Altachem Pharma Ltd., of Edmonton, Alberta, signed a memorandum of understanding with the Research Centre for Bioactive Materials at Korea's Chonbuk National University. The memorandum is meant to identify collaborative research programs and is expected to lead to the establishment of specific projects to underpin Altachem's discovery programs in cancer.
Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its partner Boston Scientific Corp., of Natick, Mass., received CE Mark approval for its Taxus Liberté paclitaxel-eluting stent system. The company plans to launch the product in European markets and other CE Mark-dependent international markets immediately. Taxus Liberté was launched earlier this year in select international markets and is expected to launch in the U.S. in 2006.
Barr Pharmaceuticals Inc., of Woodcliff Lake, N.J., and its subsidiaries entered a nonbinding letter of intent to acquire exclusive rights to the Mircette (desogestrel/ethinyl estradiol) oral contraceptive product from Organon USA and Organon Ltd., of Dublin, Ireland. Barr also agreed to settle the pending patent litigation with Organon and East Brunswick, N.J.-based Savient Pharmaceuticals Inc., concerning Barr's generic version of Mircette, which is marketed under the trade name Kariva. The parties agreed to stay further proceedings to allow time to negotiate a definitive settlement agreement.
Bayer Healthcare AG, of Wuppertal, Germany, and InfoSense Ltd., of London, agreed that Bayer will use InfoSense's computer technology to process its data and applications to identify and optimize potential drug leads. Financial terms were not disclosed.
Blue Heron Biotechnology Inc., of Bothell, Wash., was awarded a Phase I Small Business Innovation Research grant from the National Institute of General Medical Science and the National Institute of Allergy and Infectious Disease. The grant funds development of molecular biological tools to enable research on genes that are difficult to grow in bacteria.
Crucell NV, of Leiden, the Netherlands, and Aeras Global TB Vaccine Foundation in Bethesda, Md., initiated a series of clinical studies for their AdVac-based tuberculosis vaccine. The studies, which follow promising results for the vaccine obtained in animal studies, are set to start in Europe, the U.S. and Africa during the second quarter of 2006. AdVac is a vaccine technology developed by Crucell, and is designed to insert genetic material through vectors.
Cyberkinetics Neurotechnology Systems Inc., of Foxborough, Mass., and Brown University in Providence, R.I., signed an agreement that would give certain neuroscience researchers at Brown access to clinical research data from Cyberkinetics. Under the terms, Cyberkinetics will provide certain human clinical data obtained through its development programs, in exchange for the company's right to a range of options to exclusive worldwide licenses from inventions derived from the collaboration.
Discovery Laboratories Inc., of Warrington, Pa., completed its first pilot Phase II feasibility study of Aerosurf, its precision-engineered aerosolized surfactant replacement therapy, administered via nasal continuous positive airway pressure to treat premature infants at risk for respiratory distress syndrome. Results showed that the product could be safely delivered and was well tolerated.
GlycoGenesys Inc., of Boston, said preliminary results from its ongoing Phase I trial of GCS-100 in patients with solid tumors indicated that 11 of the 14 patients for which response data was available have experienced periods of stable disease. The study also established a maximum tolerated dose for the regimen of five consecutive days of therapy followed by two weeks off. Preliminary safety data shows that GCS-100 is well tolerated and was not associated with decreased white blood cell counts or nerve damage. A Phase I/II study in multiple myeloma was initiated in April, and GlycoGenesys anticipates a Phase I/II trial in chronic lymphocytic lymphoma to begin in October.
Icoria Inc., of Research Triangle Park, N.C., said its gene-expression profiling service unit, Paradigm Array Labs, signed three contracts this quarter that are expected to generate up to $1.1 million in revenue. Under the contracts, which are unrelated, Icoria will provide microarray expression services, analysis and reporting to Duke University, the U.S. Environmental Protection Agency and an unnamed biotechnology company. Further financial terms were not disclosed.
Indevus Pharmaceuticals Inc., of Lexington, Mass., initiated a Phase III program for Sanctura XR in patients with overactive bladder. The program will consist of two 12-week studies totaling 1,200 adults, with the objective of evaluating the effects of once-daily dosing of the drug on urinary frequency, urge incontinence and other related symptoms associated with overactive bladder. Sanctura XR is the once-daily formulation of Sanctura, which is being marketed in the U.S.
