• 4SC AG, of Martinsried, Germany, and Sanofi-Aventis Group, of Paris, completed a research agreement. The former used its High-Throughput Screening technology to identify and provide small molecules predicted to bind to two specific targets provided by Sanofi-Aventis. Sanofi-Aventis now is responsible for further development and 4SC could receive milestone payments.

• Active Biotech AB, of Lund, Sweden, began Phase I trials of its candidate drug 57-57 against systemic lupus erythematosus. The trials entail a dose-escalation study of ABR-215757 in parallel groups of healthy volunteers. The study is taking place at the Karolinska Institute hospital in Stockholm and is scheduled for completion during the first half of 2005.

• Advancis Pharmaceutical Corp., of Germantown, Md., said its researchers presented findings regarding the company's pulsatile dosing of antimicrobials during the 44th annual Interscience Conference on Antimicrobial Agents and Chemotherapy, which was held through Tuesday in Washington. Pulsatile dosing of clarithromycin and amoxicillin alone or in combination demonstrated a superior bactericidal effect against a resistant strain of Streptococcus pneumoniae compared to traditional dosing.

• Adventrx Pharmaceuticals Inc., of San Diego, received permission from the FDA to begin recruiting patients for the second stage of its Phase II trial using CoFactor to modulate the effect of 5-fluorouracil for metastatic colorectal cancer. The company reported clinical data to the FDA from the 23 initial patients recruited as part of the two-stage trial design. The company now is able to enroll an additional 25 patients.

• Amylin Pharmaceuticals Inc., of San Diego; Eli Lilly and Co., of Indianapolis; and Alkermes Inc., of Cambridge, Mass., decided to initiate a Phase II multidose study of exenatide long-acting release in patients with Type II diabetes using a once-a-week dosing regimen. The multidose study is expected to begin in the first quarter of 2005. Data from the ongoing Phase II single-dose study of 60 patients have demonstrated sustained release of exenatide with no dose-limiting side effects. The injection has been well tolerated.

• AstraZeneca plc, of London, presented data demonstrating Iressa's (gefitinib) antitumor activity as a single agent and in combination with chemotherapy in a variety of common solid tumors. Researchers saw encouraging disease control rates of Iressa in combination with chemotherapy in advanced non-small-cell lung cancer (57.7 percent), metastatic colorectal cancer (97.5 percent) and advanced ovarian cancer (61.2-80.9 percent), it said. As a monotherapy in advanced esophageal cancer, the control rate was 33 percent to 37 percent.

• Cambrios Technologies Corp., of Palo Alto, Calif., said it was granted a patent license to Cambridge, Mass.-based Dyax Corp.'s peptide phage display patent portfolio for use in the electronics industry field, with an option to maintain an exclusive license to the Dyax patents for the synthesis and assembly of materials and structures used in electronic applications.

• Centocor Inc., of Malvern, Pa., presented data at the 69th American College of Gastroenterology Annual Meeting and Postgraduate Course in Orlando, Fla., showing that while severity and duration of Crohn's disease were associated with the development or exacerbation of intestinal strictures, stenosis or obstruction, the use of Remicade (infliximab) and other Crohn's disease medications did not appear to contribute to that risk. In addition, the company said a new study based on nearly 30,000 Crohn's disease cases observed that patients taking Remicade every eight weeks only marginally increased their doses over time. Remicade also was found to reduce pain associated with the disease. Remicade was first approved for Crohn's disease in 1998.

• Discovery Laboratories Inc., of Doylestown, Pa., said available funds under its existing capital lease financing facility with GE Healthcare Financial Services have been increased by up to $6.5 million. Including the $2.5 million currently employed under the arrangement, Discovery Lab's lease line now is about $9 million. Under terms of the expanded arrangement, $5 million is immediately available while an additional $1.5 million remains subject to FDA approval of Surfaxin, the company's lead product for the prevention of respiratory distress syndrome in premature infants. Subject to terms of the lease facility, GE will make the finances available for certain capital equipment purchases, including manufacturing, information technology systems, laboratory, office and other related capital assets. The funds may be drawn down through September and are payable over three or four years, depending on the equipment.

