From gwyn@annwfn.indstate.edu Wed Nov 23 14:19:45 1994 The following is the top front-page story from _The Globe and Mail_, November 21, 1994. What I find interesting about this otherwise typical "breakthrough" story is that it ends with four paragraphs on the effect of the announcement on the stock of the company which developed 3TC, but contains not one comment from anyone involved in AIDS activist or support groups. David Vereschagin quadrat@interlog.com 75645.1572@compuserve.com * * * * * AIDS drug shows dramatic results Montreal firm's discover reduces virus in combination therapy by Andrew Bell The Globe and Mail A drug discovered by BioChem Pharma Inc. of Montreal may become a powerful weapon against AIDS, new research indicates. The compound, 3TC, dramatically reduces the level of AIDS virus in blood when used in combination with the drug AZT, scientists say. In two European studies, people with the HIV virus taking the combination therapy also had an increased level of T-cells, a key component of the immune system that are attacked by the virus. "These data are extremely significant not only for their effectiveness in reducing virus and increasing CD4 cell [T-cell] levels but also because these effects persisted throughout the year-long study," said researcher Professor Christine Katlama of Pitie Salpetriere hospital in Paris. "It is also important to note that the combination was very well tolerated by patients," she told the Second International Congress on Drug Therapy in HIV Infection, held in Glasgow on the weekend. "We've never seen such dramatic results" in AIDS drug research, said Dr. Gervais Dionne, executive vice-president for research and development at BioChem. "These resul have surprised us." Experts cautioned that more work is needed to show whether a combination of AZT and 3TC can extend the lives of patients. "The results of these studies are encouraging, but these are laboratory studies," said Martin Sutton, a spokesman for British drug giant Glaxo Holdings PLC. Glaxo sponsored the studies and is licenced to develop and market 3TC. BioChem will get a royalty based on sales. AZT, also known by its trade name, Retrovir, was developed by Wellcome PLC of Britain, which is in talks with Glaxo to sell 3TC. "It is only when clinical endpoint studies have been ... completed that the precise clinical relevance of these results will be understood," Mr. Sutton said. End-point studies will focus on whether the combination actually extends the lives of patients and is successful at staving off the "opportunistic infections" that take advantage of patients' weakened immune systems. BioChem president and chief executive Francesco Bellini called the studies "very encouraging," but said it is too early to tell whether full-blown AIDS could be delayed using the drug combination. "I cannot guarantee what we will find in the future, but the indications are that it delays the onset of the disease." Dr. Robert Schooley, head of the immunology committee of the AIDS Clinical Trials Group at the National Institutes of Health, who attended the AIDS meeting in Scotland, said in a telephone interview that "3TC by itself is not much of a winner because resistance develops quickly, but the virus has a tough time maintaining resistance to both [3TC and AZT]." Prof. Katlama of Paris studied 129 HIV-positive people who received either 3TC and AZT or AZT alone. Patients on AZT alone were given the opportunity to switch to the combination of drugs after 24 weeks. She reported that for patients taking the combination of 3TC and AZT, levels of virus in blood cells were reduced by 99 per cent by week 48. For patients taking AZT alone, levels of virus in the blood cells were reduced by 70 per cent by week four, but the reduction was only 11 per cent by week 24. Patients on AZT alone who switched to the combination therapy at week 24 had a reduction of 98 per cent at week 48. Her research and the other study, by Dr. Schlomo Staszewski from the Goethe Universitat in Frankfurt, also found that the combination therapy increased CD4 cell counts for a sustained period. In both studies, more than one-quarter of the patients suffered from nausea and vomiting, but the drug did not have dangerous side effects, Dr. Bellini said. BioChem is still awaiting results of a larger, more comprehensive North American study, which the company's Dr. Dionne expects to be released at an AIDS conference in Washington in late January. If all goes as expected, Glaxo will apply to begin distributing 3TC early next year. That could make the drug widely available by the end of 1995. When stock markets open today, eyes will be on BioChem shares to see how investors react to the news. The shares closed at $15.75 on the Montreal Exchange on Friday (down from more than $30 in 1992), meaning that investors are already valuding the drug company at about $740 million. Cameron Groome, who watches BioChem for investment dealer First Marathon Securities Ltd. in Montreal, said the results of the 3TC studies are better than the market had expected. He said the fact that benefits seem to last for a sustained period is particularly promising. Many new treatments show early promise, but lag in later response as the virus adapts, AIDS researchers have found. Michael Jams of Montreal-based Dlouhy Investments Inc., noted that BioChem shares have already climed from $12 this summer. He said the shares have been lifted by the prospects for 3TC in AIDS treatment and optimism about potention use of the drug in treating hepatitis B. Investors are already building high hopes for 3TC into the stock prince, Mr. Jams said. With files from Reuter, AP, CP and Bloomberg. * * * * *