• Access Pharmaceuticals Inc., of Dallas, said a Phase III study of OraDisc A for established canker sores achieved its primary endpoint, a measure of accelerated healing by the product on the fifth day. Though Access said the finding was statistically significant, a full statistical analysis of the 700-patient, placebo-controlled, multicenter study has not been completed. The company's stock (AMEX:AKC) gained 11 cents Tuesday to close at $2.41.

• Advanced Tobacco Products Inc., of San Antonio, agreed to merge with IVAX Corp., of Miami. ATP's nicotine impermeable co-polymer technology is used in the Nicotrol/Nicorette inhaler, marketed for smoking cessation by Pharmacia Corp., now Pfizer Inc., of New York. ATP also has an exclusive license to dry powder inhaler applications from Duke University and has obtained patents covering that technology. The transaction has been approved by both companies' boards of directors and is subject to approval by the shareholders of ATP. IVAX discovers, develops, manufactures and markets branded and generic pharmaceuticals and veterinary products. Shareholders of ATP would receive the number of shares of IVAX stock determined by multiplying the number of outstanding shares of ATP stock by 54 cents and dividing the result by the average closing price of IVAX's stock for the 45 business days immediately preceding the closing of the merger. The number of shares to be received by ATP shareholders is subject to possible reduction if ATP has less than $1.9 million in cash, investments and net accounts receivable when the merger closes.

• Agencourt Bioscience Corp., of Beverly, Mass., was named the exclusive North American distributor of CloneSmart cloning kits and research products for Lucigen Corp., of Middleton, Wis. Lucigen will retain rights to continue to sell directly to those markets, but transferred to Agencourt certain new product rights arising from its Single Cell Genomics gene discovery libraries in return for in-kind genomic sequencing services provided by Agencourt and undisclosed financial payments.

• Agilent Technologies Inc., of Palo Alto, Calif., and Rosetta Biosoftware, a business unit of Rosetta Inpharmatics Inc., a wholly owned subsidiary of Merck & Co. Inc., of Whitehouse Station, N.J., entered an agreement to license the Rosetta Resolver system to the Stichting Netherlands Bioinformatics Center, which will make the gene expression data-analysis system available to the Dutch research community. Financial terms were not disclosed, although at least 10 academic research labs will access the system at the outset.

• Bioenvision Inc., of New York, received $1.25 million after agreeing to sublicense U.S. and Canadian marketing and development rights to trilostane for animal health applications to Dechra Pharmaceuticals plc, of Staffordshire, UK. Bioenvision, which also would receive an additional $750,000 upon submission of a new animal drug application to the FDA and $3 million upon approval, will receive royalties on future sales. Dechra's subsidiary, Arnolds Veterinary Products, markets trilostane in the UK under the trade name Vetoryl.

• Bioniche Life Sciences Inc., of Belleville, Ontario, closed a private placement of C$13.5 million (US$9.8 million) royalty-enhanced debentures to the Business Development Bank of Canada and two other Canadian financial institutions. Harris Partners Ltd. was lead agent, and Octagon Capital Corp. co-led the financing. A tranche of about C$4 million has been advanced to the company and the balance is expected within 90 days. Bioniche said it plans to use 38 percent for working capital and the balance will be used to repay the 7.5 percent convertible debentures that mature in 2005. The debentures are secured, bearing a basic interest at 9.5 percent per annum, and are repayable to 20 percent on June 30, 2006, 2007 and 2008, with the balance maturing on June 30, 2009. Holders of the debentures also are entitled to be paid bonus interest, based on product sales and licensing revenues in excess of $35 million per year, of 0.0025 percent (per million of principal) of such revenues between $35 million and $60 million and 0.00192 percent on sales greater than $60 million, subject to a maximum internal rate of return of 25 percent per year.

