• Accelrys Inc., of San Diego, said it would release a full suite of modeling and simulation tools to be used on the Linux operating system of IBM Corp., of Somers, N.Y. The company plans to launch Cerius2 and Quanta, software tools for 2-D and 3-D modeling, on Red Hat Linux operating platform. Accelrys' stock (NASDAQ:ACCL) rose 83 cents, or 14.4 percent, to close at $6.59.

• Agrisoma Biosciences Inc., of Burnaby, British Columbia, and Dow AgroSciences LLC, of Indianapolis, entered an agreement to research, develop and commercialize animal health products using Agrisoma's ACE system. Terms of the deal, which include up-front and milestone payments, call for Agrisoma to apply its gene delivery and expression technology to Dow's plant systems. Specific financial details were not disclosed.

• Amarin Corp. plc, of London, signed a settlement agreement with Valeant Pharmaceuticals International Inc., of Costa Mesa, Calif., resolving a dispute related to the February sale of Amarin Pharmaceuticals Inc. (API). Amarin completed the sale of API and a majority of its U.S. products to Valeant, with API becoming a wholly owned subsidiary of Valeant. The asset-purchase agreement provided for a purchase-price adjustment based on variations in a pro-forma balance sheet the parties agreed on and a closing-date balance sheet to be prepared after the closing. Under the settlement agreement and in consideration of a mutual release of claims, the companies agreed to amend the asset-purchase agreement to waive $6 million of the $8 million in contingent milestones due to Amarin. The remaining $2 million is no longer contingent and is payable by Valeant on Nov. 30. Valeant waived Amarin's contingent obligation to repurchase $414,000 of wholesale inventory. The settlement agreement is subject to approval from Elan Corp. plc, of Dublin, Ireland, on or before Oct. 7. Of the $2 million, half is payable to Elan as part of a February settlement between Elan and Amarin.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its partner Boston Scientific Corp., of Natick, Mass., announced two-year follow-up data from Boston's Taxus II and Taxus IV paclitaxel-eluting stent system clinical trials. Data demonstrated that the safety and efficacy benefits were maintained at two years. The data also indicate that the stents might prevent, rather than just delay, in-stent restenosis and there were incremental benefits with the Taxus stent system compared to a bare-metal stent.

• Arius Research Inc., of Toronto, raised C$2.55 million (US$2 million) in a private placement with Biotechnology Value Fund LP in San Francisco and associated funds. Arius sold 3.4 million common shares at C75 cents apiece, and issued warrants to purchase 3.4 million additional shares at the same price. The warrants expire Sept. 27, 2006. Separately, Arius issued convertible debentures for gross proceeds of C$70,000 to Loewen, Ondaatje, McCutcheon Ltd. They bear interest at 20 percent annually and will either be redeemed by Arius immediately or exchanged at the holders' option, in whole or in part, for up to 77,840 common shares at C90 cents. Also, Arius concurrently issued Loewen 77,840 warrants that entitle the holder to purchase one common share at C90 cents each for up to 12 months after closing. Arius develops antibodies for cancer indications using its FunctionFIRST technology platform.

• ArQule Inc., of Woburn, Mass., reported interim Phase I data 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 showing a dose-proportional response in treatment with ARQ 501, with no evidence of accumulation. The maximum tolerated dose and dose-limiting toxicity have yet to be determined, the company said. The study will continue to enroll patients until the maximum tolerated dose and optimal dose regimen for Phase II is identified. The monotherapy study has recruited 18 patients, with a range of tumor types, who failed standard chemotherapy. ArQule also announced plans to study ARQ 501 in combination with Taxotere, in addition to a previously announced combination study with gemcitabine.

• Biomira Inc., of Edmonton, Alberta, and Merck KGaA, of Darmstadt, Germany, said their BLP25 liposome vaccine (L-BLP25) received fast-track status from the FDA. The companies are investigating its use in non-small-cell lung cancer. Biomira's fast-track application included encouraging results from a Phase IIb study in Stage IIIB and IV lung cancer patients. Those results will be reported in November at the European Society of Medical Oncology meeting to be held in Vienna, Austria. Biomira's stock (NASDAQ:BIOM) gained 41 cents, or 35.3 percent, to close at $1.57.

• Cellerant Therapeutics Inc., of Palo Alto, Calif., was awarded a two-year, $800,000 Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health in Bethesda, Md. Cellerant will use the funds for a project titled "Expansion of Human Hematopoietic Stem Cells for Rescue in Biodefense Applications." It marks Cellerant's second NIH grant related to the use of adult hematopoietic stem and progenitor cells for people exposed to lethal doses of radiation.

