This is probably the news that has got the stock moving nicely upwards.
Good luck to all in the next few days ... then months as the FDA considers Pennsaid.
Greg
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Monday December 15, 2:54 pm Eastern Time
Company Press Release
Dimethaid Research Files New Drug Application With FDA
Seeks U.S. Marketing Approval For Pennsaid(TM)
MARKHAM, Ontario--(BUSINESS WIRE)--Dec. 15, 1997--Dimethaid Research I(TSE:DMX. - news) Dimethaid Research Inc. announced today that it has filed a new drug application (NDA) with the United States Food and Drug Administration (FDA) for PENNSAID(tm), a topical non-steroidal anti inflammatory drug (NSAID) for the relief of osteoarthritic pain.
This is the third application for approval of PENNSAID(tm), with earlier applications made to the Therapeutic Drugs Directorate (formerly Health Protection Branch) of Health Canada and the Medicines Control Agency of the United Kingdom.
''This is a very important milestone for us,'' said Rebecca Keeler, President and CEO of Dimethaid Research Inc. ''This submission culminates years of clinical study and means we are now entering the final stage prior to commercialization of PENNSAID(tm),'' Mrs. Keeler added. ''We intend to license PENNSAID(tm) to a commercial partner for worldwide sales and this significant development should also be beneficial to us in our continuing negotiations.''
Arthritis is a chronic condition that affects about 40 million Americans who receive an estimated 68 million prescriptions for medications to help alleviate their pain. According to the Centers for Disease Control, the direct medical cost of arthritis is estimated to be $15.2 billion per year. PENNSAID(tm) has been studied for the treatment of osteoarthritis, the most prevalent form of the disease. The Arthritis Foundation estimates that 15.8 million Americans suffer from osteoarthritis.
PENNSAID(tm) is the first product utilizing Dimethaid's patented formulation for the delivery of active drug compounds through the skin and tissue to the site of pain. The expected benefits include localized relief at the site of application, few side effects and negligible toxicity. Most conventional methods of drug delivery, including oral, injection, and patch, deliver the active ingredient into the blood supply which in turn distributes the drug throughout the entire body, including the site of pain. This systemic distribution can lead to serious side effects such as gastro-intestinal bleeds and even death. In contrast, PENNSAID(tm) avoids the systemic distribution by using its unique carrier to access the micro-circulatory system within each cell to deliver the medication. In an ongoing Phase IV study in Canada, over 600 physician-investigators have prescribed PENNSAID(tm) to more than 2,200 patients in a primary care setting without any report of the serious adverse events that have been associated with the use of oral-NSAIDs. Dimethaid Research Inc. intends to pursue additional indications for this carrier in combination with other drugs
Dimethaid Research Inc. is a pharmaceutical company engaged in the development and commercialization of innovative therapeutic products which work with the body's own healing mechanisms. The other major product under clinical development is an immune modulator called WF10, currently being tested for the treatment of HIV/AIDS and cancer. Dimethaid Research Inc. owns 20 percent of Oxo Chemie AG, the private Swiss company that owns WF10, and retains an option to further increase its position to 25 percent.
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Contact:
Dimethaid Research Inc.
Peter Block, 905/415-1446
e-mail: pblock@dimethaid.com
or
Dimethaid Research Inc. (Media contact)
Vince Segreto, 905/415-1446
www.dimethaid.com |
