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 PALO ALTO, Calif., and CINCINNATI, Jan. 11 /PR Newswire/ -- Syntex Corp.(NYSE: SYN) and The Procter & Gamble Co. (NYSE: PG) announced today that the Procter-Syntex joint venture has received clearance to market a new non-prescription pain reliever. The new product, ALEVE(R), is the first non-prescription pain reliever containing a new analgesic ingredient in nearly a decade.
 ALEVE contains a fast-acting, non-prescription strength of naproxen, the medicine in Naprosyn(R). Naprosyn is the number-one selling prescription brand in its class in the United States. ALEVE will be indicated, in adults and children age 12 and over, for the temporary relief of minor aches and pains associated with the common cold; headache; toothache; muscular aches; backache; the minor pain of arthritis; the pain of menstrual cramps; and the reduction of fever. ALEVE (naproxen sodium) contains 200 mg of naproxen in a fast-acting, non-prescription formulation that optimizes absorption into the body.
 Data from 32 clinical studies involving more than 7,000 patients -- and safety-related information on naproxen, which has been available in 92 countries for the past 20 years and used by patients in more than 12.7 billion days of therapy -- were submitted to the U.S. Food and Drug Administration (FDA) as part of a New Drug Application.
 Product Benefits
 As the first non-prescription pain reliever to contain naproxen, ALEVE offers consumers important benefits in over-the-counter (OTC) pain relief. While other OTC pain relievers call for re-medication, if needed, every 4 to 6 -- or 6 to 8 -- hours, ALEVE provides pain relief that lasts 8 to 12 hours.
 "We are very pleased to make naproxen available to consumers in non-prescription strength," said Paul E. Freiman, chairman and chief executive officer of Syntex Corp. "We believe ALEVE will be welcomed by health care professionals and consumers alike, who are familiar with prescription naproxen's track record of efficacy and tolerability," he said.
 "ALEVE offers some real advantages to consumers who are not entirely satisfied with current non-prescription pain relievers," said Thomas A. Moore, president of health care products for Procter & Gamble. "Because it lasts up to 12 hours, ALEVE is a convenient new choice for people with minor aches and pains who don't want to be slowed down during the day or awakened at night by the need to take more medicine," he said.
 Clinical Findings
 In controlled clinical testing, ALEVE was shown to be a fast-acting, strong and long-lasting pain reliever. ALEVE provided pain relief in some people in as little as 20 minutes and for up to 12 hours with only one dose. Its duration of pain relief was shown to be longer than that of Extra Strength Tylenol. ALEVE was also shown, in clinical trials, to be at least as effective as Advil, with evidence of a longer duration of pain relief in some studies.
 "ALEVE offers strength and rapid onset of analgesia," said James F. Fries, M.D., professor of medicine, Stanford University Medical Center, who is familiar with data from the ALEVE clinical trials. "It was developed from naproxen and provides a good balance between efficacy and tolerability."
 New, Patented Package Design
 ALEVE will be the first OTC pain reliever to be sold in a patented, child-resistant package design called SAFETY SQUEASE (TM), developed by Procter & Gamble. SAFETY SQUEASE can be easily opened by adults, even those with restricted hand mobility due to injury or arthritis, while still providing child-resistance. The cap shuts with an audible click, indicating that the product is safely closed. To make usage information easier to read, ALEVE bottles of 24 and 50 tablets and caplets also feature a unique fold-out label attached directly to the container.
 Safety Precautions
 Patients who are allergic to ibuprofen, aspirin or any pain-relieving drug are advised not to use this product, since they may also be allergic to ALEVE. Moreover, ALEVE should not be taken in combination with acetaminophen, ibuprofen, aspirin or any other naproxen- containing product without a doctor's approval.
 ALEVE will be the first non-prescription pain reliever to carry in its label an alcohol precaution relevant to all non-prescription pain relievers. As such, Procter & Gamble and Syntex will be the first non-prescription drug marketers to educate the public about the need for caution when combining daily
alcohol consumption and the use of non-prescription pain relievers. The label for ALEVE advises people who generally consume 3 or more alcoholic beverages a day to consult their doctor about how and when to use pain relievers. All non-prescription pain relievers are expected to carry an alcohol precaution in their labels in the near future.
 Instructions for Use
 Directions call for adults and children age 12 and over to take 1 tablet or caplet of ALEVE every 8 to 12 hours while symptoms persist, not to exceed 3 tablets in 24 hours unless directed to do so by their physician. The label notes that with experience some people may find an initial dose of 2 tablets, followed by 1 tablet 12 hours later, if necessary, provides better pain relief.
