AtheroGenics Inc., of Atlanta, formed a committee including North American cardiovascular doctors to help design and oversee the Phase III trial of AGI-1067 in atherosclerosis. In a 305-patient, six-week Phase II study, AGI-1067 met its primary endpoint of reducing post-angioplasty restenosis. A post-study analysis showed AGI-1067 to have an anti-atherosclerotic effect on coronary blood vessels, consistent with reversing the progression of coronary artery disease. AtheroGenics already began a 500-patient, 12-month Phase IIb trial with AGI-1067 for atherosclerosis and restenosis.
Axonyx Inc., of New York, said its chairman, CEO, another board member and other company insiders acquired about 865,000 shares of its common stock from an unnamed co-founder that is no longer connected to the firm. Axonyx added that several institutional investors and an existing shareholder acquired the unnamed co-founder's remaining 866,000 shares.
Codexis Inc. raised $25 million in its first private financing since its establishment as a subsidiary of Maxygen Inc., of Redwood City, Calif. CMEA Ventures, of San Francisco, and Pequot Ventures, of New York, led the round, which also included investments from ChevronTexaco Technology Ventures, of San Ramon, Calif., and Maxygen. The funds will be used to advance Codexis' products, with a focus on developing biocatalysts and improved manufacturing processes for drugs.
Elite Pharmaceuticals Inc., of Northvale, N.J., agreed with Elan Corp. plc, of Dublin, Ireland, to acquire all of Elan's interest in a joint venture, Elite Research Ltd. The termination of the joint venture is part of Elan's restructuring efforts. Elite now owns 100 percent of the joint venture, which has completed a Phase I study of its first product, a once-a-day Oxycodone formulation. The joint venture also is developing a product in the central nervous system area. Elite agreed to pay a royalty on certain revenues from the Oxycodone payment. Elite and its transferees retained Elite securities that were issued in connection with the joint venture, and they are being converted into Elite common stock. Further financial details were not disclosed. Last week, Elan divested two products for a total of more than $400 million. (See BioWorld Today, Oct. 3, 2002, and Oct. 4, 2002.)
Inspire Pharmaceuticals Inc., of Durham, N.C., entered a collaboration with Cystic Fibrosis Foundation Therapeutics Inc., of Bethesda, Md., to fund a Phase II study for INS37217 Respiratory for the treatment of cystic fibrosis. Cystic Fibrosis Foundation Therapeutics will provide the majority of funding of external costs for the 28-day, double-blind, placebo-controlled, parallel group study in exchange for post-commercialization milestone payments to be made following FDA approval. Further financial terms were not disclosed.
ISTA Pharmaceuticals Inc., of Irvine, Calif., received a letter from Nasdaq indicating that ISTA is not in compliance with the minimum bid price requirement for continued listing and that its securities are subject to delisting. ISTA said its previously announced plan for a reverse stock split would return it to compliance.
Lexicon Genetics Inc., of The Woodlands, Texas, said it discovered a new role in the immune system for a secreted protein that may serve as a target for the development of drugs to treat inflammation associated with arthritis and autoimmune disease. Lexicon said it moved the protein into its drug discovery program to create antibodies that typically allow for more rapid development toward clinical use. In other news, Lexicon said that as part of an ongoing drug discovery and development collaboration, Abgenix Inc., of Fremont, Calif., plans to develop antibodies to block Lexicon's LG688 using Abgenix's XenoMouse technology.
Ligand Pharmaceuticals Inc., of San Diego, amended its preferred shares rights plan, originally adopted Sept. 13, 1996. According to the amendment, Ligand reduced from 20 percent to 10 percent the trigger percentage of outstanding shares that, if acquired, would permit the rights to be exercised. Share acquisitions by Elan Corp. plc, of Dublin, Ireland, and its affiliates remain unchanged and continue to be subject to a separate, higher trigger.
Northfield Laboratories Inc., of Evanston, Ill., said it is collaborating with the U.S. Army to develop a treatment investigational new drug application for the battlefield use of its oxygen-carrying blood substitute, PolyHeme. A treatment IND is typically submitted for experimental drugs showing promise in a clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place, the company said. The proposed protocol would have PolyHeme being used in remote battlefield settings where red blood cells are not available. Northfield submitted a biologics license application for PolyHeme in August 2001. (See BioWorld Today, Aug. 29, 2001.)
Novavax Inc., of Columbia, Md., reported at the North American Menopause Society's meeting in Chicago results from a randomized, double-blind, Phase III trial in postmenopausal women. Data showed that at least 2.5 to three times more patients using Estrasorb (estradiol topical emulsion), compared with those using placebo, achieved a complete cessation of moderate to severe hot flashes over a seven-day period. The incidence of women achieving a clinical response ranged from 15 percent in week three to 40 percent in week 12 for women receiving Estrasorb, compared with 3 percent in week three to 16 percent in week 12 for those using placebo. Between week eight and week 12, women receiving Estrasorb saw their clinical response rise from 36 percent to 44 percent, compared with a climb from 10 percent to 16 percent of women receiving placebo.
Paladin Labs Inc., of Montreal, entered a licensing agreement regarding the Canadian rights to a once-yearly implant (Histrelin Hydrogel Implant) for the palliative treatment of advanced prostate cancer with Hydro Med Sciences Inc., of Cranbury, N.J. Paladin receives exclusive sales and marketing rights for the product in Canada while Hydro Med will assume responsibility for manufacturing and completing the development of the implant. Further financial terms were not disclosed.
Telik Inc., of South San Francisco, said the underwriters of the company's follow-on public offering exercised in full their option to purchase an additional 975,000 shares of stock at $11.50 per share for a total of about $11.2 million. Telik announced the offering of 6.5 million shares on Sept. 27, resulting in gross proceeds of about $86 million. (See BioWorld Today, Sept. 30, 2002.)
Virocell Inc., of Sainte-Foy, Quebec, completed Phase I trials of its lead compound, BG-777, an immunomodulator shown in preclinical studies to have efficacy against viral and bacterial infections. In the clinical trial, BG-777 was administered for seven consecutive days and well tolerated by all healthy volunteers at all doses tested. Also, added dose-related biological activities were successfully monitored in all subjects. Virocell said the data would be used in dose selection during Phase II trials in HIV patients, scheduled to begin early next year.
Viventia Biotech Inc., of Toronto, optioned and agreed to potential licensing terms for two hybridoma cell lines developed at The University of Texas M.D. Anderson Cancer Center in Houston. The first hybridoma produces antibodies that target ovarian and endometrial malignancies and the other targets squamous cell carcinomas, such as are found in various cervical, skin and head and neck cancers. Details were not released on the second cell line, nor were financial terms.