• Amylin Pharmaceuticals Inc., of San Diego, said a dose-titration study of its diabetes drug candidate Symlin (pramlintide acetate) met prospectively defined parameters for its non-inferiority objective. In addition to reductions in HbA1c consistent with the non-inferiority objective in the 296-patient study, Symlin-treated subjects used 12 percent less insulin overall compared to control. Symlin also was associated with a significant reduction in post-meal blood glucose concentrations compared to the group using insulin alone, and the effect was sustained over the entire seven months of the study. At the end, Symlin-treated subjects experienced a reduction in weight, while subjects treated with insulin alone gained weight, with about a six-pound difference from baseline between the groups.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., entered definitive agreements with The Riverview Group LLC, the private equity investment arm of Millennium Partners LP, and Merlin Biomed Group for the purchase of 4 million shares at $2.50 per share for proceeds of $10 million. The price represents the average closing price of the company's common stock for the past 10 trading days. The offering is expected to close within two days. Rodman & Renshaw Inc. served as placement agent for the offering. The shares were offered through prospectus supplements pursuant to its effective shelf registration statements. Ariad's stock has been on the rise as of late, helped by a court ruling in a patent infringement case with Eli Lilly and Co., of Indianapolis. (See BioWorld Today, May 19, 2003.)

• AVAX Technologies Inc., of Overland Park, Kansas, said it was notified by the Nasdaq Stock Market that its stock will be delisted from the Nasdaq SmallCap Market on May 23, subject to the stay of the delisting upon an appeal of the staff's determination. Nasdaq is taking the action because the stock failed to trade above the $1 minimum closing bid price per share for more than 30 consecutive trading days. AVAX said it intends to appeal the decision by May 21.

• BioAlliance Pharma, of Paris, completed a fund-raising of €10 million, its third round of financing since the founding of the company in 1997. The round was led by Auriga Partners, of Paris, which was joined by two other new investors, ING, of Amsterdam, the Netherlands, and the French Co-Investment Fund. The round also was supported by previous investors, including two funds managed by Capricorn Venture Partners, ABN-AMRO Capital France, SPEF Ventures and a number of individuals. The company develops products for cancer and AIDS patients.

• Biota Holdings Ltd., of Melbourne, Australia, was awarded a $2.7 million R&D Start Grant to advance its respiratory syncytial virus drug development program. Biota's RSV program aims to develop an orally available antiviral drug for the treatment and prevention of RSV infection. The program targets the F protein (fusion protein) on the surface of the virus. Using the same structure-based drug design technology that gave birth to the flu drug Relenza, Biota scientists developed a model of the F protein and then identified compounds that inhibit its function.

• Cell Therapeutics Inc., of Seattle, presented preliminary data from three separate trials of Trisenox (arsenic trioxide) injection in 145 patients with myelodysplasia, in a satellite symposium and poster presentations at the 7th annual International Symposium on Myelodysplasia. The data suggest that it could be active and well tolerated against the disease. The company said the final data from U.S. and European clinical trials might provide a basis to pursue a label expansion for Trisenox in the disease.

• Cengent Therapeutics, of San Diego, was formed through the completed merger of Structural Bioinformatics Inc. and GeneFormatics Inc., both of San Diego, originally announced in early January. Cengent is a structure-guided company. It uses its Genes To Leads technology, Structure Determination Services and X-ray crystallography to develop drugs. It has four preclinical programs in obesity/diabetes, anti-infectives, oncology and inflammation. (See BioWorld Today, Jan. 7, 2003.)

• Cerus Corp., of Concord, Calif., was awarded an additional $6.2 million cooperative agreement by the Army Medical Research Acquisition Activity division of the Department of Defense. Cerus received the award for continued development of technologies to improve the safety and availability of blood that may be used by the U.S. armed forces for medical transfusions. Cerus, in collaboration with outside laboratories, will conduct research on inactivation of infectious blood-borne agents, which may present heightened risk in military settings, including unusual pathogens identified as emerging or rare contaminants in the blood supply.

• ChondroGene Ltd., of Toronto, said it was conducting negotiations with GeneNews Inc., of Ontario, for the acquisition of all of its issued and outstanding shares, or alternatively, substantially all of its assets. The principal asset of GeneNews is its proprietary technology, in which ChondroGene holds certain licensing rights limited to the general area of arthritis. The aggregate consideration proposed for the acquisition is $100,000 payable in cash and $2 million payable by the issuance of common shares.

