¿ Aclara BioSciences Inc., of Mountain View, Calif., filed its response to claims by Caliper Technologies Corp., also of Mountain View, that Aclara infringed certain patents naming J. Michael Ramsey as inventor and allegedly licensed to Caliper. Aclara denies that it infringes any of the patents and asserts the Ramsey patents are invalid. In a counterclaim, Aclara alleges the patents should not be enforceable because the named inventor failed to disclose conflicts of interest.
¿ Affymetrix Inc., of Santa Clara, Calif., entered into an AcademicAccess Preferred agreement with AMDeC, of New York. Through the agreement, medical schools, health centers and research institutions that are part of AMDeC will gain access to Affymetrix¿ GeneChip arrays, instrumentation and software to monitor gene expression.
¿ Alexion Pharmaceuticals Inc., of New Haven, Conn., said it filed an investigational new drug application with the FDA to begin a Phase Ib pilot clinical trial with its anti-inflammatory complement inhibitor drug candidate 5G1.1 in patients with pemphigoid, a severe inflammatory skin disorder.
¿ Alteon Inc., of Ramsey, N.J., said it initiated a Phase IIa trial of its novel therapeutic agent, ALT-711, which has shown potential to reverse age-related cardiovascular disease and restore the cardiovascular system to a more youthful state by cleaving pathological protein-glucose structures called Advanced Glycosylation End-product Crosslinks. The double-blind, placebo-controlled study will involve 72 men and women over age 50 whose cardiovascular systems show measurable stiffening due to aging and/or diabetes.
¿ Atugen AG, of Berlin, said it signed a research collaboration agreement with Boehringer Ingelheim, of Ingelheim, Germany to exploit Atugen¿s rapid, high quality gene target validation services. Boehringer Ingelheim will provide Atugen with gene target sequences and specific cell lines, and Atugen will provide delivery optimization to the cell lines and develop GeneBloc reagents to inhibit the expression of the target genes.
¿ Aurora Biosciences Corp., of San Diego, and Organon, of Oss, the Netherlands, entered into a three-year agreement to develop high-throughput drug discovery screening assays for key molecular target classes, including orphan G protein-coupled receptors, ion channels and enzymes. Organon will gain access to aspects of Aurora¿s ion channel technology platform, including its Voltage Ion Probe Reader. Aurora then will develop assays for Organon research facilities in the Netherlands and Scotland, receiving up-front and annual payments, as well as milestone and royalty payments. Organon has an option to have Aurora perform screening on its ultra-high throughput screening system (UHTSS) platform.
¿ Avanir Pharmaceuticals, of San Diego, said its stock began trading on the American Stock Exchange on Thursday under the symbol AVN.
¿ Avax Technologies Inc., of Kansas City, Mo., said its Australian joint venture, Avax Australia Pty. Ltd., received an additional $3 million investment from Neptunus International Holdings Ltd., which was renamed Australian Vaccine Technologies Ltd. (AVT). Avax Australia has now received a total of $7 million from AVT for a 35 percent interest in the joint venture entity.
¿ Axonyx Inc., of Stockholm, Sweden, said findings suggest its proprietary ¿beta-sheet breaker¿ compounds provide a novel strategy to inhibit and dissolve amyloid deposits in the brain. The preclinical study conducted in rats suggests the compounds have the potential to slow and reverse the deposition of amyloid in Alzheimer¿s disease.
¿ BioTransplant Inc., of Charlestown, Mass., said enrollment and treatment began in a multicenter Phase I/II trial of the AlloMune Cancer System under and investigational new drug application for the treatment of therapy-refractory Hodgkin¿s and non-Hodgkin¿s lymphoma. The system is being designed to re-educate the body¿s immune system to accept foreign cells with the potential to produce powerful antitumor effects and minimize the occurrence of severe graft-vs.-host disease.
¿ British Biotech plc, of Oxford, England, and CareScience Inc., of Philadelphia, signed a five-year collaboration for the provision of strategic information services in the field of oncology. The two companies will develop a Web-based analytical tool for acquiring, managing and evaluating clinical data in the field of oncology. British Biotech will have exclusive use of the technology for a time and will pay development and service fees of US$1.5 million over the first three years of the collaboration.
¿ Covance, of Princeton, N.J., and Variagenics Inc., of Cambridge, Mass., said they achieved the first milestone in their collaborative agreement, with Variagenics completing 17 validated genotyping assays for incorporation into clinical trial designs for Covance¿s pharmaceutical customers. The assays will be used to identify genetic variances, predicting responses of patients to specific classes of drugs.
¿ Genentech Inc., of South San Francisco, said it purchased a cell culture manufacturing facility in Porrino, Spain, from Glaxo Wellcome Biofarma SA. The facility has been established as a wholly owned subsidiary company called Genentech Espana SL and will supplement Genentech¿s existing bulk cell culture production capacity.
