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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly)

PFE 25.08

-2.7%

Nov 14 9:30 AM EST

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To: Anthony Wong who wrote (145)	6/1/1998 3:03:00 PM
From: Anthony Wong	Read Replies (1) of 1722

Harvard Scientific gets ok on impotence drug trial Monday June 1, 2:28 pm Eastern Time LAKE MARY, Fla., June 1 (Reuters) - Harvard Scientific Corp. (HVSF - news) said on Monday it won approval from the U.S. Food and Drug Administration to start Phase II clinical trials of its male impotence treatment, called Prostaglandin E-1. The green light for the second phase comes just over two months after leading pharmaceutical company Pfizer Inc. (PFE - news) started selling its oral impotence drug Viagra, which is estimated to be one of the biggest selling drugs ever. Harvard Scientific said the FDA completed the review of the Phase I submimssion data and said it was quickly moving toward a New Drug Application and toward customers as soon as possible. It did not give any expectations for when it would reach the market. A spokesman said the treatment is taken by inserting a catheter into the penis and squeezing a liquid into the urethra. The company said the treatment avoids potentially life threatening side effects from oral medication. The announcement comes amid reports at the end of May that six men died after taking Viagra. Pfizer subsequently said it was standing behind the drug and that it had no plans to change the drug's labeling. Harvard Scientific said an estimated 30 million men in the United States suffer from some form of male erectile and sexual dysfunction, making the market for impotence drugs at more than $1 billion. ''This is a tremendous mileston for Harvard Scientific Corp. and its shareholders as it offers validation that the company's product has merit as a viable treatment product...'' President and Chief Executive Thomas Waite said in a statement. He said the drug should become the treatment of choice ''...due to its painless delivery method and its ability to be stored at room temperature for prolonged periods of time...'' Harvard Scientific shares were 1/2 higher at 8-1/8 in volume of 59,600 in electronic trading. The stock hit a record high of 157-1/2 in February 1996. biz.yahoo.com

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