Dimethaid gains final PENNSAID(R) approval in Italy
Partner ready to market new osteoarthritis drug
TORONTO, March 4 /CNW/ - Dimethaid Research Inc. (TSX: DMX) has received
final marketing approval from Italian regulatory authorities for PENNSAID, the
company's first commercial product based on its patented transcellular
technology. PENNSAID is a topical, nonsteroidal anti-inflammatory drug (NSAID)
for treating the pain, stiffness and impaired physical function associated
with osteoarthritis. The drug will be available by prescription, only.
"This is another milestone for the company," commented Rebecca Keeler,
President and CEO, Dimethaid Research Inc. "Our agreement with Italchimici
gives us access to local opinion leaders who understand the product and how it
fits into the overall treatment of osteoarthritis, as currently practiced by
Italian physicians."
In May 2002, Dimethaid signed a distribution agreement with Italchimici
SpA, a privately owned, fully integrated pharmaceutical company headquartered
in Pomezia, Italy. As part of a European pharmaceutical alliance, Italchimici
offers Dimethaid the marketing expertise to address local payment and
reimbursement systems, prescribing habits, attitudes, culture and language.
"Given the product's unique delivery system and well-documented efficacy
and safety, we think PENNSAID represents an important opportunity for us,"
said Bill Garrow, CEO, Italchimici SpA. "Over the last several months,
Italchimici has identified a significant target market, which our sales force
is ready to start covering, immediately."
Dimethaid's topical technology is designed to deliver active drug through
the skin, providing an alternative to oral medications, which depend on
bloodstream circulation. The Company believes that PENNSAID has the potential
to compete against both topical and oral NSAIDs. In Italy, spending on oral
NSAIDS, which can be used for a variety of arthritic conditions, totals
approximately (euro) 373 million. Topicals account for another (euro) 100
million. Osteoarthritis is generally recognized as the predominant form of
arthritis and the world's most common joint disease.
PENNSAID has marketing approval in the U.K. and several European
countries. It has been granted an approvable letter in Canada, and it is
currently under review by the Food and Drug Administration in the United
States.
In other developments, Dimethaid has increased the amount borrowed
pursuant to the short-term loan arranged in December, by an additional $1.0
million CDN. The proceeds will be used for general corporate purposes,
including the Canadian launch of PENNSAID.
The company is also continuing to work with regulators in finalizing a
rights offering and has scheduled a hearing before the Ontario Securities
Commission (OSC) to resolve issues relating to the offering. The hearing will
take place on March 7, 2003 at 9:15 am at the offices of the OSC. Shareholders
will be notified once all outstanding issues have been resolved.
About Dimethaid Research Inc.
Dimethaid Research Inc. is a publicly traded, Canadian, pharmaceutical
company headquartered in Markham, Ontario, with manufacturing facilities in
Varennes, Québec and Wanzleben, Germany. The company develops and
commercializes targeted therapeutic drugs designed to produce minimal side
effects. Dimethaid's two technology platforms focus on transcellular drug
delivery and immune system regulation. Products have potential applications in
such areas as osteoarthritis, onychomycosis and HIV/AIDS. For more
information, please visit www.dimethaid.com
About Italchimici SpA
Italchimici SpA is a private pharmaceutical company headquartered in
Pomezia, Italy, near Rome. The company has over 105 sales representatives
detailing general practitioners and specialists with a therapeutic focus on
gastroenterology, rheumatology and respiratory conditions.
This release may contain forward-looking statements, subject to risks and
uncertainties beyond management's control. Actual results could differ
materially from those expressed here. Risk factors are discussed in the
Company's annual information form filed with the securities commissions in
each of the provinces of Canada. The Company undertakes no obligation to
revise forward-looking statements in light of future events. |
