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PROSTEP NICOTINE TRANSDERMAL SYSTEM RECEIVES APPROVAL

 PROSTEP NICOTINE TRANSDERMAL SYSTEM RECEIVES APPROVAL
 WAYNE, N.J., Jan. 28 /PRNewswire/ -- Lederle Laboratories, a


division of American Cyanamid Company, today announced it has been cleared to market a new, patented nicotine patch called ProStep(TM) (nicotine transdermal system), the first of its kind that will be recommended to help people quit smoking in as little as four to eight weeks normally with a single dosage strength.
 In clinical studies conducted at the Mayo Clinic and other prestigious medical centers across the United States, once-daily application of a ProStep patch has been shown to be a useful aid to smoking cessation, when coupled with a program of patient education, counseling and support. Study participants started and stayed with a single dosage strength of ProStep throughout the treatment period.
 The ProStep patch, utilizing a proprietary transdermal delivery system developed by Elan Corporation, plc. (AMEX: ELN), is engineered to maintain therapeutic levels of nicotine through the skin over 24 hours. The ProStep delivery system is highly efficient; of the approved brands of nicotine patches, ProStep has the lowest residual of nicotine left in the patch after the 24-hour period. ProStep maintains consistent levels of nicotine throughout the day and even in the early morning waking hours, helping to relieve the craving for cigarettes and other withdrawal symptoms.
 The ProStep patch is round and beige-colored, similar to an adhesive bandage, and contains nicotine in a gel matrix. It may be worn inconspicuously under clothes on a hairless part of the upper body, usually the upper arms, back or chest. The patch is to be used in combination with a comprehensive behavior modification program.
 ProStep Quit Rate Confirmed in
 Multi-Center Studies
 Clinical studies of ProStep were conducted with 516 moderate to heavy smokers at medical centers, including the University of Wisconsin, University of Michigan, University of Missouri and Duke University, in addition to the Mayo Clinic.
 "In our clinical studies, the quit rate with ProStep was consistently twice as effective as the placebo patch when both were used along with a counseling program," said Michael C. Fiore, M.D., director, Tobacco Research and Intervention Program at University of Wisconsin School of Medicine in Madison, Wis.
 The quit rate in these studies was defined very strictly as total abstinence from smoking -- not even one puff from a cigarette over a four-week period -- and was verified by chemical testing.
 "We've known for some time that nicotine replacement therapy has the potential to help motivated smokers overcome the most daunting hurdles associated with quitting smoking -- the withdrawal symptoms caused by nicotine addiction," said Richard D. Hurt, M.D., director of the Nicotine Dependence Center at the Mayo Clinic. "Nicotine patch therapy is most effective when combined with smoking cessation counseling."
 Patient Support Program Announced
 Along with a prescription for ProStep, patients may enroll in the ProStep Personal Support Program, an easy-to-initiate-and-use patient support program, which includes free motivational aids, telephone support, referral services and patient education materials.
 "For people who want to quit smoking, we believe the ProStep patch, along with a comprehensive behavior modification program, offers a short, supportive and well-tolerated course of therapy to help them go smoke-free," said David Mason, M.D., vice president of scientific affairs and medical director at Lederle.
 Well-Tolerated
 ProStep therapy was well-tolerated by patients in the clinical studies. A low incidence of insomnia was reported. The most frequent side effect cited was mild skin irritation and redness. While some patients experienced transient, localized skin reactions, these usually did not lead to discontinuation of therapy. To reduce the potential for skin irritation, patients should apply the patch to a different area of the skin each day.
 Use of Product Abroad
 The patented transdermal technology in ProStep was developed by Elan Corporation, plc. The product is approved for marketing in six other countries in Europe and Asia. In August 1991, Lederle Laboratories obtained the rights from Elan to market the product in the United States.
 The ProStep patch comes in two dosage strengths, 22 mg/day and 11 mg/day, in convenient packages of seven patches, one week's course of therapy. The product will be available by prescription shortly, in time for smokers to make a St. Valentine's Day promise to a loved one to quit smoking.
 Lederle Laboratories, a division of American Cyanamid Company, headquartered in Wayne, is a research-intensive organization that manufactures and markets worldwide a broad range of health care products, including ethical pharmaceuticals, vaccines, generics, and vitamins and nutritionals.
 -0- 1/28/92
 /CONTACT: Jeff Hoyak of American Cyanamid, 201-831-4619/ CO: American Cyanamid Company ST: New Jersey IN: MTC SU:


GK-KW -- NY071 -- 4320 01/28/92 14:39 EST
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Date:Jan 28, 1992
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