• Elan Corp. plc, of Dublin, Ireland, said it expects to provide additional guarantees of the outstanding 7.25 percent senior notes issued by its wholly owned subsidiary, Athena Neurosciences Finance LLC, and guaranteed by Elan. The guarantees will be provided by all subsidiaries of Elan expected to guarantee notes issued pursuant to the recently announced offering. The provision of the note guarantees will be conditioned upon, and is expected to occur concurrently with, the completion of that offering.

• FibroGen Inc., of St. Louis, said FG-3019 significantly improved glomerular filtration rate and reduced proteinuria in a preclinical model of overt diabetic nephropathy (DN). The data support the therapeutic potential of FG-3019 in treating DN by inhibiting fibrosis, or excessive and persistent scarring, which ultimately causes kidney failure. FG-3019 is a fully human monoclonal antibody designed to inhibit the fibrotic activity of connective tissue growth factor.

• Genentech Inc., of South San Francisco; Biogen Idec Inc., of Cambridge, Mass.; and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said a Phase IIb study of Rituxan met its primary endpoint with a greater proportion of patients treated with Rituxan and methotrexate achieving an American College of Rheumatology 20 response at week 24, compared to placebo. Patients with moderate to severe rheumatoid arthritis who received two infusions of Rituxan over a two-week period in combination with a stable dose of methotrexate experienced improved symptoms compared to patients who received placebo and methotrexate. The benefit was present regardless of whether additional corticosteroids were administered.

• Generex Biotechnology Corp., of Toronto, said data reported at the International Anticancer Conference in Corfu, Greece, detailed melanoma vaccine research done by scientists at its Antigen Express subsidiary. They have been stimulating T-helper cells to create a hybrid linking the peptide recognized by T-helper cells through a chemical linker to an immunoregulatory segment of the Ii-protein, the Ii-Key peptide. Such Ii-Key peptide-linked epitope peptide hybrids are presented 200 times more effectively than the epitope-only peptide in vitro. Applying those methods to melanoma, Antigen Express found similar results with Ii-Key hybrids containing melanoma epitopes.

• Gilead Sciences Inc., of Foster City, Calif., said findings reported at the American Association for the Study of Liver Diseases meeting in Boston detailed 144-week data from a clinical trial (Study 437) of its oral antiviral drug Hepsera (adefovir dipivoxil 10 mg) in patients with hepatitis B "e" antigen-positive (HBeAg-positive) chronic hepatitis B virus. The percent of undetectable hepatitis B virus DNA at the 144th week was 56 percent. The percent normalization of alanine aminotransferase, an enzyme found in the liver that when elevated indicates liver disease, was 81 percent. The percent of HBeAg loss was 51 percent, and the percent HBeAg seroconversion was 43 percent. All figures were higher than those seen at 48 and 96 weeks. Also, the safety profile over 144 weeks was consistent with that seen over the first 48 weeks.

• Helix BioPharma Corp., of Aurora, Ontario, initiated its Phase II study for its lead product, Interferon-alpha cream, under development at the Friedrich-Schiller-University of Jena in Germany. The study is expected to take about 18 months to complete and will evaluate the efficacy and safety of the cream in the treatment of women with low-grade squamous intraepithelial lesions that are positive for human papillomavirus infection.

• Human Genome Sciences Inc., of Rockville, Md., said findings reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington detailed its identification and characterization of a panel of 38 monoclonal antibodies, including 15 fully human monoclonal antibodies, for their ability to bind the CCR5 receptor and to inhibit CCR5-dependent infection by HIV-1. The company also said preclinical results reported at the European Society for Medical Oncology meeting in Vienna, Austria, showed that TRAIL-R2 is expressed on a broad variety of human tumor types, and strong staining for TRAIL-R2 was most frequent in tumors of the colon, stomach and pancreas. Separate immunogenicity data from a Phase I/II study of Albuferon in treatment-experienced chronic hepatitis C patients, reported at the American Association for the Study of Liver Diseases meeting in Boston, showed that the vast majority of Albuferon antibody titers were low (<100 ng/mL) and that there is no apparent correlation between the emergence of antibodies and adverse events, antiviral response or pharmacokinetics.

