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COLLAGEN CORP./GE JOINT VENTURE WILL DEVELOP COLLAGEN/LASER VISION CORRECTION

This article was originally published in The Gray Sheet

Executive Summary

COLLAGEN CORP./GE JOINT VENTURE WILL DEVELOP COLLAGEN/LASER VISION CORRECTION system, Collagen announced Jan. 12. Speaking at the Hambrecht & Quist life sciences conference in San Francisco, Collagen President and CEO Howard Palefsky said that Collagen had joined with General Electric to form CollOptics, which will develop a system for semi-permanent vision correction based on proprietary technologies from each parent company. According to Collagen, the system will combine a GE laser with a highly purified bovine collagen product under development by Collagen. The collagen will be formed into a "lenticule" that is placed over the cornea. The laser then will be used to sculpt the lenticule. The CollOptic technology is in a "very early" development stage, Collagen says. The firm is expecting to conduct one-to-two years of preclinical work before starting clinical trials. Collagen says that the collagen/laser system is likely to have advantages over laser procedures that mold the cornea itself. Because the laser shapes the removable lenticule and not the cornea, the procedure may be reversible. In addition, applying the laser to a collagen implant rather than the cornea would make the procedure less risky. Collagen also notes that the shape of the eye may gradually change over a period of years; therefore, permanently changing the shape of the cornea may only provide temporary vision correction. Eye shape modifications may be addressed with new lenticules. Collagen made most of the initial capital investment in CollOptics -- about $500,000. At the Hambrecht & Quist conference, Palefsky said Collagen has a "sizeable equity stake, product development agreement and supply agreement with" CollOptics. Palefsky also provided updates on Contigen and Collagraft, two products currently awaiting FDA approval. He said that on Dec. 21, the firm responded to a Sept. 30 FDA request for additional information on Contigen, the collagen-based incontinence treatment Collagen developed with Bard ("The Gray Sheet" Oct. 26, I&W-6). The response included additional clinical data from Collagen's ongoing follow-up study. Of 148 patients treated more than two years ago, Palefsky reported, 72% of males and 79% of females were "dry" or "improved." For 54 patients treated more than three years ago, he said, 86% of males and 82% of females were dry or showed improved continence. Palefsky said that Collagen is "working closely" with marketing partner Bard "to determine the initial stocking levels [for Contigen] given our estimated ranges of first-year sales." Discussing the Collagraft orthopedic implant, Palefsky said that Collagen had responded on Jan. 11 to four manufacturing questions raised by FDA in a letter received by the firm Dec. 31. "The problem here has been...validating" the manufacturing plant of Zimmer, Collagen's manufacturing partner for Collagraft, Palefsky said. Collagen received an approvable letter for Collagraft in September 1991. Collagen's own manufacturing facilities have been operating at 40% utilization, Palefsky remarked, noting that approvals of Contigen and Collagen should make the facility more cost- effective, bringing it up to 80% utility within the first 12 months after the launch of the two products. Palefsky also remarked that the firm has "developed a new generation of Collagen-based biomaterials which will improve product offerings" in the markets the firm currently serves. The materials also may "hold significant promise in expanding our product applications in orthopedics" and may allow the firm to enter the cardiovascular market. "These materials are now in preclinical evaluation and discussions are being held with the appropriate potential partners," he added.
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