MediQuest Therapeutics Submits Drug Application To FDA To Treat Raynaud's Disease

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Apr 2008 - 2:00 PST

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MediQuest Therapeutics Inc. announced that it has reached a major milestone in its corporate history by submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MQX-503, a topical formulation designed to treat Raynaud's Disease. This submission must be accepted by the FDA before it is reviewed for market approval.

"After less than six years of research and clinical trials, submitting our application is a major accomplishment and milestone for our company as we move closer to bringing this treatment to market for the millions of patients who suffer from the symptoms of Raynaud's Disease," said Dr. Frederick Dechow, MediQuest president and CEO. "Getting to this point represents an enormous effort and commitment by our employees and investors."

Once an NDA is submitted, the FDA must agree to accept it for review. If accepted, the agency begins a careful evaluation of the efficacy and safety of the product before determining its final approval for market use. This process can take several months.

"Because the active agent used in MQX-503 has already undergone rigorous FDA review and has been approved for use in patients for other diseases, its safety profile is well understood," said Dr. Jeff Gregory, Chief Medical Officer for MediQuest.

Raynaud's patients, 90 percent of whom are women, can experience severe pain associated with chronic vasospasm episodes in their hands, feet and other extremities. MQX-503 is a locally acting, topical formulation that is designed to be applied to prevent or treat the symptoms associated with Raynaud's episodes, which would allow patients control over their disease.

"We are delighted to see a therapy specifically targeted to symptoms of Raynaud's attacks be submitted for FDA review," said Lynn Wunderman, founder and chairman of the Raynaud's Association. "This announcement is encouraging for the millions of sufferers that cope with this painful and potentially debilitating disease."

In November 2007, MediQuest announced that patients enrolled in a confirmatory Phase III study of MQX-503, showed statistically significant improvements in their condition when treated with the therapy.

"Results from this study reinforced previous clinical results and showed that patients saw improvements in their condition when taking MQX-503," said Dr. Gregory. "Equally important, the therapy was well-tolerated with a side effect profile similar to placebo."

In addition to MQX-503, MediQuest's robust pipeline includes two other drug candidates in clinical trials, one at the pre-clinical stage and others at the research stage. The company develops first- and best-in-class topical therapies to treat patients suffering from inflammatory and infectious diseases.

About Raynaud's Disease

An estimated 9-11 million people in the United States suffer from Raynaud's Disease, 2.1 million of which have been diagnosed and are seeking medical treatment. Raynaud's patients can experience severe pain associated with chronic vasospasm episodes in their hands, feet and other extremities. No drugs have been approved by the FDA for the treatment of Raynaud's.

About MediQuest Therapeutics, Inc.

MediQuest Therapeutics is a specialty pharmaceutical company using its proprietary topical delivery system in late-stage clinical trials targeting infectious and inflammatory skin diseases and conditions. The Company's major efforts are focused on projects targeting Raynaud's phenomenon, nail psoriasis and actinic keratosis. http://www.mqti.com

In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the 'Safe Harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's current expectation or forecasts of future events. MediQuest's performance and financial results could differ materially from those reflected in these forward-looking statements due to the decisions of regulatory authorities, ability to implement its commercial plans, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may affect the forward-looking statements please contact the Company. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. MediQuest undertakes no obligation to update publicly any forward-looking statement.

MediQuest Therapeutics, Inc.