 Adults over age 65 are directed not to take more than 1 tablet every 12 hours, unless directed to do so by a physician.
 ALEVE is not to be taken by children under 12, unless directed to do so by a physician.
 Future Class Requirements
 Syntex has agreed to comply with any future requirements which may result from changes in FDA policy and which are concurrently imposed on the entire OTC analgesic drug class. Such requirements could include modified labeling and/or additional studies. Naproxen, ibuprofen, acetaminophen and aspirin are among the pharmaceuticals that make up the OTC analgesic class of drugs.
 ALEVE will be available this spring in SAFETY SQUEASE bottles of 24, 50 and 100 tablets and caplets, in pharmacies, supermarkets, convenience stores and other retail outlets. The product has been developed by a joint venture between affiliates of Syntex Laboratories Inc., headquartered in Palo Alto, and Procter & Gamble, headquartered in Cincinnati. It will be manufactured by Syntex and distributed by Procter & Gamble. Syntex will market ALEVE to physicians and other health professionals. Procter & Gamble will market the product to consumers and dental professionals.
 Syntex Corp. is a multinational, research-based health care company dedicated to the discovery, development, manufacture and marketing of prescription medicines, with more than $2 billion in sales. ALEVE is Syntex's first major non-prescription product in the United States.
 Procter & Gamble is the world's largest OTC company with nearly $3 billion in worldwide health care sales. Procter & Gamble's health care business includes both prescription and non-prescription drugs, which are available in 60 countries.
 NOTE: Consumer labeling leaflet is attached.
 Consumer Labeling Leaflet
 Naproxen Na
 Naproxen Sodium, USP
 Pain reliever/Fever reducer
 ALLERGY WARNING: Do not take this product if you have had either hives or a severe allergic reaction after taking any pain reliever. Even though this product may not contain the same ingredient, ALEVE could cause similar reactions in patients allergic to other pain relieving drugs.
 ALCOHOL WARNING: If you generally consume 3 or more alcohol-containing drinks per day, you should consult your physician for advice on when and how you should take ALEVE and other pain relievers.
 INDICATIONS: For the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, for the minor pain of arthritis, for the pain of menstrual cramps and for the reduction of fever.
 DIRECTIONS: Adults: Take 1 tablet every 8 to 12 hours while symptoms persist. With experience, some people may find that an initial dose of 2 tablets followed by 1 tablet 12 hours later, if necessary, will give better relief. Do not exceed 3 tablets in 24 hours unless directed to do so by your doctor. The smallest effective dose should be used. A full glass of water or other liquid is recommended with each dose.
 Adults over age 65: Do not take more than 1 tablet every 12 hours, unless directed to do so by a doctor.
 Children under age 12: Do not give this product to children under 12, except under the advice and supervision of a doctor.
 GENERAL WARNINGS: Do not take ALEVE for more than 10 days for pain, or for more than 3 days for fever, unless directed by a doctor. Consult a doctor if:
 -- your pain or fever persists or gets worse
 -- the painful area is red or swollen
 -- you take any other drugs on a regular basis
 -- your have had serious side effects from any pain reliever
 -- you have any new or unusual symptoms
 -- more than mild heartburn, upset stomach or stomach pain occurs with use of this product or if even mild symptoms persist
 Although naproxen is indicated for the same conditions as aspirin, ibuprofen and acetaminophen, it should not be taken with them or other naproxen-containing products except under a doctor's direction. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. IT IS ESPECIALLY IMPORTANT NOT TO USE NAPROXEN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.
 Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Store at room temperature; avoid excessive heat 40o C (104o F).
 Active Ingredient: Each tablet contains naproxen 200 mg, sodium (Na) 20 mg as naproxen sodium.
 Inactive Ingredients: Magnesium Stearate, Microcrystalline Cellulose, Povidone, Talc, Opadry YS-1-4215.
 If you have questions, comments or problems, call 800-395-0689 to report them.
 U.S. Patent Nos. 3,998,966 and others. (C)1994 P-S HPC Distributed by Procter & Gamble, Cincinnati, Ohio 45202
 -0- 1/11/94
 /CONTACT: Kris Burbank of Procter & Gamble, 513-945-8066; or Linda Thomas of Syntex, 415-852-1321/

CO: Syntex Corp.; Procter & Gamble Co. ST: California, Ohio IN: MTC SU: PDT JVN

RB -- SJ006 -- 1008 01/11/94 12:56 EST
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Date:Jan 11, 1994

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