• Accelrys Inc., of San Diego, completed its merger with SciTegic Inc., of San Diego, a provider of workflow software solutions for the research science market. SciTegic now is a wholly owned subsidiary of Accelrys. Accelrys is a provider of software for computation, simulation and the management and mining of scientific data.

• Amarin Corp. plc, of London, received shareholder approval for its acquisition of Laxdale Ltd., of Stirling, Scotland. The company also was authorized to proceed with a private equity offering. The companies' relationship stems from Amarin's access with its lead product, Miraxion, which it gained from Laxdale. The drug is in development for Huntington's disease and treatment-unresponsive depression. Amarin detailed its post-acquisition plans last month. (See BioWorld Today, Aug. 25, 2004.)

• BioInvent International AB, of Lund, Sweden, entered a long-term collaborative research and licensing agreement with ThromboGenics Ltd., of Dublin, Ireland, to co-develop antibody-based drugs for vascular indications. Both parties will provide core intellectual property based on specific therapeutic targets and will share costs and revenues equally, though when a candidate has been identified prior to the collaboration, the revenue split will be 60/40. The initial program will focus on the co-development of ThromboGenics' fully human anti-Factor VIII monoclonal antibody as an anticoagulant therapy for indications such as the prevention and treatment of deep-vein thrombosis and treatment of atrial fibrillation.

• BTG, of West Conshohocken, Pa., formed an agreement with Collegium Pharmaceutical Inc., of Cumberland, R.I., to develop formulations of BTG's combination drug therapy being developed for the treatment of sleep apnea. Collegium will employ its experience in product development with the goal of establishing a patented single product with optimal properties for sleep apnea. BTG will fund the program, and the companies have a revenue-sharing arrangement. Separately, BTG formed a licensing and research agreement with the University of Illinois at Chicago to develop a pharmacological therapy for sleep apnea. BTG plans to invest in the development of the therapy to expand its portfolio of therapeutic programs, particularly in the area of drug re-positioning. BTG gets exclusive rights to intellectual property and inventions related to the development of therapeutic treatment of sleep apnea, as well as rights to intellectual property developed through the BTG-funded research program.

• Cardiome Pharma Corp., of Vancouver, British Columbia, exercised its right to place $4 million of equity at C$7.89 with Fujisawa Healthcare Inc., of Deerfield, Ill. The equity was placed at a 25 percent premium to the 30-calendar-day average market price of $6.31. The equity placement right is defined in the October 2003 co-development agreement in which Cardiome licensed North American rights to the intravenous formulation of RSD1235 to Fujisawa. Cardiome retains worldwide rights to oral RSD1235 for the prevention of atrial fibrillation and all rights to the intravenous formulations outside of Canada, the U.S. and Mexico. Cardiome stands to receive an additional $54 million in milestones from Fujisawa over the course of the agreement, based upon the achievement of certain clinical and commercial milestones.

• DOV Pharmaceutical Inc., of Hackensack, N.J., began a pivotal Phase III trial of bicifadine in about 600 patients with moderate to severe chronic lower-back pain. The randomized, double-blind, placebo-controlled, multicenter study is designed to assess the analgesic's efficacy and tolerability at three dose levels over a three-month period. Three co-primary efficacy endpoints, based on the change in scores from pretreatment baseline to end of treatment, include changes in pain-severity ratings by the patient, measures of functional disability and patients' global impression of change. The trial is beginning in accordance with the FDA's special protocol assessment guidelines and is expected to serve as one of two pivotal studies required to support a new drug application for the management of chronic lower-back pain. Days earlier, DOV began the first of four pivotal Phase III trials in another indication, acute pain. (See BioWorld Today, Sept. 27, 2004.)

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., signed a clinical trial agreement with the National Cancer Institute's Division Of Cancer Prevention for the development of Levulan photodynamic therapy in high-grade dysplasia within Barrett's esophagus. DUSA and the division will work together to prepare an overall clinical development plan for Levulan PDT in that indication, starting with a Phase II trial and continuing through Phase III studies, if appropriate. The NCI division will use its resources to file its own investigational new drug application

• Genaera Corp., of Plymouth Meeting, Pa., began its third Phase II trial of squalamine, its anti-angiogenic drug candidate for wet age-related macular degeneration (AMD). The MSI-1256F-208 study will evaluate three different doses (10, 20 or 40 mg) of squalamine in combination with an initial treatment of Visudyne (verteporfin, QLT Inc.) in 45 wet AMD patients. The study will evaluate the safety and effect of systemically administered squalamine pretreatment on the actions of Visudyne, and the effect of administering squalamine after Visudyne.