• Devgen NV, of Ghent, Belgium, signed a three-year research collaboration with Sumitomo Chemical Company Ltd., of Tokyo, to develop insecticides. Devgen will select and further validate insecticidal targets and format high-throughput assays to screen small-molecule compounds designed by Sumitomo. Devgen will deliver insect active hits, which Sumitomo will develop further into marketed products. Devgen will receive an undisclosed up-front payment and research funding and is eligible for milestones and royalties.

• Eidogen Inc., of Pasadena, Calif., deposited a high-resolution 3-dimensional structural model of the protease enzyme from the coronavirus that causes severe acute respiratory syndrome into the publicly available Protein Data Bank. Eidogen's comparative analysis of the two protease structures, coronavirus and human rhinovirus, revealed significant similarities in the substrate binding sites. Eidogen said its analysis also revealed that unique structural features of the SARS protease in the P4 substrate binding subpocket could be exploited for the development of drugs with improved potency against SARS.

• Enanta Pharmaceuticals Inc., of Watertown, Mass., presented the latest data on its cyclosporine program at the third annual meeting of the Federation of Clinical Immunology Societies in Paris. The presentation included information on the cyclosporine analogues, EP-314 and EP-012637, which, when converted into nontoxic metabolites, prove to be distinct from cyclosporine A and its metabolites, which have limited therapeutic potential due to kidney toxicity. The analogues can be delivered either systemically or topically to the target organ, exerting a strong anti-inflammatory effect and are inactivated upon systemic absorption thus limiting their toxicity, the company said.

• Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., filed with the SEC for a secondary offering of 15 million common shares, all of which are issued and outstanding. The vast majority are being sold by Endo's controlling shareholder, Endo Pharma LLC, an affiliate of the private equity investment firm Kelso & Co., in which certain members of management have an ownership interest and prior to the offering owned about 75 percent of the outstanding shares. Senior management will sell less than 5 percent of its aggregate ownership, while the selling stockholders have granted the underwriters an overallotment option to purchase an additional 2.25 million common shares. Upon closing, Endo Pharma LLC would hold about 64 percent of Endo's outstanding common stock, or about 62 percent if the overallotment is exercised in full. Endo, which has about 131.7 million shares outstanding, will not receive any proceeds from the offering. Citigroup Global Markets Inc. and Bear, Stearns & Co. Inc. lead the underwriting syndicate, with Jefferies & Co. Inc. and SG Cowen Securities Corp. acting as co-managers.

• eXegenics Inc., of Dallas, said Ira Gelb and Irwin Gerson resigned from its board and Gary Frashier's service as a director has ended. At the same time, eXegenics named Joseph Davie to its board's audit committee and elected Walter Lovenberg lead director. The company also said a class-action lawsuit was filed against it in a complaint that alleges, among other things, that the defendants have mismanaged eXegenics, have made unwarranted and wasteful loans and payments to certain directors and third parties, have disseminated a materially false and misleading proxy statement in connection with the upcoming annual meeting of eXegenics' stockholders and have breached their fiduciary duties to act in the best interests of eXegenics and its stockholders. eXegenics said the allegations were without merit.

• Genaera Corp., of Plymouth Meeting, Pa., and its collaborators at MedImmune Inc., of Gaithersburg, Md., presented preclinical data on the potential benefit of using an anti-interleukin-9 antibody to prevent or treat asthma. The mice data were presented at the annual meeting of the American Thoracic Society in Seattle. Data showed improvement in all measures of lung allergic inflammatory response by blocking IL-9. Genaera's stock (NASDAQ:GENR), also buoyed by Genentech Inc.'s news, rose 45 cents Monday, or 49.5 percent, to close at $1.36.

• Genomic Profiling Systems Inc., of Bedford, Mass., received a $119,820 Phase I Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. The grant is for developing its MultiPath test for detection of a spectrum of biological warfare agents.

• Hemispherx Biopharma Inc., of Philadelphia, reported the results of a double-blind study conducted in a pig population suffering from the pig coronavirus. After therapeutic intervention with one of the company's lead products, Alferon N, newborn piglets had significantly greater survival rates than placebo-treated piglets. Since human SARS apparently has its roots in animal coronavirus, the company said it believes the drug's effect in the animal study may be relevant to humans.

• Hybridon Inc., of Cambridge, Mass., initiated a Phase I trial of HYB2055, the company's second-generation immunomodulatory oligonucleotide, in patients with malignant solid tumors. Hybridon also reported that its ongoing Phase I study of HYB2055 in healthy volunteers to assess safety and immunological activity over a 16-fold range of dosages is nearing completion.

