• Aclara BioSciences Inc., of Mountain View, Calif., entered an agreement with London-based GlaxoSmithKline plc to evaluate Aclara's eTag technology assays for potential use in patient selection for certain GSK-targeted cancer therapies. GSK will provide Aclara with funding and drug-treated biological samples that Aclara will test with its eTag assays. The companies then will correlate the parameters measured as biomarkers with response to the drug.

• Acologix Inc., of Emeryville, Calif., presented data from in vivo preclinical studies of its lead compound, AC-100, which suggest that it promotes fracture healing in an experimental model and could have potential as an anabolic drug to increase bone mass. AC-100 is a synthetic peptide being developed for bone and dentin regeneration and related indications.

• Adventrx Pharmaceuticals Inc., of San Diego, received orphan drug status from the FDA for its lead compound, CoFactor, to treat pancreatic cancer. The company plans to file an investigational new drug application in the fourth quarter for clearance to begin a Phase II trial in the U.S. CoFactor is a form of folic acid that acts by enhancing the antitumor effects of 5-FU while reducing side effects compared to current therapies.

• Aerogen Inc., of Mountain View, Calif., and Respironics Inc., of Murrysville, Pa., entered a worldwide, nonexclusive distribution agreement for Aerogen's Aeroneb Professional Nebulizer System. Respironics will market and distribute the system for use with its new and existing Ventilator Support Systems. The Aeroneb Pro incorporates Aerogen's OnQ Aerosol Generator, for pulmonary drug delivery.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, signed service and license agreements in the area of mouse genetics and genomics. Boehringer Ingelheim granted Artemis a worldwide exclusive commercial license and a nonexclusive research license, including sublicensing rights, to the patented tetraploid technology for the generation of genetically modified mice. The technology facilitates the generation of modified mice directly from mouse embryonic stem cells.

• Avanir Pharmaceuticals Inc., of San Diego, signed an exclusive agreement with ACO HUD, of Stockholm, Sweden, to manufacture and market Avanir's docosanol 10 percent cream as a treatment for cold sores in Sweden, Norway, Denmark and Finland. ACO HUD will be responsible for all sales and marketing activities, as well as manufacturing and distribution. It plans to launch Avanir's product in 2005. Avanir will receive a license fee, royalties and milestones related to product approval.

• Becton Dickinson & Co., of Franklin Lakes, N.J., said its board approved a plan to sell the company's Clontech operation, specifically a unit of BD Biosciences. Goldman Sachs and Co. is acting as BD's financial adviser in the planned sale. BD estimates that it will record a pretax charge in the fourth quarter of about $125 million ($115 after taxes), or about 44 cents per share, for the sale.

• BioInvent International AB, of Lund, Sweden, said the American Heart Association's journal, Circulation, presented in its latest issue a report on antibody-based treatment of atherosclerosis. The report describes research performed by a team led by professor Jan Nilsson at the University Hospital MAS in Malmo, Sweden, in collaboration with BioInvent. The antibody-based drug candidates have been shown to reduce plaque formation in preclinical animal studies, the company said.

• Calypte Biomedical Corp., of Pleasanton, Calif., entered a worldwide, nonexclusive licensing agreement with Bio-Rad Laboratories Inc., of Hercules, Calif., for patents relating to HIV -2. Bio-Rad exclusively licenses the HIV-2 patents from the Institut Pasteur in Paris. The license allows Calypte's tests to diagnose a broader population of HIV-infected individuals, the company said.

• Carrington Laboratories Inc., of Irving, Texas, said its wholly owned subsidiary, DelSite Biotechnologies Inc., was awarded a $6 million grant from the National Institute of Allergy and Infectious Diseases to develop an inactivated influenza nasal powder vaccine against the H5N1 strain, commonly known as bird flu. The grant was awarded as part of a biodefense and severe acute respiratory sydrome product development initiative and will fund a three-year preclinical program using Carrington's GelVac delivery system.

• Chlorogen Inc., of St. Louis, signed a joint development and supply agreement with Sigma-Aldrich Fine Chemicals, a division of Sigma-Aldrich Corp., of St. Louis, which is expected to produce the first commercial products from chloroplast transformation technology. Sigma-Aldrich will fund an undisclosed portion of Chlorogen's efforts to produce four specific proteins in tobacco plants. The proteins, which have pre-identified applications as active pharmaceutical ingredients, are expected to be sold in the reagent and cell culture markets.

