• Access Pharmaceuticals Inc., of Dallas, reported commercialization plans for OraDisc A, a product that earlier this week received FDA approval. Initially, the company plans to embark on a dental campaign to gain professional endorsement for the product, a delivery system for amlexanox, which is approved to treat canker sores. Ultimately, Access plans to move OraDisc A from prescription status to an over-the-counter consumer product. To accomplish these commercialization objectives, it intends to out-license OraDisc A. On Friday, Access' stock (AMEX:AKC) gained 53 cents, or 15.3 percent, to close at $4.

• Allergan Inc., of Irvine, Calif., and Peplin Biotech Ltd., of Brisbane, Australia, agreed to discontinue their collaboration for the development and commercialization of skin cancer products in North and South America based on Peplin's cancer compound PEP005. Allergan said it continues to believe that Peplin's lead investigational product PEP005 Topical has potential in the market for treating non-melanoma skin cancer. Terms of the deal's dissolution were not disclosed.

• Benitec Ltd., of Queensland, Australia, granted a nonexclusive license to Revivicor Inc., of Blacksburg, Va., to use Benitec's ddRNAi technology in the field of regenerative medicine to replace human cells, tissues and organs. The ddRNAi will be used to down-regulate genes in transgenic pigs, supplying tissues and organs for grafting and transplantation in humans, called Xenotransplantation. Revivicor already has begun preclinical trials. In exchange, Benitec will receive up-front and annual maintenance fees, a milestone payment upon FDA approval and ongoing royalty payments upon commercialization. Further financial terms were not disclosed.

• Chiron Corp., of Emeryville, Calif., revised its reconciliation of pro-forma and GAAP earnings guidance for this full year. Its full-year pro-forma earnings per share guidance of 70 cents to 80 cents per share excludes amortization expense on acquired intangible assets related to the acquisitions of PathoGenesis, Chiron Behring, Pulmopharm and PowderJect, and purchased in-process research and development charge related to the acquisition of Sagres totaling about 38 cents per share as opposed to 35 cents as reported on Oct. 5. As a result, Chiron revised its full-year GAAP earnings to between 32 cents to 42 cents per share. The company said the revision was unrelated to its news last week that Fluvirin would not be shipped this year. In a development related to that news, Chiron's president and CEO, Howard Pien, submitted written testimony to a government reform committee hearing on the nation's flu shot shortage. Among statements made in the letter, he said the company intends to be transparent with the government regarding its manufacturing situation, and would make necessary investments to ensure that the company meets the highest standards of GMP. (See BioWorld Today, Oct. 6, 2004.)

• DeCode genetics Inc., of Reykjavik, Iceland, was awarded a five-year, $23.9 million contract by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md. Under the contract, DeCode will apply its population approach and resources to discover genetic factors associated with susceptibility to certain infectious diseases and with vaccine response. DeCode will work with scientists at the University of New Mexico to conduct functional validation of biological pathways discovered through its genetics research. The National Center for Genome Resources will provide bioinformatics resources to make study information and results available to the scientific community.

• Endovasc Inc., of Montgomery, Texas, said that as part of its holding company strategy, it has transferred the intellectual property of its cardiovascular and metabolic drugs into two wholly owned subsidiaries. Liprostin Inc. will develop Liprostin, a liposome-encapsulated form of prostaglandin E-1, which recently completed Phase II. Angiogenix Ltd. gained worldwide exclusive rights to an isomer of nicotine that has shown the potential to stimulate angiogenesis in oxygen-deprived tissue.

• Gene Logic Inc., of Gaithersburg, Md., could receive $6 million in revenue over the next four years after entering an agreement with the National Institute on Drug Abuse, an institute of the National Institutes of Health in Bethesda, Md., to provide preclinical safety and pharmacology studies focused on developing safe and effective medications for the treatment of drug addiction. The project is federally funded and provides for Gene Logic to achieve up to $6 million based on specific studies and services requested by the agency over the life of the agreement.

• Incyte Corp., of Wilmington, Del., filed a shelf registration statement for the proposed offering, from time to time, of up to $175 million of its common stock. The company said it intends to use any proceeds for general corporate purposes, which might include repayment or redemption of outstanding indebtedness and funding of clinical trials and drug discovery activities.

• Marnac Inc., of Dallas, reported Phase II findings at the American Neurological Association meeting in Toronto detailing the use of pirfenidone for secondary progressive multiple sclerosis. Results from the trial demonstrated that adults with secondary progressive MS experienced improvement in physical functioning and halted disease progression with pirfenidone, based on standard assessment tools. Improvement in walking, balance, hand function and bladder control was seen, and several people were no longer fully reliant on a wheelchair.

• MedImmune Inc., of Gaithersburg, Md., said FluMist (Influenza Virus Vaccine Live, Intranasal) is available to the general public in doctors' offices, hospitals and some pharmacies throughout the U.S. The company will provide 1 million to 2 million doses of the product for this flu season, and its price is half that of last year.

• MorphoSys AG, of Martinsried, Germany, reported initial in vitro and in vivo data on its internal cancer antibody program, MOR202, at the Human Antibodies & Hybridomas conference in Dublin, Ireland. By directing the antibodies against primary patient tumor material and specific hematologic cancer cell lines, the assays demonstrated that the antibodies were able to kill cancer cells efficiently. A MOR202 antibody also proved to be effective in an in vivo animal model. The fully human antibodies are directed against CD38, and the MOR202 program is in preclinical development for multiple myeloma and other blood cancer-related diseases. MorphoSys plans to out-license the MOR202 antibody program before starting clinical development.