• Biota Holdings Ltd., of Melbourne, Australia, signed a letter of intent with Sankyo Co. Ltd., of Tokyo, covering Biota's Flunet and a similar Sankyo compound. The companies expect to enter an agreement to pool their long-acting neuraminidase inhibitor flu drug pipelines and jointly seek development and commercialization partnerships. The companies would share equally in all future licensing and royalty revenues.

• Cell Therapeutics Inc., of Seattle, said Trisenox (arsenic trioxide) injection produced high response rates in multiple myeloma patients who failed not only chemotherapy but also investigational compounds. Preliminary data from 86 patients in several studies showed that Trisenox produced objective responses in 31 of the 78 evaluable patients. The patients were chemotherapy resistant and/or advanced multiple myeloma patients. The data were presented in a satellite symposium sponsored by Cell Therapeutics and in presentations at the 9th International Workshop on Multiple Myeloma in Salamanca, Spain.

• Chiron Corp., of Emeryville, Calif., said that Chiron UK-1 Ltd., an indirect wholly owned subsidiary of Chiron, purchased 500,000 shares of PowderJect Pharmaceuticals plc, of Oxford, UK, at a price of 544 pence per share. The purchases increase Chiron UK-1 Ltd.'s shareholding from 1.28 percent to 1.82 percent of the total outstanding shares of PowderJect. Chiron reported May 19 that it launched a recommended cash tender offer for all outstanding ordinary shares of PowderJect, valued at about $878 million. (See BioWorld Today, May 20, 2003.)

• EvoGenix Pty Ltd., of Sydney, was awarded an Australian federal government START grant of A$900,000 (US$592,400) to support its therapeutics development program over the next two years. EvoGenix will apply its technology for altering and optimizing proteins to the development of a protein pharmaceutical for the treatment of osteoporosis.

• Gene-IT Inc., of Worcester, Mass., reported the completion of two comparative genomics projects for Aventis SA, of Paris. As part of an anti-infectives study, Gene-IT used its Biofacet software for Aventis to determine the conserved protein sequences of a set of bacterial genomes. For a second study, Gene-IT applied its comparative genomics methodology to identify the DNA fragments shared among particular fungal species. Gene-IT also reported the purchase by Aventis of the company's Biofacet software for in-house computational biology research.

• Generex Biotechnology Corp., of Toronto, and Eli Lilly and Co., of Indianapolis, agreed to end a development and license agreement for a buccal delivery of insulin. Generex said both parties are working on terms for Lilly to continue to supply a specified amount of insulin for Generex's further development work. All of Generex's intellectual property and commercialization rights with respect to the buccal spray drug delivery technology will revert to Generex, which will have the continuing right to develop and commercialize the product at its own expense.

• Generex Biotechnology Corp., of Toronto, said that, pursuant to authorization from the Health Products and Food Branch of Health Canada, it would begin Phase IIb studies in Canada for Oralin, an oral insulin spray, in June. The studies are designed to evaluate the long-term efficacy of Oralin in a large number of patients with Type I and Type II diabetes. The study protocol for patients with Type I diabetes will compare the metabolic effects and the reproducibility of its oral insulin spray formulation at mealtimes. The study protocol for patients with Type II diabetes will analyze the metabolic effects of Oralin given at mealtimes and with snacks in patients with Type II diabetes and poorly controlled blood glucose (HbA1>0.075) where conventional tablet therapy failed.

• Genetronics Biomedical Corp., of San Diego, entered an exclusive agreement with privately held Genteric Inc., of Alameda, Calif., covering joint evaluation of gene expression using electroporation-assisted delivery of DNA to the salivary gland. Data from the collaboration will be owned by both parties and could lead to commercial development of multiple gene therapy products. More specific financial terms were not disclosed.

• Genta Inc., of Berkeley Heights, N.J., reported results from clinical presentations that featured Genasense (oblimersen sodium), its lead anticancer agent, in combination with chemotherapy for the treatment of multiple myeloma. In a Phase I/II study of 15 evaluable patients, three patients (20 percent) achieved a complete or near-complete response, and five patients (33 percent) achieved a partial response, for an overall major response rate of 53 percent. Four other patients (27 percent) achieved a minor response. Eleven patients continue to receive treatment. The results were presented at the 9th International Workshop on Multiple Myeloma in Salamanca, Spain.