• Compound Therapeutics Inc., of Waltham, Mass., granted nonexclusive rights to Abbott Laboratories, of Abbott Park, Ill., to use its PROfusion technology and certain antibody libraries. PROfusion is an in vitro display technology for the selection and optimization of high-affinity antibodies and other binding proteins. Abbott can use the technology and libraries for drug discovery research to find leads for development and commercialization of human antibody products. Compound Therapeutics will receive an undisclosed up-front payment, milestone payments contingent on clinical and commercial objectives and potential royalty payments related to resulting products.

• Cytogen Corp., of Princeton, N.J., reached a settlement in a suit against it and C.R. Bard Inc., of Murray Hill, N.J. The patent-infringement complaint was brought by Immunomedics Inc., of Morris Plains, N.J., which filed suit in February 2000 alleging that Cytogen's ProstaScint product infringed U.S. Patent No. 4,460,559, which claims a method for detecting and localizing tumors. The settlement includes an undisclosed payment, without admission by Cytogen or Bard of fault or liability.

• Enzo Biochem Inc., of Farmingdale, N.Y., said a Phase II study of Alequel, its investigational therapeutic for Crohn's disease, met its endpoints, and the company is moving forward with expanded studies. The randomized, double-blind, 31-patient trial showed that 67 percent of treated subjects had a clinical response, compared to 43 percent of the placebo group. Also, 58 percent of the treated group achieved clinical remission, compared to 29 percent of placebo subjects, and Alequel-treated patients achieved a mean improvement of 43 percent in quality of life compared to 12 percent in the placebo group.

• Evolutionary Genomics LLC, of Aurora, Colo., will use its technology to identify natural genes that control yield in rice in a collaboration with RiceTec Inc., of Alvin, Texas. Specifically, Evolutionary Genomics will identify genes that have undergone adaptive evolution in domesticated rice (Oryza sativa) compared with the rice ancestor (Oryza rufipogon). The companies will work to establish connections between the adapted genes and control of rice yield. RiceTec will have exclusive rights to use resultant products in its hybrid-breeding program to develop naturally high-yielding, hybrid rice seed. Financial terms were not disclosed.

• Genaera Corp., of Plymouth Meeting, Pa., received a $100,000, Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases. The grant will be used to further develop trodusquemine (formerly trodulamine), Genaera's lead preclinical compound for the treatment of obesity. Treatment with the small-molecule aminosterol has been shown to regulate food intake and prevent weight gain in genetically obese and normal mice, and reducing fat stores while maintaining normal water and electrolyte balance, Genaera said. Also, trodusquemine prevented abnormal weight gain and re-established normal blood glucose levels in genetically obese mice with diabetes.

• Guava Technologies Inc., of Hayward, Calif., expanded the geographic scope of its previously announced distribution agreement in Japan with GE Healthcare, of Chalfont St. Giles, UK. The exclusive three-year agreement, centered on Guava's Personal Cell Analysis system and reagents, will include South Korea, Mexico and certain countries in Latin America and the Caribbean.

• Human Genome Sciences Inc., of Rockville, Md., priced $250 million in 2.25 percent convertible subordinated notes due 2011 through a previously announced private placement to qualified institutional buyers. The placement was $50 million higher than first planned due to market demand, HGS said. The notes are convertible into the company's common stock at about $15.55 per share, and HGS intends to use all net proceeds to repurchase a portion of its outstanding convertible subordinated debt. The company also granted initial purchasers a 30-day option to buy up to an additional $50 million of the notes. The transaction is expected to close on or about Oct. 4. Separately, the company said results of an ongoing Phase I trial demonstrate the safety and tolerability of HGS-ETR2 (agonistic human monoclonal antibody to TRAIL Receptor-2) in cancer patients with advanced solid tumors, and support continued dose escalation and evaluation in those patients. The data were reported at the EORTC-NCI-AACR 2004 Symposium on Molecular Targets and Cancer Therapeutics meeting in Geneva.

• ID Biomedical Corp., of Vancouver, British Columbia, was awarded a $9.5 million grant from the National Institutes of Health in Bethesda, Md., to develop its cell culture-based influenza vaccine. The manufacturing process is being developed to potentially replace the egg-based process used by flu vaccine manufacturers, including ID Biomedical, particulary in the event of an influenza pandemic, the company said, adding that the grant allows it to further develop and conduct early stage human trials on the cell culture-based vaccine.

