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Small Bulgarian wildflower may have big promise for Alzheimer's patients By JULIA FERGUSON VIENNA (July 5, 1999 10:03 p.m. EDT http://www.nandotimes.com) - A field of wild-growing Caucasian snowdrops in Bulgaria hardly sounds like a money-spinning harvest that could spawn a flurry of international patents. But the chance discovery that the snowdrops hold an active ingredient that postpones the outbreak of the devastating Alzheimer's disease, has led one tiny Austrian firm to slug it out with the big pharmaceutical concerns. And the potential earnings growth is phenomenal. According to the World Health Organization, around 35 million people in industrialized countries will suffer from Alzheimer's by 2010. The probability of contracting Alzheimer's increases with advancing age. According to the WHO, the percentage of sufferers among those aged from 65 to 69 is 1.4 percent, but among those who are between 85 and 89 it is already 21.6. Thanks to the progress of medicine and healthier living habits, more and more people are living into old age, which means that ever more will be suffering from Alzheimer's. "We know that we can't cure the disease - the mechanisms just aren't there yet - however, we can postpone the disease," Johann Roither, chief executive of Sanochemia, said in an interview. "We are faced with an increasing age population, so the aim is to try and make those afflicted live as well as possible. At present we can postpone the full onset of the disease by three years," Roither said. "We're the only ones who can do that, and who have the clinical tests to prove it," he added. When someone develops Alzheimer's, the production of messenger substances in the nervous system consistently declines. Consequently memory fails and the patient eventually falls into a vegetative state. Sanochemia's medication Galanthamine is an alkaloid found only in Caucasian snowdrops. It has a dual-effect mechanism in that it raises the distribution of acetylcholine - a messenger substance for chemical conduction in the nervous system - and also slows down the breakdown of these substances in the human brain that are required for memory function. Sanochemia, which traces its roots back to 1441 when it was a Viennese apothecary, hopes to get the nod next year from U.S. and European authorities to sell Galanthamine on the market. The drug is so far only available in Austria. If granted, Galanthamine could become a major competitor to Eisai/Pfizer's Aricept and Novartis's Exelon. "Unlike the other two, Galanthamine has a very favourable efficacy/side effect ratio. The body actually gets used to the side effects and the symptoms disappear," Roither said. "We've also got 30 years of recorded practice on humans." Sanochemia went public on Frankfurt's Neuer Markt for growth stocks in May to gain a much-needed financial injection to ensure further research and development. "It took around 20 years from the discovery of Galanthamine to the marketing of it, so we realised that in this business one is in for a long haul," Roither said. "Going public was also a self-defence ploy against being taken over. We've had many takeover offers, but want to remain independent, unencumbered in our research," he added. According to legend, a Bulgarian pharmacologist discovered Galanthamine in the early 1950s after one of his students said the people in her village rubbed snowdrops on their forehead to ease nerve pain. Sanochemia received a license in Austria in 1961 to use Galanthamine, then called Nivalin, as a medication against against nerve pain and polio. In 1985 it started extensive trials of Galanthamine as a treatment for Alzheimer's. But it found scouring Bulgarian fields for enough snowdrops to produce the extract was time-consuming and expensive, as well as yielding very limited supplies. It also could not patent a wild snowdrop. So the Austrian group attempted to breed its own Caucasian snowdrops - in vain since cultivation of the wild plant saw a dramatic loss of the active substance. By 1995, Galamantine was approved by Austrian authorities as a treatment for Alzheimer's. Since a patient needs 10 grams per year of Galanthamine and the harvest of snowdrops was a mere 88 pounds in a good year, Sanochemia had to find another source. It therefore set about chemical synthesis and met with success in 1996 when it obtained the first patent on the process which ensures the group exclusive global rights until the year 2014 at the earliest. Now it can manufacture 40 tonnes per annum of Galanthamine and has entered into marketing agreements with Johnson&Johnson's Belgian subsidiary Janssen Pharmaceutica and Britain's Shire Pharmaceuticals Group. Roither rebuffs criticism that Sanochemia puts all its energy into the one product for the one disease and points out that the group is researching other areas, notably stroke, cranial-cerebral trauma, hypoxia, chronic fatigue syndrome and Parkinson's Disease, using derivatives of Galanthamine. "And in 2001 we're bringing out a revised form of the muscle relaxant tolperisone," he said, from which he sees "huge potential" from the fact that in Germany alone 53 percent of the working population suffers from painful back muscle tension. Sanochemia said the costly research and development of its Galanthamine plus will cause the group to write losses over the next three years, but that the effort will set its cash till ringing in 2002.