¿ Altea Development Corp., of Atlanta, has received a $99,910 Phase I grant to study its MicroPor system for non-invasive delivery of insulin. The National Institute of Diabetes and Digestive and Kidney Diseases division of the National Institutes of Health awarded the grant. Altea's patented MicroPor technology creates microscopic pores in the outermost dead layer of skin cells, opening tiny pathways to the underlying viable tissues. As part of the grant, Altea will evaluate the clinical delivery profile of insulin through MicroPor in response to parameters such as low-dose current.
¿ Antex Biologics Inc., of Gaithersburg, Md., said its wholly owned subsidiary, AntexPharma, signed a development and licensing agreement with the University of Maryland, Baltimore, for the development of peptides intended for treatment of symptoms related to lung disorders, including chronic bronchitis, asthma, cystic fibrosis and bronchiectasis. The therapies will target mucus hyperproduction.
¿ ArQule Inc., of Woburn, Mass., amended a 1998 drug-discovery agreement with The R.W. Johnson Pharmaceutical Research Institute (PRI), a Johnson & Johnson company, to provide PRI and other J&J companies access to ArQule's Compass Array libraries. Each Compass Array library is a diverse set of compounds selected from and representing each array within ArQule's Mapping Array repository.
¿ Cangene Inc., of Toronto, said its earnings from pharmaceutical sales in the U.S. will be adversely affected due to product unavailability. FDA officials have required a regulatory submission for the release of WinRho and Nabi-HB in addition to a specific release of each product lot. Cangene's marketing partner, Nabi Inc., of Boca Raton, Fla., said it will be affected by the shortage as well.
¿ Chiron Corp., of Emeryville, Calif., has successfully completed the $700 million cash tender offer for all the outstanding common stock of PathoGenesis Corp., of Seattle. Preliminary information indicates about 96 percent of the outstanding common shares of PathoGenesis were validly tendered prior to the Sept. 18 expiration of the offer. Chiron extended the all-cash tender offer in August for all of PathoGenesis' outstanding common stock at a price of $38.50 per share. Each share of common stock not tendered will be converted into the right to receive $38.50 in cash. (See BioWorld Today, Aug. 15, 2000, p.1)
¿ Chromos Molecular Systems Inc., of Burnaby, British Columbia, said underwriters of the company's July initial public offering of common stock have exercised an overallotment option to purchase 562,500 shares at the IPO price of $8 per share. The move boosts total proceeds of the offering before underwriting discounts and expenses to $34.5 million.
¿ Compugen Ltd., of Jamesburg, N.J. and Tel Aviv, Israel, has made commercially available its Z3 high-throughput 2D gel electrophoresis analysis system. Z3 is Compugen's first product for proteomics research.
¿ Curis Inc., of Cambridge, Mass., completed enrollment in a Phase III clinical trial of Chondrogel, a cell-based, minimally invasive tissue augmentation product for the treatment of vesicoureteral reflux. Data from the trial should be available in 2001. Vesicoureteral reflux is a congenital condition in children in which urine flows backward from the bladder through the ureter toward the kidney and results in urinary tract infection and kidney damage. Chondrogel is a structural tissue product comprised of autologous cartilage cells taken from the patient's own ear, expanded in culture and injected into the bladder.
¿ Eos Biotechnology Inc., of South San Francisco, expects to receive about $3 million out of a $6.7 million, 4.5-year grant from the National Cancer Institute to identify genes activated in aggressive colon cancers. The company will work with a multi-disciplinary research group to identify new diagnostic markers for predicting which colon cancer patients can be cured though surgery alone.
¿ Epix Medical, of Cambridge, Mass., entered an agreement with Acqua Wellington North American Equities Fund Ltd. for an equity financing facility covering the sale of up to $45 million of the company's common stock over the next 28 months. These shares may be sold, at Epix's discretion, at a small discount to the market price at the time of sale.
