• Amarin Corp. plc, of London, successfully completed a preclinical proof-of-concept study using a nasal formulation of lorazepam. The preclinical study evaluated the extent of absorption of lorazepam after nasal administration and the pharmacokinetics of the formulation. Amarin now is working with a subsidiary of Elan Corp. plc, of Dublin, Ireland, to prepare the nasal formulation for human pharmacokinetic trials.

• BioAlliance Pharma SA, of Paris, received marketing authorization for Loramyc in the UK and Denmark, which triggered a €2.5 million (US$3.7 million) milestone payment from partner Spepharm Holding BV, of Amsterdam, the Netherlands, under the terms of the companies' March agreement. BioAlliance continues to develop Loramyc in the U.S., where it is in Phase III development in oropharyngeal candidiasis.

• BioCurex, of Richmond, British Columbia, and Inverness Medical Innovations, of Waltham, Mass., have entered into a licensing agreement for BioCurex's RECAF material and technology. Inverness will obtain semiexclusive worldwide rights to commercialize products using the technology, and BioCurex will be paid up-front fees, product and development milestones plus royalties on product sales. Financial terms were not disclosed.

• BioTime Inc., of Emeryville, Calif., has signed a licensing agreement with the Wisconsin Alumni Research Foundation for 173 patents and patent applications filed internationally relating to human embryonic stem cell technology created by James Thomson at the University of Wisconsin-Madison. BioTime's subsidiary, Embryome Sciences, plans to develop and commercialize a technology platform called Embryomics, a collection of research tools to facilitate stem cell research by providing researchers with new products for the identification, scale-up, and purification of the many cell types that emerge from human embryonic stem cells.

• ExonHit Therapeutics SA, of Paris, amended its cancer diagnostics partnership with bioMerieux SA, of Marcy l'Etoile, France, which gives ExonHit commercial rights to diagnostic kit development through the alliance and allows bioMerieux greater flexibility to start new research and development projects in that field. The collaboration, initiated in October 2005, is based on ExonHit's gene expression analysis expertise and bioMerieux's know-how in the field of in vitro diagnostics. The goal is to develop DNA microarrays that can detect cancer makers in blood samples. Three programs are under way: one in breast cancer, one in colorectal cancer and one targeting prostate cancer. Financial terms of the deal were not disclosed.

• Helicos BioSciences Corp., of Cambridge, Mass., entered a collaboration with Victor Ambros at the University of Massachusetts Medical School's Program of Molecular Medicine. Ambros and team will use Helicos' quantitative sequencing technologies to develop an assay to characterize known species of microRNA and discover new noncoding RNAs. Terms were not disclosed.

• Hemispherx Biopharma Inc., of Philadelphia, responded to the FDA's questions regarding the new drug application for Ampligen in chronic fatigue syndrome, which was filed in October but deemed not sufficiently complete for review. The agency had raised questions regarding preclinical and clinical data, as well as management of high-risk patients. Ampligen, a double-stranded RNA toll-like receptor-3 agonist, could become the first approved therapy for CFS and the first approved systemic TLR drug. (See BioWorld Today, Oct. 12, 2007.)

• Ikaria Holdings Inc., of Clinton, N.J., has appointed Daniel Tasse as president and chief executive officer, succeeding David Shaw, who has served as chairman and interim CEO since the creation of Ikaria Holdings in March 2007. Shaw will serve as executive chairman and chairman of the board. Tasse most recently was general manager of Baxter International's pharmaceuticals and technologies business and prior to that held management positions at GlaxoSmithKline and Upjohn.

• MorphoSys AG, of Martinsried, Germany, said data published in the Journal of Virology identified a new epitope on the HIV-Protein gp41 that is capable of neutralizing various HIV strains. The research was conducted by NIH scientists using MorphoSys' HuCAL technologies.

• Morphotek Inc., of Exton, Pa., a subsidiary of Eisai Co. Ltd., has signed a cooperative research and development agreement with the National Cancer Institute for development of therapeutic antibodies to a cancer-associated protein identified by NCI researchers. Morphotek will apply its Morphodoma antibody technology to the development of therapeutic antibodies for the treatment of prostate cancer. Financial details were not disclosed.

• Ortec International Inc., of New York, changed its name to Forticell Bioscience to reflect its product line, which includes OrCel, a bilayered cellular matrix of engineered tissue for chronic and acute wound healing, as well as two fibrin-derived advanced biomaterial technologies acquired in 2006. Beginning today, the company's stock will trade under the new symbol "FORB."

• Semafore Pharmaceuticals Inc., of Indianapolis, said a paper published in Cancer Research reported that SF1126, the company's lead product candidate, exhibits antitumor and antiangiogenic activity. The paper is based on preclinical studies conducted by Semafore and collaborators at Children's Healthcare of Atlanta, Emory University School of Medicine and M.D. Anderson Cancer Center. In the studies reported, SF1126 showed favorable pharmacokinetics and pharmacodynamic and potent antitumor and antiangiogenic activity in mouse models against a variety of human cancer cell types, including prostate, breast, neuroblastoma and glioblastoma.

• Somaxon Pharmaceuticals Inc., of San Diego, has completed a 26-week transgenic mouse carcinogenicity study of doxepin, the active pharmaceutical ingredient in its insomnia product candidate Silenor. Based on the results, which were not disclosed, Somaxon said it intends to proceed with the submission of a new drug application by mid-February. Somaxon has completed four successful Phase III clinical trials for Silenor.

• Tissera Inc., of Herzliya, Israel, said diabetic model experiments of pancreatic xenotransplantation successfully weaned diabetic nonhuman primates from the use of exogenous insulin. After pig embryonic pancreatic tissue was transplanted into the diabetic primates, a reduction of insulin amounts required for maintenance of near-normal blood sugar levels was observed, with less than 10 percent of starting daily insulin dose by month four after transplantation and reaching complete exogenous insulin independence at about five months, meaning that endogenous insulin production had taken over control of blood sugar levels. Further studies are under way.

• Upstream Biosciences Inc., of Vancouver, British Columbia, has entered into a collaboration with the Combinatorial Chemistry Center of the Chemistry Department of Lomonosov Moscow State University for the chemical synthesis of novel compounds that Upstream intends to test for efficacy and toxicity against tropical parasitic diseases, including malaria, leishmaniasis and African sleeping sickness, as well as for cancer indications. The center will provide Upstream with drug candidates for in vivo testing. It also has agreed to incorporate the in vivo test results from Upstream's ongoing preclinical studies to synthesize additional compounds for Upstream's chemical libraries. Upstream's initial drug candidates for leishmaniasis and trypanosomiasis have demonstrated encouraging potential in vitro, and are undergoing further preclinical testing. No financial terms were disclosed.

No Comments