ALZHEIMR's DRUG R&D: THREE PRODUCTS HAVE REACHED PHASE III

ALZHEIMR's DRUG R&D: THREE PRODUCTS HAVE REACHED PHASE III trials, according to a recent survey by the Pharmaceutical Manufacturers Association (PMA) on research activity for diseases affecting the elderly. The three drugs in the late stages of clinical development are Warner-Lambert's tacrine (THA), SmithKline's Neuromet (oxiracetam) and Miles' Nimotop (nimodipine). Nimotop was actually approved late last year for treatment of subarchnoid hemorrhage for treatment of subarachnoid hemorrhage from congenital intra-cranial aneurysms and will enter the U.S. market at mid-year ("The Pink Sheet", Jan. 2, page 14). The disease affects about 25,000 patients annually in the U.S. FDA rated the product as a major therapeutic breakthrough for its approved indication. Overall, PMA found 15 Alzheimer's drugs which companies reported are under active consideration for development. Hoechst-Roussel, with three projects, has the most products listed from the PMA survey. The Warner-Lambert tacrine project is the fruit of at least a decade of work by the company in the cognition activator category. THA is reportedly being studied in about 300 patients in double-blind trials. An FDA advisory committee recently conducted a preliminary safety review of the compound ("The Pink Sheet" Jan. 30, p. 8). For a number of years, Warner-Lambert was pursuing pramiracetam as its lead senile dementia project. The product is in Phase II trials as a cognition activator and for pediatric dyslexia. However, the company did not mention progress on the compound at a recent meeting with financial analysts. The firm also has two other compounds as backups to THA: CI-844 (in active Phase II trials) and CI-933. Those compounds were not included in PMA's survey total for Alzheimer's treatments. SmithKline's work on oxiracetam indicates one of the problems in Alzheimer/cognition research. FDA's notorious distaste for that class of products is apparently discouraging domestic research on compounds. SmithKline reported on Neuromet in a meeting with analysts on Feb. 2. The company noted that it was launched in Italy over 1-1/2 years ago in the second quarter of 1987. The product generated $12 mil. in sales in Italy with a 12% share of the nootropic market. Further filings in collaboration with Ciba-Geigy are expected in the "rest of the world," with the exception of the U.S., during the second quarter of this year. "Research focus is strong on medicines for the diseases that most often result in loss of independence for older person," Mossinghoff said. The PMA chart, he noted, "shows 48 companies are developing 69 new drugs that will treat nine diseases that often cripple and disable older persons." In addition to Alzheimer's, PMA looked at treatments for rheumatoid and osteoarthritis (15 and 10 drugs in development, respectively), osteoporosis (10), depression (16), Parkinson's disease (6), adult onset diabetes (4), glaucoma (3) and gout (2). The PMA press briefing was the third and final installment in a series of reports on drugs for the elderly in clinical development. The "New Medicines for Older Americans" series began in October with a review of treatments for cardiovascular disease, the category with the most compounds in clinical stages of development, PMA noted. PMA's survey found 87 drugs in clinical development for heart disease, hypertension and stroke. In December, the association reported drugs in clinical development for cancer, where 19 of the 65 drugs are biotechnology-based agents. The association survey was initiated six months ago with the cooperation of six disease and patient groups: Alliance for Aging Research, American Cancer Society, American Diabetes Association, Arthritis Foundation, American College of Cardiology and the National Council on the Aging. One of the important corollary benefits to PMA from the study is the cooperation that it engenders with these groups. PMA plans to update the survey each year.