• Genentech Inc., of South San Francisco, and Celera Genomics Group, of Rockville, Md., entered a collaboration to discover and develop targeted therapies for cancer. Genentech may develop various products against therapeutic targets licensed from Celera, including antibodies, antibody fragments, proteins or small-molecule drugs. Celera will nominate a number of cell-surface antigens discovered and validated with its proteomic platform as potential therapeutic targets during the multiyear agreement, and any of the antigens might be designated by Genentech for further validation and research to identify therapeutics for further development solely by Genentech. In return, Genentech will make milestone payments based on achievement of preclinical, clinical and commercial milestones, and will pay royalties on net sales of any resulting products. Celera Diagnostics, a joint venture between Celera Genomics and Applied Biosystems Group, of Foster City, Calif., retains certain diagnostic rights associated with the targets. Separately, Genentech said its board extended its ongoing stock repurchase program for the repurchase of up to an additional $1 billion of shares through the end of next year. The board also increased the maximum number of shares that can be repurchased to 50 million from 25 million shares. As of Aug. 31, Genentech has bought back $748 million worth of its stock.

• Generex Biotechnology Corp., of Toronto, said its wholly owned subsidiary, Antigen Express, entered a Collaborative Research and Development Agreement with the Uniformed Services University of the Health Sciences and The Henry Jackson Foundation for the Advancement of Military Medicine Inc. to work with George Peoples, of the Medical Corps, U.S. Army, to advance HER-2/neu vaccine efforts for breast cancer. Peoples is assigned to the Walter Reed Army Medical Center and works in conjunction with the Clinical Breast Care Project.

• Genomatica Inc., of San Diego, received a Phase II Small Business Innovation Research grant from the U.S. Department of Energy under its Genomics:GtL program. The two-year award for about $750,000 will be used to enhance core components of SimPheny and expand Genomatica's ability to support collaborative research efforts focused on metabolic research.

• Epimmune Inc., of San Diego, reported plans for a Phase II study of its EP-2101 vaccine in patients with late-stage non-small-cell lung cancer, based on evidence of relevant biological responses in early clinical trials in both NSCL and colorectal cancer. The Phase II study will be conducted in Stage IIIb/IV NSCL patients with advanced disease as a single-dose, open-label study.

• Hemosol Corp., of Toronto, signed a multiyear agreement with Organon Canada, the pharmaceutical division of Akzo Nobel. The agreement, with an initial term of three years, makes Hemosol the exclusive Canadian manufacturer and supplier of licensed Hepalean products to Organon. Shipments of the first Hepalean products are scheduled to begin in early 2005.

• ImaRx Therapeutics Inc., of Tucson, Ariz., began a Phase I/II study of SonoLysis, its technology designed to dissolve blood clots, in 24 deep-vein thrombosis patients. The clot-dissolving therapy uses ultrasound to cavitate gas-filled microbubbles to dissolve clots. They are injected near the clot site via catheter or intravenous injection, and the ultrasound releases specific pulse sequences activating the microbubbles in the vicinity of the clot for final dissolution.

• Immtech International Inc., of Vernon Hills, Ill., said enrollment has been completed in the Phase IIb extended-dose regimen arm of its trial of DB289 for African sleeping sickness. That arm of the open-label trial, conducted in the Democratic Republic of the Congo, included treatment of patients twice per day (100 mg each dose) for 10 days. Its objective was to determine if extended therapy would increase DB289's efficacy or the percentage of patients cured. To date, all the patients reported have been parasite-free in follow-on testing and are still being evaluated and monitored for late recurrence. The company said such results confirm the treatment regimen to be tested in an upcoming randomized, open-label pivotal Phase III study in Angola and the Congo.

• International Therapeutics Inc., of Seattle, agreed to provide to Rosetta Inpharmatics LLC, also of Seattle, a worldwide nonexclusive license to International Therapeutics' ProxiQuant technology for research and development applications. ProxiQuant is an enzymatic application enabling stoichiometric generation of surrogate DNA targets from primary RNAi molecules in biological samples. Financial terms were not disclosed.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., reacquired all rights to market and sell Vitrase (hyaluronidase for injection; lyophilized, ovine) for all uses in the U.S. and many other worldwide markets after revising a four-year-old agreement with Allergan Inc., also of Irvine. ISTA will pay $10 million to Allergan, of which $6.5 million will be payable within 15 days with the remainder payable subject to ISTA's completion of qualified financing. ISTA also will make royalty payments to Allergan on U.S. sales of Vitrase for use in the posterior segment of the eye. ISTA will be responsible for filing Vitrase for vitreous hemorrhage in Europe, and Allergan will have an option to commercialize Vitrase in Europe subsequent to approval in that territory. If Allergan does not exercise its option, then European rights would revert to ISTA, and Allergan would get a royalty on ISTA's European sales of Vitrase for use in the posterior segment of the eye. ISTA outlined its plans last month upon closing a $13.3 million financing deal. (See BioWorld Today, Aug. 9, 2004.)