• Immucor Inc., of Norcross, Ga., said its president and CEO would step down from the CEO position during an internal investigation launched as a result of a criminal investigation in Milan, Italy, centered on him and the company's Italian subsidiary. The investigation is looking at the activities of an Italian physician and hospital administrator, and concerns alleged improper cash payments by several companies to the physician in exchange for favorable contract awards by his hospital in Italy. Immucor develops a line of reagents and automated systems used primarily by hospitals, clinical laboratories and blood banks. On Tuesday, its stock (NASDAQ:BLUD) dropped $4.14, or 13.6 percent, to close at $26.28.

• La Jolla Institute for Allergy & Immunology, of San Diego, said a team of scientists added a milestone to scientific understanding of the role viruses play in the development of autoimmune diseases, such as diabetes. Matthias von Herrath and the team found that while viruses alone do not initiate autoimmune diseases, they can accelerate their development when paired with a genetic predisposition to autoimmune disease. The finding was published Monday in the Journal of Clinical Investigation.

• Microbia Inc., of Cambridge, Mass., said data reported at the American College of Gastroenterology meeting in Orlando, Fla., demonstrated that MD-1100 effectively decreases gastrointestinal pain in multiple preclinical models of both inflammation- and stress-induced gastrointestinal hypersensitivity. MD-1100, an orally delivered compound that acts as a superagonist of guanylate cyclase-C, a receptor found on the surface of intestinal cells, promotes gastrointestinal transit and secretion and specifically alleviates gastrointestinal pain. Microbia recently moved the product into Phase I studies for irritable bowel syndrome.

• Molecular Diagnostics Inc., of Chicago, entered a five-year alliance with the biotechnology division of a Fortune 500 health care company. The alliance calls for the manufacture and distribution of MDI's automated image proteomic system, with the initial distribution to MDI at more than $600,000. The companies will collaborate and develop antibodies used in the MDI proteomic cell-based assay systems, the first of which is the CVX cervical-screening system. That division will manufacture the MDI-designed AIPS hardware and then distribute those systems through its international sales organization.

• NeoPharm Inc., of Lake Forest, Ill., said preliminary Phase I data reported at the European Society for Medical Oncology meeting in Vienna, Austria, provide preliminary evidence on the safety and tolerability of the company's NeoLipid compound LEP-ETU in patients with advanced cancers. LEP-ETU appeared to be well tolerated in terms of typical paclitaxel side effects by the majority of patients, including those receiving higher doses, as well as those who were not premedicated with antihistamines and steroids.

• NitroMed Inc., of Lexington, Mass., said it submitted to the FDA data from the African American Heart Failure Trial (A-HeFT). The submission is in accordance with an understanding between the agency and the company that the A-HeFT dataset would be provided prior to submission of an amendment to the new drug application for BiDil, in order to facilitate a timely review. Other parts of the submission, including the chemistry, manufacturing and controls section, will be submitted as soon as they are available. NitroMed said it would complete the submission by the end of the year. Earlier this year, the company stopped its pivotal trial of the drug early, as positive results pointed to its efficacy. (See BioWorld Today, June 20, 2004.)

• NsGene A/S, of Copenhagen, Denmark, reported that Biogen Idec Inc., of Cambridge, Mass., moved Neublastin, NsGene's protein, from research into development in neuropathic pain. NsGene and Biogen Idec entered a license and collaboration agreement in June 2000 granting Biogen Idec exclusive rights to use Neublastin for indications outside the central nervous system. NsGene will receive fees and milestone payments, in addition to royalties, if a product is developed and commercialized by Biogen Idec. Further details were not disclosed.

• Nucleonics Inc., of Horsham, Pa., filed with Australian authorities a request for re-examination of Benitec Ltd., of Queensland, Australia, and Commonwealth Scientific and Industrial Research Organization's Australian Innovation Patent No. 2001100608, called "Control of Gene Expression." The request submits prior art documents showing that the patent claims are invalid. Nucleonics believes the claims are ambiguous. The company previously filed a request for re-examination for another of Benitec and CSIRO's Australian patents and for a U.S. patent. The patents prevent Nucleonics from advancing its expressed interfering RNA technology.

