Atrix Laboratories Inc., of Fort Collins, Colo., signed an exclusive licensing agreement with Israel-based Luxembourg Pharmaceuticals Ltd. for the Israeli marketing rights to Atrix’s four Eligard leuprolide acetate prostate cancer products. The agreement provides Atrix with a royalty on net sales. Luxembourg will be responsible for regulatory submissions and any studies that may be necessary to gain approval with Israeli regulatory authorities. Atrix will manufacture the products for Luxembourg in its facility in Fort Collins.
Biokeys Pharmaceuticals Inc., of San Diego, said the Securities and Exchange Commission has declared the company’s Form 10-SB filing effective. Biokeys therefore is a “fully reporting” company under Rule 12b of The Securities Act of 1933. Biokeys is commercializing medical research through licensing agreements with universities and research institutions.
British Biotech plc, of Oxford, UK, and Biocompatibles International plc, of Surrey, UK, said that recruitment in Brilliant II, a double-blind pivotal trial designed to secure CE Mark Approval for the Batismastat BiodivYsio stent in Europe, was suspended pending review of further data from the Brilliant I trial. Brilliant I is a 150-patient multicenter open trial, the recruitment for which was completed in November. Six-month angiographic and clinical follow-up on an initial group of patients from Brilliant I indicated that the stent did not show the benefit that was evident in preclinical studies. British Biotech’s stock (NASDAQ:BBIOY) fell 50 cents Friday, or 21.7 percent, to close at $1.80.
Miravant Medical Technologies Inc., of Santa Barbara, Calif., released a statement regarding its receipt of a Nasdaq notification that the company has not met certain requirements for continued listing. The company has requested a hearing with Nasdaq, and the stock will remain listed on Nasdaq until at least the date of the hearing, which has not been determined.
Galaxy Investments Inc., of Denver, executed a letter of intent agreement to acquire Nevada-based start-up biotech company Elasticated Adhesive Technologies Inc. (E.A.T.), which is focused on the development of transdermal drug delivery systems. The parties plan to execute a definitive share exchange agreement within 30 days, whereby Galaxy is to acquire 100 percent of the issued and outstanding capital stock of E.A.T. in exchange for the issuance of 10 million restricted common shares and up to 10,000 preferred common shares of Galaxy. Galaxy also will undertake a private placement of equity of $2.5 million in conjunction with the acquisition.
Oncolytics Biotech Inc., of Calgary, Alberta, filed an investigational new drug application with the FDA to initiate a Phase I/II trial studying Reolysin to treat recurrent malignant glioma, the most aggressive form of brain cancer. In June 2001, Peter Forsyth and a research group with the Alberta Cancer Board and the University of Calgary published the results of their research in which mice with brain tumors were treated with a single injection of Reolysin. Benefits included complete tumor regression in 20 of 23 treated animals, a statistically significant increase in survival, an increase in body weight and no impairment of their cognitive functions.
Oridigm Corp., of Seattle, changed its name to MediQuest Therapeutics Inc. Its president and CEO said Oridigm is a very different company than when it was formed in 1994. Frederick Dechow said the company’s new strategic direction involves an emphasis on drug discovery using its Quest technology platforms.
Orthologic Corp., of Tempe, Ariz., was authorized by the FDA to begin a combined Phase I/II trial of Chrysalin for spinal fusion under an investigational new drug application. The trial will include about 300 patients and will be performed at 15 to 20 centers in the United States. The study is designed to evaluate the safety and preliminary efficacy of Chrysalin in combination with allograft when used in spinal graft surgery. Chrysalin represents a portion of the receptor-binding domain of the human thrombin molecule, which is actively involved in the healing of both soft tissue and bone.
Schering AG, of Berlin, its U.S. affiliate Berlex Laboratories Inc. and Collateral Therapeutics Inc., of San Diego, reported results from a Phase II study demonstrating that Ad5FGF-4 showed improvement in myocardial perfusion in patients with moderate to severe exertional angina. Ad5GFG-4 is an angiogenic gene therapy product being developed to treat those with stable exertional angina due to coronary artery disease. The double-blind, placebo-controlled study included 52 patients who were randomized to receive either a one-time administration of Ad5FGF-4 (35 patients) or placebo (17 patients) via intracoronary infusions into the left and right coronary systems. The mean reversible perfusion defect size at eight weeks post-treatment, which was the primary endpoint, was reduced by 21 percent from baseline in patients treated with Ad5FGF-4.
StemCells Inc., of Palo Alto, Calif., filed with the Securities and Exchange Commission to sell, from time to time, 15 million common shares to raise a maximum of $37.8 million. The company will use the funds for general corporate purposes, including working capital, product development and capital expenditures. A portion of the net proceeds may also be used for the acquisition of businesses, products and technologies that are complementary to StemCells.