¿ Alkermes Inc., of Cambridge, Mass., reported the successful completion of the first clinical trial as part of its collaboration with GlaxoSmithKline plc, of London. With the completion of the trial, the companies are proceeding with plans to develop advanced formulations of GSK¿s respiratory drugs based on Alkermes¿ AIR pulmonary drug delivery system. The single-administration, dose-escalation study in healthy volunteers was designed to test the safety, tolerability and pharmacokinetics of a formulation of an undisclosed asthma treatment.
¿ Amylin Pharmaceuticals Inc., of San Diego, reported positive results from a 12-patient Phase II study of its second diabetes drug candidate, AC2993 (synthetic exendin-4), on fasting blood glucose in people with Type II diabetes. The study showed that all three doses of AC2993 stimulated insulin secretion and lowered fasting plasma glucose in a dose-dependent manner following an overnight fast. No hypoglycemia was observed, which suggests a glucose-dependent effect. All patients were being treated with metformin or thiazolidinediones, and received AC2993 in addition to their current therapies.
¿ Avanir Pharmaceuticals Inc., of San Diego, received a $5 million licensing milestone payment from GlaxoSmith-Kline Consumer Healthcare, the consumer product division of GlaxoSmithKline plc, of London. GSK is Avanir¿s marketing partner in the U.S. for Abreva, Avanir¿s over-the-counter cold sore product. Under the terms of the agreement, Avanir receives up to $25 million in licensing fees plus royalties on sales. A total of $20 million has been paid to date, with the final $5 million expected in the fourth quarter.
¿ Avanti Polar Lipids Inc., of Alabaster, Ala., was awarded a Phase I Small Business Innovation Research grant to investigate the relationship between structural integrity and taste for a lipid nutritional supplement, known as Lym-x-sorb (LXS), developed for cystic fibrosis patients. The lipid matrix is a readily absorbable supply of essential fatty acids and phospatidylcholine that improves the clinical well-being of cystic fibrosis patients.
¿ AVI BioPharma Inc., of Portland, Ore., initiated a Phase I trial of its Neugene antisense technology. The study will evaluate the effectiveness of AVI¿s antisense drug, AVI-4557, in modifying the function of the Cytochrome P450 liver enzyme, which regulates the breakdown of approximately 50 percent of the drugs currently approved by the FDA, AVI said. In preclinical trials AVI-4557 downregulated the enzyme, favorably altering the rate at which an accompanying drug was cleared. The study will be conducted in Belfast, Ireland.
¿ Cambridge Antibody Technology Group plc (CAT), of Melbourn, UK, received four U.S. patents covering antibody expression libraries, called the Huse/Lerner/Winter patents. The patents are co-owned by the Medical Research Council, The Scripps Research Institute and Stratagene. CAT also reported filing an infringement suit alleging that MorphoSys AG and MorphoSys USA Inc. infringe two of the Huse/Lerner/Winter patents. The suit was filed in the U.S. District Court of Washington, D.C.
¿ Cepheid Inc., of Sunnyvale, Calif., said that the complaint filed by Fisher Scientific Co. LLC, of Hampton, N.H., in the U.S. District Court for the Western District of Pennsylvania against Cepheid and two of its employees, has been resolved and dismissed by agreement of both parties. Additionally, Cepheid has agreed to extend, through at least May 31, 2004, the term of its distribution agreement under which Fisher is the exclusive distributor of Cepheid¿s SmartCycler line of DNA analysis products.
¿ Endovasc Inc., of Montgomery, Texas, plans to purchase up to 1.4 million shares of its common stock. The company said it is joining other business in the U.S. in efforts to bolster the economy. Endovasc develops liposomal drug delivery technology.
¿ Epicyte Pharmaceuticals Inc., of San Diego, was awarded a $150,000 grant from the California Technology Investment Partnership for the development of the company¿s Plantibody products to prevent the sexual transmission of viral infections. Funds will be used to support Epicyte¿s greenhouse facilities and staff, as well as marketing studies.
¿ Epimmune Inc., of San Diego, granted Anosys Inc., of Menlo Park, Calif., formerly AP Cells, a nonexclusive license to certain cancer antigens for use in Anosys¿ cancer therapy program. The license covers certain patented and nonpatented rights to Epimmune¿s universal breast, colon, lung and prostate epitope packages for use in ex vivo cancer therapy. The license is worldwide, except for Japan, where Epimmune previously licensed the rights. The agreement also includes the option to acquire nonexclusive rights to an additional group of cancer antigens. Financial terms include an up-front license fee, milestones and royalties on product sales.
¿ Genzyme Corp., of Cambridge, Mass., signed a conditional agreement to acquire certain assets of Pharming N.V., of Leiden, the Netherlands, the subsidiary of Pharming Group N.V. The agreement is expected to close in October and is subject to the approval of the Commercial Court in Turnhout, the Province of Antwerp and the board of Genzyme and the receipt of a favorable soil attestation for the land. Further details were not disclosed.
¿ Human Genome Sciences Inc., of Rockville, Md., said the FDA approved its investigational new drug application to begin trials of BlyS as a potential treatment for patients with IgA (immunoglobulin-A) deficiency. HGS will move forward with a Phase I trial. BlyS is a therapeutic protein that stimulates B lymphocyte cells to develop into mature plasma B cells.