• InterMune Inc., of Brisbane, Calif., reported follow-up data at the American Thoracic Society meeting in Seattle, from its Phase III trial of Actimmune (interferon gamma-1b) in idiopathic pulmonary fibrosis patients. Findings from the randomized, double-blinded, placebo-controlled study failed to show a significant treatment effect on the primary endpoint, conventional measures of physiologic function or quality-of-life scales. But in a secondary endpoint, it was suggested that interferon gamma-1b provides a survival benefit in the intent-to-treat population (41 percent relative reduction in the risk of death; p=0.08). An interim analysis of an independent, European, randomized, controlled study showed a statistically significant survival benefit (p=0.01) as well. Also at the conference, InterMune reported that findings from a randomized, double-blinded, placebo-controlled Phase II trial suggested that Actimmune downregulates molecules associated with fibrosis, inflammation and angiogenesis, while up-regulating molecules associated with antimicrobial defense, immunostimulation and anti-angiogenesis.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., and Ercole Biotech Inc., of Chapel Hill, N.C., initiated a multiyear collaboration to discover antisense drugs that regulate alternative RNA splicing. Isis and Ercole will engage in a drug discovery collaboration and cross-license splicing-related intellectual property. Ercole will receive a license to certain Isis antisense drugs, based on the RNA splice variant research conducted. Each company will pay the other for certain preclinical, clinical and commercial achievements, as well as royalties on sales. Additionally, Ercole will receive a license to Isis' Bcl-x preclinical antisense drug.

• Neurocrine Biosciences Inc., of San Diego, said indiplon showed no evidence of rebound insomnia or withdrawal in a Phase III trial with two doses (10 mg and 20 mg) of the immediate-release formulation in 200 chronic primary insomnia patients. Results demonstrated that there was no evidence of rebound insomnia at either dose using the primary measure, which compared patient's latency to persistent sleep on nights 36 and 37 (visit seven) vs. during the pretreatment visit (visit three). Along with efficacy and safety results reported a month ago, the study was designed to evaluate the potential for rebound insomnia and withdrawal effects after discontinuation of indiplon following 35 consecutive nights of treatment. (See BioWorld Today, April 23, 2003.)

• Prometheus Laboratories Inc., of San Diego, said it is introducing the first genetic test to help physicians identify a specific genetic cause of lactose intolerance in patients. The test identifies patients with a certain genetic marker associated with lower than normal levels of the lactase enzyme. The test, PRO-GenoLogix Lactose Intolerance, is being launched at Digestive Disease Week in Orlando, Fla., which continues through Thursday.

• SkyePharma plc, of London, and King Pharmaceuticals Inc., of Bristol, Tenn., entered a licensing agreement to develop and commercialize a modified-release formulation of King's product Altace (ramipril) - an angiotensin converting enzyme inhibitor with net sales in the U.S. and Puerto Rico of $534.7 million for the 12 months ending March 31 - using SkyePharma's oral, controlled-release Geomatrix drug delivery technology. King is paying SkyePharma $1 million up front, potential milestones of $6.5 million, reimbursement expenses and royalties on sales of any resulting products.

• The Immune Response Corp., of Carlsbad, Calif., reported the forthcoming publication of results from a trial involving Remune in the journal AIDS. The trial, while enrolling only a limited number of patients, concluded that vaccination with Remune increased HIV-1 specific immune response in chronic HIV patients receiving suppressive antiretroviral therapy.

• The Medicines Co., of Parsippany, N.J., said it holds exclusive worldwide rights, except for Japan, for clevidipine. The company had the option to license the product, which it will develop in perioperative hypertension Phase III trials, from AstraZeneca plc, of London, through their March 2002 agreement. Financial terms of the licensing were not disclosed. The company said it expects to begin Phase III trials in the fourth quarter of 2004 and said the Phase III program has been reviewed by the FDA. (See BioWorld Today, March 8, 2002.)

• United Therapeutics Corp., of Silver Spring, Md., said the National Institutes of Health in Bethesda, Md., agreed to use the company's multigram, drink-based formulation of arginine in a study of sickle cell disease. A five-month study will be conducted by the NIH titled "Evaluation of Potential Synergy of Combining Hydroxyurea with Nitric Oxide Donors on Fetal Hemoglobin Synthesis in Patients with Sickle Cell Anemia."

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