• Acadia Pharmaceuticals Inc., of San Diego, presented results of a Phase Ib/IIa trial of ACP-103 in patients with Parkinson's disease and from a human brain-receptor occupancy study of ACP-103, performed using positron emission tomography. Results demonstrated that ACP-103, Acadia's 5-HT2A inverse agonist, was safe and well tolerated in Parkinson's disease patients at drug plasma levels many times higher than those required for maximal brain occupancy of the 5-HT2A receptors. ACP-103 was discovered by Acadia scientists and is being developed as a therapy for treatment-induced dysfunction in Parkinson's disease. The results were presented at the CNS Disease Congress in Philadelphia.

• Alteon Inc., of Parsippany, N.J., published a preclinical study in the July issue of Diabetes: Journal of the American Diabetes Association identifying the role of sugar-protein bonds, or Advanced Glycation End products, as a culprit in the progression of atherosclerosis. The study demonstrated that drugs designed to target the AGE pathway reduce measures of atherosclerosis in diabetic mice. Alteon's A.G.E. Crosslink Breaker alagebrium and AGE inhibitor pimagedine both target the AGE pathway.

• Antares Pharma Inc., of Exton, Pa., said its U.S. licensee BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., completed Phase II trials of LibiGel (transdermal testosterone gel) to treat female sexual dysfunction. Antares will receive a royalty on U.S. sales of LibiGel by BioSante, and it will have the opportunity to independently submit the product for approval in Europe and Japan.

• Biovail Corp., of Toronto, and Depomed Inc., of Menlo Park, Calif., said that Biovail's new drug application for Glumetza was accepted for review by the FDA. The companies submitted the NDA in April. Glumetza is a once-daily, extended-release formulation of metformin HCl for treatment of Type II diabetes. Metformin is indicated for the control of hyperglycemia in Type II diabetes when it cannot be controlled by diet, exercise, weight reduction or insulin therapy.

• Cambridge Crystallographic Data Centre (CCDC) in Cambridge, UK, and SciTegic Inc., of San Diego, reported the availability of integration components that allow CCDC's GOLD docking program to be accessed through SciTegic's data-pipelining software, Pipeline Pilot. That integration allows Pipeline Pilot users to construct automated virtual screening protocols that rely on GOLD's protein-ligand docking and scoring to rank corporate, vendor or virtual compound libraries accessed or generated from within Pipeline Pilot.

• Cellomics Inc., of Pittsburgh, and UK-based GE Healthcare, a unit of General Electric Co., formed a software development and commercialization agreement aimed at facilitating faster and more efficient drug development. The companies will collaborate to develop and market an interface that permits high-content screening analysis using both GE Healthcare's sub-cellular imaging instruments and Cellomics' high-content informatics platform.

• CytoGenix Inc., of Houston, engaged Jesup & Lamont Securities Corp., of New York, as exclusive financial adviser and placement agent as it prepares to raise equity capital to support its product development efforts. The company is conducting preclinical studies and plans to file investigational new drug applications soon for lead compounds against bacterial infections, sepsis and herpes. It also plans to use proceeds from a financing to build a DNA manufacturing facility.

• DNAPrint genomics Inc., of Sarasota, Fla., entered an algorithm development collaboration with genetic epidemiologist Paul McKeigue to develop statistical genomics algorithms for a new style of genome screening called admixture mapping. McKeigue invented the admixture mapping technique in 1998. It employs knowledge of population structure to identify genes that underlie diseases and drug responses.

• Eiffel Technologies Ltd., of Sydney, Australia, signed an agreement with NanoMaterials Technology Pte. Ltd., of Singapore, to jointly develop new technology for use in re-engineering drugs. The companies will develop a hybrid technology combining the performance benefits of Eiffel's Super Critical Fluids with the production efficiency of NanoMaterial's High Gravity Controlled Precipitation technology. They are conducting feasibility studies to test the hybrid concept on model anti-inflammatory and asthma drugs.

• Epimmune Inc., of San Diego, published data in the June 23, 2004, issue of Vaccine demonstrating the use of Padre, the company's synthetic, universal helper-T-lymphocyte (HTL) epitope, to boost immune response. Padre, when coupled with Streptococcus pneumonia capsular polysaccharides through use of single conjugate chemistry, induced the HTL responses needed to support the development of polysaccharide-specific antibodies.

