• Acadia Pharmaceuticals Inc., of San Diego, said an interim analysis of its 60-patient Phase II trial of ACP-103 for treatment-induced psychosis in Parkinson's disease showed that patients in the treatment group demonstrated greater reductions in psychotic symptoms compared to the placebo group. Those results were based on data collected from the first 30 patients, with 13 receiving ACP-103, a selective 5-H2A inverse agonist, and 17 receiving placebo. Acadia expects to report results in late 2005 or early 2006.

• Archemix Corp., of Cambridge, Mass., received an undisclosed milestone payment after its partner, New York-based Eyetech Pharmaceuticals Inc., selected the first preclinical candidate from the companies' 2004 agreement. Eyetech chose an aptamer directed against platelet-derived growth factor-B (PDGF-B) for potential use in neovascular age-related macular degeneration. Results from preclinical studies indicated that aptamers directed against PDGF-B might work as a single-agent therapy and in combination with Macugen, Eyetech's marketed AMD drug.

• Arpida Ltd., of Basel, Switzerland, said results from a Phase I trial to measure lung levels of iclaprim in healthy volunteers showed that the antibiotic achieved high concentrations in specific lung compartments, leading the way for additional trials in pneumonia. The injectable form of iclaprim is in a Phase III program for the treatment of complicated skin and skin-structure infections in hospitals.

• BioMarin Pharmaceutical Inc., of Novato, Calif., launched its enzyme-replacement therapy Naglazyme (galsulfase) in the U.S. to treat patients with mucopolysaccharidosis VI (MPS VI), a rare genetic disease. The FDA approved Naglazyme May 31, and the product will be distributed to physicians this week. Naglazyme, which is administered once weekly via intravenous infusion, demonstrated in clinical trials the ability to improve patients' walking and stair-climbing capacity. (See BioWorld Today, June 2, 2005.)

• Biosite Inc., of San Diego, said it is developing a second-generation Triage Cardio ProfilER Panel that will include myeloperoxidase (MPO), a marker of inflammation in the walls of coronary arteries. The company believes the addition of MPO can advance the diagnostic use of the product in emergency assessment of chest pain.

• Carrington Laboratories, of Irving, Texas, said its subsidiary, DelSite Biotechnologies, presented data showing that the GelVac nasal powder delivery system can be used for vaccines and potential therapeutics, and provides better antigen deposition.

• Compound Therapeutics Inc., of Waltham, Mass., initiated animal safety studies with CT-322, an AdNectin blocker of vascular endothelial growth factor receptor-2. The product has significantly reduced tumor growth in preclinical models and demonstrated a clear dose response. The studies are intended to enable the company to file an investigational new drug application.

• The Epilepsy Project, of Reston, Va., and the Epilepsy Foundation, of Landover, Md., awarded three grants totaling $425,000 for the development of new therapies. Recipients are working on initiatives, such as the development of an antiepileptic drug-delivery system via injection using nanoparticles, a therapeutic agent to treat neonatal seizures and a new method to predict and control seizures through electrical stimulation.

• Eyetech Pharmaceuticals Inc., of New York, revised its 2005 revenue guidance to increase estimated sales of Macugen (pegaptanib sodium injection), its FDA-approved therapy for neovascular age-related macular degeneration. The company said it expects net product revenues to range from $175 million to $190 million, up from its previous estimates of $135 million to $150 million. Eyetech and partner, New York-based Pfizer Inc., launched Macugen in the U.S. Jan. 20. Shares of Eyetech (NASDAQ:EYET) gained 45 cents Wednesday to close at $13.44.

• Genelabs Technologies Inc., of Redwood City, Calif., said the FDA confirmed that Prestara, the company's investigational drug for lupus, qualifies for orphan drug exclusivity for the prevention of loss of bone mineral density in systemic lupus erythematosus patients on glucocorticoids. Prestara, which failed to meet its primary endpoint in a six-month trial, demonstrated a statistically significant improvement over placebo during a subsequent 12-month study measuring bone mineral density. Genelabs is conducting a 12-month extension study, expected to end in August, and the company plans to meet with the FDA to determine Prestara's future development. Shares of Genelabs (NASDAQ:GNLB) rose 24.4 percent Wednesday, gaining 11 cents to close at 56 cents.

• Generex Biotechnology Corp., of Toronto, said its subsidiary, Antigen Express Inc., agreed to collaborate with Stallergenes SA, of Antony, France, on studies to design and test Ii-Key/allergen epitope hybrid peptides to control of asthma and allergic reactions. Financial terms were not disclosed.

• Geneva Bioinformatics SA, of Geneva, signed an agreement under which Singapore-based KOOPrime Pte. Ltd. will distribute its Phenyx software platform in Singapore, Malaysia, China and Taiwan. Phenyx is used for the identification and characterization of proteins and peptides from mass spectrometry data.

• Geron Corp., of Menlo Park, Calif., said a report published in the June 15, 2005, issue of Blood showed that hematopoietic cells can be derived from human embryonic stem cells maintained in a simple culture system without feeders or conditioned mediums. Geron said the work shows that hESCs can be propagated in a culture system appropriate for efficiently manufacturing therapeutically relevant cells.

• Gilead Sciences Inc., of Foster City, Calif., began enrolling patients in a Phase I/II study of its oral HIV integrase inhibitor, GS 9137 (also known as JTK-303), to evaluate its tolerability, safety and antiviral activity in HIV-positive patients. The product was discovered by Japan Tobacco Inc. and licensed to Gilead in March. (See BioWorld Today, March 23, 2005.)