¿ Genencor International Inc., of Palo Alto, Calif., expanded a research collaboration with Xgene Corp. The companies began working together in May 1999 to develop human skin models and in vitro assays useful for pharmaceutical and personal care applications. The companies will collaborate for an additional two years to develop tools to test compounds for activity against the human papilloma virus and test the efficacy of compounds for the treatment of skin inflammation. Under terms of the research agreement, Genencor will fund Xgene's research activities for the development of an in vitro skin equivalent useful for testing the anti-HPV activity of Genencor's compounds. Xgene will develop a second in vitro assay to test efficacy of therapeutic proteins to treat dermatological disorders. Genencor will receive exclusive rights to use the assays developed under this agreement.
¿ Genta Inc., of Lexington, Mass., expects to complete patient accrual in the Phase III trial of Genasense in malignant melanoma by mid-summer 2001. Raymond Warrell, president and CEO, presented the update of the company's ongoing clinical trials, along with plans for future registration studies, at the Anticancer Biopharmaceuticals conference in San Francisco. Warrell said the peer-reviewed report from the Phase I/II study of Genasense has been accepted for publication in The Lancet.
¿ Genzyme General, of Cambridge, Mass. said its biologics license application (BLA) for Fabrazyme (agalsidase beta) has been accepted for review by the FDA. The agency also has approved Genzyme's request for priority review of the BLA, meaning the agency's review should be completed within six months of submission. Fabrazyme is Genzyme's investigational enzyme replacement therapy for patients with Fabry's disease. (See BioWorld Today, Sept. 8, 2000, p. 1.)
¿ Human Genome Sciences Inc., of Rockville, Md., has approved a two-for-one stock split of the company's common stock. Shareholders will receive one additional common share for every share held at the close of business Sept. 28. As of Sept. 15, HGS had about 56 million shares outstanding. The number will increase to about 112 million upon completion.
¿ Icogen Corp., of Seattle, received a Phase I Small Business Innovation Research grant from the National Institute of Health to fund the first application of Icogen's proprietary high-throughput proteomics screening technology, ISOPLeC, to identify an effector protein for sickle cell anemia therapy. Icogen has received $4.6 million in grant money from NIH since 1996.
¿ ImClone Systems Inc., of New York, has approved a two-for-one split of the company's outstanding shares of common stock, to be effected in the form of a stock dividend. At the close of business Sept. 29, each stockholder of record will be entitled to receive one additional share of common stock for each share of common stock held on that date. As of Sept. 18, ImClone had about 32.4 million common shares outstanding.
¿ Maxygen Inc., of Redwood City, Calif., said its Maxygen ApS subsidiary signed an agreement to research and develop a protein pharmaceutical product that could be used for central nervous system diseases including multiple sclerosis. H. Lundbeck A/S, of Copenhagen, licensed rights to the product, but Maxygen has retained rights for neurological indications in key Asian markets and global rights for all indications outside of central nervous system diseases, including inflammatory diseases and cancer. Under the agreement, Maxygen will receive license fees and research and development funding. Maxygen also will receive milestone payments and royalties on product sales.
¿ The Mayo Clinic and the University of Minnesota have collaborated to form Copharos Inc., a venture capital-funded company with offices in Ponte Vedra Beach, Fla. The company's mission will be to direct the commercial development of proprietary Vitamin B12-based imaging and therapeutic agents to be used in the early detection and treatment of breast, lung and other cancers.
¿ NexMed Inc., of Robbinsville, N.J., completed testing of 190 patients under its U.S. Phase II clinical program for Alprox-TD, a topical treatment for male erectile dysfunction. The studies, which took place at 12 clinical research sites in the U.S., were randomized, double-blind, placebo-controlled and designed to investigate the dose-response relationships for topical application of Alprox-TD cream versus a placebo, in men with mild to moderate ED.
¿ Nycomed Amersham plc, of London, agreed with Theragenics Corp., of Atlanta, to distribute TheraSeed, a device used in the treatment of localized prostate cancer with a one-time minimally invasive procedure.
¿ OraPharma Inc., of Warminster, Pa., said data related to the company's bone regeneration technology were presented at the 86th American Academy of Periodontology (AAP) Annual Meeting. Two studies suggest the company's osteopontin protein may be useful in accelerating the process of bone formation in large bone defects and in the healing of dental implants. Osteopontin is a glycoprotein that is abundant in the mineral matrix of bones. OraPharma licensed rights to the technology from Children's Hospital in Boston.