• Chromatin Inc., of Chicago, said the current issue of Nature Methods published an article describing findings by the company's co-founder, Daphne Preuss, supporting extending technology for rapidly identifying centromeres in plants. The article describes a whole-genome fractionation technique that can identify centromeric DNA in genomes, and suggests those techniques could extend to crops and mammals. The technology is licensed exclusively to Chromatin by the University of Chicago.

• Critical Therapeutics Inc., of Lexington, Mass., said it will begin enrolling patients in a Phase II study this month to assess the efficacy and safety of Zyflo, the tablet formulation of zileuton, in patients with moderate to severe acne. The study will consist of two groups of about 45 patients each, with the active drug group receiving Zyflo for 12 weeks. Zyflo was approved by the FDA in 1996 to treat asthma in patients 12 years and older. Zyflo blocks the activity of 5 lipoxygenase.

• Discovery Laboratories Inc., of Doylestown, Pa., said a marketing authorization application was submitted to the European Medicines Evaluation Agency to market Surfaxin in Europe for the treatment and prevention of respiratory distress syndrome in premature infants. Surfaxin is a peptide-containing, humanized lung surfactant developed from Discovery Lab's surfactant-replacement technology platform.

• Encysive Pharmaceuticals Inc., of Houston, reported top-line results from STRIDE-6, which is studying Thelin (sitaxsentan) in patients with pulmonary arterial hypertension who discontinued treatment with bosentan. Data suggest Thelin might provide benefits. The study enrolled 48 patients, 35 of whom had discontinued bosentan therapy for lack of efficacy and 13 for safety-related reasons. Of the 35 patients, 33 percent in the Thelin 100-mg group and 10 percent in the 50-mg group improved. Continued deterioration was seen in 20 percent of the 100-mg group and 15 percent of the 50-mg group.

• Ferring Pharmaceuticals A/S, of Copenhagen, Denmark, said degarelix, its new gonadotrophin-releasing hormone blocker (GnRH), showed rapid onset and sustained activity in a Phase II study in men with prostate cancer. Degarelix is designed to target and block the GnRH receptor. At the highest dose, 97.5 percent of patients experienced a reduction in testosterone to target levels of less than 0.5 ng/ml within three days of treatment.

• Genentech Inc., of South San Francisco, received a subpoena from the U.S. Attorney's Office for the Eastern District of Pennsylvania, requesting documents related to the promotion of Rituxan, a treatment for relapsed or refractory, low-grade or follicular, CD20+, B-cell non-Hodgkin's lymphoma. Genentech said it plans to cooperate with the civil and criminal investigations.

• GlycoFi Inc., of Lebanon, N.H., and Cambridge, Mass., appointed Sylvie Gregoire CEO. She joins the company from Biogen Idec Inc., of Cambridge, Mass., where she was executive vice president, technical operations. Gregoire replaces Charles Hutchinson, who remains as executive chairman. GlycoFi uses its protein-production technology to develop, produce and commercialize next-generation biotherapeutics.

• Juvaris BioTherapeutics Inc., of Pleasanton, Calif., said that researchers at the University of New Mexico began testing the efficacy of the JuvImmune immunostimulant platform against anthrax and smallpox infection models. The technology is designed to activate the innate immune response for the production of cytokines including interferons, as well as IL-12 and TNF-alpha. In addition, the testing will evaluate the efficacy of the vaccine platform containing disease-specific antigens as a potential oral vaccine against anthrax.

• Karo Bio AB, of Huddinge, Sweden, carried out a new share issue with preferential rights for the company's shareholders generating about SEK96 million (US$13.1 million), excluding transaction costs. The subscription period ended Oct. 1. The rights issue was expected to be 98.9 percent subscribed with preferential right for the shareholders. Remaining shares will be allocated by the company's board.

• Medarex Inc., of Princeton, N.J., said the FDA granted fast-track status for MDX-010 in combination with MDX-1379, a melanoma vaccine, for the treatment of previously treated, unresectable Stage III and Stage IV metastatic melanoma. Medarex is conducting a Phase III trial with MDX-010 and MDX-1379 combination therapy in Stage III and IV melanoma at multiple sites within the U.S. MDX-010 is a fully human antibody against human CTLA-4, a molecule on T cells believed to suppress the immune response.