• Exelixis Inc., of South San Francisco, submitted an investigational new drug application to the FDA for XL999, a cancer compound. Preclinical studies with XL999 demonstrated inhibition in vivo against multiple receptor tyrosine kinases that are implicated in tumor angiogenesis. Pending clearance by the FDA, the company intends to initiate a Phase I trial.

• Genedata AG, of Basel, Switzerland, expanded its collaboration with Altana Pharma, part of Altana AG, of Bad Homburg, Germany, to provide enterprise-wide scientific computing infrastructure for Altana's research programs in Constance, Germany, and Waltham, Mass. The original license was signed five years ago for Genedata's scientific computing platform.

• Healthcare Technologies Ltd., of Ashdod, Israel, plans to acquire Evanston, Ill.-based ImmvaRx Inc.'s allergy therapies business, issuing 350,000 shares, a two-year warrant to purchase up to 1 million shares of Healthcare and a 30-month warrant to be issued about 14.7 million ordinary shares of Healthcare. The companies also agreed to negotiate the transfer of ImmvaRx's cancer diagnostics and therapies business to Healthcare against additional shares. ImmvaRx has the right to commence a tender offer for all of Healthcare's outstanding shares no later than 30 months following the closing of the transaction at a price of $1.60 per share. Gamida for Life, Healthcare's largest shareholder, will have the right to purchase all of Healthcare's subsidiaries and affiliates for $7.2 million. ImmvaRx focuses on immune-based therapies for allergies and cancer.

• Icagen Inc., of Research Triangle Park, N.C., entered an agreement with McNeil Consumer & Specialty Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to develop and commercialize ICA-17043, a small molecule to treat sickle cell anemia and related genetic variants. Icagen completed a Phase II trial of a once-daily oral formulation of the drug. ICA-17043 has both orphan drug designation and fast-track status in the U.S. The companies will jointly develop the product in the U.S. and equally share development expenses and commercial returns. Icagen will receive an up-front payment and will be eligible for milestone payments. It also has an option to collaborate with McNeil on development and commercialization of the product in Canada. McNeil holds rights in all other markets and would pay Icagen a royalty on sales.

• Inyx Inc., of New York, received a multiyear contract from London-based AstraZeneca plc to assist in the development and production of a non-ozone-depleting hydrofluoralkane version of AstraZeneca's Pulmicort asthma spray for European markets. Inyx's UK subsidiary, Inys Pharma Ltd., will begin development and commercialization work on AstraZeneca's HFA-version of Pulmicort. The three-and-a-half-year contract is valued at more than $6.5 million annually to Inyx, based on present sales of the chlorofluorocarbon version of Pulmicort.

• MethylGene Inc., of Montreal, filed a final prospectus in Canada in connection with an initial public offering of common shares to raise C$20 million (US$14.9 million). The company will offer 4.71 million shares at C$4.25 each. A syndicate of investment dealers co-led by Orion Securities Inc. and RBC Dominion Securities Inc., and including Desjardins Securities Inc. and Raymond James Ltd., are participating. The underwriters have an overallotpating option for 706,500 shares. MethylGene will complete a concurrent private placement of 323,576 common shares at the IPO price, for gross proceeds of about C$1.4 million. Once the IPO is completed, MethylGene's shares would trade on the Toronto Stock Exchange under the "MYG" symbol.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said data from a Phase Ic dose-sequencing study of PYY3-36 nasal spray for obesity showed it reduced caloric intake, demonstrated weight loss and is safe and well tolerated in obese men and women. The spray is designed to deliver the natural, appetite-regulating hormone PYY directly to the bloodstream. The trial involved 37 subjects who received three daily doses of the spray or placebo one hour before each meal for eight consecutive days.

• NeuroSearch A/S, of Ballerup, Denmark, said its wholly owned subsidiary Azign Bioscience A/S and the diagnostics company Atonomics ApS, of Copenhagen, Denmark, agreed to merge. Atonomics will acquire all shares of Azign, while NeuroSearch retains the patents, know-how and other relevant assets within drug research through exclusive licensing agreements. Azign's drug discovery technologies will be consolidated within NeuroSearch. NeuroSearch and Vaekstfonden, the Danish Fund for Industrial Growth, will make a net contribution of DKK6.5 million (US$1.1 million) to the new Atonomics, giving NeuroSearch about a 25 percent stake in the company. Other investors will be Japan-based MuRata and a number of private shareholders.