• Halozyme Therapeutics Inc., of San Diego, said results of clinical trials demonstrated increased fertilization rates in oocytes that were treated with Cumulase prior to in vitro fertilization. Those data were presented at the 21st annual meeting of the European Society of Human Reproduction and Embryology in Copenhagen, Denmark. At another meeting, the BIO 2005 conference in Philadelphia, Halozyme reported results showing the absence of allergic reactions to its recombinant human hyaluronidase (rHuPH20), along with significantly reduced injection site discomfort compared to saline control.

• Helsinn Healthcare SA, of Lugano, Switzerland, agreed to grant Lisbon, Portugal-based Angelini Farmaceutica exclusive license and distribution rights for Aloxi (palonosetron hydrochloride) in Portugal. Aloxi is a long-acting anti-emetic, belonging to the class of second-generation serotonin (5-HT3) antagonists. It has been granted European registration in the prevention of nausea and vomiting associated with chemotherapy. Financial terms were not disclosed.

• InSite Vision Inc., of Alameda, Calif., met with the FDA to review manufacturing processes, data inclusion and other issues associated with its proposed new drug application for AzaSite, an ocular anti-infective in late-stage development for the treatment of bacterial conjunctivitis.

• Neurocrine Biosciences Inc., of San Diego, presented data at the Associated Professional Sleep Societies meeting in Denver, demonstrating that indiplon safely and effectively helps elderly patients with chronic insomnia fall asleep faster and stay asleep throughout the night. A Phase III study of indiplon in 358 patients, ages 65 to 80, showed that the drug significantly improved latency to sleep onset as compared to placebo. Data from a second study showed that treatment with indiplon tablets resulted in significant improvement in sleep maintenance when compared to placebo. Neurocrine completed a new drug application last month, and pending approval, will co-promote indiplon in the U.S. with Pfizer Inc., of New York.

• Orphan Medical Inc., of Minnetonka, Minn., said its stockholders approved the company's proposed acquisition by Palo Alto, Calif.-based Jazz Pharmaceuticals Inc. Under terms of the merger, Orphan Medical's stockholders will receive $10.75 in cash for each share of Orphan Medical common stock. The acquisition was announced April 19, and is expected to close Friday. (See BioWorld Today, April 20, 2005.)

• Peptech Ltd., of Sydney, Australia, said its joint venture partner, Biosceptre International Ltd., also of Sydney, reported significant results from a study of the development of a diagnostic test for cancer. The study tested 55 ovarian tissue samples, and Biosceptre's antibody detection method identified all of the invasive ovarian carcinomas included in the tissue analysis.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., presented data at the BIO 2005 meeting in Philadelphia demonstrating that its anti-phospholipid therapy Tarvacin binds to enveloped virus particles representing six different virus families. It also binds to virally infected cells and inhibits viral replication in multiple virus systems. Peregrine received FDA approval last month to begin a Phase I trial of Tarvacin in hepatitis C patients, and is recruiting patients for a Phase I trial in advanced solid tumors.

• Power3 Medical Products Inc., of The Woodlands, Texas, has enrolled 137 participants for its study using proteomics analysis to detect the early stages of breast cancer from samples of nipple aspirate fluid and blood serum. The company will continue enrollment in the trial to determine whether the specific NAF and blood serum protein profiles can differentiate between women who have a normal proteomic pattern and those whose patterns might be suggestive of cancer or benign disease.

• PPD Inc., of Wilmington, N.C., said it was selected by Whitehouse Station, N.J.-based Merck & Co. Inc. to provide protein biomarker analysis for Merck's therapeutic business. Terms call for PPD to use its integrated platform for proteomic analysis to evaluate bioanalytical data on Merck samples and identify candidate biological markers. Financial terms were not disclosed.

• Sepracor Inc., of Marlborough, Mass., said studies of Lunesta (eszopiclone) showed that 3-mg doses of the drug significantly improved sleep maintenance endpoints vs. placebo. Studies also demonstrated that a mild to moderate correlation exists between patient-reported next-day function and patient-reported sleep parameters, and that improvements in next-day function were most strongly related to Lunesta-mediated improvements in sleep quality. The data were presented at the 19th annual meeting of the Associated Professional Sleep Societies in Denver.

• Serologicals Corp., of Atlanta, said its wholly owned subsidiary, Upstate Group, agreed to collaborate with CXR Biosciences Ltd., of Dundee, UK, to establish a battery of in vitro screens to select early stage candidate molecules for further development. The screening platform will use predictive toxicity and drug metabolism screens to profile compounds in various cell-based and in vitro assays.

• Stressgen Biotechnologies Corp., of San Diego, said it completed manufacturing of HspE7 to use in its upcoming Phase III study in recurrent respiratory papillomatosis. The study, set to begin during the first quarter of 2006, will assess the product's safety, as well as efficacy, as measured by increases in intersurgical interval. Because of the change in the biological profile of the newly manufactured HspE7, Stressgen said it does not expect to gain FDA concurrence under a special protocol assessment. The company is developing an additional HspE7 product that incorporates the reformulation of the compound with an adjuvant, and a Phase I/II proof-of-concept study of that compound also is set to begin in the first quarter of next year. Stressgen's shares (TSE:SSB) gained C13 cents Wednesday, or 96.3 percent, to close at C27 cents.

• Valentis Inc., of Burlingame, Calif., granted an exclusive, worldwide license to Jena, Germany-based Biolitec AG for development and commercialization of drug formulations using Valentis' pegylated liposome technology. Terms of the agreement call for Valentis to receive an up-front payment, as well as potential milestone and royalty payments.

• VaxGen Inc., of Brisbane Calif., said Celltrion Inc., its joint venture with three South Korean partners, entered an agreement to manufacture biologic products being development by New York-based Bristol-Myers Squibb Co. The Celltrion facility is located in Incheon, South Korea, and VaxGen said it is capable of producing products such as BMS' abatacept and belatacept. Terms were not disclosed.

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