• Geron Corp., of Menlo Park, Calif., said it is debt free after amending its Series D convertible debentures to provide for an automatic conversion into equity on the maturity date. They currently amount to $15 million plus accrued interest, and have a maturity date of June 30, 2005. The amendment eliminates future interest accruals and provides for a fixed conversion price of $5 per share, with a mandatory conversion date of June 30, 2005, if not previously converted. The terms of the warrants issued with the debentures also were amended to adjust the exercise prices to a premium to Geron's current market price. The exercise periods on the warrants were unchanged.

• Gilead Sciences Inc., of Foster City, Calif., said European regulatory authorities expanded the indication of Viread (tenofovir disoproxil fumarate) to include its use in antiretroviral-naive HIV infected patients. In the European Union's 15 member states, Viread now is approved for broad use in combination with other antiretrovirals for HIV-1-infected adults older than 18, including patients beginning antiretroviral therapy as well as previously treated patients.

• Hemispherx Biopharma Inc., of Philadelphia, filed patent applications covering the use of both of its lead compounds, Alferon N Injection and Ampligen, for the potential treatment and prevention of severe acute respiratory syndrome (SARS). The patent applications that have been filed provide procedures for combating the effects of coronavirus-induced conditions by the administration of Alferon N Injection or Ampligen or in combination therapy. Hemispherx's stock (AMEX:HEB) gained 35 cents Tuesday, or 16 percent, to close at $2.54.

• ImClone Systems Inc., of New York, received $6 million for a manufacturing-related milestone under its Erbitux license agreement with Merck KgaA, of Darmstadt, Germany. The milestone related to Merck's approval of an import license from German regulatory authorities. ImClone issued 334,471 common shares to Merck, a 10 percent premium to market value as provided in the December 1998 agreement under which Merck licensed the right to develop Erbitux outside the U.S. and Canada and the coexclusive right to develop Erbitux in Japan. ImClone's stock (NASDAQ:IMCLE) gained $4.75 Tuesday, or 24 percent, to close at $24.60.

• Immerge BioTherapeutics Inc., of Charlestown, Mass., reported publication in this week's Proceedings of the National Academy of Sciences that it identified the receptors used by porcine endogenous retrovirus (PERV) in order to enter and infect a cell. Immerge said the discovery allows scientists to begin to develop strategies to prevent replication of PERV, which has been considered a key safety issue in the development of xenotransplantation using pig organs because the virus has shown the ability to infect some human cells in laboratory tissue cultures.

• Immtech International Inc., of Vernon Hills, Ill., began a Phase IIb trial of the oral drug DB289 to treat Pneumocystis carinii pneumonia (PCP). PCP is a fungus that can cause lung infections in immunosuppressed patients. The trial seeks to determine the most efficacious dose regimen of the drug and will enroll patients in Peru who have failed common PCP therapies.

• Ingenuity Systems, of Mountain View, Calif., said it launched the Ingenuity Pathways Knowledge Base, a curated database of biological networks created from modeled relationships between proteins, genes, complexes, cells tissues, drugs and diseases.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said at the Manhattan Alzheimer's disease conference in New York that toxic amounts of a substance called spherotoxin were discovered in human brain areas believed to trigger brain damage in Alzheimer's patients. The company said that after extracting the material, it was able to produce the type of brain damage found in the disease. Nymox also said it would file an investigational new drug application later this year with the FDA for a new Alzheimer's drug.