• Nonlinear Dynamics, of Newcastle Upon Tyne, UK, said Proteomic Research Services Inc., of Ann Arbor, Mich., chose Progenesis Discovery to enhance its 2D electrophoresis capabilities. Progenesis Discovery will form the core of PRS' proteomic lab services, delivering 2D spot detection and matching.

• NuGEN Technologies Inc., of San Carlos, Calif., said the J. David Gladstone Institutes will begin using NuGEN's Ovation Biotin System as the standard RNA-amplification and labeling system for small samples in its genomics core laboratory. The Gladstone Institutes is affiliated with the University of California at San Francisco.

• Nymox Pharmaceutical Corp., of Maywood, N.J., reported a new study published in the June 2004 issue of the Journal of Alzheimer's Disease. The company reported finding evidence linking neural thread protein (NTP), the brain protein measured by the company's urine AlzheimAlert test, to impaired insulin functioning and accelerated death in brain cells. The study provides evidence that increased NTP production kills by interfering with the insulin signaling required for normal functioning and setting off a cascade of changes, leading to cellular and protein dysfunctions characteristic of Alzheimer's disease and to increased cell death.

• OctoPlus Technologies BV, of Leiden, the Netherlands, granted Surmodics Inc., of Eden Prairie, Minn., an option to acquire an exclusive license to two classes of biodegradable polymers for use in the site-specific delivery of drugs from medical devices. Biodegradable polymers have the ability to be combined with one or more drugs and applied to a medical device, but naturally are degraded by the body over time. The two families covered under the agreement are PolyActive and OctoDEX.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said the new drug application for Tarceva (erlotinib HCl) was accepted into the FDA's Pilot 1 program for continuous marketing applications. The program is designed for products that have been designated fast-track status and have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy. It recently was reported that Tarceva performed well in a Phase III trial in advanced non-small-cell lung cancer. (See BioWorld Today, June 8, 2004.)

• Pain Therapeutics Inc., of South San Francisco, reported study results in humans that demonstrate Remoxy is significantly less abusable than Oxycontin. In a head-to-head clinical comparison, Oxycontin released more than 200 percent more drug than Remoxy (p=0.03) in an abuse study in high-proof alcohol and more than 170 percent more drug in a chewing study (p=0.02) in the first hour of studies (when the abusers presumably expect to get high). The company also reported Remoxy is bioequivalent to Oxycontin.

• Paracel Inc., of Pasadena, Calif., said the Nestle Research Center, the University of Wuerzburg and the Institute of Molecular Pathology chose GeneMatcher2 to support their bioinformatics research. GeneMatcher2 is a supercomputer designed to accelerate dynamic programming algorithms for genomic analysis.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., signed an agreement with Sydney, Australia-based Pharmatel PTY Ltd. to market Colazal in Australia and New Zealand. Pharmatel made a one-time milestone payment upon execution of the agreement and will make royalty payments based on product sales. Pharmatel will fund and conduct a study of Colazal in the treatment of irritable bowel syndrome, and Salix has the first right of negotiation for U.S. rights to all Pharmatel gastrointestinal products. Salix also signed an agreement for Rimaco Inc. to distribute, market and sell Salix products in Puerto Rico.

• SuperArray Bioscience Corp., of Frederick, Md., launched the first two arrays in its new line of pathway-specific Oligo GEArray Focused DNA Microarrays. The initial Oligo GEArray offerings include gene content specific to human hematology and cancer.

• Vela Pharmaceuticals Inc., of Ewing, N.J., said the FDA cleared its investigational new drug application for VPI-013, a Phase II compound in-licensed from Otsuka Pharmaceutical Co. Ltd., of Tokyo, to treat depression. Vela now will advance VPI-013 into a double-blind, placebo-controlled study in the U.S. The company holds exclusive U.S. and major European marketing rights, while Otsuka retains marketing rights in Japan and several other countries.

• Xenon Genetics Inc., of Vancouver, British Columbia, changed its name to Xenon Pharmaceuticals Inc. The company said the new name more accurately reflects its drug discovery and development focus and its goal of commercializing drugs. Xenon's shareholders unanimously approved the change at the company's annual meeting on June 25.

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