¿ Actelion Ltd., of Allschwil, Switzerland, said that it has extended for a third year its collaboration with the R.W. Johnson Pharmaceutical Research Institute, a division of Ortho-McNeil Pharmaceutical Inc., both of Raritan, N.J., and both Johnson & Johnson companies. Under the terms of the agreement, Actelion will continue to combine its base in vascular endothelium biology with expertise in medical chemistry to discover compounds targeting the vascular endothelium. Johnson & Johnson will develop and commercialize any new drugs arising from the project. Actelion is a biopharmaceutical company specializing in science related to the endothelium, a single layer of cells that separates every blood vessel in the bloodstream.
¿ Ariad Pharmaceuticals Inc., of Cambridge, Mass., filed a shelf registration for the issuance of up to 4.5 million shares of its common stock. Based on Friday¿s closing price of $5.18, the shelf registration is worth about $23.3 million. After the offering, the company would have about 34.6 million shares outstanding. It had $35.0 million in cash, cash equivalents, and marketable securities as of March 31.
¿ Bayer Corp., of Pittsburgh, said the results of its Phase III study of vardenafil, the company¿s erectile dysfunction treatment, showed statistically significant results in improving erectile function for men with diabetes. In the placebo-controlled study of 452 men, ages 18 and older, 72 percent of participants in the 20-mg vardenafil group reported a statistically significant improvement in erectile function compared to 13 percent in the placebo group (p<0.0001). Sixty-four percent reported erections hard enough for penetration, compared to 36 percent in the placebo group. Bayer plans to submit a new drug application for vardenafil later this year.
¿ BioMarin Pharmaceutical Inc., of Novato, Calif., filed a clinical trial exemption application with the Medicines Control Agency in the United Kingdom for permission to conduct human clinical trials of Vibriolysin Topical in patients with serious burns. Vibriolysin Topical has displayed efficacy in preclinical studies related to the debridement of dead tissue resulting from serious burns, BioMarin said.
¿ Bioniche Life Sciences Inc., of Belleville, Ontario, said results of its Phase I/II study for carcinoma in situ of the bladder refractory to bacillus Calmette Guerin (BCG) and chemotherapy with its mycobacterial cell wall technology (MCC), its lead cancer treatment, were positive. Results showed a 59 percent complete response to MCC, and a 65 percent positive response. The trial enrolled 23 patients with carcinoma in situ of the bladder refractory to BCG. The company intends to present the results at an upcoming urology conference and initiate a Phase III trial in the first quarter of 2002.
¿ Boston Probes, of Bedford, Mass., said it has entered into a development and license option agreement with Human Genetic Signatures Pty Ltd., of Sydney, Australia. The development efforts will focus on the emerging fields of epigenetics and personalized medicines. Boston Probes will grant Human Genetic Signatures a license to use and sell products based on Boston Probes¿ peptide nucleic acid (PNA) technology in return for an equity stake in Human Genetic Signatures, as well as milestone fees and royalties on product sales. Human Genetic Signatures develops foundations for personalized medicine using phenomic platforms that are interfaces with PNA technologies to diagnose disease predisposition via the interpretation of individual genetic signatures. Boston Probes also reports that it has developed a breakthrough capability in the field of PNA oligomer synthesis that the company said will accelerate the development of diagnostic and therapeutic products derived from human genome project sequence data.
¿ Carrington Laboratories Inc., of Irving, Texas, said it presented data on its compound, CR1013, related to its new drug delivery technology, at the 28th International Symposium on Controlled Release of Bioactive Materials. The presentation was given on the chemistry and functional attributes of the new polymer-based technology for injectable and topical delivery that could potentially allow for controlled release of a variety of drug candidates ranging from small- to large-molecular weight compounds.
¿ Celera Genomics Inc., of Rockville, Md., said Yamanouchi Pharmaceutical Co. Ltd., of Tokyo, signed a five-year subscription agreement, giving it access to the Celera Discovery System and use of Celera¿s database products, bioinformatics systems and other discovery tools. Financial terms were not disclosed.
¿ Collgard Biopharmaceuticals Ltd., of Newton, Mass., said its lead compound, Halofuginone, reduced the severity of fibrosis in both renal glomeruli and stroma in a well-known animal model in a concluded preclinical study. The data were presented at the 38th annual scientific meeting of the European Renal Association, held in Vienna, Austria. Halofuginone is a small-molecule derivative of a natural plant alkaloid that has been shown to inhibit collagen Type I synthesis in soft tissue, Collgard said.
