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QUADRA LOGIC-CYANAMID PHOTOFRIN NDA FILING TARGETED BY END OF 1992

Executive Summary

QUADRA LOGIC-CYANAMID PHOTOFRIN NDA FILING TARGETED BY END OF 1992 for photodynamic treatment of esophageal cancer, Quadra Logic Technologies CEO William Foran reported at the Medical Investments Northwest conference in Seattle on Sept. 11. "Cyanamid, who has responsibility to make these submissions has advised us that they expect to be able to make the filing for esophageal to the FDA by year end," Foran said. "The patient data base [on 230 patients] has been completed and they are compiling all the information in preparation for submission." American Cyanamid's Lederle subsidiary is currently in discussions with a number of laser manufacturers to submit a PMAA (premarket approval application) for the drug/device combination treatment. Cyanamid and QLT have indicated that they hope to reach an agreement with FDA to review the photodynamic therapy as a drug/device combination that will not restrict use of Photofrin with one manufacturer's laser product ("The Pink Sheet" Sept. 16, 1991, p. 17). QLT Senior VP Julia Levy, PhD, noted that medical laser manufacturer Coherent Laser has already developed a specialized product for use in photodynamic therapy and that other manufacturers are working on solid state dio-lasers for use in PDT that could cost as low as $15,000. Levy added that "there are currently over 120 suitable lasers already in place at hospitals and cancer centers around the world." Vancouver-based Quadra Logic Technology and Cyanamid will file additional submissions in the U.S. for use of Photofrin (porfimer sodium) in treating lung and bladder cancer once additional Phase III trials are completed. A marketing application for the treatment of lung and bladder cancer has been pending in Canada since July 1989 based on Phase II data. Foran noted that Canada's Health Protection Branch requested more information in December 1991. Quadra Logic responded to all of the questions raised by the Canadian regulatory authorities and submitted Phase III data for lung, bladder and esophageal cancers in April of this year, Foran said. Cyanamid and QLT applied for marketing in Denmark and Belgium in March and filings in "all other" EC countries are expected "by the end of October," Foran reported. Earlier this summer, Foran added, QLT and Cyanamid filed for Photophrin approval in Japan for use in treating early stage lung, bladder, esophagus, stomach and cervix cancers. Foran estimated the total worldwide market for the cancer indications the company is seeking at approximately $1 bil. Assuming worldwide regulatory clearance by 1995 and a 10% market penetration in the first year of marketing, Foran predicted that Photofrin could generate sales of $100 mil. in 1996. QLT's marketing agreement for royalty payments from Cyanamid calls for 32.5% of Photofrin gross revenues. QLT is required to pay royalties of 5% of gross revenues for patent rights to Photofrin and 2% of gross revenues for manufacturing. Foran described QLT's relationship with Cyanamid as "excellent." Cyanamid shares 50% of development costs for Photofrin and QLT's second generation product benzoporphyrin derivative (BPD) and has full responsibility for marketing and distribution. He noted that Cyanamid has developed a training program for a specialty sales force for Photofrin and "has estimated it will spend over $50 mil. for the product launch of Photofrin." Cyanamid currently holds a 12% equity stake in QLT. The two companies also are developing Photofrin for a broad range of other solid tumors. Photodynamic therapy with Photofrin has been studied in clinical trials for basal cell, breast, brain, colorectal, eye, ovarian cervical, head and neck squamous cancers. In addition, the company indicated that the photodynamic therapy could have potential use in treating AIDS, autoimmune diseases and atherosclerosis. However, the two companies are likely to address future non-cancer indications and potential uses for treating non-life-threatening diseases, such as psoriasis and rheumatoid arthritis, with BPD, Levy indicated given the second generation product's improved target cell selectivity, half-life, and relatively limited skin sensitivity compared with Photofrin. She noted that patients receiving Photofrin must avoid prolonged exposure to sunlight for four to six weeks after therapy. Patients receiving BPD must avoid sunlight for only two or three days, she said. BPD is currently in Phase I/II trials at the University of British Columbia for malignant skin lesions and at Massachusetts General Hospital. Clinical studies with BPD for treating psoriasis are planned for 1993, Levy reported. QLT had a cash position of $30.6 mil. (Canadian) as of June 30 and an unused secured line of credit from Cyanamid of $10 mil. (U.S.). QLT is spending approximately $3 mil. per quarter, including about $2.3 mil. (Canadian) on BPD and Photofrin development. Last year, Foran noted, QLT spent $13.3 mil. on Photofrin and BPD R&D.
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