• Advanced Cell Technology Inc., of Los Angeles, said it is seeking international partners for its myoblast program for treating heart failure, its retinal pigment epithelium program for treating degenerative retinal disease and the firm's hemangioblast program for the treatment of blood and cardiovascular indications.

• Amgen Inc., of Thousand Oaks, Calif., said the European Commission approved Vectibix (panitumumab) as a monotherapy treatment in patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer with non-mutated KRAS genes after failure of standard chemotherapy regimens. Vectibix, a fully human anti-EGFR monoclonal antibody, previously received a positive opinion from the European Committee for Medicinal Products for Human Use.

• Anavex Life Sciences Corp., of Geneva, said that data from preclinical animal studies demonstrated that ANAVEX 2-73 and its active metabolite ANAVEX 19-144 have potent anticonvulsive, antiamnesic, neuroprotective and antidepressant properties. In 90 percent to 100 percent of the treated animals vs. the control group, both ANAVEX 2-73 and ANAVEX 19-144 exhibited extremely significant anticonvulsive action by providing almost complete protection from tonic seizures, the firm said. The compounds are being explored to treat epilepsy.

• Ipsen SA, of Paris, submitted a biologics license application for Dysport for injection in cervical dystonia. The product has been granted orphan drug status and its BLA is based on data from two pivotal Phase III studies in 252 patients followed up for up to 12 treatment cycles, in addition to substantial patient exposure in other clinical studies in cervical dystonia. Dysport, which contains botulinum neurotoxin Type A complex as its active ingredient, currently is marketed as Reloxin in the U.S. aesthetic market.

• Memory Pharmaceuticals Corp., of Montvale, N.J., received notice from the Nasdaq Stock Market that it is not in compliance with the $1 minimum bid price and has 180 days to address the issue. Shares of Memory slipped under a buck in October after MEM 1003 failed a Phase IIa trial in Alzheimer's disease. (See BioWorld Today, Oct. 16, 2007.)

• Nabi Biopharmaceuticals, of Rockville, Md., said its board of directors approved a $65 million share repurchase plan. The company will purchase the shares in the open market or in private transactions. Nabi reported $99.8 million in cash, equivalents and marketable securities at the end of the third quarter and gained $185 million in cash through the recent sale of its biologics assets. (See BioWorld Today, Sept. 12, 2007.)

• Onset Therapeutics, of Cumberland, R.I., submitted an application to the FDA requesting approval of a topical treatment for external genital warts. The company has opted not to disclose the product's active ingredient at this time. Onset is a wholly owned subsidiary of Collegium Pharmaceutical Inc., also of Cumberland.

• Oxford Biomedical Research Inc., of Rochester Hills, Mich., received a one-year SBIR grant from the NIH to develop a blood test for NAG-1, a protein that may be a cancer biomarker. The $100,884 grant will be used to develop a prototype assay.

• ProBioGen AG, of Berlin, agreed to license its avian cell line AGE1.CR to an undisclosed U.S. vaccine company for use in influenza and other disease areas. Financial terms were not disclosed, but ProBioGen will receive up-front and milestone payments as well as potential royalties. AGE1.CR is designed to replace embryonated chicken eggs and chicken embryonic fibroblasts as substrates for production of human and animal vaccines.

• PTC Therapeutics Inc., of South Plainfield, N.J., said it will receive an additional $1.6 million from the Spinal Muscular Atrophy (SMA) Foundation under an expanded research collaboration agreement. Payments of the funds are based on the attainment of certain milestones, the firm said. The collaboration is focused on identifying and characterizing compounds that have the potential to treat SMA by increasing production of the survival motor neuron protein, the absence of which causes SMA.

• Raven Biotechnologies Inc., of South San Francisco, said Wyeth Pharmaceuticals Inc., a division of Madison, N.J.-based Wyeth, exercised an option to extend its evaluation of selected monoclonal antibodies for potential licensure. Raven will receive an undisclosed milestone payment. Raven agreed last month to merge with VaxGen Inc., a deal that is expected to close in the first half of next year. (See BioWorld Today, Nov. 14, 2007.)

No Comments