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 - news) announced today that it has received final marketing approval from the UK Medicines Control Agency (MCA) for its lead product, PENNSAID® 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® 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® 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
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