddinge, Sweden, issued about 2.8 million shares at SEK8.50 apiece for gross proceeds of SEK24 million (US$3.3 million). The stock sale follows a rights issue that generated SEK96 million before costs. The company said it would use the funds to take internal projects into clinical trials. ABG Sundal Collier was Karo Bio's financial adviser.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., and XOMA Ltd., of Berkeley, Calif., restructured their agreement related to the development of MLN2222, which is in a Phase I trial for coronary artery bypass graft surgery. XOMA now is responsible for development work and expenses related to MLN2222 through completion of the ongoing Phase I trial, when Millennium will assume responsibility for all subsequent development work and expenses. XOMA also will receive an undisclosed royalty on future net sales of MLN2222, as well as clinical and regulatory milestone payments. Under the original agreement signed in November 2001, XOMA was responsible for costs through Phase II testing and had the option of entering either a profit-sharing arrangement or a milestone and royalty arrangement. The investment agreement between the companies was terminated, and XOMA will not issue any further shares to Millennium.

• Momenta Pharmaceuticals Inc., of Cambridge, Mass., said an article published in this month's issue of Nature Reviews Drug Discovery describes the challenges associated with analyzing complex sugars and highlights the potential of sugars for therapeutic drug development. The company is developing drugs based on sugar-sequencing technology.

• Perlegen Sciences Inc., of Mountain View, Calif., said it will begin a new study with GlaxoSmithKline plc, of London, by performing a high-density whole-genome scanning project. GSK was the first pharmaceutical company to collaborate with Perlegen in September 2002, following the company's identification of more than 1.5 million single nucleotide polymorphisms.

• PowderMed Ltd., of Oxford, UK, began a Phase I trial of a therapeutic DNA vaccine for herpes simplex Type 2. The vaccine uses PowderMed's Particle Mediated Epidermal Delivery technology to deliver a DNA plasmid coding for four herpes simplex Type 2 antigens. The trial is being conducted in 36 otherwise healthy individuals with recurrent genital herpes caused by herpes simplex Type 2. In addition to assessing the vaccine's safety and tolerability, the study also will assess the patients' immune response.

• Prana Biotechnology Ltd., of Melbourne, Australia, released results of the open-label, 84-week extension of its Phase II trial of PBT-1 (clioquinol). All patients in the 36-week blinded and placebo-controlled portion of the trial continued PBT-1 treatment. Nine patients completed the full 84-week study, which demonstrated that PBT-1 appears to slow the expected progression in Alzheimer's disease by about half, the company said. The data were published in the December 2003 issue of Archives of Neurology.

• Rutgers University in New Jersey said its researchers reported findings in Genome Research and the Proceedings of the National Academy of Sciences detailing their survey of the maize genome. They established the genome's magnitude, about 59,000 genes, and the relative position of the genes. The research was conducted with support from the National Science Foundation.

• Senetek plc, of Napa, Calif., reported settlement of a lawsuit brought in June 2003 against Eagle-Picher Technologies Inc., of Joplin, Mo., and an affiliate for non-performance under a 1998 manufacturing contract for its Chemsyn Laboratories Division to supply an active ingredient in Senetek's erectile dysfunction drug, Invicorp. Senetek will receive a lump-sum payment of $235,000 on Dec. 1 in release of all claims.

• Sirenade Pharmaceuticals AG, of Martinsried, Germany, expanded its Tau program after demonstrating proof of concept in the first successful preclinical study for a tau-directed protein to treat Alzheimer's disease. Tau-related tangles and beta-amyloid peptide-related plaques are the two known pathologies associated with Alzheimer's disease. Sirenade is expanding its efforts toward the development of therapeutics that target Tau-protein related pathologies. The company's lead product is a kinase inhibitor that represses the formation of tau-protein-related neurofibrillary tangles in Alzheimer's disease.

• Stanford University in Palo Alto, Calif., said Dean Felsher, assistant professor of oncology and pathology at the school of medicine, conducted research suggesting that cancer cells can be reformed. His work was published in the Oct. 10, 2004, advance online issue of Nature. Felsher found that turning off just one cancer-causing gene was enough to eliminate aggressive, incurable liver tumors in mice in just four weeks. The aim was to find drugs that make ineffective the Myc protein, which is one of the most commonly mutated oncogenes in cancer cells. Felsher turned off the Myc protein by feeding the mice the antibiotic doxycycline.

• Unigene Laboratories Inc., of Fairfield, N.J., said results of an ongoing Phase I trial conducted by London-based GlaxoSmithKline plc to test an oral formulation of parathyroid hormone demonstrated that the formulation can deliver PTH into the bloodstream of human subjects and that the PTH molecule was intact and biologically active. The companies are jointly developing the compound for osteoporosis. They entered their agreement in April 2002, which gave GSK an exclusive, worldwide license to develop PTH using Unigene's manufacturing and oral delivery technologies. The agreement is worth up to $150 million for Unigene, not including royalties.

• Xenogen Corp., of Alameda, Calif., entered a five-year global licensing deal with Merck & Co. Inc., of Whitehouse Station, N.J., extending an existing relationship. Merck will purchase five of Xenogen's biophotonic imaging systems (IVIS Imaging System 200 Series) and the accompanying software for use in oncology research and development at its global research sites in the U.S., Canada, Japan and Italy. In addition to purchasing the IVIS systems, Merck will pay an annual license fee for use of Xenogen's software and methods for in vivo imaging. Merck previously has worked with Xenogen in biophotonic imaging and with Xenogen's wholly owned subsidiary, Xenogen Biosciences, on transgenic animal models.

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