¿ Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., said its catalytic antioxidant reduced brain tissue damage and specific markers of free radical damage, and improved neurological function when administered 7.5 hours after the interruption of blood flow in a rat model of ischemic stroke. The data are published in a paper in the July 1, 2001, issue of the Journal of Neuroscience.
¿ Draxis Health Inc., of Mississauga, Ontario, received a Notice of Compliance from Health Canada granting approval to market Levulan Kerastick Photodynamic Therapy (PDT) in Canada for the treatment of acnitic keratoses, precancerous skin lesions of the face and scalp. The product will be sold by Draxis¿ pharmaceutical business. Levulan uses a photosensitive agent, 5-aminolevulanic acid (5-ALA), that is taken up preferentially in the diseased cells of precancerous lesions when applied to the affected areas of the skin. When the treated area is exposed to an appropriate light source, 5-ALA is activated to destroy the cells via PDT. Draxis holds the exclusive rights to Levulan through DUSA Pharmaceuticals Inc., of Wilmington, Mass. DUSA received FDA approval to market Levulan in December 1999. (See BioWorld Today, Dec. 7, 1999.)
¿ EntreMed Inc., of Rockville, Md., and Aventis Pharmaceuticals Inc., of Parsippany, N.J., are collaborating on Phase II studies in patients with hormone-refractory prostate cancer. The collaboration will study safety, dose finding and tolerability of daily oral Panzem in combination with weekly Taxotere in prostate cancer patients and measure PSA levels and tumor responses following the combination treatment. Financial details were not disclosed. Separately, EntreMed said it has entered a two-year cooperative research and development agreement with the National Eye Institute, part of the National Institutes of Health, of Bethesda, Md., to study the role that Panzem can play in treating the retinal angiogenesis that leads to age-related macular degeneration. Panzem is the fourth angiogenesis inhibitor EntreMed has brought to the clinic.
¿ Gene Logic Inc., of Gaithersburg, Md., formally launched Genesis, the GeneExpress Enterprise System, at the BIO 2001 International Convention and Exhibition in San Diego. Genesis contains a proprietary connector component that provides support for interactive sample and gene expression data acquisition and validation, as well as transformation, integration and migration of the data into the data warehouse.
¿ Genta Inc., of Berkeley Heights, N.J., presented two scientific studies documenting the synergy between its lead compound, Genasense, and drugs used in the company¿s ongoing, late-stage clinical trials in patients with both multiple myeloma and acute myeloid leukemia (AML). The studies were presented at the European Hematology Association, held in Frankfurt, Germany. The first presentation showed the Genasense target, Bcl-2, was a factor in the resistance of myeloma to standard chemotherapy and Genasense treatment markedly reduced Bcl-2 levels in myeloma cells. The second presentation showed that Genasense decreased Bcl-2 protein in acute myeloid leukemia cells by 72 hours. Also, Genasense in combination with the monoclonal antibody to treat AML patients, Mylotarg (Wyeth-Ayerst Laboratories), increased cell death up to 63 percent, compared to treatment with Mylotarg alone.
¿ Immunomedics Inc., of Morris Plains, N.J., presented interim results at the 48th Annual Meeting of the Society of Nuclear Medicine on the use of CD22 antibodies for the therapy of non-Hodgkin¿s lymphoma. Its founder, David Goldenberg, reported that the yttrium-labeled CD22 antibody, (90)Y-LymphoCide, has been showing encouraging therapeutic responses in advanced NHL patients who did not respond to chemotherapy.
¿ InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., enrolled the first patient for treatment in the pivotal trial of Colirest in patients with mild-to-moderate active Crohn¿s disease. In the Phase II trial, 82 percent of evaluable patients with Crohn¿s responded to treatment with Colirest, InKine said. The trial will be randomized, double blind, placebo controlled and has a planned enrollment of about 250 patients at approximately 50 sites in North America. The trial will test the safety and efficacy of two doses of Colirest, 400 mg and 1,000 mg a day, compared to placebo. (See BioWorld Today, Feb. 28, 2001.)
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its compound, ISIS 2302, achieved high drug levels in patients¿ psoriatic plaques, demonstrating that topical antisense drugs penetrate psoriatic lesions. ISIS 2302 is an antisense inhibitor of intercellular adhesion molecule-1. The trial evaluated five concentrations of ISIS 2302 in patients with moderate plaque-type psoriasis. There was a strong trend (p=0.053) favoring a relationship between increased concentrations of drug and reduction of thickness in plaques, the primary endpoint of the study. In the study, 37.5 percent of plaques that contained drug achieved a two-point or greater improvement on a 0-to-5-point scale. However, no concentration of ISIS 2302 demonstrated a statistically significant improvement compared to placebo.
