• 4SC AG, of Martinsried, Germany, began Phase I trials of SC12267, its first small-molecule candidate for rheumatoid arthritis. The compound will be examined in 56 healthy volunteers divided into seven groups to evaluate the safety, tolerability and pharmacokinetics of the agent under increasing dosage.

• Adherex Technologies Inc., of Ottawa, Ontario, signed a memorandum of agreement to acquire non-cancer-related cadherin-based intellectual property from Cadherin Biomedical Inc. Both boards have approved the terms of the agreement. The closing will require CBI shareholder approval, an independent valuation and regulatory approval, as well as certain other conditions. Adherex agreed to pay CBI $1 million through the issuance of up to a maximum of 2.2 million common shares, based on a 20-day weighted average trading price. CBI also will receive a 2 percent royalty on gross revenues received by Adherex for products developed and sold for non-cancer uses. The agreement provides that CBI will hold a special meeting of its shareholders in January to approve the recommendation of the board.

• Aton Pharma Inc., of Tarrytown, N.Y., said Phase II data reported at this week's American Society of Hematology meeting in San Diego showed that treatment with its SAHA (suberoylanilide hydroxamic acid) candidate resulted in five partial remissions among 13 patients with refractory or relapsed cutaneous T-cell lymphoma unresponsive to conventional therapies. Another five had stable disease and three progressed on therapy. Rapid reduction in pruritus, a major symptom of the disease, was seen in most patients, and adenopathy regressed in seven of nine patients. A Phase I study in patients with advanced leukemias or myelodysplastic syndromes showed that histone hyperacetylation was induced in the peripheral blood and marrow of all three patients treated at the first dose level. One patient with relapsed acute myelogenous leukemia had disappearance of peripheral blasts and a decrease in bone marrow blast from 26 percent to 7 percent.

• AVI BioPharma Inc., of Portland, Ore., is presenting preclinical data at two international conferences, the first detailing a drug delivery mechanism, its microbubble technology, which is currently being evaluated in clinical studies for the systemic delivery of cardiovascular restenosis-inhibitory drugs. The presentation was made at the 5th international Meeting on Interventional Cardiology, held in Tel Aviv, Israel. The second presentation highlights the advantages of AVI's Neugene antisense drugs in a solid-tumor cancer strategy and will be presented at the 12th international Conference on Gene Therapy of Cancer in San Diego.

• Celmed BioSciences Inc., of Montreal, signed a collaboration agreement with the National Heart, Lung and Blood Institute and the National Institutes of Health in Bethesda, Md. The agreement involves preclinical research in human cells using Celmed's photodynamic Theralux device, for the treatment of graft-vs.-host (GvHD) disease. Celmed's approach is aimed at specifically eliminating the T lymphocytes that cause GvHD following an allogeneic transplant while keeping the antileukemic effect of the graft.

• Chiron Corp., of Emeryville, Calif., said the National Blood Service in England began nucleic acid testing at its Brentwood, Calif., site with Chiron's Procleix HIV-1/HCV Assay. The assay is expected to test about one-third of the 2.6 million units of blood annually tested in England. The Procleix HIV-1/HCV Assay, developed in collaboration with Gen-Probe Inc., of San Diego, has been commercially available in Europe since 1999. It also is approved for use in the U.S. and Australia.

• Chronogen Inc., of Montreal, secured an exclusive worldwide license from McGill University in Montreal for screening assays for targets and drugs useful in the treatment and prevention of lipid disorder linked to atherosclerosis. Chronogen and McGill also concluded a multimillion-dollar research collaboration to develop preclinical models that will guide the selection of clinical indications for new drug candidates.

• CIMA Labs Inc., of Eden Prairie, Minn., said it held its end-of-Phase II meeting with the FDA regarding its OraVescent Fentanyl transmucosal dosage form under development for the treatment of breakthrough cancer pain. CIMA expects to begin clinical trial activities in early 2004, with enrollment scheduled to begin in the second quarter. CIMA is not planning to conduct carcinogenicity studies.

• Corixa Corp., of Seattle, provided an update on two late-stage products containing Corixa's MPL adjuvant featured during London-based GlaxoSmithKline plc's research and development meeting with investors. GSK incorporates Corixa's MPL adjuvant in several of its vaccines in development, including Cervarix vaccine for the prevention of human papillomavirus infection and Simplirix vaccine for the prevention of genital herpes. In a presentation to its investors in London on Dec. 3, GSK highlighted a variety of programs, including Cervarix and Simplirix containing Corixa's MPL adjuvant, as promising treatments, Corixa said.

