¿ Agilent Technologies Inc., of Palo Alto, Calif., released its Mouse cDNA Microarray Kit (G4104A), featuring sequence-verified cDNA clones from Incyte Genomics Inc., also of Palo Alto. This microarray is the third in a series of genome-screening kits that provide researchers with genomic information to discover new drugs and diagnose diseases. The cDNA kit gives researchers the ability to conduct large-scale, differential gene expression screens on over 8,500 mouse genes in a single microarray experiment.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., submitted an abbreviated new drug application following a successful clinical trial for approval of a generic formulation of an undisclosed dermatology product. Current U.S. sales of the innovator product exceed $150 million annually, Atrix said.
¿ AVI BioPharma Inc., of Portland, Ore., initiated a Phase I/II study of its antisense drug, AVI-4126, in patients with polycystic kidney disease (PKD). AVI-4126 is a third-generation antisense drug that specifically targets and inhibits c-myc, a gene believed to be critical in PKD. Unrestrained cell growth caused by growth factors produced by this gene is thought to be responsible for the cystic changes that characterize the kidneys of PKD patients. Preclinical studies with AVI-4126 have demonstrated its effectiveness in preventing some of the clinical manifestations of PKD.
¿ Biotechnology Industry Organization, of Washington, selected Chicago as the host city for BIO 2006 International Biotechnology Convention & Exhibition. This annual event has grown more than sevenfold since it was created in 1993, with attendance surpassing 14,000 at BIO 2001 in San Diego. BIO¿s convention will be held in Toronto in 2002, Washington in 2003, San Francisco in 2004 and Philadelphia in 2005.
¿ Celera Genomics, of Rockville, Md., said that Merck & Co. Inc., of Whitehouse Station, N.J., extended their osteoporosis drug discovery collaboration for a sixth year until November 2002, working with Celera¿s South San Francisco operation (formerly Axys Pharmaceuticals Inc.). This is the fourth extension for the collaboration that focuses on the development of small-molecule inhibitors of cathepsin K, a cysteine protease target that has been shown to play a role in bone resorption. Cathepsin K is a member of a large family of cysteine proteases, and has been highly associated with the ability of osteoclasts to degrade bone, a condition which is exacerbated in osteoporosis. (See BioWorld Today, Nov. 18, 1996.)
¿ Columbia Laboratories Inc., of Livingston, N.J., raised $2.97 million in proceeds through a private sale of 1,118,866 shelf-registered shares of common stock. Aqua Wellington, Curran Partners and John Curran Affiliates, EGS Partners, Hillhouse Capital, Irvine Capital and Knott Partners participated in the financing. The funds will help accelerate development programs, including the submission of worldwide registration documents for the company¿s Testosterone Buccal Tablet for men, estimated to be filed in the first quarter of 2002. Also, the funding will provide resources to cover corporate overhead for the next year, including projected legal expenses.
¿ Pyrosequencing AB, of Uppsala, Sweden, sold a customized, high-throughput system to the Max Delbruck Center for Molecular Medicine in Berlin. The Gene Mapping Center and Department of Molecular Genetics will use the company¿s 384-well system to analyze SNPs in their research program on the genetics of complex diseases. This is Pyrosequencing¿s fourth high-capacity system sold since launching the Preferred Technology Program earlier this year.
¿ Entelos Inc., of Menlo Park, Calif., entered a science and technology collaboration with Pfizer Inc., of New York. Pfizer will provide research funding and license fees to Entelos, as well as success fees for achieving specific research objectives. Entelos also will receive milestone payments for certain novel biological insights and biomarkers accepted by Pfizer. Entelos will prioritize specific Pfizer asthma drug candidates based on their predicted clinical efficacy using Entelos¿ Asthma PhysioLab technology. Entelos also will analyze phenotypic response patterns, as simulated in normal and asthmatic patients, to recommend appropriate treatment for each phenotype. Entelos aims to identify novel insights related to the therapeutic efficacy of certain respiratory pathways, as well as novel biomarkers of drug response.
¿ Genentech Inc., of South San Francisco, said the FDA approved the inclusion of median survival data in the package insert of Herceptin (trastuzumab). The new labeling references the 24 percent increase in median overall survival for women with HER2 (human epidermal growth factor receptor2)-positive metastatic breast cancer treated initially with Herceptin and chemotherapy compared to chemotherapy alone (median 25.1 months compared to 20.3 months). Genentech submitted a supplemental biological license application to the FDA for the label change in January.
