Acorda Therapeutics Inc., of Hawthorne, N.Y., said preclinical results showed its enzyme product chondroitinase was effective in improving recovery after spinal cord injury. The data, reported in the Feb. 23, 2005, issue of the Journal of Neurotrauma, showed that rats treated with the product demonstrated significant improvements in motor functions of the limbs and bladder function, compared to rats treated with a control enzyme. Acorda said it is working to move into human trials.
ActiveSight, of San Diego, and Serenex Inc., of Durham, N.C., entered an agreement related to protein crystallography for drug discovery. The agreement covers the co-crystallization of Serenex molecules with proteins expressed by ActiveSight. Additional details of the agreement were not disclosed.
Altachem Pharma Ltd., of Edmonton, Alberta, said it will refocus its efforts on development of photodynamic treatments for cancer and other proliferative diseases, building its pipeline based on its Sonolight and CDK technologies, while discontinuing other operations. The company said its lead product, ACT-HIP, in Phase I trials for Kaposi's sarcoma, might be delayed due to manufacturing issues. Altachem also decided to close operations in China, likely involving the sale of its Shanghai-based companies, though specific details have not been determined. In order to advance a core oncology program, Altachem said it intends to engage one or more investment dealers to secure equity capital from public markets to fund drug development programs.
Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, and partner Boston Scientific Inc., of Boston, began enrolling patients in a drug-eluting stent registry. The Taxus Olympic registry plans to enroll more than 30,000 patients at more than 600 centers and is designed to collect and analyze data for the Liberte paclitaxel-eluting stent system in the treatment of coronary artery disease.
BioCryst Pharmaceuticals Inc., of Birmingham, Ala., completed a $23.9 million registered direct offering of about 4.4 million shares of its common stock, priced at $5.50 per share. The company said net proceeds totaled about $22.7 million and will be used to fund trials of its lead cancer product, forodesine hydrochloride, planned for this year. (See BioWorld Today, Feb. 18, 2005.)
BioDelivery Sciences International Inc., of Morrisville, N.C., closed a $2.5 million secured convertible debt financing from New York-based Laurus Master Fund Ltd. Proceeds will be used primarily to retire the company's existing secured equipment loan, to support research, development and commercialization opportunities, and for general working capital purposes. Ferris, Baker Watts advised BioDelivery on the transaction.
Cardiome Pharma Corp., of Vancouver, British Columbia, received a $6 million milestone payment from its co-development partner, Fujisawa Healthcare Inc., of Deerfield, Ill. The payment was triggered by the completion of ACT 1, the first of three Phase III trials for Cardiome's lead anti-arrhythmic product, RSD1235. Cardiome licensed North American rights for the intravenous formulation to Fujisawa in October 2003.
ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, achieved a research milestone in its depression target discovery program with Vernalis plc, of London, that will result in a payment of A$720,000 (US$568,000). The research agreement between ChemGenex and Vernalis was signed in August.
Cubist Pharmaceuticals Inc., of Lexington, Mass., received approval from the FDA for commercial production of the active ingredient in Cubicin (daptomycin for injection) at a second bulk drug facility, operated by Agnani, Italy-based ACS Dobfar SpA. Cubicin is approved in the U.S. to treat complicated skin and skin-structure infections caused by Gram-positive microorganisms.
EntreMed Inc., of Rockville, Md., presented preclinical research results for its Proteinase Activated Receptor (PAR-2) inhibitor program at the New York Academy of Sciences conference on PAR-2: Understanding the Links Between Protease Activation and Disease. Results indicated that EntreMed's PAR-2 antagonist inhibited both tumor growth and the formation of new blood vessels in cancer models. The compound also has been shown to be an inhibitor of inflammation in preclinical rheumatoid arthritis and acute inflammation models.
Gilead Sciences Inc., of Foster City, Calif., said the European Commission granted marketing approval for Truvada (emtricitabine and tenofovir disoproxil fumarate) in European Union states. Truvada combines the company's HIV products Emtriva and Viread in one tablet, taken once a day with other antiretroviral agents. In the U.S., Truvada is indicated in combination with other antiretrovirals, and safety and efficacy studies evaluating Truvada or a combination of Emtriva and Viread are ongoing.
Human Genome Sciences Inc., of Rockville, Md., completed the enrollment and initial dosing of patients in a Phase II trial of HGS-ETR1 (mapatumumab) in patients with advanced colorectal cancer. The trial is an open-label study being conducted in Germany and evaluates tumor response. Patients are receiving up to six cycles of treatment in the absence of disease progression, with HGS-ETR1 administered intravenously every 14 days.
Memory Pharmaceuticals Corp., of Montvale, N.J., added a PDE10A inhibitor program to its pipeline based on promising preclinical research suggesting that the inhibition of PDE10A might reduce psychotic effects. PDE10A is a class of phosphodiesterases that degrades cAMP and cGMP, molecules responsible for improving the function of neurons and other cells. PDE10A has been shown to be present at high levels in neurons closely associated with schizophrenia, Parkinson's disease and obsessive compulsive disorder.