• Depomed Inc., of Menlo Park, Calif., and Biovail Corp., of Toronto, reported positive top-line results from the second pivotal Phase III trial of Metformin GR, a once-daily, extended-release formulation of metformin based on Depomed's Gastric Retention (GR) drug delivery system. The trial addressed, among other things, the common prescribing and dosing practices in the treatment of Type II diabetic patients in whom sulfonylureas often are administered. The trial compared the safety, efficacy and tolerability of Metformin GR in combination with glyburide, a sulfonylurea (SU) and glyburide alone in Type II diabetes patients. Following a six-week stabilization period on SU alone, 575 Type II diabetes patients were randomized to one of four treatment groups: SU alone or SU and one of three different Metformin GR doses for six months. In the trial, the Metformin GR and glyburide combination achieved its primary endpoint of producing clinically large and statistically significant (p<0.001) reductions in hemoglobin A1C (HbA1c). Also, Metformin GR and glyburide produced clinically large and statistically significant (p<0.001) reductions in every other measure of glycemic and lipid control compared to treatment with the sulfonylurea alone. The trial showed the Metformin GR and glyburide combination treatment to be well tolerated. Depomed and Biovail expect to file a new drug application for Depomed's once-daily Metformin GR in the first half of 2004. In Depomed's first Phase III trial, 536 patients were randomized to receive one of several doses of Metformin GR or Glucophage (Bristol-Myers Squibb Co.) an immediate-release, twice-daily formulation of metformin HCl. Treatment with Metformin GR produced clinically meaningful and statistically significant reductions in HbA1c, and all doses of Metformin GR were well tolerated and controlled glucose levels as effectively as immediate-release metformin.

• Entelos Inc., of Foster City, Calif., said that Johnson & Johnson Pharmaceutical Research & Development LLC, of La Jolla, Calif., will expand its research collaboration with Entelos to include target validation, lead optimization and clinical development in the field of obesity. In addition, McNeil Nutritionals Division, of McNeil-PPC Inc., will join the collaboration with Entelos.

• eXegenics Inc., of Dallas, said its board was replaced by five nominees of the Meyers-Weiss Group, which last week provided a consent solicitation that contained sufficient votes cast to elect a new slate of directors. eXegenics said its officers and employees were awaiting instructions from the new board in order to effectuate the orderly transfer of corporate authority.

• Generex Biotechnology Corp., of Toronto, is presenting results at the Drug Delivery - Latest Technology and Strategic Partnerships conference in Munich, Germany, from dose-ranging studies that were performed in patients with Type I diabetes using the glucose clamp technique. The patients showed progressive proportional increases in blood insulin concentration with progressive increases in insulin doses. Studies looking at insulin, c-peptide and glucose in healthy volunteers gave similar results. Reproducibility in individuals was performed by studying patients three to seven days apart. Oralin was administered to patients with Type I and Type II diabetes. Following a meal challenge, its efficacy in controlling post-prandial glucose was equal to or better than very rapid-acting insulin. Similar results were seen in patients with Type II diabetes. In addition, patients with Type II diabetes failing on oral agents lowered their A1c hemoglobin significantly after 90 days. Patient satisfaction was high and preference for buccal delivery over injection was high, Generex said.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., entered a nonexclusive co-promotion agreement with Sigma-Tau Pharmaceuticals Inc., a subsidiary of Sigma-Tau International SA, of Rome. InKine's U.S. gastrointestinal sales force will promote Sigma-Tau's VSL#3 in the second sales position behind InKine's purgative product, Visicol. VSL#3 is a probiotic designed to treat certain gastrointestinal disorders, including pouchitis, an inflammation of the small bowel reservoir. InKine could receive up to $1.5 million during the one-year term based on the completion of 15,000 second-position quarterly sales calls. Additional performance-based incentives are in place to further align InKine's sales force with the success of VSL#3. The company will use a portion of the cash generated from the co-promotion agreement to fund the expansion of its gastrointestinal sales force to about 50 sales professionals.

• Innogenetics NV, of Ghent, Belgium, raised €23 million following a secondary public offering of about 1.9 million shares priced at €12 apiece. The fully subscribed offering was coordinated and managed by ING Belgium, lead manager and sole bookrunner, together with KBC Securities, co-lead manager. The company said the added proceeds combined with existing cash, future cash flows generated by its diagnostics business, and income from existing and future collaborations, should ensure that the company has sufficient funds to reach sustained profitability by 2006. Innogenetics is focused on specialty diagnostics and therapeutic vaccines.

