¿ Atrix Laboratories Inc., of Fort Collins, Colo., released results from its Phase III study of Leuprogel Three-Month Depot for the treatment of advanced prostate cancer. Atrix will submit a new drug application later this year for the product. It earlier submitted for approval of a one-month formulation. The Phase III trial involved 117 patients and showed 100 percent suppression of serum testosterone to very low levels. Also, mean PSA levels were decreased to low-single-digit levels and no serious treatment-related adverse events were recorded.
¿ Biovail Corp., of Warren, N.J., and Celgene Corp., of Toronto, filed a new drug submission with Canada¿s Therapeutic Products Program for d-methylphenidate (d-MPH), Celgene¿s chirally pure version of dl-methylphenidate for the treatment of attention deficit disorder. The companies expect approval in 18 to 24 months. Celgene granted Biovail exclusive Canadian marketing rights for d-MPH in exchange for licensing fees and royalties. Celgene licensed the rights to d-MPH in all other markets to Novartis Pharma AG, which will promote the drug under the trade name Ritadex.
¿ Blue Heron Biotechnology Inc., of Bothell, Wash., obtained an exclusive worldwide license to a gene synthesis patent issued to Amgen Inc., of Thousand Oaks, Calif. The patent, No. 4,652,639, was issued to Amgen in 1987. The patent describes procedures for the synthesis of linear double-stranded DNA. Blue Heron is the sole licensee and has the right to sublicense, although Amgen retains rights to practice under the patent.
¿ Collateral Therapeutics Inc., of San Diego, completed the expansion of its Research and Development Center. The new facility increases the company¿s manufacturing and other capabilities for the advancement of preclinical research and development programs in cardiovascular-related diseases. The facility doubled in size to 22,000 square feet and will accommodate approximately 50 employees.
¿ Endovasc Ltd. Inc., of Montgomery, Texas, signed a nonbinding letter of intent to purchase Intermed 2000 Inc., of Israel, a life science company that promotes women¿s health through wellness centers, medical technology companies and its web site. Endovasc is a biopharmaceutical company focused on developing liposomal drug delivery technology.
¿ Genzyme Diagnostics, a unit of Genzyme General, of Cambridge, Mass., and SYN-X Pharma Inc., of Mississauga, Ontario, entered an agreement to develop, manufacture and commercialize a technology for diagnosing, distinguishing, managing and monitoring stroke. This agreement supercedes prior agreements between the businesses regarding this technology and resolves all disputes between them. Financial terms were not disclosed.
¿ Introgen Therapeutics Inc., of Austin, Texas, received $25 million from Aventis Pharma AG, of Frankfurt, Germany, through the purchase of non-voting Introgen preferred stock, convertible into common stock at $10.67 per share. The transaction differs from the terms of a letter of intent announced in April in that Introgen has decided to forego a 5 percent equity interest in the proposed Aventis spinout, Gencell, in favor of increasing Aventis¿ investment in Introgen to $25 million. The transaction gives Introgen worldwide commercial rights to p53-based gene therapy products developed during the companies¿ six-year collaboration, including INGN 201, which currently is in Phase III trials for the treatment of head and neck cancer, Phase II trials for lung cancer, and Phase I trials for other cancer indications. (See BioWorld Today, April 4, 2001.)
¿ Lexicon Genetics Inc., of The Woodlands, Texas, and Oriental Yeast Co., of Tokyo, extended and expanded their marketing collaboration and distribution agreement. The expanded terms call for Oriental Yeast to assist Lexicon in the promotion of its LexVision database to Japanese pharmaceutical companies and in marketing Lexicon¿s drug target validation technologies in the Japanese market. Financial terms were not disclosed. LexVision is one of the world¿s largest repositories of new information on in vivo mammalian gene function for drug discovery, the company said.
¿ LifeCell Corp., of Branchburg, N.J., completed a $6 million private financing. Equity funds managed by OrbiMed Advisors LLC purchased $4.5 million of the total offering, and Special Situations Funds, one of LifeCell¿s existing investors, purchased the remaining $1.5 million. The financing consisted of the private placement of 3.125 million shared of its common stock and warrants to purchase 1.75 million shares of common stock for $1.92 per share. The company said proceeds will be used to continue product development, expand sales and marketing for current products, for potential acquisitions, and for working capital.
¿ MitoKor, of San Diego, formed a partnership with the University of California, San Diego, funded by a Life Sciences Informatics Grant from the university¿s Industry University Cooperative Research Program. The grant will be used to fund research to develop computational tools to identify and decipher the function of mitochondrial proteins, exploring the role of the proteins in human disease. This is the fifth grant MitoKor has received for work with the university.
¿ M-phasys GmbH, of T|bingen, Germany, signed a two-year collaborative agreement with Bayer AG, of Leverkusen, Germany, to discover active ingredients acting on membrane protein targets. M-phasys will use its M-Fold technology to develop assay systems for high-throughput screening. Financial details were not disclosed.
