• Affinium Pharmaceuticals Inc., of Toronto, said it received undisclosed discovery milestone payments after achieving goals for production, functional characterization and structure determination of targets in its collaboration with Pfizer Inc., of New York. The arrangement dates to May 2002. Affinium said it used its ProteoWorks and ProteoVision proteomics systems to describe the structures of a number of priority targets, and as the collaboration continues, it will apply its ChemVision System for the determination of target structures complexed with small molecules and might also take responsibility for chemistry interrogation of select targets.

The Alzheimer Research Consortium in Chicago said it is seeking grant applications to support new research model systems that mimic Alzheimer's disease. The organization expects to award between $500,000 and $750,000 by the end of the year. The group's founding members include the Alzheimer's Association, the Institute for the Study of Aging and Pfizer Inc., of New York.

• Bavarian Nordic A/S, of Copenhagen, Denmark, said it received the second installment of a U.S. government award potentially worth $23 million to further develop MVA-BN, its third-generation smallpox vaccine. With the funding, the company plans to move the product into Phase II testing in healthy volunteers and Phase I/II testing in immunosuppressed patients. Bavarian Nordic added that it is discussing a Phase I study in HIV patients with the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said its common stock would begin trading on the American Stock Exchange under the symbol "BPA" Oct. 1. Its shares will cease trading on the Over-The-Counter Bulletin Board on Sept. 30, lifting restrictions imposed by certain brokerage houses on the ability of their brokers to solicit orders or recommend the purchase of stocks that trade on the OTCBB. BioSante is developing hormone therapy products and its nanoparticulate-based platform technology for vaccines, vaccine adjuvants and drug delivery systems, including oral administration of proteins such as insulin.

• Biosite Inc., of San Diego, reported data at the Heart Failure Society of America's meeting in Las Vegas suggesting that omitting measurements of B-type natriuretic peptide (BNP), when evaluating congestive heart failure patients, could result in inappropriate triage decisions. Findings from the first part of the two-part study demonstrate that, in emergency departments, there is a disconnect between the perceived severity of congestive heart failure cases by physicians and severity as determined by BNP levels, the company said.

• Caprion Pharmaceuticals Inc., of Montreal, the University de Montreal and the Montreal Proteomics Network said data published in the Sept. 25, 2003, issue of Nature describe a newly identified cellular mechanism for killer T-cell activation. After the capture and processing of pathogens, fragments are presented to killer T-cells. Through the antigen presentation, killer T-cells are able to recognize cells that are infected or aberrant, as in cancer. The research team also included scientists from the National Institutes of Health in Bethesda, Md.

• Celgene Corp., of Warren, N.J., reported Phase I/II data at the European Cancer Conference in Copenhagen, Denmark, showing that evaluable patients achieved a 50 percent to 79 percent decline in prostate-specific antigen (PSA) after using Thalomid in combination with chemotherapy for androgen-independent prostate carcinoma, and 21 percent of the patients had a greater than 80 percent PSA decline. The study results were based on 18 of 33 patients evaluable for response.

• Cel-Sci Corp., of Vienna, Va., said it uncovered a new mechanism of action of Multikine that could increase survival in cancer patients. The finding, which the company said would be published in detail, indicated that the immunotherapy drug recruits to the tumor site immune cells that the tumor does not typically see. As a result, the tumor's defense mechanisms are rendered ineffective or less effective in shutting down a patient's antitumor immune response. Earlier this year, Cel-Sci reported that pretreatment with Multikine renders remaining cancer cells highly susceptible to follow-on radiation/chemotherapy, with data scheduled for publication this year in a peer-reviewed cancer journal.

• Crucell NV, of Leiden, the Netherlands, and Novavax Inc., of Columbia, Md., entered a license agreement to offer vaccine-manufacturing services for clinical grade materials on Crucell's PER.C6 technology. Also, Novavax will use Crucell's PER.C6 technology for research on two targeted vaccines. Crucell will receive up-front and annual payments, and would receive royalties on contract manufacturing sales by Novavax. Additional financial details were not disclosed.