• Meridian Bioscience Inc., of Cincinnati, received a Phase I Small Business Innovation Research grant from the National Institutes of Health. The grant will help fund research to develop highly specific recombinant antibodies to Clostridium-difficile toxins A&B. The company will use the antibodies to develop diagnostics. The company also has submitted an SBIR Phase I proposal to the Small Business Biodefense Program to develop reagents and test methods to detect toxins produced by pathogenic E. coli strains.

• Merix Bioscience, of Durham, N.C., said it is changing its name to Argos Therapeutics Inc., as it prepares for an HIV clinical trial with its RNA-loaded dendritic-cell vaccine. The name change reflects the evolution and success of the company's technology platform, said its chairman and CEO, Clint Dederick. Argos' HIV vaccine is designed to generate antiviral immune targeted at the patient's viral species.

• Metabasis Therapeutics Inc., of San Diego, said that an abstract describing pharmacokinetic and pharmacodynamic results of a recently completed trial of remofovir in patients with hepatitis B has been posted on the American Association for the Study of Liver Diseases' website. The 45-patient study enrolled adult Asian patients with compensated HBV infection. At all doses, serum HBV DNA levels decreased with time. After 28 days of treatment, the median log10 HBV decline from baselines was 1.64 at the 5-mg dose, 2.48 at the 10-mg dose, 2.72 at the 20-mg dose and 2.66 at the 30-mg dose.

• Nabi Biopharmaceuticals Inc., of Rockville, Md., said it is replacing the PhosLo PRECISE study with the CARE-2 study that will compare efficacy and arterial calcification in patients treated with PhosLo and Renagel. The redesign was prompted by new guidelines from the National Cholesterol Education Program on lipid control in high-risk and very-high-risk patients. In the new study, Lipitor will be added to both treatment arms. The study is designed to show that when end-stage renal disease patients achieve the same level of lipid control, there will be no significant difference in the development of coronary artery calcification. It will test PhosLo control on serum phosphorus and calcium phosphorus product over a one-year follow-up period vs. Renagel.

• NuGen Technologies Inc., of San Carlos, Calif., adopted the Ovation Biotin system for use with Santa Clara, Calif.-based Affymetrix Inc.'s GeneChip arrays at the Microarray Core Facility at Weill Cornell Medical College in New York. The system allows researchers to generate results on samples that had not succeeded in microarray analysis, NuGen said.

• ParAllele BioScience Inc., of South San Francisco, entered a collaboration with Novartis Pharma AG, of Basel, Switzerland, to discover genetic variations associated with coronary artery disease. Results will be used to identify biomarkers to help diagnosis disease and potentially guide treatment options, as well as identify and prioritize new drug targets.

• Perlegen Sciences Inc., of Mountain View, Calif., the Max Planck Institute for Developmental Biology in Martinsried, Germany, and the Salk Institute for Biological Studies in La Jolla, Calif., said they will collaborate to identify the DNA variation in 20 strains of Arabidopsis thaliana, the first plant to be sequenced. Planck is funding the collaboration.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., said another research milestone has been reached in its oncology collaboration with Schering-Plough Corp., of Kenilworth, N.J. The milestone was triggered by Schering-Plough's decision to begin preclinical development of a candidate identified in the company's deal. Pharmacopeia received an undisclosed cash payment.

• ReNeuron Holdings plc, of London, presented efficacy data with its lead stem cell line at the American Neurological Association annual meeting in Toronto. The company has generated preclinical efficacy data in stroke using ReN001, a stable human neural stem cell line preselected from ReNeuron's library of stem cell lines. The line was created with the company's c-mycER technology. Separately, ReNeuron said it intends to seek further funding in order to progress its lead stem cell therapy programs to the clinic.

• RiboNovix Inc., of Detroit, said it is addressing antibiotic-resistant bacteria by developing less susceptible new anti-infectives. Over the last few months, the new company completed an exclusive license agreement with Wayne State University in Detroit for the rights to a functional genomics platform technology developed by Philip Cunningham, assembled a research team in the field of antibiotic resistance and received a $346,066 Phase I SBIR grant by the National Institutes of Health in Bethesda, Md.