• ILEX Oncology Inc., of San Antonio, said clofarabine would be reviewed by the FDA's Oncologic Drugs Advisory Committee on Dec. 1. ILEX filed a new drug application for the treatment of refractory or relapsed acute leukemia in children. The Prescription Drug User Fee Act response date on the application is Dec. 30. ILEX has U.S. and Canadian rights to clofarabine, while Bioenvision Inc., of New York, has rights in the rest of the world. Bioenvision, which obtained clofarabine's development and commercialization rights from the Southern Research Institute in Birmingham, Ala., is entitled to milestone payments tied to development and royalties on North American sales.

The J. Craig Venter Institute in Rockville, Md., was created through the consolidation of three not-for-profit research institutes. The new institute will continue the research and policy activities of the merged institutes - the Center for the Advancement of Genomics, the Institute for Biological Energy Alternatives and the J. Craig Venter Science Foundation Joint Technology Center. The organizations are devoted to genomic research, high-throughput genomic sequencing and genomic policy research.

• Liberty Mint Ltd., of La Jolla, Calif., signed a definitive merger agreement with Akesis Pharmaceuticals Inc., also of La Jolla. Akesis is developing therapies for diabetes and other metabolic disorders. Financial terms were not disclosed.

• Medarex Inc., of Princeton, N.J., began patient enrollment at multiple U.S. sites for its Phase III trial of MDX-010 for metastatic melanoma. About 750 patients with previously treated Stage III or IV metastatic melanoma are expected to be enrolled and will be randomized to receive one of three regimens: MDX-010 in combination with MDX-1379, MDX-010 alone or MDX-1379 alone. The trial was designed as part of the FDA's special protocol assessment process and agreed upon last month. Separately, Medarex and collaborators at the Massachusetts Biologic Laboratories of the University of Massachusetts' medical school received the agency's approval to begin a Phase I trial of CDA-1 (MDX-066), a fully human monoclonal antibody designed to treat Clostridium difficile-associated diarrhea. The dose-escalation trial is expected to enroll up to 30 healthy volunteers. (See BioWorld Today, Aug. 24, 2004.)

• Medical Discoveries Inc., of Twin Falls, Idaho, raised $500,000 in an equity financing with subscriptions of restricted common stock by private investors. The company said the funds would help support the completion of preclinical testing and chemistry, manufacturing and control milestones in preparation for submitting investigational new drug applications to the FDA. It is developing anti-infective technology for two initial target indications, HIV and cystic fibrosis.

• Metaphore Pharmaceuticals Inc., of Fort Lee, N.J., began a Phase II trial of its lead compound, M40403, for pain associated with cancer. The product will be administered with opioids in 24 patients suffering from moderate to severe cancer pain to evaluate the potential for enhanced analgesic response as its primary endpoint. The company said earlier clinical trials demonstrated the non-narcotic's ability to selectively amplify the pain-relieving effects of opioids, while reducing the unwanted side effects associated with both acute and chronic opioid use. Previous findings also have shown that M40403 improves the effectiveness and predictability of opioids.

• Microbix Biosystems Inc., of Toronto, said it would receive $600,000 after an exclusive review and negotiation period for its influenza virus yield-enhancement technology ended without the parties entering a definitive agreement. The company said the unnamed reviewing party determined Microbix's technology to be incompatible with its existing manufacturing process. Microbix, which remains in discussions regarding a further milestone payment of $1 million related to the breakup, believes its technology is capable of delivering substantial yield improvements. It received several offers in April to license the technology and will go back to the same group in November following the completion of additional testing designed to accelerate future reviews and support the technology.

• Neurologix Inc., of Fort Lee, N.J., said it received a favorable review of its clinical trial protocol for NLX-E201, its gene-therapy product for intractable temporal lobe epilepsy, from the Recombinant DNA Advisory Committee of the National Institutes of Health in Bethesda, Md. Based on comments from the committee, the company plans to submit an investigational new drug application to the FDA in the first half of next year to begin a Phase I study. Neurologix also said it continues to sponsor ongoing research programs conducted by epilepsy researchers.

• NovaDel Pharma Inc., of Flemington, N.J., said its new drug application for its aerosol nitroglycerin lingual spray has been accepted for review by the FDA. If approved, the product would be indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. The Prescription Drug User Act goal date is June 4.

