• Avant Immunotherapeutics Inc., of Needham, Mass., said its partner, GlaxoSmithKline plc, of London, reported that Mexican authorities approved the Rotarix vaccine for marketing in that country for the prevention of gastroenteritis caused by rotavirus infection. Rotarix is an oral, two-dose, live attenuated vaccine developed from a single human strain designed to protect against multiple rotavirus strains and provide early protection before the onset of infection.

• Avigen Inc., of Alameda, Calif., reduced its staff by 39 percent, laying off 38 employees. The restructuring stems from its recent decision to halt patient enrollment in the Coagulin-B trial for hemophilia B and its newly realigned product development strategy focused on serious neurological disorders. Avigen said it continues to work with the FDA to begin a Phase I trial of AV201, or Parkinson's disease, adding that the restructuring also is driven by longer-than-anticipated clinical development timelines for AV201. It stopped the Coagulin-B trial more than a month ago. (See BioWorld Today, June 1, 2004.)

• Bavarian Nordic A/S, of Copenhagen, Denmark, and GlaxoSmithKline plc, of London, entered an international collaboration on the production and marketing of Bavarian Nordic's smallpox vaccine, Imvamune. Bavarian Nordic will transfer its technology on production and use of the product to GSK, which will manufacture and market Imvamune to most international markets, including North and South America, Japan and a number of European Union markets. Bavarian Nordic will continue to manufacture and market Imvamune to all German-speaking countries, the Nordic countries, the Baltic States, China, the Middle East and Southeast Asia. It also will be responsible for development and production of Imvamune to the U.S. government.

• BioMimetic Pharmaceuticals Inc., of Franklin, Tenn., said the FDA's Dental Products Advisory Panel unanimously recommended approval for GEM 21S, for bone defects of the jaw in patients with advanced periodontal and periodontal-related diseases requiring surgical treatment. GEM 21S is a combination of a synthetic bone matrix and a tissue growth factor.

• BioTrove Inc., of Woburn, Mass., acquired an exclusive license from Stanford University in Palo Alto, Calif., for patent applications that cover the use of a through-hole structured microarray to perform polymerase chain reaction. BioTrove is commercializing its OpenArray platform, a nanofluidic system for massively parallel analysis using its Thru-Hole technology.

• Cell Genesys Inc., of South San Francisco, began enrollment in a Phase III trial of its GVAX prostate cancer vaccine. The study, called VITAL-1, is based on findings from two previous Phase II trials in more than 100 advanced prostate cancer patients. The trial will compare GVAX to docetaxel (Taxotere, Aventis SA) and is expected to enroll about 600 patients at more than 50 U.S. sites. Two months ago, the company received a special protocol assessment from the FDA for the VITAL-1 trial in which the agency confirmed the trial design would adequately support a product registration application. (See BioWorld Today, May 11, 2004.)

• Chiron Corp., of Emeryville, Calif., said results from a multicenter trial of Procleix Ultrio Assay presented at the International Society of Blood Transfusion meeting in Edinburgh, Scotland, indicated the assay detected a hepatitis B-positive blood donation that would otherwise have gone undetected by previously approved assays. The Procleix Ultrio Assay, which adds a hepatitis B virus assay to the approved assays for HIV-1 and hepatitis C virus, received marketing approval in the European Union earlier this year.

• ConjuChem Inc., of Montreal, said results from its Phase II trial of DAC:GLP-1 to treat Type II diabetes showed there were no drug-related serious adverse events and that glucose levels were lowered by more than 30 percent compared to patients who received no treatment. Other than nausea and vomiting, the tolerability of the product was good, the company said, with no immune reactions, material injection-site reactions or blood pressure modifications. The monotherapy trial, which began in October at 26 centers in the U.S., Canada and Europe, was designed to assess the compound's effectiveness in reducing glucose levels, as well as its impact on a patient's weight. It enrolled 206 patients. GLP-1 is a naturally occurring 36-amino-acid peptide with a half-life of about five minutes. Using DAC technology, ConjuChem is able to extend that. Jacques Lapointe, chairman, president and CEO of ConjuChem, said the company "must effectively deal with the nausea observed in this trial." The company's stock (TSE:CJC) dropped C$5.45, or 53.2 percent, on Thursday to close at C$4.80.

• Corautus Genetics Inc., of Atlanta, said the FDA approved its Phase IIb trial to treat severe cardiovascular disease using its vascular endothelial growth factor-2 (VEGF-2). The randomized, double-blind, dose-ranging, placebo-controlled study in up to 404 patients at 20 U.S. centers will evaluate the efficacy and safety of defined doses of VEGF-2. The treatment will be percutaneously delivered via the Stiletto endocardial direct-injection catheter from Boston Scientific Corp., of Natick, Mass. Patient enrollment should begin in the third quarter.