• Onyx Pharmaceuticals Inc., of Richmond, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., reported results from several Phase I trials of BAY 43-9006 administered in combination with conventional chemotherapy drugs in patients with various tumor types, including hepatic cancer and colorectal cancer, at the 29th European Society of Medical Oncology meeting in Vienna, Austria. Data from the Phase I studies showed that BAY 43-9006 could be combined with the other cancer agents evaluated, and it required no dose adjustment when administered with ketoconazole. Safety data generated showed no unexpected treatment-related adverse events.

• Peptimmune Inc., of Cambridge, Mass., named Thomas Mathers CEO. Already the company's president, he also was elected to the board. Mathers succeeds former CEO Robert Carpenter, who will remain executive chairman. Privately held Peptimmune is developing therapies for chronic autoimmune and metabolic disorders.

• PharmaMar SA, of Madrid, Spain, presented new data on Yondelis and Aplidin at the 29th European Society for Medical Oncology meeting held in Vienna, Austria. Data showed that the combination of Yondelis with Doxil was safe and feasible, forming the basis for future development of Yondelis in ovarian cancer and other tumors. New data from a Phase II study of Aplidin demonstrated evidence of the compound's activity in patients with advanced or metastatic melanoma. Yondelis is a marine-derived antitumor agent isolated from the colonial tunicate Ecteinascidia turbinate, while Aplidin is a marine-derived peptide originally from Aplidium albicans.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Cytogen Corp., of Princeton, N.J., received a $7.4 million award in the form of two Phase II Small Business Innovation Research grants to cover four years of research from the National Institutes of Health in Bethesda, Md. The grants will be used to develop immunotherapies for prostate cancer based on prostate-specific membrane antigen. The first $3.8 million grant will fund the development and clinical testing of a fully human monoclonal antibody for the treatment of metastatic prostate cancer, while the second $3.6 million grant will fund the continued development of a recombinant soluble PSMA vaccine.

• Questcor Pharmaceuticals Inc., of Union City, Calif., said that Albert Hansen, a current director of Questcor, was named chairman and acting CEO. Hansen has been a director of Questcor since May and a managing director of the investment firm Sanders Morris Harris since January 2002, helping to manage the firm's life sciences private equity investment portfolio. Questcor is a specialty pharmaceutical company.

• Reata Discovery Inc., of Dallas, completed a license agreement with Dartmouth College and The University of Texas M.D. Anderson Cancer Center, providing Reata with exclusive worldwide rights to a promising new class of cancer compounds. The company has selected a clinical candidate, RTA 401, for advanced development and intends to initiate clinical testing in 2005. It first was synthesized by investigators at Dartmouth College and developed in collaboration with M.D. Anderson and the National Cancer Institute. RTA 401 and its analogues are based on compounds found in medicinal plants.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said it received no objections from the FDA within the statutory 30-day comment period and will initiate its first Phase II trial to test its drug, Thymosin beta-4, for the treatment of chronic pressure ulcers. The trial is a randomized, double-blind, placebo-controlled trial designed to test several dosages of TB4.

• The Medicines Co., of Parsippany, N.J., said findings from an economic study published in this month's issue of the Journal of the American College of Cardiology demonstrate significant in-hospital cost savings of $405 per patient (p<0.001) with the use of Angiomax (bivalirudin) in percutaneous coronary interventions. The economic study was pre-specified in the protocol of the REPLACE-2 trial, one of the largest studies of acute anticoagulation therapies ever conducted in patients undergoing percutaneous intervention, the company said.

• Torrey Pines Institute for Molecular Studies in San Diego received a $4.8 million contract from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., to discover smallpox vaccines. The five-year contract is part of the government institute's Large-Scale Antibody and T-Cell Epitope Discovery Program to find vaccines, therapies and diagnostic tools against infectious diseases and bioterror agents. Torrey Pines will use a combinatorial approach to test trillions of peptides to elucidate the specificity of cells responsible for the immune response against the virus used for vaccination against smallpox. Results will be made available to scientists through a database system under development.

• United Therapeutics Corp., of Silver Spring, Md., said the Centers for Medicare and Medicaid Services updated its payment policies relating to Remodulin. As a result, the under-reimbursement situation relating to certain Medicare patients on Remodulin during this year has been resolved favorably, the company said.