¿ Medarex Inc., of Princeton, N.J., and Epicyte Pharmaceutical Inc., of San Diego, are collaborating for the joint discovery, development and commercialization of antibody-based products. Medarex will use its UltiMAb Human Antibody Development System to generate antibodies to antigen targets and the companies may elect to use Epicyte¿s Plantibody technology for manufacturing products. Medarex and Epicyte will share the costs associated with the preclinical and clinical development of the products and expect to share equally in commercialization rights of any antibody therapeutics. Financial terms were not disclosed.
¿ MediGene AG, of Martinsried, Germany, and Aventis Pharma AG, of Frankfurt, Germany, started a Phase I/II trial for a vaccine against malignant melanoma. The vaccine is based on adeno-associated virus gene transfer. MediGene received a DM2 million (US$878,149) milestone payment from Aventis Pharma for initiating the trial. The study will be conducted in several European companies and will include patients diagnosed with Stage IV melanoma.
¿ MedImmune Inc., of Gaithersburg, Md., and BioTransplant Inc., of Charlestown, Mass., said the initial data for MEDI-507 (siplizumab) as a potential treatment for psoriasis were presented at the International Psoriasis Symposium and European Congress of Psoriasis, held in San Francisco. Results from the Phase I and Phase I/II trials showed the drug was generally safe and well tolerated. Patients experienced improvement in psoriasis, as measured by Psoriasis Area and Severity Index score, via both intravenous and subcutaneous routes of administration.
¿ Nabi, of Boca Raton, Fla., said it signed a definitive agreement to sell the operating assets of a majority of its antibody collection business to CSL Ltd., of Melbourne, Australia. Nabi will receive $152 million from CSL, subject to closing adjustments, and will realize approximately $20 million upon liquidation of the related net current assets, principally receivables. Nabi said the funds from the sale will allow it to immediately repay its current bank debt of about $20 million. The funds will also be used to advance Nabi¿s product pipeline and for further growth.
¿ NicOx SA, of Sophia-Antipolis, France, signed a research and co-development agreement on a class of nitric oxide-releasing respiratory therapeutics with Swedish-based Biolipox. NicOx, which brings its expertise in nitric oxide to the collaboration, will synthesize a series of new compounds for preclinical evaluation by privately held Biolipox, which is focused on characterizing the mechanisms and screenings of compounds for treatment of airway diseases.
¿ Nortran Pharmaceuticals Inc., of Vancouver, British Columbia, said preclinical studies confirmed its antiarrhythmic drug RSD1235 has oral bioavailability in dogs. An average of 75 percent of the drug administered orally was found in the bloodstream. The study confirmed earlier studies in rats.
¿ Palatin Technologies Inc., of Princeton, N.J., said positive interim results from a Phase II trial of LeuTech in patients with osteomyelitis were presented at the Society of Nuclear Medicine annual meeting in Toronto. The objectives of the study were to evaluate the safety and utility of LeuTech for diagnosing osteomyelitis and to compare LeuTech to both Indium oxine-labeled white blood cells and 3-phase bone scan. The data from the 19 patients show LeuTech to be well tolerated and superior to both Indium and 3-phase bone scan, Palatin said.
¿ SIGA Technologies Inc., of New York, appointed Philip Sussman president and CEO. Sussman was previously executive vice president, corporate development at Memory Pharmaceuticals Corp., of Montvale, N.J. SIGA identifies and develops anti-infective agents based on its research in the field of bacterial surface proteins.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., initiated the first Phase I trial of its sulfonyl hydrazine prodrug, VNP40101M, an anticancer alkylating agent. The multicenter study is being conducted at the West Haven Veterans Administration Hospital in Connecticut, the Yale Cancer Center in New Haven, and the Arizona Clinical Research Center in Tucson. The trial is scheduled to enroll about 20 to 30 patients. The compound has shown activity against several tumor types in mice.
¿ Zycos Inc., of Lexington, Mass., and Aventis Pasteur, of Lyon, France, extended their drug discovery collaboration, originally initiated in 1999, on an undisclosed cancer antigen. The companies will continue to work on identifying drug targets that may be useful in treating cancer. The extended agreement provides Zycos with additional research and development payments, milestone payments and royalties on any commercialized products. No further financial details were disclosed.