New presidents message:
I lifted this from Rochm on SH. Thanks for posting that.
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Welcome to the Dimethaid Research Inc. website. We are a publicly traded pharmaceutical company (Toronto Stock Exchange: symbol DMX), engaged in the development and commercialization of innovative therapeutic products that minimize the unwanted side effects of drugs on the body.
This web site is intended to provide you with information on our Company and its on-going developments. While other sections report in more detail our accomplishments to date, I have chosen this forum to provide our shareholders with regular updates on corporate developments and to address any recurrent issues raised in our on-going investor relation's efforts.
Rebecca Keeler,
C.E.O. & President
As our last quarter of fiscal 2001 begins, I would like to review with you some of Dimethaid's significant developments since my last letter at the end of December.
We made excellent progress toward commercial sales of PENNSAID® Topical Solution, signing an exclusive marketing agreement with Provalis Healthcare in the United Kingdom. Since the publication of the approval of PENNSAID® by the Medicines Control Agency (MCA), both Provalis and the Company have received numerous requests from hospitals, physicians, patients and the media in the UK, inquiring as to its availability. We are very encouraged to see such interest in PENNSAID®, even prior to the launch of the product. We believe this interest confirms the need for a safe and effect treatment for osteoarthritis. In anticipation of commercial launch at the end of March, we made our first shipment of commercial product to Provalis in February.
January also saw the completion of our private placement agreement for equity financing with Acqua Wellington North American Equities Fund. This agreement provides us with equity financing of up to $50 million, which we can access as we need the funds, ensuring that we have the necessary resources to implement our business plan and expand our product pipeline. At the end of February, we effected our first draw-down pursuant to this agreement, receiving net proceeds of $2,618,790 upon the issuance of 351,947 common shares to Acqua Wellington.
In late January, we began the Mutual Recognition Procedure for approval to market PENNSAID® in various European Union (EU) member states. The British MCA is acting as our agent in this process, and must prepare its report recommending the approval of PENNSAID® by the end of April. The MCA then submits the report to the EU member states selected by Dimethaid International. Following the submission, these member states then have two months thereafter to either approve PENNSAID® or provide queries on the British report. Consequently, we anticipate receiving approval in a number of EU countries during the second half of this calendar year and are in negotiations with a number of companies for the distribution rights to PENNSAID® for these new markets.
Due to retail and institutional interest in investing in Dimethaid's stock, a German brokerage firm registered as a market-maker for our stock. Trading commenced on January 11th, 2001 on the Berlin Stock Exchange. This gives European investors the option of investing in the company with the stock priced in Euros via this market.
In early February, the US Food and Drug Administration's Arthritis Advisory Committee met to review the request for labeling changes by the manufacturers of the two Cox-2 inhibitors, Celebrex® and Vioxx®. Both were seeking the removal of the NSAID class warnings with respect to gastrointestinal (GI) safety. (A sample is provided on page 12 of our 2000 Annual Report.) The long-term study with Celebrex® included both osteoarthritis (OA) and rheumatoid arthritis (RA) patients and failed to demonstrate GI superiority over ibuprofen and diclofenac. The Celebrex® study did allow aspirin use for prevention of heart attack or stroke (a common practice in patients of this age-bracket suffering with OA). The long-term study with Vioxx® included only patients with RA and did show GI superiority over naproxen. Patients were not allowed to take aspirin for cardiovascular prophalyxis. However, the Vioxx® study also showed a statistically significant increase in cardiovascular side effects, particularly heart attacks, and had more overall serious adverse events than did the patients who took naproxen (i.e. more heart attacks occurred than GI events were avoided). As a result, the Advisory Committee did not recommend the removal of the GI safety warnings from the product monographs of these products. It remains to be seen what changes, if any, will be made to the labeling of these two drugs since the FDA is not bound to follow the Advisory Committee's recommendations. It appears that more questions have been raised with the results of both these long-term studies, than answers provided.
While the debate on the safety of the Cox-2 inhibitors continues, we can point to the excellent safety profile of PENNSAID®. In all the studies we have conducted to date, there have been no reports of any serious adverse events related to PENNSAID®. We are also encouraged that this safety profile established in the controlled environment of our clinical studies, has been duplicated in the 'real world' setting of the long-term safety study conducted in Canada. Since the amount of drug entering the patient's bloodstream with PENNSAID® use is miniscule, there should be no concerns regarding drug-drug interactions and no GI, cardiac or renal concerns either. We believe that we can offer a worry-free alternative to both physicians and patients for the treatment of the symptoms of OA, including pain, stiffness and physical function.
Despite the unsettled safety concerns surrounding the Cox-2 inhibitors, they have nevertheless generated combined annual worldwide sales of approximately US$5 billion, which some market analysts have suggested represents only 40% of the total market. Provalis will be aggressively targeting a substantial market in the UK and the unsolicited interest to date bodes well for PENNSAID®. In anticipation of North American approvals, we are continuing the expansion of our manufacturing facility in Québec in order to supply anticipated world demand.
Our path to commercialization has been a long but exciting journey. With our first commercial launch only a few weeks away, we have reached a significant milestone for our Company that would not have been possible without a tremendous effort from all our employees in Ontario, Québec and Barbados. We look forward to rewarding the patience and support of our shareholders on this journey.
I now invite you to browse the rest of our website. Please note that there is a place where you can sign up for e-mail notification of future announcements and website updates.
Sincerely,
Rebecca E. Keeler
President & C.E.O.
Dimethaid Research Inc.
March 2001 |