• CytRx Corp., of Los Angeles, said its collaborator at the University of Massachusetts Medical School used RNAi technology to successfully silence the mutant SOD1 gene that causes familial amyotrophic lateral sclerosis in a mouse model. CytRx has an exclusive license for the technology from the university. The data are detailed in Aging Cell.

• Diversa Corp., of San Diego, launched its Luminase enzyme, a product designed to allow pulp and paper manufacturers to improve pulp processing. Luminase enzyme can be used over a range of manufacturing conditions, including time, temperature and alkalinity, the company said.

• Entropin Inc., of Indio, Calif., said its associates at Dow Pharmaceutical Sciences, a unit of Dow Chemical Co., of Midland, Mich., completed the initial phase in the selection of a topical formulation of ENT-103, a therapy for pain, to be used in clinical studies. Dow's studies concluded that ENT-103 is a promising drug candidate for topical-product delivery when formulated with approved topical-formulation enhancers.

• Europroteome AG, of Berlin, extended its research collaboration with Abbott Laboratories, of Abbott Park, Ill., for the discovery and development of breast cancer diagnostic tests upon successfully reaching a project milestone. The extension triggers a milestone payment from Abbott to Europroteome. Under the February agreement, Europroteome is applying proteomic and bioinformatic technologies to analyze serum samples from women with breast cancer. Data are aligned with a panel of cancer markers available from Abbott on its automated immunoassay platforms.

• Genzyme Corp., of Cambridge, Mass., and Project HOPE extended their partnership to provide enzyme-replacement therapy to Gaucher's patients worldwide. Since 1999, more than 200 patients in 17 countries have received Cerezyme (imiglucerase for injection) through the Gaucher's Initiative project. The new partnership provides continuation of the program for another five years. Patients can access the therapy, regardless of their ability to get reimbursement from insurance providers or government authorities.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said its multicenter Phase II study of INKP-102 showed the drug had a similar bowel-cleansing rate as InKine's approved product Visicol. INKP-102 is a new-generation purgative being developed for use in cleansing the bowel as a preparation for colonoscopy in adults. It is free of microcrystalline cellulose, smaller in size and easier to swallow than Visicol. InKine has filed a patent application. The Phase II trial included 214 adults randomized to one of seven dosing regimens. The success rate with Visicol was 86.2 percent, and five of the six new formulation treatment arms of INKP-102 had success rates higher than Visicol tablets. There were no serious adverse events in the study.

• Jerini AG, of Berlin, transferred its peptide technologies business unit to a wholly owned subsidiary called JPT Peptide Technologies GmbH intended to further growth and increase market penetration. JPT will provide peptide-based products and services, while Jerini will focus on drug discovery and development.

• Large Scale Biology Corp., of Vacaville, Calif., and Planet Biotechnology Inc., of Hayward, Calif., entered a biomanufacturing agreement to extract and purify Planet's lead product, CaroRx, a plant-made antibody to control dental caries. Planet's tobacco plants expressing CaroRx secretory IgA will be extracted by LSBC at its Owensboro, Ky., manufacturing facility. CaroRx has completed Phase I trials.

• Medical Discoveries Inc., of Twin Falls, Idaho, said a large mammal toxicity study of its MDI-P drug found no sign of any toxicities. A separate genomic analysis showed that MDI-P had no effect on bone marrow function, hematocrit levels in peripheral blood, serum levels for alanine aminotransferase levels and aspartate aminotransferase levels, serum protein and albumin levels, bound urinary nitrogen levels, serum calcium levels and blood glucose levels.

• MethylGene Inc., of Montreal, said its isotypic selective cancer HDAC inhibitor, MGCD0103, continues to advance through two Phase I trials at sites in Canada and the U.S. in patients with advanced solid malignancies refractory to available therapies. The dose-escalation trials, which began in April, are designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MGCD0103 when administered orally. Phase II trials are expected to begin next year.

• Myogen Inc., of Denver, began a Phase IIb trial to evaluate the safety and efficacy of darusentan in patients with resistant systolic hypertension. The randomized, double-blind, placebo-controlled study's primary objective is to determine if the product is effective in reducing systolic blood pressure. Darusentan is a Type A selective endothelin receptor antagonist and inhibitor of endothelin-induced vasoconstriction.

