Subject: Du Pont and HEM Settle Lawsuits Over AIDS Drug Date: Published: 7/17/90 (78 lines) Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Technology: Du Pont and HEM Settle Lawsuits Over AIDS Drug ---- By Richard Koenig Staff Reporter of The Wall Street Journal Du Pont Co. and HEM Research Inc. agreed to settle litigation stemming from the collapse of their joint venture with an experimental AIDS drug. Under the agreement, Du Pont will pay HEM $2.8 million, give up the 5% stake in HEM that it acquired in 1987 and relinquish certain marketing and royalty rights to the drug, called Ampligen. The agreement, announced yesterday by HEM, brings to an end the lawsuits that ensued after the close of a big clinical trial meant to determine whether Ampligen slowed the progression to acquired immune deficiency syndrome in patients infected with the AIDS virus. Du Pont, the Wilmington, Del., chemicals giant, had quickly allied itself with HEM after HEM researchers reported in the British medical journal Lancet encouraging but inconclusive results from a small trial of Ampligen. Du Pont has since said in court papers that it invested more than $30 million in HEM and its work with Ampligen, including the large trial, which involved more than 300 patients. But after Ampligen failed to show efficacy in the large trial, Du Pont alleged that it had been provided misleading information by HEM, a closely held company based in Philadelphia. Du Pont said the damages sought in its suit, filed in a Delaware state court, far exceeded HEM's net worth of $8.5 million at the end of 1988. HEM, for its part, has contended that the plastic bags Du Pont used to package Ampligen, which is given intravenously, impaired the drug's potency. During the initial trial reported in the Lancet, the drug was packaged in glass bottles. HEM countersued Du Pont, seeking $7.4 million it said it was owed by Du Pont, plus other damages under breach-of-contract claims. Those claims, as well as Du Pont's, were dropped under the pact. E. Paul Charlap, HEM's chairman and chief executive officer, called the settlement a "favorable outcome" for HEM. A Du Pont spokesman replied that "both sides had claims and counterclaims, and we came to this agreement." Even as the settlement was reached, though, another point of contention between HEM and Du Pont arose. Although Du Pont is to give its unused vials of Ampligen to HEM under the accord, Du Pont destroyed raw material used to make the drug, an anti-viral agent fashioned from double-stranded ribonucleic acid. HEM officials estimated that the raw material could have been used to make enough Ampligen to treat some 3,000 patients for a year. "Obviously, this is going to cause this little company a lot of trouble" in expanding future trials, said William M. Mitchell, a consultant to HEM and a pathology professor at Vanderbilt University, adding that HEM had thought it might gain possession of the material. The Du Pont spokesman said, "We had asked" HEM about the raw material during settlement talks, "and they had no interest. We had no use for it, so we destroyed it." About 30 people infected with the AIDS virus continue to be treated with Ampligen from glass bottles under HEM's auspices. In addition, HEM said, it recently expanded its U. S. clinical trials in the use of Ampligen against a virus-caused blindness related to AIDS and is seeking clearance from the Food and Drug Administration to broaden its trials in AIDS-related disorders. [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.]