Subject: Insiders Shed Shares of Sagging Epitope Date: Published: 6/17/92 (88 lines) Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Inside Track: Insiders Shed Shares of Sagging Epitope ---- By Alexandra Peers Staff Reporter of The Wall Street Journal NEW YORK -- Insiders have been selling at Epitope Inc., a biotechnology highflier whose shares took a hit this week amid reports that the Food and Drug Administration is questioning the company's research data. At issue is Epitope's chief product, OraSure, a saliva test for the AIDS virus that hasn't yet been approved for sale in the U. S. by the FDA, but is sold in Canada, among other countries. A 22-page document about OraSure, said to be issued by the FDA's Bothell, Wash., district office in April, has been making the rounds of Wall Street fax machines lately. "Questions and rumors" about the document have been driving down the company's stock price, said Adolph J. Ferro, Epitope's president. FDA officials declined to comment about the document. Shares of the Beaverton, Ore., company have fallen $2.25, or 13%, since last Friday. They closed at $15.75, down $1.25, in American Stock Exchange composite trading yesterday. The stock closed as high as $27 on Jan. 15. So far this year, Securities and Exchange Commission filings show, seven insiders at Epitope have trimmed their holdings by a total of 59,138 shares, all at prices above the current level. Their shares fetched prices ranging from $18 to $24.25 each, according to the filings. About half the shares were sold in option-related transactions, according to SEC filings. But in two cases, SEC filings show, insiders sold large blocks of stock outright. On Feb. 26, Mr. Ferro sold 14,000 shares at $20.13 a share, retaining an indirect holding of just 35 shares, according to the filings. On Jan. 30, Director F. Douglas Lawrason sold all his holdings, 16,500 shares, at $24.50 each, SEC filings show. Charles Biderman, editor of Market Trim Tabs, an investment newsletter based in Santa Monica, Calif., that recommends short-selling the stock, said that "the insider selling started right after" Epitope was visited by FDA officials in November and December. Since early last year, he said, "insiders have sold about $1.5 million in stock -- about as much as company revenues" in its past two quarters. Mr. Lawrason couldn't be reached for comment on the sales. Mr. Ferro said the insider selling and the purported FDA report have been completely misinterpreted on Wall Street. As far as his sale of stock goes, he said that in 1991, the company paid him in Epitope shares and he sold in part to pay taxes on their receipt. He said he holds vested options representing another 70,000 shares. The Epitope president said that the report attributed to the FDA, dated April 30, is essentially old news, and that the issues it raises have "already been addressed" with FDA staff or in an amendment Epitope added to its request for approval of OraSure in mid-April. He said the FDA's problems were with recordkeeping and procedures, "not the data." The document, obtained by this newspaper, states that Epitope's research data boosted the number of samples studied by taking more than one saliva sample from each patient, and that some data was not verified. It also claims that Epitope gave out literature at the American Dental Association annual convention last year that "inappropriately promotes safety and effectiveness of OraSure." OraSure is a kind of high-technology absorbent toothbrush soaked in chemicals that collects saliva and cheek tissue for laboratory testing for AIDS-virus antibodies, evidence of drug use or other diseases such as mumps or measles. Epitope also sells standard blood tests for AIDS and is developing OraQuick, a product similar to OraSure that wouldn't have to be sent to a lab for testing. Epitope claims saliva tests are as reliable as blood tests for AIDS. Mr. Ferro said investors are overlooking the fact that, if approved by the FDA, OraSure and OraQuick products have "enormous market potential." He predicted that the company would be profitable almost immediately after approval. Epitope is also developing genetically altered food and flowers. [This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.]