Anika Therapeutics Inc., of Woburn, Mass., renewed its contract with Boehringer Ingelheim Vetmedica Inc., a subsidiary of Boehringer Ingelheim Corp., of Ridgefield, Conn., to market Anika's Hyvisc product. Hyvisc is an injectable, high-molecular-weight hyaluronic acid-based product used in the treatment of joint dysfunction in horses with equine osteoarthritis. The contract extends exclusive U.S. marketing rights to Boehringer through May 2006.
Ariad Pharmaceuticals Inc., of Cambridge, Mass., said that Ariad, the Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research and the president and fellows of Harvard College filed a patent infringement lawsuit against Eli Lilly and Co., of Indianapolis. The group alleges infringement by Lilly of the newly issued U.S. patent covering methods of treating human disease by regulating NF-kB cell-signaling activity. The lawsuit, filed in the U.S. District Court for the District of Massachusetts in Boston, alleges infringement by Lilly through its sales of the therapies Evista and Xigris and seeks monetary damages from Lilly.
Arrow Therapeutics Ltd., of London, entered a collaboration with Toyama Chemical Co. Ltd., of Tokyo, to discover antifungal compounds targeting Candida, Aspergillus and other causes of systemic fungal infections. Arrow will provide the target protein and the screening assay. Initial screening will be done using Arrow's selected in-house chemical library and enzyme kinetics, and the resulting lead compounds will be jointly chosen. Toyama Chemical will be responsible for all the formal preclinical studies and the medicinal chemistry. The target is known as AROM and is part of the Aro pathway. The deal gives Toyama rights to the Japanese and Pacific Rim markets for any successful compounds, while Arrow retains the rights to European and U.S. markets.
Biogen Inc., of Cambridge, Mass., saw its product, Avonex, examined in a subgroup of multiple sclerosis patients. A study presented at the 12th annual meeting of the European Neurological Society in Berlin showed that early treatment with Avonex (interferon beta-1a) can reduce the rate at which individuals at particularly high risk for the disease develop clinically definite multiple sclerosis. The subgroup results suggest there is a greater benefit of treatment with Avonex for patients with more disease activity as measured by MRI.
Biopure Corp., of Cambridge, Mass., appointed Thomas Moore president, CEO and a board member, effective in early August. Moore previously was president and CEO of Nelson Communications Worldwide, a member of the Publicis Groupe SA, of Paris. Current President and CEO Paul Looney will retire in mid-August and then act as a consultant to the company. Charles Sanders was elected chairman. Carl Rausch was elected chief technology officer and vice chairman of the board.
BioXell SpA, of Milan, Italy, said the May issue of The American Journal of Respiratory and Critical Care Medicine published a study on the identification of the receptor CXCR3 as a protein associated with the inflammatory process underlying chronic obstructive pulmonary disease. CXCR3 is a member of a family of receptors that allow the cells responsible for the inflammatory process to migrate from the blood to tissues at sites of inflammation, in this case, the lung.
Connetics Corp., of Palo Alto, Calif., initiated a Phase III trial of Actiza, a formulation of 1 percent clindamycin in the company's foam delivery system for the treatment of acne. The Phase III program will consist of two pivotal trials in which patients will be treated for 12 weeks in double-blinded, placebo- and active-controlled format. The program is designed to include about 1,000 patients at more than 15 centers. Connetics plans to submit a new drug application to the FDA in late 2003.
Cytyc Corp., of Boxborough, Mass., said the Federal Trade Commission agreed not to institute suit to block Cytyc's proposed acquisition of Digene Corp., of Gaithersburg, Md., at this time. However, Cytyc must provide the FTC with written notice 10 business days before the acquisition is to be consummated, at which time the FTC would be free to institute suit. In February, Cytyc said it planned to acquire Digene in a deal then valued at $554 million. (See BioWorld Today, Feb. 20, 2002.)
DeCode genetics Inc., of Reykjavik, Iceland, said a team of its scientists located a gene related to high blood pressure. The gene was mapped to a small region on chromosome 18, which previous studies suggest may play a role in blood pressure regulation in humans, mice and rats. An article authored by the DeCode team and collaborating cardiologists from Iceland's National University Hospital is published in the latest edition of the American Heart Association journal Hypertension.
F2G Ltd., of Manchester, UK, entered an agreement with Genome Therapeutics Corp., of Waltham, Mass., to discover antifungal drugs. F2G will use Genome Therapeutics' in-house compound library and F2G's antifungal whole-cell assay screening capabilities to identify specific compounds with activity against human fungal pathogens. Genome Therapeutics retains rights to the compounds. Financial details were not disclosed.
Invitrogen Corp., of San Diego, launched the ORFeome BioCharter Program, a subscription-based service platform that provides scientists tools for drug discovery research. The company said its goal is to build the human ORFeome into a system that facilitates functional analysis. The BioCharter Program is part of Invitrogen's platform designed to bridge genomic and proteomic research.
Islet Technology Inc., of St. Paul, Minn., said Artium Technologies Inc., its wholly-owned engineering subsidiary, received a $750,000 Phase II Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. The grant will fund Artium's work on a project that is part of Islet's efforts to encapsulate insulin-producing islets for transplantation to cure Type I diabetes.