¿ Pain Therapeutics Inc., of South San Francisco; VI Technologies Inc., of Watertown, Mass.; and Applied Molecular Evolution Inc., of San Diego, were all added to the Russell 3000 Index. La Jolla Pharmaceutical Co., of San Diego; Seattle Genetics Inc., of Bothell, Wash.; Insmed Inc., of Richmond, Va.; Dendreon Corp., of Seattle; and InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., were added to the Russell 3000 Index and the Russell 2000 Index. MacroChem Corp., of Lexington, Mass., was added to the Russell 2000 Index.
¿ Penwest Pharmaceutical Co., of Patterson, N.Y., agreed to sell 2.4 million shares of its newly issued common stock to institutional and other accredited investors for $30 million. The $12.25-per-share price is roughly a 15 percent discount to a 20-prior-day average trading price. Prior to the transaction, the company had 12.7 million shares outstanding. The proceeds from the sale will be used to fund the development of additional drug delivery programs, as well as research and development of new oral drug delivery technology.
¿ SangStat Inc., of Fremont, Calif., said subsidiary IMTIX-SangStat was awarded a EUR2.6 million (US$2.2 million) European grant to study next-generation compounds of RDP58 in inflammation. The grant will fund research using a variety of techniques, including rational drug design, modification of the mouse genome, gene transfer, signal transduction and disease models. RDP58 is a small molecule that inhibits tumor necrosis factor synthesis.
¿ SciClone Pharmaceuticals Inc., of San Mateo, Calif., received expanded indications in Mexico for its Zadaxin immune system enhancer. The company now can market Zadaxin for the treatment of hepatitis C and B, as well as for use as an influenza adjuvant, for which it originally was approved. This is SciClone¿s first approval for hepatitis in North America. There currently is a Phase III trial under way in the U.S. combining Zadaxin with pegylated alpha interferon.
¿ Sepracor Inc., of Marlborough, Mass., sold shares of Rockland, Mass.-based BioSphere Medical Inc. common stock in connection with a public offering by BioSphere of 4 million shares at $11 per share. Sepracor and BioSphere each sold 2 million shares. Sepracor also granted underwriters an option to purchase up to an additional 600,000 shares to cover any overallotments. Sepracor said it would use the proceeds from the sale for the development and commercialization of existing and proposed products; to enhance sales, marketing and manufacturing capabilities; and for general corporate purposes.
¿ Sepragen Corp., of San Leandro, Calif., is executing a plan to restructure its existing business. The company said that the key to the plan is separation and spinout of its biotech and neutraceutical businesses. The company said each of the businesses represents a large growth opportunity and will require separate management focus. The biotech component will focus on developing a line of systems and consumables for high-throughput clinical development and manufacturing of biological drugs.
¿ Sequenom Inc., of San Diego, sold five of its Mass-ARRAY systems. BioServe Biotechnologies Ltd., Centagenetix, Indiana School of Medicine, LGC (Teddington) Ltd., and an undisclosed party purchased the system, which is used to analyze genes to determine their association to disease and to accelerate genetics-based diagnostics and drug development. These sales bring the total number of systems sold during the second quarter to nine.
¿ YM BioSciences Inc., of Mississauga, Ontario, said the Health Products and Food Protection Branch of Canada approved YMB¿s investigational new drug application to conduct a Phase I/II study of its epidermal growth factor receptor antibody, TheraCIM h-R3, in conjunction with radiotherapy in patients with brain cancer resulting from metastases from non-small-lung cancer. TheraCIM h-R3 is a humanized monoclonal antibody tyrosine kinase inhibitor.
¿ Targeted Genetics Corp., of Seattle, said an interim safety analysis of its ongoing Phase II trial of tgAAVCF in patients with cystic fibrosis determined there have been no serious adverse events related to the product that would warrant discontinuation of the study. An independent data and safety monitoring committee also determined the age limit for participation in this study could be lowered from 18 to 15. A complete efficacy analysis will be undertaken once the study is completed and unblinded. Celltech Group plc, of Abingdon, UK, is collaborating with Targeted Genetics on the development of tgAAVCF.
¿ ViroLogic Inc., of South San Francisco, said that a new generation of its drug-resistance assay, PhenoSense HIV, is nearly 10 times more sensitive than other commercially available drug resistance assays, according to research presented at the International AIDS Society Conference on HIV Pathogenesis and Treatment in Buenos Aires, Argentina. The new assay will be available in the fourth quarter. According to ViroLogic, the enhanced sensitivity of the new assay will help physicians identify and address emerging HIV drug resistance in patients with low viral loads, who previously have been unable to benefit from resistance testing.
¿ Visible Genetics Inc., of Toronto, received licenses for its Trugene HIV-1 genotyping test and hardware from the Therapeutics Product Directorate of Health Canada. Each individual component of the OpenGene system is filed and reviewed separately in Canada. Visible Genetics has received licenses for all components except for the software that generates the reports, although that is expected by the fourth quarter. Until then, the hardware and kits can be sold for routine clinical or research use in Canada, the company said.