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Executive Summary

ORTHO RETIN-A .05% NDA FOR PHOTOAGING CLAIM was filed in July. Johnson & Johnson subsidiary Ortho Pharmaceutical submitted the NDA for a .05% cream formulation of the topical prescription product tretinoin based on efficacy studies in 650 patients. The studies, conducted at nine centers, followed patients for six months and tracked Retin-A's efficacy in reducing the signs of photoaging damage due to sun exposure, such as wrinkling, blotching and loss of elasticity. The NDA focuses on a mid-level concentration of the acne drug. Retin-A was originally approved for acne at a 0.1% concentration; a milder, 0.25% version was approved in September 1988. Ortho has a .05% gel form of Retin-A in addition to the cream. Ortho said it is "looking for successor compounds to Retin-A which are equally effective" but less irritating in the treatment of photoaged skin. Researchers are also examining the drug's potential in other areas such as preventing the progression of actinic keritoses -- premalignant growths -- into skin cancer. Ortho's photaging NDA filing comes nearly two years after Retin-A began to receive substantial consumer interest for its potential as an anti-wrinkling therapy. Pharmacy sales for Retin-A in 1988 more than doubled following widespread publicity on the drug's efficacy as an anti-wrinkling agent. Sales jumped 127% to $ 63.8 mil. for the year, according to the audit service firm Pharmaceutical Data Systems ("The Pink Sheet" March 20, T&G-6). Retin-A's potential as a photoaging treatment was discussed at an April 1986 Boston University Medical Center seminar. In a 1988 press conference, University of Michigan Medical Center dermatologist John Voorhees, MD, presented results of a four-month 30-patient study sponsored by Ortho on the effect of Retin-A as a photoaging treatment. The study was published in the Jan. 22/29, 1988 Journal of the American Medical Association. A National Institutes of Health panel concluded in May that available data on tretinoin did not demonstrate "sustained improvement, reversibility of tissue pathology, or the preservation of normal skin function by those agents." In addition, the panel noted that no long-term data exists regarding repeated application toxicity ("The Pink Sheet" May 15, p. 16).

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