Innocoll Inc., of Ashburn, Va., said its wholly owned subsidiary, Innocoll Technologies, entered an agreement with Medexis SA, of Athens, Greece, part of the Gerolymatos Group of Companies, for the development of a wound-healing product based on Innocoll's CollaRx membrane technology. Under the terms, Medexis will fund the cost of development and be responsible for regulatory applications. Financial details were not disclosed.
Intrac Inc., of New York, changed its name to Javelin Pharmaceuticals Inc., as part of a reincorporation in Delaware. Javelin common stock will trade under the symbol "JVPH" on the Over-the-Counter Bulletin Board. Javelin is a specialty pharmaceutical company focused on pain management.
MedImmune Inc., of Gaithersburg, Md., and VasGene Therapeutics Inc., of Los Angeles, entered an agreement to develop cancer-focused monoclonal antibodies targeting a member of a subfamily of receptor tyrosine kinases, EphB4, as well as its ligand, EphrinB2. MedImmune will be responsible for the clinical development and commercialization of any resulting products. VasGene will provide research and development support and receive an up-front fee, development and regulatory milestone payments, as well as royalties.
Metabolox Inc., of Hayward, Calif., said findings from a preclinical study comparing metaglidasen, an oral insulin sensitizer for Type II diabetes, to the marketed insulin sensitizer rosiglitazone showed that metaglidasen has blood glucose and lipid-lowering effects without weight gain and edema. Metaglidasen, designed as a selective partial PPAR-gamma modulator, is being evaluated by Metabolox in a clinical program. Those data will be presented at Keystone Symposia's Scientific Conference on Tissue - Selective Nuclear Receptors in Breckenridge, Colo., on Sept. 21.
Microbix Biosystems Inc., of Toronto, ceased negotiations with a vaccine manufacturer that was evaluating the company's yield enhancement technology. The company is seeking to commercialize a viable vaccine yield enhancement process that can be integrated into a vaccine supplier's commercial manufacturing process.
MorphoSys AG, of Martinsried, Germany, and Shionogi & Co. Ltd., of Osaka, Japan, signed a three-year agreement on the use of MorphoSys' HuCAL technology. MorphoSys grants Shionogi access to its HuCAL GOLD antibody library for drug discovery, in exchange for an up-front payment an annual user fees during the span of the agreement.
Nektar Therapeutics, of San Carlos, Calif., has had trading of its common stock halted Thursday by Nasdaq as the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA reviewed Nektar's New Drug Application for Exubera, an inhaled, fast-acting, powder insulin for the treatment of adults diabetes. The drug is being developed by Pfizer Inc., of New York, and Sanofi-Aventis Group, of Paris.
Pharmacyclics Inc., of Sunnyvale, Calif., initiated an open-label Phase II trial of Xcytrin (motexafin gadolinium) injection, the company's lead cancer drug, as a second-line treatment for patients with recurrent, metastatic non-small-cell lung cancer. The trial is expected to enroll 108 patients who have failed one platinum-based chemotherapy regimen. Primary endpoints are safety and efficacy, as measured by tumor response rate and duration of response. Xcytrin is designed to selectively concentrate in tumors and induce apoptosis.
Prima Biomed Ltd., of Melbourne, Australia, agreed to allow its subsidiary, Arthron Pty. Ltd., to nonexclusively license use of its Fc receptor technology to Monrovia, Calif.-based Xencor Inc. for up to two years of research. Terms calls for Arthron to receive an up-front fee, and subsequent license fee. In addition, Xencor has the option to receive a nonexclusive license to the technology for the development and commercialization of products arising from the research program, and would pay Arthron an additional license fee, as well as milestones and royalties on any approved products.
Sepracor Inc., of Marlborough, Mass., said the FDA received an abbreviated new drug application from Breath Ltd. for a generic version of levalbuterol hydrochloride inhalation solution. Breath Ltd.'s submission includes a Paragraph IV certification alleging that Sepracor's patents listed in the Orange Book for Xopenex inhalation solution are invalid, unenforceable or not infringed by Breath's proposed product. Sepracor said it believes its patent position is strong and it will "vigorously protect" its patent rights.
VasoGenix Pharmaceuticals Inc., of Lenexa, Kan., said that, through the Cleveland Clinic Cardiovascular Coordination Center, a research steering committee was constituted. The committee will assist the company in focusing its clinical research plan for the company's cardiology drug, Calcitonin Gene Related Peptide.