• Janssen Pharmaceutica Products LP, a unit of Johnson & Johnson, of New Brunswick, N.J., said data from a one-year, open-label study published in the Journal of Clinical Psychiatry showed that Risperdal Consta ([risperidone] long-acting injection) demonstrated positive safety and tolerability over the entire trial period and further reduced the symptoms of schizophrenia in many patients who were considered stable on other antipsychotic medications. The product was developed in collaboration with Alkermes Inc., of Cambridge, Mass.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said preliminary Phase I/II results reported at this week's American Society of Hematology meeting in San Diego showed that treatment of resistant advanced-stage multiple myeloma patients with Velcade, thalidomide and dexamethasone induced responses in patients who had previously received treatment with thalidomide. More than 20 percent of patients achieved a complete or near-complete response and overall more than 50 percent patients achieved at least a partial response.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., updated its StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine) manufacturing and clinical trial plans. Currently in a confirmatory Phase III trial, StaphVAX is designed to prevent Staphylococcus aureus bloodstream infections. The company said that because the peak forecasted demand for StaphVAX is expected to be higher than the capacity at Cambrex Corp., of East Rutherford, N.J., the company has decided to develop its own manufacturing capacity. The company is evaluating the build-out of a vaccine manufacturing plant in an unused portion of its manufacturing facility in Boca Raton. Also, the company is conducting a search for a suitable existing manufacturing facility close to Nabi's research and development location in Maryland. The decision between the two alternatives will be based primarily on cost and time to market adjusted for risk in both.

• Neurocrine Biosciences Inc., of San Diego, said preliminary Phase II/III results showed that its immediate-release formulation of indiplon achieved statistically significant results in patients with chronic insomnia characterized by waking up in the middle of the night. Findings showed that patients who woke up in the middle of the night and had difficulty in falling back to sleep and took indiplon were able to return to sleep with fewer awakenings and a better quality of sleep. Also, there was no evidence of next-morning residual effects and patients taking indiplon demonstrated more next-day alertness than those who took placebo. The product is the subject of nine separate studies as part of a Phase III program.

• OpGen Inc., of Madison, Wis., added a genome map of the Category A pathogen, Francisella tularensis, the causative agent of tularemia, to its genome map database. The organism poses a potential biothreat because it is one of the most infectious bacteria known.

• OriGene Technologies Inc., of Rockville, Md., reported the addition of the GPCR CloneSet, a designated subset of more than 300 full-length human non-olfactory G protein-coupled receptors, to the TrueClone Collection product line. The GPCR CloneSet is the largest commercial cDNA sources of that gene family, the company said.

• Oxigene Inc., of Waltham, Mass., said it expanded its research and development program in ophthalmology to include plans to begin human studies in several retinal degenerative indications and to develop formulations of its lead vascular targeting agent, Combretastatin A4 Prodrug (CA4P), for local delivery to the eye. Oxigene decided to broaden its ophthalmic program after a 35-year-old man suffering from myopic macular degeneration showed improvement following treatment with CA4P, it said.

• Peninsula Pharmaceuticals Inc., of Alameda, Calif., completed a preliminary analysis of results from its first international Phase II trial of doripenem (S-4661), a broad-spectrum carbapenem antibiotic. In the trial, doripenem was well tolerated by patients and met the primary endpoints of the trial in patients with complicated urinary tract infections. The trial investigated doripenem in hospitalized patients with complicated urinary tract infections, including pyelonephritis. Endpoints for the study were microbiological efficacy, clinical efficacy and safety of the compound.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., executed a license agreement with Avanir Pharmaceuticals Inc., of San Diego, for an antibody Avanir produced for a cancer target in Peregrine's Vascular Targeting Agent (VTA) product pipeline. The drug is the product of a previous antibody research agreement between them that was designed to develop monoclonal antibodies for the treatment of solid-tumor cancers. Avanir received a license fee and might receive a milestone payment and a royalty on sales. The VTA antibody was developed using a fully human constant region identified and isolated from Avanir's Xenerex technology. The antibody and the antibody-producing cell line have been transferred to Peregrine for preclinical development. Peregrine's stock (NASDAQ:PPHM) fell 28 cents Wednesday, or 11.3 percent, to close at $2.20.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., said the Drug Development Group of the National Cancer Institute's Division of Cancer Treatment and Diagnosis approved a collaboration for the clinical development of the company's compound PPI-2458, a methionine aminopeptidase Type 2 (MetAP2) inhibitor. Praecis is studying the compound in a Phase I trial in non-Hodgkin's lymphoma. The company will work with the NCI division to establish a development plan for PPI-2458 targeting various forms of cancer. The division will solicit proposals from investigators and will sponsor clinical trials at various institutions with intramural and/or extramural clinical investigators.

