To: Hal who wrote (3627 ) 6/10/1998 3:00:00 PM From: Dan Dieffenwierth Respond to of 3906
[ Business | US Market | Industry | IPO | S&P | Int'l | PRNews | BizWire | Finance Home ] Wednesday June 10, 2:07 pm Eastern Time Here it is now: Company Press Release Harvard Scientific Introduces New Topical Treatment for Male Erectile Dysfunction LAKE MARY, Fla.--(BW HealthWire)--June 10, 1998--Harvard Scientific Corp., (OTC Bul Bd:HVSF) a Nevada corporation, announced today that it has developed a topically applied product for treatment of male erectile and sexual dysfunction that utilizes the Company's patented lyophilized liposomal delivery of Prostaglandin E-1 and will compliment its aqueous solution, intrameatal delivery treatment for this specific ailment that affects over 30-million men in the U.S. This new product will be administered locally to the penis as a lotion and is very similar to the Company's new treatment for female sexual dysfunction which was announced last month. A Company spokesperson stated that the reasons for the secrecy of the project were not only to ensure patent protection, but to produce a product that does not have to utilize a transdermal enhancer to ensure effective delivery of the active ingredient Prostaglandin E-1 (''PGE-1'') to the glans of the penis, thereby stimulating the erection. The Company intends to petition the U.S. Food and Drug Administration (''FDA'') for approval to begin its combined Phase I/II clinical trials, shortly. There are currently other companies in developmental stages of topically applied treatment products. However, they are administered accompanied by dermal enhancement agents. It is the Company's belief that the use of such agents also enhances the likelihood that the patient could contract sexually communicable diseases and thereby present another problem for which the patient would have to contend. Thomas E. Waite, the Company's President and CEO stated, ''the launch of this new topically applied product as a first-line treatment will certainly compliment the Company's intrameatally delivered, treatment product and should provide the Company a very distinctive, competitive edge for treatment of male erectile and sexual dysfunction. I give all the credit to Dr. Jackie R. See, (the Company's Director of Research and principal inventor of the technology) for these medical breakthroughs. This new product will utilize a combined science that was researched and developed not only for the female/male sexual dysfunction treatment products, but the Company's psoriasis treatment product, as well. The Company's internal studies have shown that its psoriasis product successfully delivers PGE-1 in lyophilized liposomal form through the skin to the underlying dermis without the need or use of transdermal enhancers.'' Mr. Waite further stated that ''although no human clinical trials have been done to date on this new product, the Company's sophisticated R & D team, comprised of Dr. Jackie See, Dr. Darryl See, Dr. Irwin Goldstein and Mr. Medhat Gorgy of Pyramid Labs, all leaders in their respective fields, expressed to me in a telephone conference last night that they feel extremely confident the product will prove to be a medical breakthrough for the treatment of male erectile dysfunction.'' Prostaglandin E-1 is a naturally occurring vasodilator originally approved by the U.S. Food and Drug Administration for intravenous infusion in neonates. In 1995, PGE-1 was approved by the FDA for use in Pharmacia & Upjohn Inc.'s (NYSE:PNU - news) Caverject(r), which is administered by needle injection as a treatment for male erectile dysfunction. In November 1996, Vivus, Inc.'s (NASDAQ:VVUS - news) MUSE(r) delivery system was approved by the FDA. Recently, the FDA approved PGE-1 again by needle administration via Edex(r), (Schwartz-Pharma). Viagra(r), Pfizer, Inc.'s (NYSE:PFE - news) oral medication treatment was approved by the FDA in March, 1998. Zonagen Inc. (NASDAQ:ZONA - news) has in development an oral treatment product as well. The Company believes that its product represents a substantial treatment advantage over other delivery systems currently being utilized in the industry. From time to time the Company may issue forward looking statements which involve risks and uncertainties. This statement may contain forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results could differ and any forward looking statements should be considered accordingly. Contact: I.W. Miller & Co. Ira Miller 714/833-9001 or Martin E. Janis & Co. Hal Schweig 312/943-1100 or Harvard Scientific Corp. Michael Snell 407/324-1606 www.harvardscientific.com More Quotes and News: Harvard Scientific Corp (OTC BB:HVSF - news) Pfizer Inc (NYSE:PFE - news) Pharmacia & Upjohn Inc (NYSE:PNU - news) Vivus Inc (Nasdaq:VVUS - news) Zonagen Inc (Nasdaq:ZONA - news) Related News Categories: biotech, medical/pharmaceutical Help Copyright c 1998 Business Wire. All rights reserved. All the news releases provided by Business Wire are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving ina public database, redistributing via a computer network or in a printed form. See our Important Disclaimers and Legal Information. Questions or Comments?