Press on panel for Intergel.
Lifecorp Product to Be Reviewed by FDA Advisory Committee
Chaska, Minnesota, Dec. 10 (Bloomberg) -- Lifecore Biomedical Inc. said an advisory committee for the U.S. Food and Drug Administration will examine the company's Intergel, an experimental product for reducing internal scarring caused by surgery, during a January 12 meeting.
Shares in the medical and surgical device company rose 1 to 19 11/16, or 5 percent, in morning trading, after gaining 25 percent yesterday.
The company's gel product is designed to be applied inside the body following gynecological surgery, before the wound is closed. By filling the space where scar tissue -- or adhesions -- could grow as a patient's heals, surgical gels are meant to prevent the painful internal scars from forming.
The company said today that its data demonstrates ``that Intergel Solution is safe and effective in significantly reducing the incidence, extent and severity of post-surgical adhesions.'
The FDA usually asks its advisory panels to review applications to sell new drugs or devices when a product is the first of its kind or when the agency has specific questions about the safety or side effects of a new therapy.
The FDA said in May that it would expedite its review of Intergel to try and reach a decision within six months about whether to approve the product. The panel hearing may be seen as a sign that the agency is nearing action, though the six-month window expired in November,.
Johnson & Johnson's Gynecare division markets the product outside the U.S. under the name Intergel. Shares in Johnson & Johnson rose 5/8 50 93 7/8 in morning trading. Shares in Gliatech Inc., which sells a surgical gel called Adcon, fell 1 1/4 to 16 1/8, or 7 percent, after dropping 8 percent yesterday.
Dec/10/1999 10:57
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