• Qiagen GmbH, a wholly owned subsidiary of Qiagen NV, of Venlo, the Netherlands, and Artus GmbH, of Hamburg, Germany, entered a manufacturing and supply agreement. Artus will integrate Qiagen's nucleic acid sample preparation products in its diagnostic systems for use in the detection of a variety of infectious diseases, such as severe acute respiratory syndrome, herpes simplex virus 1/2, EBV and others. Those diagnostic solutions employ Artus' RealArt amplification technology.

• QTL Biosystems LLC, of Santa Fe, N.M., released the QTL Lightspeed Caspase-3 Assay Kit. The assay uses a fluorescent polyelectrolyte-based super-quenching polymer that is designed to offer an advantage compared to conventional small-molecule fluorescence. The Lightspeed platform is designed to provide single-step, homogenous assays and addressed a spectrum of drug targets in high-throughput screening, the company said.

• Repligen Corp., of Waltham, Mass., initiated a Phase II trial of RG1068, a synthetic human secretin, in refractory schizophrenia. The trial will evaluate the potential of multiple doses of RG1068 to treat the deficits in social cognition in schizophrenia including social interaction and communication deficits, which are generally resistant to treatment with existing antipsychotic therapy. At selected sites, subjects also will be evaluated with functional magnetic resonance imaging to assess activation in various brain regions in response to RG1068 or placebo. The trial will be conducted at about six medical centers in the U.S. Repligen is conducting two Phase III trials of RG1068 in autism and plans to initiate a study of RG1068 in an anxiety disorder in the second half of 2004.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA received the company's Nov. 25 amendment to the Rifaximin new drug application. The FDA considers the amendment to be a complete response to the Oct. 25, 2002, approvable letter and has assigned a user fee goal date of May 26 to review and act on the application. The company is seeking approval to market Rifaximin, a non-systemic, gastrointestinal site-specific antibiotic, as a treatment for travelers' diarrhea.

• Sangamo BioSciences Inc., of Richmond, Calif., said its partner, Edwards Lifesciences Corp., of Irvine, Calif., is planning a first-quarter filing of an investigational new drug application for its ZFP VEGF therapeutic with the FDA to develop zinc finger DNA-binding protein transcription factors (ZFP TFs) for treating peripheral arterial disease. The AVENGE trial (Activating Vascular Endothelial Growth Factor A), scheduled to begin in the first half of 2004, will be the first clinical trial of a ZFP TF designed to activate the endogenous vascular endothelial growth factor A gene.

• StemCells Inc., of Palo Alto, Calif., raised $9.5 million after completing the sale of 5 million common shares at $1.90 apiece to an unnamed institutional investor. The company said it would use the proceeds primarily for general corporate purposes, including current and future preclinical trials of its lead product candidate, a human neural central nervous system stem cell for the treatment of brain and spinal cord diseases and injuries. StemCells previously said it intends to file its first investigational new drug application with the FDA to begin clinical trials of the product for Batten disease, a rare but fatal neurodegenerative disorder.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said that the third and highest dosing level has been completed in the Phase I study of Oxycyte, its perfluorocarbon-based blood substitute and therapeutic oxygen carrier. The company is expecting to begin Phase II studies in early 2004. So far, results are in line with expectations based on preclinical animal safety studies, it said.

• Transgenomic Inc., of Omaha, Neb., entered an agreement for a revolving line of credit with Laurus Master Fund Ltd. The facility allows the company to have access to $7.5 million, based on eligible accounts receivable and inventory balances. The new facility replaces a previous $5 million commercial bank line of credit that had a higher interest rate. Transgenomic issued warrants to Laurus Funds to acquire up to 550,000 shares of the company's common stock at exercise prices that are based on a premium to the average trading price of the company's common stock for 10 trading days prior to execution of the agreement.

• Tularik Inc., of South San Francisco, began a Phase II study to test orally administered T487's efficacy and safety in psoriasis patients. The double-blinded, randomized, placebo-controlled, Europe-based study will enroll about 40 patients with moderate to severe psoriasis for 28 days. Efficacy endpoints include an improvement in the Psoriasis Area and Severity Index score and measures of inflammatory cell infiltration in psoriasis skin lesions.

• Xcyte Therapies Inc., of Seattle, said preliminary results were presented from two company-sponsored Phase I/II trials in chronic lymphocytic leukemia and multiple myeloma at the 2003 American Society of Hematology meeting in San Diego. Xcyte Therapies also presented results on its new custom-bioreactor process demonstrating that it improved efficiency and reduced manufacturing costs as well as increased the activity of Xcellerated T Cells. Separately, is said several research and development studies using their patented Xcellerate Technology were presented. Xcyte's scientists and their collaborators reported progress in laboratory studies of potential new applications of the Xcellerate Technology including the treatment of autoimmune diseases. Xcyte Therapies is developing the Xcellerated Technology for applications in cancer and HIV.

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