Isotechnika Inc., of Edmonton, Alberta, enrolled 200 patients in the Phase II trial evaluating its lead drug, ISATX247, as a potential treatment therapy for moderate to severe psoriasis. ISATX247 is being developed under a global collaboration agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, signed in April and valued at more than $400 million. The trial is a double-blind, randomized study with 80 patients, and will continue for 90 days. (See BioWorld Today, May 13, 2002, and April 10, 2002.)
Large Scale Biology Corp., of Vacaville, Calif., and StemCell Technologies Inc., of Vancouver, British Columbia, entered a collaborative agreement to jointly explore applications of LSBC's Plurigen CM stem and progenitor cell cultivation product. Plurigen is a stabilized formulation of hematopoietic growth factors inhibiting proliferative activity on a variety of stem and progenitor cells.
MGI Pharma Inc., of Minneapolis, and its partner, Helsinn Healthcare SA, of Lugano, Switzerland, presented results from a Phase III trial of palonosetron in patients with chemotherapy-induced nausea and vomiting. The results were presented at the Multinational Association of Supportive Care in Cancer's 14th International Symposium in Boston. Results reported from the multicenter, randomized, double-blind trial comparing palonosetron to an approved 5-HT3 receptor antagonist in patients receiving moderately emetogenic chemotherapy demonstrated that a single intravenous dose of palonosetron achieved statistical significance for both primary and secondary endpoints. Palonosetron is a 5-HT3 receptor antagonist with a plasma half-life of about 40 hours. The company, which had released preliminary positive data in April, said it expects to file a new drug application for the product in the third quarter. (See BioWorld Today, April 18, 2002.)
Nymox Pharmaceutical Corp., of Maywood, N.J., filed an investigational new drug application with the FDA for the company's prostate drug candidate, NX-1207. NX-1207 is designed to treat benign prostatic hyperplasia.
Pharmacopeia Inc., of Princeton, N.J., achieved a milestone in its lead discovery collaboration with NV Organon, of Oss, the Netherlands. Pharmacopeia identified a lead series of active compounds against an Organon target, resulting in a payment by Organon to Pharmacopeia. Pharmacopeia is screening its available internal sample collection, now numbering more than 4 million small molecules, against targets chosen by Organon. Organon received a license to the active compounds identified by Pharmacopeia and will pursue additional chemical optimization. (See BioWorld Today, Feb. 14, 2002.)
Pharming Group NV, of Leiden, the Netherlands, entered an agreement with GTC Biotherapeutics Inc., of Framingham, Mass., to accelerate commercialization of its recombinant protein technology. The companies cross-licensed technology patents for the production of therapeutic proteins. Pharming will receive an up-front payment of €1.5 million (US$1.5 million) from GTC and royalties on products developed by GTC using Pharming's technology. GTC also granted rights to its monoclonal antibody technology to Pharming, under certain conditions and for certain territories.
PPD Inc., of Wilmington, N.C., made an equity investment in BioDelivery Sciences International Inc., of Newark, N.J. PPD bought 690,000 units in BioDelivery's recent public offering. Each unit consists of one share of BioDelivery common stock and one warrant to purchase common stock. The total investment is valued at about $3.6 million. BioDelivery's cochleate drug delivery vehicles are rolls or stacks of lipids that provide a platform for oral and systemic drug delivery.
ProMetic Life Sciences Inc., of Montreal, said the collaboration between its Cambridge, UK-based subsidiary, ProMetic BioSciences Ltd., and Menarini Biotech, of Florence, Italy, reached a milestone by developing a new scaleable purification process for Amediplase, a thrombolytic agent designed to treat acute myocardial infarction. Amediplase is a recombinant tPA-urokinase fusion protein and is expected to enter Phase III trials shortly, the company said.
Protalex Inc., of Albuquerque, N.M., said it named William Hitchcock chairman. Hitchcock is a director of Plains Resources Inc. and Thoratec Corp. Protalex developed a bioregulator compound, called PRTX-001, for the treatment of rheumatoid arthritis and other autoimmune diseases.
Santarus Inc., of San Diego, began a Phase III trial of Acitrel to compare the efficacy of its oral delivery to intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill adult patients. Santarus expects to enroll about 300 patients in 50 centers in the U.S. Endpoints will be the occurrence of clinically significant bleeding and gastric pH levels, plus safety and tolerability. Santarus also intends to evaluate other dosage formulations and pursue additional indications for Acitrel relating to upper GI diseases and disorders. Acitrel combines omeprazole, a proton pump inhibitor, with an antacid (sodium bicarbonate) in an immediate-release formulation as a suspension powder.
Syn X Pharma Inc., of Toronto, enrolled its first U.S. patient in a trial using its blood test for detecting Alzheimer's disease. The trial will be conducted at six centers in the U.S. and three in Canada. About 530 patients will be enrolled and the trial is expected to finish within a year. Syn X also focuses on therapeutics using its Proteomics Discovery Platform.