Hemosol Inc. was advised by Health Canada that its new drug submission for Hemolink would not be approved at least not now news that didn’t come as a complete shock to its CEO, John Kennedy.
Kennedy told BioWorld Today that the company is still on course to get approval from its pending new drug application in the UK by the end 2002 and in the United States by mid-2003. Hemolink, or hemoglobin raffimer, is an oxygen therapeutic designed to improve oxygen delivery to the circulatory system.
“The key thing is the fundamentals of the company are very sound, very strong,” Kennedy said, adding that he “knew going in that it was not a slam dunk.”
“The major markets are the U.S. and Europe anyway, so it doesn’t really affect our financial forecast,” he said.
Toronto-based Hemosol’s stock (NASDAQ:HMSL) fell $1.07 Thursday, or 28.6 percent, to close at $2.67.
While Hemosol has not received written feedback regarding its application first filed two years ago, Kennedy conceded that not getting approval in Canada will set the company back by about 18 months in that country.
Because the company was unable to add more recent data to the application while the agency reviewed it, Kennedy said the process offered little flexibility, but the company decided to go for approval anyway. Once the final written response from Health Canada is received, the company will respond and ultimately re-file the NDS, Kennedy said.
Hemosol plans to use data it is gathering in two Phase II trials in the United States to provide additional data to the Medicines Control Agency in the UK, as well as to the FDA. Those trials are scheduled to be completed in the second quarter, with results available and scheduled to be reported in the third quarter.