Article in DJ
IF you are subscribing to the Wall Street Journal on-line, you can search and find the following article.
I dont know if the link will work. Here it is below with the COMPLETE release underneath.
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November 27, 2000
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Dimethaid Sees PENNSAID Sales Starting In March
By PAUL HAAVARDSRUD
Of DOW JONES NEWSWIRES
TORONTO -- After getting final marketing approval from the U.K. Medicines Control Agency, Dimethaid Research Inc. (T.DMX) expects to begin selling its lead product, PENNSAID Lotion, in the U.K. in March, the company's top executive said.
"We are in the home stretch with respect to determining our marketing partner in the U.K.," said Rebecca Keeler, the company's president and chief executive. "We're expecting to launch in the U.K. in the spring, so sometime in March."
In a news release, Dimethaid said it will immediately seek approvals for PENNSAID from other European Union countries. Under the mutual recognition procedure prevailing in the EU, the U.K. will act as agent for other EU member states, who can recognize this approval and issue their own authorizations.
"Because the British regulatory agency is so well-recognized in Europe, we don't anticipate any negative responses when they submit on our behalf to the other countries," Keeler said, noting that submissions for approval will be made in January to Germany, France, Italy, Sweden and Switzerland, with other European countries to follow.
Submissions for approval take 90 days to be processed, under the mutual-recognition procedure, Keeler said.
In Toronto trading Monday, Dimethaid is up 0.90, or 20%, to 5.40 on about 573,000 shares.
Company Web Site: dimethaid.com
Dimethaid Research Inc. (T.DMX) plans to identify marketing partners for its PENNSAID Lotion, its first product to gain commercial approval, on a country-by-country basis, said Rebecca Keeler, the company's president and chief executive.
Keeler declined to provide specific financial projections for the PENNSAID product, a topical lotion used to treat the pain associated with arthritis, but said, "we certainly see revenue generation from PENNSAID within our current fiscal year, which ends May 31."
Dimethaid will initially target the existing topical market in the U.K., estimated at about C$75 million annually, Keeler said.
"On the one hand we expect revenue generation, but on the other hand we expect to accelerate our new product development as well," Keeler explained. "On a net basis we expect to have a number of projects that are in pilot and early stage move on to clinical development, so we expect those to offset each other."
Dimethaid is hopeful that regulatory approval for its PENNSAID product will come in the U.S. and Canada in 2001.
The company resubmitted its application to Health Canada in October, after the Canadian regulatory authority discontinued its review of PENNSAID in August, citing the need for additional proof of effectiveness.
Keeler said she is "very confident" the data in the new submission will satisfy Canadian regulators. British regulators, she explained, have a history of approving topical treatments, which helped the process go more smoothly in the U.K. than it has in Canada.
While each regulatory body is independent, Keeler said she is hoping the U.K. approval will "at least provide some moral suasion" to the Canadian body.
Not counting upfront or milestone payments associated with the PENNSAID product, Keeler said Dimethaid has funding to take it to May 31, the end of its fiscal 2001 year.
Dimethaid has no plans to seek additional financing in the near future, Keeler said, adding the company's burn rate is about C$600,000 a month. In the long-term, she said Dimethaid will look to raise some money in conjunction with a Nasdaq listing.
-Paul Haavardsrud, Dow Jones Newswires; 416-306-2032 |