• Juvaris BioTherapeutics Inc., of Pleasanton, Calif., formed a collaboration with David Claxton at Penn State University in State College, Pa., for the development of immunostimulant and therapeutic vaccine approaches for the treatment of acute myelogenous leukemia. Juvaris' immunostimulation technology will be tested in rodent tumor models established by Claxton to evaluate the impact on leukemia using either an antigen immunostimulant or a non-antigen immunostimulant.

• KAI Pharmaceuticals Inc., of South San Francisco, initiated a Phase I/II trial of KAI-9803, a protein kinase-C inhibitor designed to reduce reperfusion injury as an adjunct to current treatments of acute myocardial infarction. KAI-9803 is the first drug candidate designed to inhibit the specific PKC enzyme responsible for reperfusion injury. The FDA has granted fast-track designation to KAI-9803 for the indication. KAI-9803 targets a specific PKC isozyme, delta-PKC, which has been found to activate a cascade of events causing cell injury and death during reperfusion injury.

• Oncolytics Biotech Inc., of Calgary, Alberta, is presenting Thursday a poster at the 16th EORTC-NCI-AACR 2004 Symposium on Molecular Targets and Cancer Therapeutics in Geneva. The paper is titled "The oncolytic reovirus, Reolysin, augments the anticancer effects of cytotoxic agents in vitro against the ras-mutated human colon cancer cell line HCT 116." The researchers were able to show that Reolysin enhances the cytotoxicity of chemotherapeutic agents including 5-FU, gemcitabine, doxorubicin and cisplatin, Oncolytics said.

• Oriel Therapeutics Inc., of Research Triangle Park, N.C., signed an agreement with an undisclosed U.S.-based biotechnology company to develop a therapy for cystic fibrosis. The therapy will be based on Oriel's dry powder inhalation technology incorporating the partner's compounds. The agreement could provide several million dollars in non-product revenues, including licensing fees and achievement of milestone fees, as well as options on other therapeutic applications and royalties, Oriel said.

• OxiGene Inc., of Waltham, Mass., said preclinical data reported at the European Organization for the Research and Treatment of Cancer-National Cancer Institute-American Association of Cancer Research Symposium on Molecular Targets and Cancer Therapeutics in Geneva confirm OXi4503's antitumor activity. One study showed that the radiation dose required to control or eradicate 50 percent of all tumors in the animals was reduced by administration of OXi4503. Additional data show that OXi4503 caused significant antitumor effects when administered as a single agent. Other data showed that administration of OXi4503 to tumor-bearing animals resulted in significant tumor-growth inhibition, and when combined with radiation at a 25mg/Kg dose, tumor cell death increased 20-fold to 50-fold over that seen with radiation alone. The company's stock (NASDAQ:OXGN) gained $1.33 Tuesday, or 24.4 percent, to close at $6.78.

• Schering-Plough Corp., of Kenilworth, N.J., said data reported at the United European Gastroenterology Week meeting in Prague, Czech Republic, demonstrate that treatment with Remicade (infliximab) results in a significant and rapid reduction of pain in Crohn's disease patients. The findings stem from the ACCENT I trial. Other data reported at the meeting, culled from a prospective analysis of 5,807 patients in the TREAT patient registry, affirm the drug's safety in treating Crohn's disease, the company said. Remicade is made by Centocor Inc., of Malvern, Pa.

• The Immune Response Corp., of Carlsbad, Calif., said data showing that Remune (HIV-1 Immunogen) appears to boost both HIV-1-specific CD4+ and HIV-1-specific CD8+ T-cell lymphocyte activity in chronically HIV-1 infected patients were published in the Sept. 20, 2004, issue of the Journal of Experimental Medicine. Remune is in Phase II development.

• U.S. Genomics, of Woburn, Mass., said that in conjunction with the launch of its first commercial product, the Trilogy platform, and the beginning of its Homeland Security contract, it has expanded with a new 34,000-square-foot facility. U.S. Genomics is focused on technologies that allow genetics, functional genomics and diagnostics to be performed at the single-molecule level.

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