¿ GPC Biotech AG, of Martinsried, Germany, said the FDA granted orphan drug designation for its Phase II compound, Bryostatin-1, in combination with Taxol to treat esophageal cancer. The orphan drug designation allows seven years of exclusive U.S. marketing rights for the esophageal cancer indication following marketing approval and also enables GPC Biotech to apply for research funding, tax credits on certain research expenses and a waiver from the FDA¿s application user fee. Preliminary results from a current Phase II study suggest Bryostatin-1 increases tumor response when used with Taxol against esophageal cancer. It is also in a number of additional Phase II trials in combination with other therapeutics for several different indications.
¿ IGEN International Inc., of Gaithersburg, Md., completed a $30 million private placement financing under which it sold a total of 1,018,808 shares of common stock to Acqua Wellington Private Placement Fund Ltd. and Acqua Wellington Opportunity I Ltd. The company plans to use the proceeds to advance its product programs, fund research and development, provide working capital, acquisitions, and for general corporate purposes, including funding costs associated with the litigation against Roche Diagnostics. (See BioWorld Today, Feb. 13, 2001.)
¿ Interferon Sciences Inc., of New Brunswick, N.J., received notification from the New Jersey Economic Development Authority of approval to sell a portion of its total available tax benefits under the state¿s Technology Tax Certificate Transfer Program. This program allows emerging technology and biotechnology companies to sell available New Jersey net operating loss carryovers and research and development credits. Interferon Sciences will receive approximately $970,000 from the sale of approximately $1.1 million of these benefits to an already identified third party during the next month. The company has an additional $2.6 million of state tax benefits to sell in future years.
¿ LifeTime Pharmaceuticals Inc., of College Park, Md., named Peter McCann CEO and president, effective immediately. The move is intended to bolster efforts to attract additional funding for its clinical research, develop partnerships with pharmaceutical companies and further its cancer drug, Beta LT, now in Phase I/II trials. McCann brings more than 31 years of corporate executive and research experience, including serving as president of British Biotech Inc.; interim president, University of Maryland Biotechnology Institute; and CEO of Oncostasis Inc. Separately, LifeTime¿s principal investigator of its Beta LT Trials discussed the trials at the annual meeting of the American Society of Hematology in Orlando, Fla. Of the lymphoma patients who did not have defective immune systems, one-third finished the 90-day study with 50 percent smaller cancers, and the majority had cancers at least somewhat smaller. This contrasts with the results in untreated patients or patients who were predetermined to have defective immune systems (p=0.02).
¿ Ligand Pharmaceuticals Inc., of San Diego, said treating cutaneous T-cell lymphoma patients with Targretin (bexarotene) boosted the activity of Ontak (denileukin diftitox) and increased patient response rates in a pilot Phase I study. Also, researchers reported that in vitro, chronic lymphocytic leukemia (CLL) cells that were exposed to bexarotene were more susceptible to treatment with denileukin diftitox than were cells treated by denileukin diftitox alone. Also, Ontak was shown to have anticancer activity in patients with fludarabine-refractory CLL. The reports were presented at the 43rd annual American Society of Hematology meeting in Orlando, Fla.
¿ MDS Pharma Services, of Montreal, part of MDS Inc., and Iconix Pharmaceuticals Inc., of Mountain View, Calif., will advance a novel chemogenomics information system for drug discovery and development. The system, DrugMatrix, is designed to bring speed and efficiency to understanding the potential safety and efficacy of new drug candidates at the genomic, chemical structure and pharmacologic levels. MDS Pharma will help develop DrugMatrix, make an equity investment in Iconix, and commit other funds and technology to the development of DrugMatrix. Financial terms were not disclosed.
¿ MetaPhore Pharmaceuticals Inc., of St. Louis, and the University of Messina in Italy said research was published in the European Journal of Pharmacology showing a superoxide dismutase (SOD) enzyme mimetic significantly reduced the extent and severity of inflammation and tissue damage to the intestinal wall in an animal model of colitis. Researchers also observed a marked reduction in the diarrhea and body weight loss typical of this disease. The SOD mimetic, M40403, also was shown to reduce elevated levels of two pro-inflammatory cytokines, tumor necrosis factor alpha and interleukin-l, implicated in the development of inflammatory bowel disease.