¿ InterMune Inc., of Brisbane, Calif., said the FDA approved the transfer of manufacturing of its lead product, Actimmune (interferon gamma-1b) from Genentech Inc., of South San Francisco, to Boehringer Ingelheim Austria GmbH, of Vienna, Austria. Boehringer Ingelheim currently manufactures InterMune¿s clinical supply of Actimmune for the treatment of chronic granulomatous disease and osteoporosis, and manufactures the European commercial supply of interferon gamma-1b under Boehringer Ingelheim¿s trade name, Imuken. InterMune expects the first commercial shipments in the fourth quarter. Earlier this year, the two companies partnered to develop and commercialize interferon gamma-1b. (See BioWorld Today, March 27, 2001.)
¿ Maxygen Inc., of Redwood City, Calif., published a study demonstrating the potential of its platform and recombination technologies to evolve a class of proteins with new activities. The enzymes the company created have a range of novel activities with potential commercial applications in the pharmaceutical, chemical and agriculture markets. In the September issue of Chemistry and Biology, the company described the creation of novel enzymes with specificities for triazine chemicals.
¿ Nabi, of Boca Raton, Fla., said its board approved the buyback of common stock in either the open market or private transactions for up to $5 million. The repurchases will allow the company to have treasury stock available in support of its stock option and stock purchase programs, the company said.
¿ NexMed Inc., of Robbinsville, N.Y., plans to begin two Phase III trials of Alprox-TD cream for the treatment of erectile dysfunction. The initiation of the Phase III studies follows the submission of results to the FDA from two Phase II trials that suggest the drug is effective.
¿ Orchid BioSciences Inc., of Princeton, N.J., said its GeneScreen business unit received certification from the American Society of Histocompatibility and Immunogenetics to conduct human leukocyte antigen testing on the LabMAP platform from Luminex Corp., of Austin, Texas. Orchid expects the accreditation to significantly reduce turnaround time for its HLA-DR tissue-typing services both for single-sample testing and for donor recruitment drives.
¿ Pharmos Corp., of Iselin, N.J., said the UK Medicines Control Agency approved the company¿s application for a clinical trial exemption to expand its pivotal Phase III trial of dexanabinol for traumatic brain injury into the UK. The UK is the eighth country to join the study. Pharmos expects approval to begin the study in Spain by the end of the month.
¿ Pozen Inc., of Chapel Hill, N.C., said it plans to release the results of a mouse carcinogenicity study in the first quarter of 2002 and continue discussions with the FDA regarding the agency¿s request to submit the final rat carcinogenicity study prior to approval of the company¿s new drug application (NDA). The company said it has been unsuccessful in convincing the FDA to change its earlier decision to require carcinogenicity studies in two species prior to NDA approval, despite the submission of new in vitro and in vivo genotoxicity data supporting the safety of MT 100, a potential migraine treatment. (See BioWorld Today, Feb. 22, 2001, and Jan. 29, 2001.)
¿ SafeScience Inc. and the Massachusetts Institute of Technology (MIT), both of Boston, entered a sponsored research program focusing on the expanded analysis of SafeScience¿s GBC-590 and identification of other compounds with promising biochemical and pharmaceutical activity. GBC-590 is a potential treatment for a number of cancer indications and currently is involved in Phase II trials for pancreatic and colorectal cancer.
¿ Seattle Genetics Inc., of Bothell, Wash., was awarded a research grant by the National Institutes of Health to support the company¿s development of monoclonal antibody drug conjugates for the treatment of cancer. The amount of the grant was not disclosed. Seattle Genetics develops monoclonal antibody-based therapeutics for cancer and related diseases.
¿ Sepracor Inc., of Marlborough, Mass., said its (R,R)-formoterol inhalation solution has advanced into Phase III studies for the treatment of bronchospasm in patients with obstructive airways disease. Results from the Phase II program demonstrated a significant improvement in FEV1 immediately after dosing and a duration of action up to 24 hours.
¿ SignalGene Inc., of Montreal, said its researchers identified a potential link between the estrogen-related receptor (ERR) family of orphan nuclear receptors and the pathology and treatment of breast cancer. ERRs, which are under development at SignalGene, could represent novel targets for breast cancer therapy. Study results showed that ERRs, like estrogen, regulate the activity of human breast cancer marker pS2, and that a drug recently reported by the company was shown to block ERR activation of pS2 and to inhibit growth of breast cancer cell lines lacking the estrogen receptor.
¿ Tangerine Technologies Inc., of Philadelphia, signed an agreement with ImClone Systems Inc., of New York, to license Tangerine¿s OligoBuyer. ImClone will use OligoBuyer to specify, order and track its purchases of custom-configured strands of DNA and RNA.
¿ Transgene SA, of Strasbourg, France, said its restructuring plan would reduce its staff of 195 by eliminating 30 positions. Transgene is focusing its business on the development of gene therapy products for the treatment of cancer, and plans to reorganize its research laboratories toward this new focus. Transgene management said it would provide personalized assistance to employees eliminated.
¿ Vical Inc., of San Diego, completed enrollment of 200 patients in a randomized, controlled Phase III registration trial to evaluate the safety and efficacy of Allovectin-7 for the treatment of chemotherapy-naove patients with metastatic melanoma. The company expects data to be available by the second quarter of next year. (See BioWorld Today, Feb. 12, 2001.)
¿ Viral Genetics Inc. of Pasadena, Calif., entered into an agreement and plan of exchange with 5 Starliving Online Inc., of Seattle, that provides for the acquisition of Viral Genetics in exchange for nearly 30 million shares of 5 Starliving Online. The deal is expected to close before the end of September. Viral will become a wholly owned subsidiary of 5 Starliving, and the former stockholders of Viral will own approximately 79 percent of the then-issued and outstanding common stock of 5 Starliving.