Friday May 14, 6:14 am Eastern Time
by Jonathan Birt, European pharmaceuticals correspondent
LONDON, May 14 (Reuters) - U.S. biotech LeukoSite Inc said on Tuesday it hoped to have its first product, for combatting chronic lymphocytic leukaemia, on the market in the U.S. in the first quarter of 2000 and in Europe early in 2001.
In an interview with Reuters, LeukoSite Chairman and Chief Executive Officer Christopher Mirabelli said further work currently underway showed the drug, Campath, also showed considerable promise in the fight against multiple sclerosis and organ transplant rejection.
LeukoSite hopes to announce its first marketing partner for Campath before the end of June. "We are now looking at establising marketing and distribution partnerships and are in negotiations with a number of U.S. and European partners," Mirabelli said during a visit to London. Key Phase III leaukaemia data for Campath, which LeukoSite licensed from British technology group BTG PLC (quote from Yahoo! UK & Ireland: BGC.L http://finance.yahoo.co.uk/quotes/ukie/quote?symbols=BGC.L&detailed=t), will be published at the European Hematology Association meeting in Barcelona in June. The data will be used to submit a regulatory application to the U.S. Food and Drug Administration (FDA) shortly, and LeukoSite is hoping strong response rates seen in Phase II trials are repeated.
These much smaller studies showed 28 percent of patients experienced either partial remission -- clearing all malignant lymphocites from the blood and half from bone marrow over eight weeks -- or total remission, a complete clearance in both sites over the same period.
LeukoSite takes its name from white blood cells, leukocyytes, which play an important role in ridding the body of infection and repairing tissue damage.
However, unwanted build up of white blood cells is associated with a wide range of diseases, including inflammatory bowel disease (IBD), asthma, leukaemia and HIV, and with damage caused after strokes, organ transplants and heart attacks.
"The drug has been given an expedited six month review by the FDA, which could have us on track to have the product (on sale) in the first quarter of 2000 -- we think a first quarter approval is certainly doable -- and the company is planning to file in Europe before the end of the year," Mirabelli said.
Much of the work on Campath has been carried out in Britain by teams under the supervision of Prof Herman Waldmann, head of the Sir William Dunn School of Pathology at Oxford University.
Waldmann, a member of Leukosite's scientific advisory board, is now studying Campath's potential in preventing rejection of transplanted organs and in multiple sclerosis, with preparations underway for intermediate, or Phase II, trials in both.
Waldmann said trials in patients so far had shown a fall in the number of rejections, and allowed a marked reduction in the need for other anti-rejection drugs such as cyclosporin.
"Of 31 (patients), five had rejections, which is much less than usual,
and this is easily reversed," he told Reuters.
In MS, Waldmann said there were signs Campath could stop the development of new brain lesions -- destruction of the myelin sheath which protects nerve cells in the brain and spinal cord.