¿ Oxford GlycoSciences, of Oxfordshire, UK, and Packard BioScience Co., of Meriden, Conn., are collaborating to apply their respective technologies to develop protein biochips.
¿ Valentis Inc., of Burlingame, Calif., said its PolyMASC Pharmaceuticals plc subsidiary will collaborate with Viragen Inc., of Plantation, Fla., to develop a new treatment for hepatitis C. The companies will use PolyMASC's novel protoMASC PEGylation process to deliver Viragen's drug, Omniferon, a natural alpha interferon currently in Phase II clinical trials in Europe for hepatitis C. Both companies believe PolyMASC's proprietary PEGylation technology should improve Omniferon's efficacy while reducing the number of injections required for the treatment of hepatitis C patients.
¿ Regeneration Technologies Inc., of Alachua, Fla., licensed exclusive rights to patented segmentally demineralzied bone technology, which allows bone to be softened in portions so that flexible and inflexible bone sections can be combined in one implant. The company plans to introduce these new allografts to market within the next 12 months.
¿ Seattle Genetics Inc., of Bothell, Wash., initiated a second Phase I clinical trial with its single-chain immunotoxin SGN-10. The study will evaluate SGN-10 in combination with Taxotere for patients with advanced carcinoma. Aventis Pharmaceuticals, of Parsippany, N.J., manufactures Taxotere and will co-fund the trial costs and will provide Taxotere for the study. A single-agent Phase I study of SGN-10 in patients with carcinoma is ongoing.
¿ The Immune Response Corp., of Carlsbad, Calif., said Remune (HIV-1 immunogen), an investigational therapeutic vaccine for the treatment of HIV infection, will be tested as part of the clinical trial QUEST. Glaxo Wellcome is the primary sponsor of QUEST, an international study designed to evaluate the effectiveness of an anti-HIV strategy that combines highly active antiretroviral therapy (HAART) and therapeutic HIV vaccination in keeping the virus suppressed after treatment cessation. The study involves HIV patients who were infected within the past two years and who immediately began HAART quadruple therapy - Combivir (AZT+3TC), Ziagen and Agenerase - lasting 18 months. A total of 150 patients from Australia, Europe and Canada will participate.
¿ Transkaryotic Therapies Inc., of Cambridge, Mass., filed a complaint against Genzyme Corp., also of Cambridge, seeking a declaratory judgment of patent infringement and invalidity in U.S. District Court of Massachusetts in Boston. The complaint alleges Genzyme filed its suit related to U.S. patent No. 5,356,804 in July as a tactic to influence public opinion. The suit centers on patent rights to enzyme replacement therapy for the treatment of Fabry's disease. (See BioWorld Today, July 26, 2000, p. 1.)
¿ University of Wisconsin researchers reported data in this week's edition of Nature that indicate a vaccine designed to trigger an immune response to the small HIV protein called Tat could fend off the virus. "Killer" T cells utilizing the vaccine targeting the Tat protein effectively contained simian immunodeficiency virus in the natural course of early infection.
¿ Vertex Pharmaceuticals Inc., of Cambridge, Mass., announced that initial purchasers of its private offering of 5 percent convertible subordinated notes, due September 2007, have exercised in full a $45 million overallotment option. The company raised $345 million in the offering. The notes are convertible into Vertex common stock at a price equal to $92.26 per share, subject to adjustment in certain circumstances. (See BioWorld Today, Sept. 15, 2000.)
¿ Zonagen Inc., of The Woodlands, Texas, published data in the September 2000 issue of Journal of Reproduction and Fertility on its contraceptive vaccine. The publication reported results from two primate studies, the first in which a recombinant zona pellucida immunocontraceptive vaccine consistently induced infertility compared to controls in a primate model without permanent disruption of the normal menstrual cycle.
¿ Zycos Inc., of Lexington, Mass., licensed from the University of Massachusetts Medical School exclusive rights to develop therapeutic and diagnostic products based on the P450 CYP1B1 cancer-related protein. The tumor-specific protein is 544 amino acids in size and belongs to the larger P450 gene family. The company said several drug candidates are already in development.