• Neuro3d, of Mulhouse, France, said ANVAR, the French Agency for Innovation, provided the company €900,000 in funding to support further clinical development of the phosphodiesterase-4 inhibitor ND1251 as a potential treatment for depression. ANVAR also has supported the company's preclinical development of ND1251 and the Phase I development of ocaperidone. Phase I trials with ND1251 recently were initiated to establish safety, tolerability and pharmacokinetics, as well as to demonstrate brain activity.

• Neurocrine Biosciences Inc., of San Diego, said a review of more than 70 indiplon studies involving more than 7,000 patients is complete. As a result, the company plans to submit new drug applications to the FDA early next quarter for immediate-release and modified-release formulations of indiplon for adult and elderly patients. To date, 14 Phase III studies have been completed. Neurocrine is planning a targeted launch date late next year.

• Pequot Capital Management Inc., of New York, said its direct investment arm, Pequot Ventures, entered a strategic relationship with Lombard Odier Darier Hentsch, of Geneva. Under the collaboration, Pequot will assume responsibility for the private equity and venture capital investments made by the private Swiss banker in the life sciences sector through its LODH Immunology Fund.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said findings reported at the International AIDS Conference in Bangkok, Thailand, showed that its HIV vaccine candidate stimulated the production of specific anti-HIV antibodies in animals. The antibodies inactivated certain strains of HIV isolated from infected patients. The vaccine-elicited antibodies were observed to bind to the surface of the virus, rendering it non-infectious.

The Project BioShield Act was passed by the House, earmarking $5.6 billion over the next decade for the purchase of countermeasures to biological or chemical threats. It is designed to encourage further research and development of such products, essentially guaranteeing companies a contract to sell their products to the government. The bill's passage remains contingent on signing by President Bush. It passed the House last summer, followed by the Senate about two months ago. (See BioWorld Today, July 23, 2003, and May 20, 2004.)

• Santarus Inc., of San Diego, began a pivotal trial evaluating a 20-mg immediate-release dose of Rapinex (omeprazole) capsules against an equivalent dose of delayed-release omeprazole capsules in about 36 healthy subjects. The FDA approved Rapinex powder 20 mg for oral suspension in June, and the 40-mg formulation is under review. The study is an open-label, randomized, crossover trial conducted at a single site. Santarus plans to begin a similar trial to evaluate the 40-mg immediate-release Rapinex capsule later this quarter. If results are positive, Santarus plans to file a new drug application with the FDA seeking U.S. marketing approval to treat heartburn and other symptoms associated with gastroesophageal reflux disease, treatment and maintenance of healing of erosive esophagitis and treatment of duodenal and gastric ulcers.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., said its chief operating officer, Alfred Rudolph, and chief financial officer, Richard Waldron, would form an office of the president to guide the company in the interim following the resignation of President and CEO Don Sellers, after 11 years of service. He also resigned from the board, though he will continue to act as a consultant to the company. The board is working to identify a successor. SciClone's lead product, Zadaxin, remains in two Phase III trials in the U.S. for hepatitis C and has completed a Phase III study in Japan for hepatitis B.

• Sepracor Inc., of Marlborough, Mass., said the FDA accepted the resubmission of its new drug application for Estorra-brand eszopiclone for insomnia as a complete response and has begun its review. The agency classified the resubmission as Class 2, which, under the Prescription Drug User Fee Act, means that it is expected to be completed within a six-month period.

• The Immune Response Corp., of Carlsbad, Calif., said preclinical research presented at the International AIDS Conference in Bangkok, Thailand, suggests its HIV candidate, IR103, generates robust HIV-1-specific immune responses. IR103 combines the company's HIV-1 immunogen with the immunostimulatory oligonucleotide adjuvant Amplivax. The company hopes to develop a saline-based product that will reduce manufacturing costs and limit the minor side effects.

• Zonagen Inc., of The Woodlands, Texas, announced additional results from a randomized clinical trial comparing Androxal to placebo and to Androgel in hypogonadal men. A total of 62 subjects were randomized and dosed into six different arms. Patients were followed for up to 10 days following the two-week drug exposure. There were no side effects found in either the Androxal or Androgel arms, and all doses of both drugs produced statistically significant changes in testosterone from baseline levels. Androxal appears to raise testosterone without causing abnormally high spikes in serum testosterone by improving the DHT/TT ratio and having a tendency to lower triglycerides. Androgel, a gel that administers exogenous testosterone in a transdermal matrix, is marketed by Solvay Pharmaceuticals Inc., of Marietta, Ga., and is the leading product in the sector. Androxal is a once-a-day oral therapy that appears to act centrally, causing an increase in hormones that stimulate increased production of testosterone by the testis.

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