• RxGen Inc., of New Haven, Conn., said the National Institutes of Health has funded the company's fast-track Phase I and II SBIR application for $1.4 million to initiate the development of PrimaTox, a predictive toxicology technology that will examine the mechanisms of human drug toxicity with a goal to improve pharmaceutical candidate selection and preclinical validation.

• Samaritan Pharmaceuticals Inc., of Las Vegas, and Pharmaplaz, of Athlone, Ireland, entered a collaboration for the production and supply of Samaritan's lead compound, SP-01A, and its product pipeline that includes AIDS, Alzheimer's disease, cancer and cardiovascular disease products. The companies will work on pipeline development, scale-up and manufacturing requirements, while Pharmaplaz also will work on drug formulation and testing, production of pilot batches, development of analytical methods, drug specifications, process validations and drug optimization.

• Santarus Inc., of San Diego, reported the U.S. market launch of its first product, Zegerid (omeprazole) powder for oral suspension 20 mg, an immediate-release formulation of the proton pump inhibitor omeprazole. The product is FDA approved for the short-term treatment of active duodenal ulcer, heartburn and other symptoms associated with gastroesophageal reflux disease and erosive esophagitis diagnosed by endoscopy.

• Siga Technologies Inc., of New York, said its lead smallpox compound, SIGA-246, demonstrated significant antiviral activity against several mouse models of poxvirus. In one of study oral administration of SIGA-246 protected mice from lethal doses of ectromelia virus, which is related to human smallpox virus. SIGA-246 also was found to reduce disease spread and lesion formation in treated mice with no obvious toxicity.

• Stressgen Biotechnologies Corp., of San Diego, filed a preliminary prospectus in Canada pursuant to raising $50 million. Stressgen has entered an agreement with two broker-dealers, in which the agents have agreed on a best-efforts basis to place the company's common shares. The offering price per share and the number of shares to be placed will be determined prior to the filing of the final prospectus. Stressgen plans to use proceeds to fund development and commercialization of HspE7, its lead product candidate.

• Theratechnologies Inc., of Montreal, released data from a Phase I study testing ThPTH, a transdermal formulation of synthetic parathyroid hormone being developed for osteoporosis in collaboration with ALZA Corp., of Mountain View, Calif. The 3-mg Macroflux-PTH patch delivered ThPTH at blood levels in the same range as subcutaneous injections. The data were the subject of a poster presentation at the American Bone and Mineral Society meeting in Seattle.

• Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., said twice as many treatment-experienced patients who used Fuzeon with an active, boosted protease inhibitor regimen experienced a significant virologic response compared to patients on that regimen alone. Fuzeon is co-developed by Roche and Trimeris and is the first and only fusion inhibitor for the treatment of HIV. In the subset analysis of 48-week Phase III data, the patients receiving Fuzeon and PI regimen (52 percent) achieved undetectable levels of HIV, compared to those receiving the PI regimen without Fuzeon (27 percent). Fuzeon was granted accelerated approval by the FDA in March 2003.

• Tripos Inc., of St. Louis, released Sybyl 7.0, the latest version of its molecular modeling environment for drug discovery research. The new software expands on Tripos' existing applications.

• Viragen Inc., of Plantation, Fla., and its majority-owned subsidiary, Viragen International Inc., reported results from a seven-year follow-up to a Phase II/III study evaluating the use of Multiferon, natural human alpha-interferon, for malignant melanoma after surgical removal of all tumor masses compared to surgery alone. The analysis confirmed a statistically significant increase in overall survival for patients treated with adjuvant dacarbazine followed by Multiferon, compared to patients with no adjuvant treatment. Data also showed an actual 51.3 percent overall survival in high-risk patients treated with short-term DTIC, followed by Multiferon as adjuvant low-dose treatment for six months vs. 30.3 percent overall survival among patients who underwent surgery only (p=0.0077).

• Zelos Therapeutics Inc., of Ottawa, Ontario, completed a Series A3 financing that garnered C$7 million (US$5.4 million). The financing was triggered by the completion of the Phase Ib trial of Zelos' lead compound, a parathyroid hormone analogue to treat osteoporosis. The proceeds will be used in early 2005 to move Ostabolin-C into a dose-ranging Phase II trial in about 200 patients. Investors included VenGrowth Capital Partners Inc. and Genesys Capital Partners, both of Toronto, and Seaflower Ventures, of Waltham. BDC Venture Capital also made an investment.

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