• Discovery Partners International Inc., of San Diego, and AstraZeneca UK Ltd., of London, entered a long-term licensing agreement. The agreement involves Discovery Partners' exclusive patent portfolio governing the use of in vitro gene expression profiling as a response to drug-induced stresses for indicating toxicity of chemical compounds. AstraZeneca will receive worldwide, nonexclusive rights to the patents.

• Diversified Biotech Holdings Corp., of New York, withdrew its registration statement for a proposed initial public offering, which it filed for in July. The company, an organization that seeks to help investors and its customers capitalize on business and investment opportunities in the biotechnology sector, said the decision better positions it for various opportunities while not in registration.

• Epimmune Inc., of San Diego, received an amendment to an existing contract from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md., to include smallpox as a target of the company's high-throughput screening approach used in development of epitope-based vaccines. The five-year contract, originally received in 1999, is aimed at developing a high-throughput strategy for identifying immunologically relevant epitopes that provide population coverage, irrespective of ethnicity. The amendment grants about $500,000 in additional funding, which brings the total value of the contract to $2.7 million. Epimmune's stock (NASDAQ:EPMN) rose 51 cents Thursday, or 20.5 percent, to close at $3.

• Gamida-Cell Ltd., of Jerusalem, reported the official start of the Israel Stem Cell Therapy Consortium projects. The programs were approved recently by the Magnet Committee of the Office of the Chief Scientist of the Ministry of Industry and Trade of Israel, the primary underwriter of the consortium. The consortium, which has a budget between $15 million and $20 million, was organized to combine the efforts of companies, academic groups and hospital research centers to develop generic technologies for industrialized stem cell therapy. Gamida-Cell is a leading member of the consortium.

• genOway SA, of Lyon, France, and its partner, L'Institut National de la Recherche Agronomique, said they published news of their production of the world's first cloned rats in the Sept. 25, 2003, issue of Science. genOway said its cloning technique was generated through its technology platform derived from nuclear transfer. The adult male and female cloned rats are fertile and exhibit no abnormalities, and the published findings demonstrate that the technology can be used to generate targeted mutations in the rat, genOway added.

• Genzyme Corp., of Cambridge, Mass., said European regulatory authorities approved an extended indication for Thyrogen (thyrotropin alfa) to include diagnostic testing for thyroid cancer using serum thyroglobulin with or without whole-body scanning. Previously, the product's European label required whole-body scanning be part of the follow-up test used to determine any recurrence of thyroid cancer. Thyrogen is a recombinant human thyroid-stimulating hormone indicated for managing patients being followed for the recurrence of well-differentiated thyroid cancer.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, was scheduled to participate in today's Nasdaq opening as its chairman and CEO, Richard Hollis, presided over the session's market open. The lead product at the company, which went public in 1997 under the ticker symbol "HEPH," is Neumune (HE2100), a drug candidate for use by the U.S. military to protect people from radiation exposure.

• InterMune Inc., of Brisbane, Calif., said Daniel Welch was appointed CEO and president, as well as a board member. Welch succeeds interim CEO William Ringo, who will remain chairman. Welch most recently worked as chairman and CEO of Triangle Pharmaceuticals Inc.

• Introgen Therapeutics Inc., of Austin, Texas, said preclinical data published in a recent issue of the Journal of Thoracic and Cardiovascular Surgery showed that INGN 241 causes lung cancer cells to undergo cell death. The study, conducted with collaborators at the University of Texas M.D. Anderson Cancer Center in Houston, showed that INGN 241 caused apoptosis in tumor cells containing either normal or a mutated p53 gene. When INGN 241 was compared to Advexin, Introgen's p53 therapy, the researchers discovered that the different tumor suppressor genes use different pathways to induce cell death. When compared to other vectors containing the bax or bak genes, INGN 241 had an advantage in that it did not kill normal cells. The mda-7 therapy also is being evaluated in a Phase II trial for various solid tumors.