¿ Genometrix Inc., of The Woodlands, Texas, said Procter & Gamble Pharmaceuticals joined the company¿s GenoVista Partnership Program, gaining access to Genometrix¿s high-throughput microarray fabrication and hybridization services for genotyping and gene expression profiling.
¿ Gliatech Inc., of Cleveland, said the FDA agreed to review ADCON-P under the premarket approval (PMA) application modular review process. The company also said the FDA accepted the first module of the modular PMA, which contains the administrative information.
¿ Hemosol Inc., of Toronto, signed a five-year renewable agreement with Pennsylvania Plasma, a division of Sera-Tec Biologicals Ltd. Partnership, of North Brunswick, N.J., to source in the U.S. human red blood cells (RBCs) used in the production of Hemolink. Pennsylvania Plasma will source RBCs from centers in the U.S. and work closely with Hemosol to identify other sources of human RBCs. Hemosol also said it has closed on a $20.1 million bought deal financing. The proceeds are earmarked for the construction of a new 200,000 unit commercial manufacturing facility to produce Hemolink.
¿ Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, said its Phase I trials with IPL576,092 showed positive results as an oral asthma therapy under development in collaboration with Aventis Pharma. Data from the trials indicate the drug is safe and well tolerated at the doses studies. The company plans to initiate Phase IIa studies in the middle of the year.
¿ MGI Pharma Inc., of Minneapolis, said interim Phase II results for irofulven in ovarian cancer showed that five of 15 evaluable patients experienced a partial response of greater than a 50 percent reduction in measurable tumor mass. Two other patients experienced stable disease. The other eight patients discontinued treatment due to malaise and fatigue and progressive disease. Other side effects were bone marrow suppression and mild to modest nausea and vomiting.
¿ Nabi, of Boca Raton, Fla., said it received notice from the National Institute on Drug Abuse that Nabi¿s grant application has been recommended for funding. The award, totaling $776,000 in the first year, will go toward a four-year project to conduct late preclinical studies and human trials evaluating the safety and efficacy of Nabi¿s vaccine against nicotine, Nabi NicVAX (nicotine conjugate vaccine), in the treatment and prevention of nicotine dependence.
¿ NeoTherapeutics Inc., of Irvine, Calif., said it received clearance from the FDA to initiate an open-label extension to its ongoing U.S. Phase IIb trial of Neotrofin in patients with mild to moderate Alzheimer¿s disease. The ongoing trial was designed to study the effects of Neotrofin in patients administered either a 150-milligram dose or placebo over a course treatment of 90 days. The open-label extension will allow patients to remain on the study medication for at least an additional year following the trial.
¿ Neurocrine Biosciences Inc., of San Diego, said Janssen Pharmaceutica, of Beerse, Belgium, intends to substitute its lead CRF antagonist with a Neurocrine/Janssen back-up compound resulting from the expanded research collaboration entered in 1999. The decision to discontinue further development of R121919 was based on observations of reversible increases in liver enzymes in two volunteers participating in an expanded safety trial in the UK. Neurocrine said a Phase I trial is scheduled to begin in the second half of this year for its unpartnered CRF antagonist compound for anxiety and depression.
¿ Nortran Pharmaceuticals Inc., of Vancouver, British Columbia, said it will receive funding from the Science Council of British Columbia through the province¿s Technology BC program. The funding will help the company set up an in-house molecular electrophysiology program to advance its current anti-arrhythmic research.
¿ Orquest Inc., of Mountain View, Calif., and Biopharm GmbH, of Heidelberg, Germany, entered into an exclusive agreement under which they will apply the latest advances in biotechnology and matrix chemistry to develop proprietary products for spine, fracture, dental and cartilage repair. Biopharm will contribute MP52, a novel recombinant growth factor, while Orquest will contribute its materials and know-how for developing and assembling combinations of growth factors and matrices. The first product, HealosMP52, is expected to enter clinical studies shortly in the U.S. and Europe for spinal fusion in collaboration with Sulzer Spine-Tech.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., and Yale University said preclinical data of the anticancer agent VNP40101M demonstrated broad antitumor activity against leukemia, melanoma, lung and colon carcinomas in animal models. The agent, which is part of the sulfonyl hydrazine prodrug class, showed excellent penetration across the blood brain barrier with antitumor activity against leukemia in the brain and activity against tumor cells resistant to standard alkylating agents. The company and university also said that while Vion¿s unarmed TAPET bacteria and radiotherapy alone slowed tumor growth and prolonged survival, the combination of the two prolonged survival as much as 50 percent over the best results obtained with radiotherapy alone. The therapy was evaluated against solid tumor models, such as melanoma, mammary and colon carcinomas in mice.