Bidding on Bay Street Update:
stockhouse.ca
UPDATE: DIMETHAID [T.DMX] RECEIVES UK APPROVAL FOR PENNSAID(R)
November 27, 2000
Bidding On Bay Street
Dimethaid Research Inc. [T.DMX]
DMX HAS A PRODUCT
DMX HAS A MARKET
MANAGEMENT HAS DELIVERED ON TIME
DMX has just announced final marketing approval for PENNSAID(R) in the UK and it is seeking approvals from other EU
countries immediately.
No mention is made in the release of a marketing partner in the UK; I expect an announcement to this effect will follow
shortly. We do know DMX has stockpiled supplies of PENNSAID(R) for a commercial UK launch in the earliest possible
timeframe following receipt of this final approval and the naming of its partner.
DMX is targeting a huge market for pain relief (OA) with a product which has a huge advantage over competing products,
that being it will not kill the patient or make him/her sicker!
On the SAFETY side, PENNSAID(R) appears to have NO MAJOR SIDE EFFECTS thus far.
On the EFFICACY SIDE, the results of the latest independent Phase III study seem to indicate PENNSAID(R) may provide
better pain relief than existing medications (NSAIDS).
PAIN RELIEF EFFICACY COMPARISONS
Comparison between PENNSAID and currently available oral medications, in terms of pain relief patients can expect with a
number of currently available pills (all of these pills also used the WOMAC scale to demonstrate efficacy; this comparison
from their published data):
Depending on the dose administered and the duration of the trial, other medications have reported a range of pain relief.
These results are not atypical as experts in the field of pain research have come to expect about a 30% improvement in pain
relief with most pills.
** Celecoxib, or CELEBREX has been the biggest selling drug ever for the treatment of OA. Their published data shows that
Celebrex offers a 26.2% to 29.5% improvement in pain.
** DICLOFENIC, which until the launch of Celebrex was the biggest selling NSAID worldwide. This is the same drug
DMX uses in its carrier. Diclofenac taken orally, offers a range of improvement in pain between 18.6% and 36.9%.
** Naproxyn sold under the trade name NAPROSYN - in published studies they have been able to demonstrate pain relief
which ranged from 18.2% to 22.2%.
** PENNSAID - patients in DMX studies have reported a range of improvement in the relief of pain from 43.1% to 48.4%.
Please note: Since these are not head-to-head comparisons with PENNSAID one cannot categorically conclude that
PENNSAID is better than these pills, however all were using the same WOMAC pain scale to measure pain relief in roughly
the same patient populations. What one can therefore conclude with confidence is that PENNSAID offers at least equivalent
pain relief to these pills, with a very important difference: there are no serious side effects with DMX' product.
Consequently, in the market place DMX needs to prove that it offers better pain relief than pills in order for physicians to
prescribe PENNSAID; its vastly superior safety profile will be the impetus.
I find it amazing that a Canadian company can come this far, all the way to a first major drug approval, with no analyst
coverage, no media support and therefore no widespread knowledge of the company or its new product/delivery system.
PRESS RELEASE:
newswire.ca
Attention Business/Health Editors:
Dimethaid receives final marketing approval for PENNSAID(R) Lotion in United Kingdom
Opens Door To Additional EU Markets
TORONTO, Nov. 27 /CNW/ - Dimethaid Research Inc. (TSE: DMX) announced today that it has received final marketing
approval from the UK Medicines Control Agency (MCA) for its lead product, PENNSAID(R) Lotion, for the treatment of
the symptoms of osteoarthritis.
The Company is proceeding immediately to seek approvals from other European Union (EU) countries. Under the Mutual
Recognition procedure prevailing in the EU, the UK will act as agent for the rest of the EU Member States, whereby they can
"mutually recognize" this approval and issue their own authorizations. Member countries include Germany, France and Italy,
three of the largest pharmaceutical markets in the world.
"This first approval of PENNSAID in an important market is a significant milestone for Dimethaid," said Rebecca Keeler,
President and CEO. "There are approximately seven million osteoarthritis sufferers in the United Kingdom, and we are very
pleased to be able to offer them a safe and effective alternative to currently marketed non-steroidal anti-inflammatory drugs
(NSAIDs)."
Osteoarthritis, also called degenerative joint disease, is the most common type of arthritis. It is characterized by the
breakdown of cartilage that normally cushions and protects joints from impact. As the cartilage erodes, many people may
experience considerable pain and loss of function.
Current recommendations for the treatment of osteoarthritis are focused on the relief of symptoms and improvement in
quality of life. Oral NSAIDs, although effective, cause serious side effects. It is estimated that every year in the UK, the use
of NSAIDs results in approximately 2,000 deaths and 12,000 hospitalizations from stomach ulcers and gastrointestinal (GI)
problems. In addition, NSAID users are twice as likely to suffer from renal (kidney) failure and approximately 300 deaths
and 30,000 hospital admissions from congestive heart failure are potentially linked to NSAID use.
Although there are a number of topical NSAIDs approved in the UK, they are generally not well regarded as they lack strong
efficacy data. In contrast, PENNSAID(R) has demonstrated efficacy using the same international standards used to establish
the efficacy of oral NSAIDs, including the new COX- 2 selective NSAIDs.
Mrs. Keeler noted that "the UK decision validates the safety and efficacy of PENNSAID and we expect its first commercial
launch to be an important source of revenue for Dimethaid in 2001 and beyond."
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) Lotion. 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 of 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, and licenses and patents. The
Company undertakes no obligation to publicly revise these forward-looking statements to reflect subsequent events or
circumstances.
For further information: Dimethaid Research Inc., Tel. (905) 415-1446,
E-mail: info@dimethaid.com; Lippert/Heilshorn & Associates, Kim Golodetz,
Tel. (212) 838-3777; Bruce Voss, Tel. (310) 575-4848;
Archived images on this organization are available through CNW E-Pix at
www.newswire.ca. Images are free to members of The Canadian Press.
To request a free copy of this organization's annual report, please go to
www.newswire.ca and click on reports@cnw.
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