• Lexicon Genetics Inc., of The Woodlands, Texas, completed its initial analysis of the physiological functions of more than 1,250 genes. The company has now completed one-quarter of its Genome5000 program to discover drug targets from the human genome. It expects to continue the project at the rate of 1,000 genes per year. As a result of its work, the company has harvested more than 20 drug discovery programs from the human genome in areas such as Alzheimer's disease, diabetes, obesity, cancer, inflammation and heart disease, it said.

• Lynx Therapeutics Inc., of Hayward, Calif., completed a $3 million private financing of common stock and warrants for common stock with independent institutional investors. The financing included the sale of 744,000 newly issued shares of common stock at about $4.03 per share and the issuance of warrants to purchase 186,000 shares of common stock at an exercise price of about $9.91 per share. Lynx focuses on genomics analysis solutions.

• Maxim Pharmaceuticals Inc., of San Diego, said it completed enrollment in a Phase III trial of Ceplene used in combination with interleukin-2 to treat advanced malignant melanoma patients with liver metastases. The trial includes 225 patients and is expected to conclude in the second half of 2004. The results will be added to the company's existing new drug application. The company initiated the trial in January 2002. (See BioWorld Today, Jan. 18, 2002.)

• Neurochem Inc., of Montreal, said it would issue an additional 750,000 common shares at $10.87 apiece to the underwriters from its recently completed public offering to cover overallotments. The additional net proceeds will total about $7.6 million. As a result, Neurochem's total net proceeds would be about $59 million. (See BioWorld Today, Sept. 19, 2003.)

• Neurocrine Biosciences Inc., of San Diego, said preliminary top-line results showed that its first Phase III trial of its indiplon modified-release product achieved statistically significant results showing that patients with chronic insomnia taking indiplon 30 mg fell asleep more rapidly and stayed asleep longer. More specifically, the modified-release formulation of indiplon following nightly administration of 30 mg over a two-week period demonstrated an improvement in the primary endpoint of patient reported total sleep time relative to placebo at both the first week (p<0.0001) and the second week (p<0.004). The company, which said it has begun and is completing all its Phase III safety and efficacy trials of the product, expects to file a new drug application in the first half of next year for multiple insomnia indications. The product's Phase III program includes two ongoing studies of an immediate-release formulation, as well as three trials on the modified-release formulation. Phil Nadeau, an analyst with SG Cowen Securities Corp. in New York, said, "Neurocrine's current market cap already assumes a successful launch for Indiplon, and therefore a meaningful step up in valuation is unlikely until all of Indiplon's Phase III data are known" in the first quarter of next year. Neurocrine's stock (NASDAQ:NBIX) fell 53 cents Thursday to close at $51.41.

• Nucleonics Inc., of Malvern, Pa., received a research grant of $1.6 million from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md. Nucleonics will use the grant over four years to support research aimed at developing nucleic acid reagents and methods for silencing hepatitis B virus gene expression and replication in vivo. Researchers also will evaluate in animal models the best DNA vector, delivery system and target HBV sequence.

• Nuvelo Inc., of Sunnyvale, Calif., completed a planned interim analysis of its Phase II trial with lead product candidate, alfimeprase, for the potential treatment of acute peripheral arterial occlusion. The analysis was conducted on data from the first 36 patients enrolled in the trial. Following review of the patient data, the Data Safety and Monitoring Board and the Trial Steering Committee recommended that the company continue to move forward with the trial in all three doses.