• OxiGene Inc., of Watertown, Mass., entered a collaboration with Cancer Research UK, which expects to complete preclinical studies of OXi4503 this year and move the compound into Phase I trials early next year. The agreement coincided with the publication in Anticancer Research of study data highlighting the ability of OXi4503, a member of the combretastatin family of vascular targeting agents, to significantly block the flow of blood to the core and periphery of solid tumors transplanted into mice. Researchers noted OXi4503's apparent potency as a single agent. OxiGene's stock (NASDAQ:OXGN) gained $1.55 Tuesday, or 55.4 percent, to close at $4.35.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., said genes analyzed and confirmed as hits in its Arabidopsis thaliana GeneFunction Factory platform moved into corn and soybean research by the Monsanto Co., of St. Louis. Paradigm is testing genes with its platform to discover those that can affect commercially relevant traits. As part of its recently restructured research plan, Paradigm also reanalyzes a subset of the genes to confirm the genes' ability to affect agronomic traits.

• Pittsburgh Life Sciences Greenhouse in Pennsylvania said LaunchCyte LLC, of Pittsburgh, will relocate its headquarters to the PLSG facilities in Pittsburgh's Technology Center as part of a partnership reached between the organizations. The organizations will share expertise in the pursuit of their respective missions, which are centered on fostering the growth of the region's life sciences community. LaunchCyte creates, seeds and harvests life science innovations, it said, and is pursuing technologies optioned from the University of Pittsburgh and Carnegie Mellon University.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., completed a $400,000 short-term private debt offering, which comes due on Dec. 31 or earlier upon completion of certain financing milestones or strategic partnerships. The company will pay 10 percent annual interest on the sum and noteholders will receive a warrant to purchase 200,000 shares of the company's restricted common stock at a nominal price for 18 months. RegeneRx is developing Tb4 as a platform technology for the treatment of acute and chronic wounds and for the treatment of human diseases involving tissue and organ repair under an exclusive worldwide license from the National Institutes of Health, also in Bethesda.

• Renovis Inc., of San Francisco, said it received two milestone payments from AstraZeneca plc, of London, connected with the advancement of Cerovive (NXY-059) into two Phase III trials for acute ischemic stroke. The trials are called the SAINT (Stroke Acute Ischemic NXY Treatment) trials and will compare the drug against placebo in disability and neurological recovery in more than 3,000 acute ischemic stroke patients. Cerovive is a nitrone with free radical-trapping capabilities. It is licensed to AstraZeneca.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said its board unanimously determined that Axcan Pharma Inc., of Mont St. Hilaire, Quebec, revised tender offer for all outstanding shares of Salix common stock at $10.50 per share remains "grossly inadequate" and not in the best interest of Salix stockholders. The basis for the board's decision was set forth in a letter to stockholders. The original cash tender offer of $8.75 per share began in early April.

• The Medicines Co., of Parisppany, N.J., reported that ChemiLog, the second-generation manufacturing process for the bulk drug substance Angiomax (bivalirudin) was approved by the FDA. The new process involves enhancements to early manufacturing steps to improve the efficiency of synthesizing bivalirudin, the active ingredient in Angiomax, the company said.

• Transition Therapeutics Inc., of Toronto, reported the initial closing of its previously reported private placement of up to 6.2 million common shares at C32 cents per share. Transition raised gross proceeds of C$664,000 (US$483,740), which will be used in the completion of Phase I studies and preclinical toxicity studies in preparation for the initiation of Phase II studies in diabetes and multiple sclerosis. Transition received C$128,000 from Tony Cruz, chairman and CEO of Transition.

• Viragen Inc., of Plantation, Fla., and Viragen International Inc. entered an exclusive distribution agreement with Arriani Pharmaceuticals SA, of Athens, Greece, to distribute Viragen's natural human alpha interferon, Multiferon, in Greece and designated Balkan countries. The agreement is estimated at $9.5 million, based on sales revenue forecasts over the first five years. The agreement provides that Arriani achieves regulatory approvals for Multiferon in Greece, Cyprus and Slovenia following the mutual recognition procedure in the European Union, as well as to obtain and maintain the appropriate regulatory approvals in Bulgaria and Croatia.

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