Alexion Pharmaceuticals Inc., of Cheshire, Conn., said it and partner Procter & Gamble Pharmaceuticals, a unit of Procter & Gamble Co., of Cincinnati, have completed enrollment of about 900 patients in their first Phase II acute myocardial infarction trial with pexelizumab. The trial is known as the Comply, or Complement Inhibition in Myocardial Infarction Treated with Thrombolytics.
Antex Biologics Inc., of Gaithersburg, Md., extended its product development agreement with the Walter Reed Army Institute for Research bioproduction facility through the end of 2003. Antex will use the Army’s Silver Spring, Md., GMP-compliant production facility to manufacture clinical trial materials. The collaboration will include manufacturing seed banks and Phase I clinical trial material for the Tracvax vaccine against Chlamydia trachomatis, and Phase III material for the Helivax vaccine against Helicobacter pylori, as well as material for other vaccines, as required.
Array BioPharma Inc., of Boulder, Colo., signed a series of nonexclusive agreements to provide Pfizer Inc., of New York, with chemical compounds from the Array Discovery Platform for its internal drug discovery program. Financial details were not disclosed.
Chiron Corp., of Emeryville, Calif., and Berlex Laboratories Inc., the U.S. affiliate of Schering AG, of Berlin, reported the FDA approved a new room-temperature formulation of Betaseron (interferon beta-1b) for subcutaneous injection. The companies said that it would be the only therapy for multiple sclerosis available as a room-temperature formulation. It is expected to be available to patients mid-year.
Boston Biostatistics Inc., of Framingham, Mass., said it will change its name to Averion. The company is a contract research organization.
Corixa Corp., of Seattle, granted Beaufour Ipsen Group, of Paris, exclusive worldwide rights to develop and market its AnergiX.MG technology for the treatment of myasthenia gravis, a chronic autoimmune neuromuscular disease. Beaufour Ipsen will pay Corixa an up-front license fee, guaranteed research support, success-based milestone payments and royalties. Further details were not disclosed. Separately, Corixa said it was notified by the FDA that the Oncologic Drugs Advisory Committee will discuss the appropriate study design and control for a second proposed Phase III trial of its Melacine melanoma vaccine on Feb. 27. Corixa’s presentation will include results from its first Phase III trial. In October, Corixa announced that FDA approval would require a second Phase III trial in class I MHC HLA- and C3-positive patients.
Crucell NV, of Leiden, the Netherlands, granted Boston-based Lexigen Pharmaceuticals Corp. a nonexclusive license for Crucell’s human cell system, PER.C6, which Lexigen will use for research and development of therapeutics in oncology. Crucell will receive up-front and annual payments, while Lexigen has an option for a commercial license. Further financial details were not disclosed.
Cumbre Inc., of Dallas, a spin-off from Tularik Inc., of South San Francisco, has moved into new facilities in Dallas. The 17,000-square-foot research and development facility includes 11,000 square feet of research laboratory space, 6,000 square feet of offices, and 6,000 square feet remaining for expansion. (See BioWorld Today, Sept. 21, 2001.)
DeCode Genetics Inc., of Reykjavik, Iceland, formed a pharmacogenomics alliance with Pharmacia Corp., of Peapack, N.J., to identify the role of genetics in the development of advanced forms of heart disease. DeCode will employ its population resources and Clinical Genome Miner discovery system to find genetic markers that can be used to identify patients who are highly predisposed to progressing from an early to an advanced form of heart disease. The companies then expect to use the information as the basis for clinical trials. The trials would then indicate genetic markers in identifying patients likely to benefit from cardiovascular drugs under development at Pharmacia.
Genaissance Pharmaceuticals Inc., of New Haven, Conn., completed enrollment of its second prospective clinical trial, Strength II (Statin Response Examined by Genetic HAP Markers), designed to evaluate the cholesterol-lowering drug lovastatin (Mevacor 1). Strength II data are expected in the second half of this year. The Strength studies are designed to link Genaissance’s markers of human gene variation to statin clinical response for the development of novel therapeutic and diagnostic products. Drugs under investigation in the Strength I study are Zocor, Lipitor, Pravachol and Baycol.
