Dimethaid plans rapid response to Health Canada issues on PENNSAID(R) new drug submission
Company expresses extreme disappointment over tardiness of Directorate's
response, 137 days beyond published deadlines
TORONTO, Feb. 7 /CNW/ - Dimethaid Research Inc. (TSE: DMX) announced
today that the Therapeutic Products Directorate has completed its review of
the Company's New Drug Submission for PENNSAID(R) Topical Solution, after 437
days with a Notice of Non-compliance; this was 137 days after the
Directorate's own self-prescribed deadline of 300 days. The Directorate has
raised issues, which the Company believes should have been resolved by
clarifying the information already submitted. The Company fully expects to
respond in writing to all issues raised within 15 days. Assuming that the
Directorate respects its own deadlines this time, it will have up to 195 days
to review the Company's response.
"Although we fully respect the Directorate's right to satisfy itself
regarding the safety and efficacy of PENNSAID(R) before allowing its sale in
Canada, it is a complete embarrassment that a product invented, developed and
manufactured in Canada, after receiving approval from several European
countries, has yet to be approved in Canada," said Rebecca Keeler, President
and CEO. "Had the review been completed within the Directorate's own published
timelines, we would have responded in early October 2001 to all the issues now
being raised, enabling the review process to be completed by the end of this
calendar quarter. However, due to this bureaucratic delay, Canadian patients
will continue to wait for a final decision from their government in order to
benefit from the option of an effective and safe alternative to pills, that
PENNSAID(R) currently provides to osteoarthritis patients in the United
Kingdom."
With the successful completion of the U.S. Food and Drug Administration's
pre-approval inspection of its Varennes, Québec plant last December, Dimethaid
fully expects the review of its U.S. New Drug Application for PENNSAID(R) to
be completed in a professional and timely manner.
Dimethaid Research Inc. is a pharmaceutical company engaged in the
development and commercialization of innovative therapeutic products that
offer the potential to minimize the unwanted systemic effects of drug therapy
on the body. Dimethaid's proprietary drug delivery technology utilizes the
cell's tubule system to deliver drugs cell-to-cell. As a result, patients are
able to treat localized conditions, such as osteoarthritis, while limiting the
body's absorption of, and associated risks from, the medication. This
technology has been applied first to produce PENNSAID(R) Topical Solution. The
Company's business development strategy is to leverage its proprietary
transdermal delivery technology into additional commercial products. For
additional information on the Company, please visit www.dimethaid.com.
This release may contain forward-looking statements. Such statements
involve known and unknown risks, uncertainties and other factors outside
management's control that could cause actual results to differ materially from
those expressed in the forward-looking statements. A discussion of such risk
factors is included in the Company's AIF filed with the OSC and includes,
without limitation, risks regarding product development, clinical trials,
dependence on third parties for development and licensing arrangements, and
risks involving regulatory approval of products, licenses and patents. The
Company undertakes no obligation to publicly revise these forward-looking
statements to reflect subsequent events or circumstances. |