• Quintiles Transnational Corp., of Research Triangle Park, N.C., again became a privately held company after completing its merger with Pharma Services Acquisition Corp., a subsidiary of Pharma Services Holding Inc., which was founded by Dennis Gillings, Quintiles' founder and chairman, and One Equity Partners LLC, the private equity arm of Bank One Corp. Each outstanding share of Quintiles stock was converted into the right to receive $14.50 in cash, without interest. Quintiles, which will continue to operate under that name, is now a wholly owned subsidiary of Pharma Services and its common stock will no longer be publicly trade. Effective at the close of yesterday's business, the stock was delisted from Nasdaq. Other equity investors in Pharma Services include Temasek Holdings, Texas Pacific Group, Perseus-Soros BioPharmaceutical Fund and Mitsui & Co.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said findings published in this month's issue of the Federation of American Societies for Experimental Biology Journal showed that its lead therapy, Thymosin Beta 4 (TB4), plays a critical role in the wound repair process. The data showed that TB4, a molecule found in blood platelets, promotes angiogenesis from a site within the molecule that binds with actin. The National Institutes of Health in Bethesda, Md., conducted the research. RegeneRx is developing TB4, to which it has an exclusive worldwide license from the NIH, for acute and chronic wounds, as well as disease involving tissue and organ repair.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and Aventis SA, of Lyon, France, said Copaxone (glatiramer acetate) would be more available to French relapsing-remitting multiple sclerosis patients through hospitals and private pharmacies. Previously, the first-line, non-interferon therapy was available only in hospitals. Separately, Teva called for an Oct. 15 redemption of all its outstanding 1.5 percent convertible senior debentures due 2005. The aggregate amount outstanding totals about $550 million.

• Vinson Biotech Inc., of Winnipeg, Manitoba, said it completed its $3.2 million acquisition of Kane Biotech Inc., which is developing products to prevent and disperse bacterial biofilms. Vinson acquired 1,000 common shares of Kane in exchange for 7.5 million of its common shares, valued at 42.5 cents apiece. Wellington West Capital Inc. acted as the transaction's sponsor.

• Virocell Inc., of Quebec City, Quebec, reported positive results from preliminary preclinical studies of the antiviral effect of its lead compound, BG-777, on two strains of human viruses (coronaviruses HCoV-OC43 and HCoV-229E) that are related to the agent responsible for the severe acute respiratory syndrome outbreak. In vitro and in vivo experiments showed that BG-777 inhibits by 50 percent to 95 percent the replication of the two strains of coronavirus. The company said Phase I results of BG-777 were positive and it will initiate Phase II studies.

• Wyeth, of Madison, N.J., said FluMist was included in a supplemental recommendation put out by the Advisory Committee on Immunization Practices. The live, attenuated influenza vaccine was incorporated into the flu vaccine recommendations as an option for the vaccination of healthy people aged 5 to 49 years. The complete updated recommendations appeared in this week's Morbidity and Mortality Weekly Report, published by the U.S. Centers for Disease Control and Prevention in Atlanta. FluMist is manufactured by MedImmune Vaccines Inc., a unit of MedImmune Inc., of Gaithersburg, Md., and co-promoted with Wyeth Vaccines. Separately, Wyeth said a European regulatory committee voted to recommend approval for Enbrel (etanercept, 25 mg twice weekly) for adults with severe active ankylosing spondylitis. An approval would be the fifth indication authorized in Europe for Enbrel, which is marketed in the U.S. by Amgen Inc., of Thousand Oaks, Calif. Wyeth markets the product outside North America.

• Xencor Inc., of Monrovia, Calif., said findings published in the Sept. 25, 2003, issue of Science demonstrated its creation of a new class of inhibitors of tumor necrosis factor (TNF) alpha. The company used its structure-based engineering platform, Protein Design Automation, to design variants of the inflammatory disease-associated protein that neither bind to nor stimulate signaling through TNF receptors, but retain the capacity to bind to native, disease-causing TNF, thereby rendering it biologically inactive. The new molecules, called Dominant Negative TNFs, block the signaling of native TNF by sequestering it from its disease-mediating receptors.

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