• Nymox Pharmaceutical Corp., of Maywood, N.J., secured a commitment for $13 million in private equity financing. The funds will be used for general corporate purposes. The placement is with institutional investors and is priced at a 3 percent discount to the market price. There are no warrants with the placement and no restrictions on other corporate financing.

• Odyssey Thera Inc., of San Ramon, Calif., expanded an agreement with Merck & Co. Inc., of Whitehouse Station, N.J., for use of Odyssey Thera's technology to elucidate the full spectrum of activity of selected Merck compounds in human cells. The agreement's goal is to characterize the on-pathway and off-pathway effects of compounds early in the drug discovery process. Financial terms were not disclosed.

• Parker Hughes Cancer Center in Roseville, Minn., said its scientists published findings in last month's issue of the British Journal of Hematology detailing their development of a technology capable of improving survival outcomes after bone marrow transplantation. It involves the design and application of tyrosine kinase inhibitors for the treatment of leukemia, lymphoma and graft vs. host disease. The scientists developed a specific BTK inhibitor, alpha-cyano-beta-hydroxy-beta-methyl-N-(2,5-dibromophenyl)-propenamide (LFM-A13). In a murine model of allogeneic bone marrow transplantation, the drug was shown to improve survival outcomes in mice. When used in combination with an internally developed anti-Graft-vs.-Host disease drug, Janex-1, survival outcomes were greater than when using LFM-AI3 alone.

• PharmaFrontiers Corp., of Houston, agreed to acquire Opexa Pharmaceuticals Inc., also of Houston. The all-stock transaction, in which Opexa will become a wholly owned subsidiary of PharmaFrontiers, will expand the latter's cell therapy technology base and bring in scientific personnel and existing research and manufacturing facilities. Opexa's platform technology focuses on the development of cell-based therapeutics for autoimmune diseases, initially targeting multiple sclerosis. Its Tovaxin T-cell therapy is in Phase I/II trials in MS. In the transaction, PharmaFrontiers was advised by Sanders Morris Harris Group Inc. Specific financial terms were not disclosed, but the merger is expected to close by Oct. 31.

• Serono International SA, of Geneva, said data reported at the European Committee for Treatment and Research In Multiple Sclerosis meeting in Vienna, Austria, showed that relapsing-remitting multiple sclerosis patients who were on placebo and then treated with Rebif in the PRISMS study showed substantial clinical benefits, with a 54 percent relative reduction in relapse rate. There was a statistically significant relative reduction in the mean number of brain lesions of 67 percent, and in addition, 76 percent of patients treated with Rebif 44 mcg remained free of disease progression. The findings are based on a prospective pre-planned analysis of the progress of patients who received two years of placebo therapy followed by two years of Rebif in PRISMS.

• Somaxon Pharmaceuticals Inc., of San Diego, completed enrollment in its Phase II trial of SO-101, low-dose doxepin, for primary sleep maintenance insomnia in adults. Conducted at 11 U.S. sites, it enrolled 67 patients. The company expects data to be available early next year.

The U.S. Department of Health and Human Services granted four new contracts totaling more than $232 million to fund development of vaccines against three potential agents of bioterrorism: smallpox, plague and tularemia. The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., will administer the contracts. Two contracts are worth up to $177 million for MVA vaccines against smallpox. The three-year contracts were awarded to Bavarian Nordic A/S, of Copenhagen, Denmark, and Acambis Inc., of Cambridge, UK. Avecia Biotechnology Ltd., of Manchester, UK, received a three-year, $50.7 million contract for the manufacture of a new plague vaccine as well as animal testing and initial human trials. The institute also modified an existing contract with DynPort Vaccine Co. LLC, of Frederick, Md., to include the manufacture of a pilot batch of live, attenuated tularemia vaccine. The three-year, $4.5 million contract modification also covers stability testing of the vaccine.

• V.I. Technologies Inc., of Watertown, Mass., said an independent data safety monitoring committee recommended that the company's ongoing Phase III acute study for the Inactine pathogen reduction system should continue without modification. But the committee also concluded that further review of submitted data was warranted as enrollment continues, and requested that Vitex provide clarification of certain data and other information. It arrived at its conclusion after reviewing preliminary data on about 20 percent of the 200 evaluable patients expected to be enrolled. The company expects to complete patient enrollment and preliminary data analysis in the first half of next year.

• Wilex AG, of Munich, Germany, entered an agreement with Centocor Inc., of Malvern, Pa., that gives Wilex the option to acquire exclusive U.S. marketing rights on the antibody Rencarex (WX-G250). Under the deal, Centocor received an option fee and is eligible for milestone payments and royalties. Wilex now has an option to own full worldwide marketing rights on its lead compound, Rencarex, excluding certain countries of southern Europe where it already has a marketing partnership with Esteve SA, of Barcelona. In August 1999, Wilex acquired an exclusive license to Rencarex from Centocor for all countries outside of the U.S. and in the process assumed full clinical development and financial responsibility for the compound. Wilex is conducting a global pivotal Phase III trial with adjuvant Rencarex in non-metastasized renal-cell carcinoma.

• Xcyte Therapies Inc., of Seattle, said it would sell 1.5 million shares of convertible exchangeable preferred stock at $10 apiece in a proposed public offering. The company plans to grant the underwriters an option to purchase up to 225,000 additional shares to cover overallotments. All the shares will be offered by the company, which is developing activated, patient-specific T cells designed to enhance a body's natural immune response to treat cancer, infectious diseases and other conditions associated with weakened immune systems.

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