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ProductsMediQuest directs its therapeutic and commercial focus through the application of a highly disciplined, multi-tiered drug candidate classification system designed to efficiently determine whether a specific product application will be developed using an off-patent active ingredient in its Topical Amphi-Matrix carrier using the rapid 505 (b)(2) approval process (505) or using a novel, proprietary new chemical entity (NCE) in the traditional approval process. These product applications are:
MediQuest's current pipeline of products address unmet needs in the following highly attractive market segments: Therapeutics – To be developed and marketed by the CompanyRaynaud's Disease: More than nine million people in the United States suffer from Raynaud's phenomenon. Many of these patients are women who experience severe pain caused by chronic vasospasm episodes in their hands and feet. The potential market for a therapeutic such as the one being developed by MediQuest is estimated to exceed $800 million annually. The MediQuest drug candidate, MQX-503(TM), restores the blood flow within five minutes of application to the fingers. MQX-503 is being developed under the rapid 505(b)(2) FDA-designation. The pivotal Phase III has been completed and the NDA is in preparation. The Company has a Special Protocol Assessment from the FDA for this development program. Onychomycosis: More than thirty million people in the United States suffer from onychomycosis, the most prevalent form of toenail fungus. Many of these patients are older people, especially those with peripheral arterial disease and those with autoimmune diseases. The potential market for a therapeutic such as the one being developed by MediQuest is estimated to exceed $600 million annually. The Company has a drug delivery technology that enables known anti-fungal agents to be delivered to the site of the nail fungus. Two known anti-fungal agents have been studied in separate clinical trials, showing greater than 90% nail clearing and lack of dermatophytes in 30% to 50%, depending on the anti-fungal agent, of the patients within nine months of treatment initiation. The Company's results with its formulation and drug candidates in this area compare very favorably with the results of the current commercial prescription topical treatment (12%). It is also being developed under the rapid 505(b)(2) FDA-designation. The Phase IIB is has completed enrollment with five centers in the United States. This project has been licensed to another company. Nail Psoriasis: There are approximately 2,000,000 patients with nail psoriasis in the United States. There is no topical treatment for this disease, with surgical removal of the nail or injections of steroids under the fingernails as the current treatment options. MediQuest will use an FDA-approved, generic agent that has been used successfully with cutaneous psoriasis as the active agent with its Topical Amphi-Matrix carrier. The Company's nail psoriasis project is at the IND development stage, and is projected to enter Phase II clinical trials in approximately three months. Actinic Keratosis: Actinic Keratosis is the most common pre-malignant type of lesions. It has been estimated that 60% of predisposed persons older than 40 years old of age have at least one such lesion. In an analysis of data from the National Ambulatory Medical Care Survey, in 1993 and 1994 there were 3.7 million office visits, and about 5.2 million procedures for AK, more than 3 times the total for squamous cell carcinoma, basal cell carcinoma, and melanoma combined. At present, there are a wide variety of surgical and non-surgical therapies for AK. However, the current approaches have not satisfied the needs of the patients for safe effective treatment. The Company's actinic keratosis project is in the pre-clinical development stage, and is projected to enter clinical trials in approximately eight months. Cutaneous Lupus: There are approximately 200,000 patients with Cutaneous Lupus Erythematosus in the United States. Each of these patients spends approximately $6,000 to $10,000 per year on medications that only treat the symptoms of this disease. At present, only palliative treatments are FDA-approved for any form of lupus. The Company's cutaneous lupus project is in the pre-clinical development stage, and is projected to enter clinical trials approximately six months after completion of the current financing. Additional disease conditions in MediQuest's therapeutic focus include Atopic Dermatitis, Psoriasis, and Eczema. The Company's initiatives addressing these conditions are currently at the early research stage.
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