• Onyx Pharmaceuticals Inc., of Richmond, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., reported Phase II data at the EORTC-NCI-AACR 2004 Symposium on Molecular Targets and Cancer Therapeutics in Geneva showing that 43 percent of BAY 43-9006-treated patients with advanced hepatocellular carcinoma or liver cancer experienced stable disease for at least four months. An additional 9 percent experienced tumor shrinkage. The 137-patient trial examined the use of the RAF kinase and VEGFR inhibitor as a single agent. Seven patients had partial responses (tumor shrinkage of 50 percent or greater), five had minor responses (tumor shrinkage of 25 to 50 percent) and 59 had stable disease for at least four months as best response. Median overall survival was 9.2 months and median time to tumor progression was 4.2 months.

• Protein Design Labs Inc., of Fremont, Calif., said interim Phase I data were reported at the Symposium on Molecular Targets and Cancer Therapeutics meeting in Geneva detailing the use of M200, its anti-alpha5beta1 integrin antibody for refractory solid tumors. Findings showed that adverse events - which included fatigue, nausea, constipation, headache and anorexia - were generally mild to moderate in intensity. There were no severe or serious adverse events that were dose-limiting or considered to be related to M200. PDL said that based on the results, it plans to begin over the next few quarters a series of open-label Phase II trials in renal, melanoma, pancreatic and non-small-cell lung cancers. Separately, it said interim results from the Phase I dose-ranging portion of a Phase I/II trial of its Nuvion (visilizumab) antibody in patients with severe ulcerative colitis that is refractory to treatment with intravenous steroids were reported at the United European Gastroenterology Week meeting in Prague, Czech Republic.

• Receptor Logic Ltd., of Amarillo, Texas, received a $2 million award from the Advanced Technology Program of the National Institute of Standards and Technology. The three-year award will fund the development of a cancer profiling and immunotherapy platform targeting breast cancer, as the company works to develop a new class of antibodies that mimic T-cell receptors designed to identify and then attack tumor-specific human leukocyte antigen complexes. Receptor Logic is owned by the venture capital firm Emergent Technologies Inc., of Austin, Texas.

• RheoGene Inc., of Norristown, Pa., was awarded a three-year, $2 million grant from the National Institute of Standards and Technology's Advanced Technology Program to develop new techniques for site-specific insertion and control of therapeutic genes in human adult neural stem cells to treat incurable ocular diseases. The project's goal is to create neural stem cell therapies to restore lost vision in patients with retinal and optic nerve degeneration to improve quality of life. RheoGene said it would use the award to develop technologies that also can be applied to enhancing the safety and efficacy of stem cell-based therapies and accelerate advancement into the clinic.

• Transkaryotic Therapies Inc., of Cambridge, Mass., received a $300,000 development grant from the FDA's Office of Orphan Products Development for iduronate-2-sulfatase (I2S), its investigational enzyme-replacement therapy for Hunter syndrome, also known as MPS II. The company said the funding would pay some of the costs of its ongoing pivotal trial, a fully enrolled study designed to evaluate the safety and efficacy of weekly and every-other-week infusions of 0.5 mg/kg of I2S. Its primary endpoint is a single composite variable that combines two clinical measurements, the forced vital capacity as a measure of respiratory function and the six-minute walk test as a measure of functional capacity. Additional efficacy endpoints include measurements of joint range of motion and combined liver/spleen size. TKT expects top-line results from the study, called AIM (Assessment of I2S in MPS II), in the second quarter of next year. If positive, the company expects to submit applications in both the U.S. and Europe in the second half of next year.

• Trinity Biotech plc, of Dublin, Ireland, received FDA approval for the use of its Uni-Gold Recombigen HIV test with finger-stick whole-blood samples. The test gives results within 10 minutes and is approved for the detection of antibodies to HIV in human serum, plasma, venous and finger-stick whole blood. The company has sold about $6 million of the products in the first three quarters of 2004. Trinity's stock (NASDAQ:TRIB) rose 10 percent, or 28 cents on Wednesday, to close at $3.06.

• Vical Inc., of San Diego, began a Phase I trial of its trivalent immunotherapeutic vaccine for cytomegalovirus (CMV), incorporating genes encoding three CMV proteins. It will test the vaccine in up to 40 healthy subjects. That study and an ongoing Phase I trial of a bivalent CMV vaccine are evaluating safety and immune responses in healthy volunteers, in preparation for planned proof-of-concept trials in hematopoietic cell transplant and solid organ transplant patients. The bivalent CMV vaccine trial recently completed enrollment of 32 volunteers, and initial data are expected to be reported in November at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

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