Genencor International Inc., of Palo Alto, Calif., and Epimmune Inc., of San Diego, identified an EpiGene clinical product candidate for the lead program in their collaboration, a therapeutic hepatitis B vaccine. As a result, Epimmune received an undisclosed milestone payment. In July, Genencor exclusively licensed Epimmune’s epitope and Padre technologies and related intellectual property rights on a worldwide basis for vaccines to treat or prevent hepatitis C, hepatitis B and human papillomavirus. The companies entered a 30-month collaboration to develop therapeutic vaccines for these three viral indications. (See BioWorld Today, July 11, 2001.)
Introgen Therapeutics Inc., of Austin, Texas, entered into a multiyear agreement with Biogen Inc., of Cambridge, Mass., to provide process development and manufacturing services for therapeutic gene delivery systems. Introgen will generate materials and make recommendations to support Biogen’s product development activities in gene therapy. Financial terms were not disclosed. Introgen recently was selected to manufacture the worldwide reference material to be used by companies and academic institutions developing adenovirus-based products based on an award from the Williamsburg BioProcessing Foundation, as advised by the Office of Cellular and Gene Therapies of the FDA. Introgen said it owns the world’s largest safety database.
Pharsight Corp., of Mountain View, Calif., said Cephalon Inc., of West Chester, Pa., has become a new customer for the Pharsight Knowledgebase Service product and other population modeling and simulation software. The service is designed to help enable drug companies to better manage and control pharmacokinetic data in compliance with the FDA’s new regulation, 21 CFR Part 11.
Pheromone Sciences Corp., of Toronto, completed the sale via private placement of 410,000 special warrants at an issue price of C55 cents per special warrant for gross proceeds of C$225,500 (US$141,958). Each special warrant will be exercisable into one common share and one common share purchase warrant. Each warrant has a term of 18 months and will be exercisable into one common share at C70 cents per share. Proceeds will be used to support research and development and ongoing operations.
PhotoCure ASA, of Oslo, Norway, submitted a marketing authorization application to the Swiss authorities for Metvix PDT (photodynamic therapy) for the treatment of basal cell carcinoma and actinic keratosis. Metvix PDT already is launched in Sweden and approved in 13 other European countries, with applications pending in Australia, New Zealand and the United States. PhotoCure licensed the rights to promote and sell Metvix outside the Nordic area to Galderma SA, a 50/50 joint venture of L’Oreal and Nestl .
Prescient NeuroPharma Inc., of Toronto, said it identified a proprietary compound (PRE703) from its library that demonstrated positive results in an animal model of anxiety. Prescient plans to complete its preclinical characterization and file an investigational new drug application before Dec. 31. The company said the molecule addresses anxiety through a non-benzodiazepine mode of action and that it is a very specific metabotropic glutamate modulator, not interfering with other metabolic brain pathways.
Proteome Sciences plc, of Cobham, UK, reported that Intronn Inc., of Raleigh, N.C., its major shareholder, has successfully used a new approach to correct the gene defect that causes cystic fibrosis. Intronn scientists and their University of Iowa collaborators used Intronn’s SMaRT (spliceosome mediated RNA trans-splicing) technology to correct the defect at the mRNA level. Using SMaRT reagents, Iowa scientists partially restored normal chloride ion transport to the mutant CFTR protein in airway cells obtained from patients with cystic fibrosis. The CFTR protein normally transports chloride ions across cell membranes to maintain electrolyte and fluid balances in cells.
Restoragen Inc., of Lincoln, Neb., appointed Ashleigh Palmer as CEO. Palmer brings more than 18 years of corporate leadership, marketing and business development experience in the biotech and pharmaceutical industries. Most recently, Palmer served as president and CEO of INO Therapeutics Inc., where he led the global development and commercialization of the selective pulmonary vasodilator, INOmax. Palmer replaces Thomas Coolidge, who will continue to serve as nonexecutive chairman.
Silicon Genetics, of Redwood City, Calif., said AstraZeneca plc, of London, licensed its enterprise-wide products, GeneSpring, GeNet and Script Editor, designed for a genomics discovery platform. Used together, these products allow for management of gene expression results, with central data storage and desktop applications.
ViaCell Inc., of Boston, received FDA clearance to begin clinical trials for its patented stem cell expansion technology, Selective Amplification. This proprietary process combines techniques for cell purification and cell culture that yield a significantly increased number of defined, pharmaceutical-grade stem cell populations from cells found in umbilical cord blood, bone marrow and peripheral blood. Stem cells from these sources are used to repopulate the blood and immune systems of patients who have undergone high-dose chemotherapy.