¿ North Carolina Genomics and Bioinformatics Consortium LLC, of Research Triangle Park, N.C., said it is delivering on its promise to strengthen the state¿s efforts in genomics, proteomics and bioinformatics by striking an agreement with MWG Biotech Inc., of High Point, N.C. As a contributing associate, MWG will provide service and instrument discounts from 10 percent to 25 percent to the consortium¿s 73 participating companies, universities and institutions. MWG offers a portfolio of genomics solutions.
¿ Palatin Technologies Inc., of Princeton, N.J., received preliminary FDA approval for a clinical trial to assess the efficacy of a (99m)Tc-labeled monoclonal antibody in imaging early stage inhalation anthrax infection, through a nuclear medicine procedure that has the potential to safely pinpoint even the smallest amounts of infected tissue. A report on this possible breakthrough will appear in the December issue of The Journal of Nuclear Medicine. Company representatives said the technique offers the ability to detect the earliest stages of involvement, before any other laboratory or radiographic diagnostic tests can detect the presence of infection and well before the more serious symptoms of inhalation anthrax infection are apparent.
¿ Protein Sciences Corp., of Meriden, Conn., signed a contract with the National Institute of Allergy and Infectious Diseases that provides for up to $76 million in funding through mid-2006 for development and production of antigens for new vaccines for HIV/AIDS. Under the contract, after NIAID approves a vaccine candidate, it will issue a task order to fund Protein Sciences to develop and manufacture clinical materials suitable for Phase I, II and III trials. Industry and institutions in the U.S. or abroad qualify for funding.
¿ Rigel Pharmaceuticals Inc., of South San Francisco, filed a Form S-3 shelf registration statement with the Securities and Exchange Commission. Through the shelf registration statement Rigel would be able to issue various types of securities from time to time, up to an aggregate of $50 million.
¿ SignalGene Inc., of Montreal, invested in a new therapeutic program to develop selective androgen receptor modulators as drug candidates for numerous indications, including prostate cancer, hormone replacement therapy for men and women, and disorders associated with muscle wasting. The SARM program applies SignalGene¿s de novo drug design technology to general small molecules that act on the androgen receptor, the site of action of testosterone. The SARM program builds on the company¿s program to develop nonsteroidal compounds for the estrogen receptor.
¿ SkyePharma PLC, of London, and Astralis LTD, of Florham Park, N.J., reached several agreements concerning the formulation and development of Astralis¿ injectable vaccine therapy, Psoraxine, to treat psoriasis. SkyePharma will receive a $5 million license fee, which will be recognized as revenue over the lifetime of the contract, for access to DepoFoam and other relevant drug delivery technologies. In addition, through a service agreement, SkyePharma will provide all development, manufacturing, preclinical and clinical development services for second-generation Psoraxine, up to the completion of Phase II. Astralis then would offer SkyePharma the option to acquire worldwide licensing and distribution rights. If SkyePharma opts out, Astralis will seek a marketing partner to fund Phase III studies and to provide a sales and marketing infrastructure. Separately, SkyePharma will make a total equity investment in Astralis of up to $20 million in convertible preferred shares, for which SkyePharma will own 15.3 percent of Astralis.
¿ SuperGen Inc., of Dublin, Calif., reported that data from a preclinical study identified the company¿s anticancer compound decitabine as one of two novel compounds that, in separate combination therapy regimens, could overcome chemotherapy resistance to Gleevec (Novartis AG) in patients with advanced chronic myelogenous leukemia. Data were presented at the 43rd annual American Society of Hematology meeting in Orlando, Fla.
¿ Transkaryotic Therapies Inc., of Cambridge, Mass., said the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products issued a positive opinion recommending approval of Dynepo (epoetin delta). Dynepo, being developed with Aventis Pharma AG, of Frankfurt, Germany, is a human erythropoietin for the treatment of anemia associated with renal disease. If approved, Aventis will be responsible for the marketing and distribution of Dynepo in the EU¿s 15 countries.
¿ Tripep AB, of Huddinge, Sweden, said its board adopted a new plan for the clinical development of GPG based on a newly developed method for direct measurement of GPG in blood. Tripep also has filed a patent application for a breakdown product of GPG with an antiviral effect. In previous clinical studies Tripep could not measure the presence of GPG in blood. Tripep also has found that one of the breakdown products of GPG has a favorable HIV-inhibiting effect, making it partly a pro-drug, i.e., a molecule from which an active drug is created within the body. A separate patent application has been filed.