Perlegen Sciences Inc., of Mountain View, Calif., was awarded a grant from the National Cancer Institute to study tumor-specific DNA mutations involved in colorectal cancer in collaboration with the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. The team will analyze at single-base resolution the DNA sequences of thousands of genes in colorectal tumor tissue as well as in normal tissue from the same patients. The effort is expected to lead to the identification of a significant number of tumor-specific mutations.
Pharmaxis Ltd., of Sydney, Australia, said the FDA granted orphan drug status for the company's Bronchitol product for the treatment of bronchiectasis, an incurable, degenerative and chronic inflammatory condition of the lungs. Late last year, Pharmaxis reported positive results from a two-week study.
ProtoKinetix Inc., of Vancouver, British Columbia, said the first series of results showing the efficacy of chemically synthesized antifreeze glycoprotein demonstrated an efficient cell preservation viability on a delicate human cell line. The molecules showed cell viability preservation at concentration levels from 10 times to 100 times lower than reported with the natural compound, and activity was seen at temperatures ranging from 4 degrees C to -4 degrees C.
Questcor Pharmaceuticals Inc., of Union City, Calif., appointed James Fares president and CEO, as well as a director. Prior to joining Questcor, Fares served as CEO and president of FGC Pharma/Novella Neurosciences. Questcor acquires, markets and sells brand name prescription drugs for neurological and gastrointestinal use.
Sentigen Holding Corp., of Phillipsburg, N.J., sold the Specialty Media Division of its wholly owned subsidiary, Cell & Molecular Technologies Inc., to Chemicon International Inc., a wholly owned subsidiary of Atlanta-based Serologicals Corp. Under terms of the agreement, Serologicals agreed to pay Sentigen $6.5 million in cash for the division's assets, and also retired the mortgage note with a balance of $243,310 on the division's facility in Phillipsburg. Chemicon provides research products, such as reagents, antibodies and kits in the areas of neuroscience, stem cell biology, cancer and infectious disease research.
Sosei Co. Ltd., of Tokyo, in-licensed the urology compound OPC-51803 (SOU-003) from Otsuka Pharmaceutical Co. Ltd., of London, which already has completed Phase I studies. Sosei has been granted the rights to develop and commercialize the compound globally, except for Japan and other Asian countries where Otsuka retains the rights. Sosei also has co-promotion rights in Japan, while Otsuka retains a co-promotion option in the U.S. and Europe. SOU-003 is an orally active small-molecule with selective vasopressin V2 receptor agonist activity.
Symyx Technologies Inc., of Santa Clara, Calif., agreed to acquire privately held Synthematix Inc., of Research Triangle Park, N.C., to broaden its software offerings for drug discovery and research. Under terms of the agreement, Symyx will pay about $13 million in cash to purchase all outstanding shares of Synthematix based on revenue outlook, plus a potential earn of $4 million over a one-year period based on achievement of incremental revenue targets. Symyx also will issue 27,500 options of its common stock for unvested Synthematix employee options. The acquisition, approved by both companies' boards, is expected to close in April.
Transgene SA, of Strasbourg, France, said its MVA-Mucl-IL2 therapeutic vaccine met the primary endpoint in a Phase II trial for the treatment of non-small-cell lung cancer. The trial is evaluating the efficacy of the up-front association of subcutaneous injections of MVA-Mucl-IL2 at a dose of 10(8) pfu with a cisplatin/vinorelbine-based chemotherapy in patients with advanced or metastatic Mucl-positive non-small-cell lung cancer. The primary endpoint was defined as tumor response rate of at least 11 responses out of the first 33 evaluable patients.
U.S. BioDefense Inc., of City of Industry, Calif., signed a 90-day option to license U.S. and European patents covering a liver cell progenitor and its use for the treatment of liver disease. The company also gains rights to related foreign applications with UCL BioMedica plc, a subsidiary of University College London. U.S. BioDefense will evaluate the hepatic cell sorting and enrichment technology with the goal of establishing a system to isolate and expand stem cells that could be used for therapeutic re-population in patients with liver disease.
United Therapeutics Corp., of Silver Spring, Md., was granted a five-year extension by the U.S. Patent and Trademark Office for its patent covering the method of treating pulmonary hypertension using Remodulin. U.S Patent No. 5,153,222 was originally scheduled to expire on Oct. 6, 2009. It will now expire on Oct. 6, 2014.
Vivus Inc., of Mountain View, Calif., announced a public offering of 7.5 million shares of its common stock. SG Cowen & Co. LLC is acting as sole book-running manager, and Wachovia Capital Markets LLC is acting a co-lead manager. Vivus, which develops products to treat sexual dysfunction, has four products in clinical development.
Xechem International Inc., of New Brunswick, N.J., said that its corporate spin-off, Ceptor Corp., successfully completed a $12 million private offering and now is an independent company with its shares traded on the Over-the-Counter Bulletin Board under the symbol "CEPO." Ceptor develops technology for neuromuscular and neurodegenerative diseases.