BASKING RIDGE, N.J., Jan. 17 /PRNewswire-FirstCall/ -- VioQuest Pharmaceuticals, Inc. , a New Jersey-based biopharmaceutical company, in partnership with the U.S. Army, has been granted orphan drug designation from the U.S. Food and Drug Administration (FDA) for the active moiety of VQD-001, sodium stibogluconate, a treatment for the cutaneous form of leishmaniasis.
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VioQuest has executed a Cooperative Research and Development Agreement (CRADA) with the U.S. Army relating to VQD-001's development and regulatory filing process for a New Drug Application (NDA) for the treatment of cutaneous leishmaniasis. VioQuest plans to submit an NDA to the FDA for VQD-001 this year based on trial data from clinical studies conducted by the U.S. Army at the Walter Reed Army Medical Center. Subject to FDA approval, VioQuest will market and commercialize VQD-001 for the treatment of cutaneous leishmaniasis in the U.S.
Orphan drug designation provides companies with a range of incentives, which include a 7-year period of market exclusivity, financial and regulatory benefits during the course of the drug development (including tax credits related to clinical trial expenses) and a possible exemption from the FDA-user fee.
Leishmaniasis currently threatens 350 million people in 88 countries around the world. The leishmaniases are parasitic diseases with a wide range of clinical symptoms. Cutaneous leishmaniasis is the most common form of leishmaniasis, a protozoan infection usually found in many developing countries world-wide. While the disease remains relatively uncommon in the U.S., military personnel returning from leishmaniasis-infested regions overseas have exhibited a dramatic rise in infection rate. To learn more please visit: http://www.cdc.gov/Ncidod/dpd/parasites/leishmania/default.htm and http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5242a1.htm .
Colonel Naomi Aronson, M.D., the principal investigator for the Walter Reed Army Medical Center trials, said, "We are very pleased that VioQuest is pursuing FDA approval of this important drug in the U.S, which has been used by the U.S. Army under research protocol since 1978 with excellent outcomes in the treatment of leishmaniasis."
VioQuest is also developing VQD-001 for other clinical indications such as melanoma, myeloma, lymphoma and renal cancers. Accordingly, there are ongoing Phase I/IIa clinical trials, both investigator initiated and corporate sponsored, at the Cleveland Clinic, Cleveland, Ohio and at MD Anderson, Houston, Texas, respectively.
Daniel Greenleaf, VioQuest's president and CEO, said, "VioQuest's path to market for VQD-001 for the treatment of cutaneous leishmaniasis has been accelerated by the data amassed from the U.S. Army and its 50+ years of use ex-U.S. The upcoming NDA filing for leishmaniasis is right on target for VioQuest and will elevate us beyond being exclusively a development stage company. It is tangible proof of our strategy to in-license compounds that have been used in humans but have not gone through the FDA."
About U.S. Orphan Drug Status
The term "orphan drug" in the U.S. refers to a product that treats a rare disease affecting fewer than 200,000 Americans. The Orphan Drug Act was signed into U.S. law in 1983. The intent of the Orphan Drug Act is to stimulate the research, development and approval of products that treat rare diseases and is accomplished through several mechanisms:
* Historically, the approval time for orphan products as a group has been considerably shorter than the approval time for other drugs. * Sponsors are granted 7 years of marketing exclusivity as an orphan drug product. * Sponsors also are granted U.S. tax incentives for clinical research they have undertaken. * FDA's Office of Orphan Products Development coordinates research study design assistance for sponsors of drugs for rare diseases. The Office of Orphan Products Development also encourages sponsors to conduct open protocols, allowing patients to be added to ongoing studies. * Grant funding is available from $200,000 (Phase I) and $350,000 (Phases 2 and 3) per year in total costs for up to 3 years to defray costs of qualified clinical testing expenses incurred in connection with the development of orphan products. About VioQuest Pharmaceuticals
VioQuest Pharmaceuticals, Inc. www.vioquestpharm.com focuses on acquiring, developing, and commercializing targeted late preclinical and early clinical stage therapies with unique mechanisms of action for oncology, viral and autoimmune disorders. VioQuest has two targeted therapeutics in Phase I/IIa clinic trials: VQD-002 which inhibits phosphorylation of Akt that is seen at abnormally high levels in breast, ovarian, colorectal, pancreatic, and hematologic tumors; and VQD-001, an inhibitor of specific protein tyrosine phosphatases, which has shown compelling preclinical activity in both renal and melanoma cancers. In addition, VioQuest and the U.S. Army are planning to submit an NDA to the FDA in 2007 for VQD-001 for the treatment of leishmaniasis. VioQuest's subsidiary Chiral Quest, Inc., a pioneer in asymmetric chemocatalysis and custom synthesis, offers its proprietary technology products to well-known pharmaceutical and fine chemical companies worldwide to improve their production efficiencies and, in some instances, to increase the overall safety and efficacy of the underlying drug. VioQuest is seeking strategic alternatives for Chiral Quest which may include its sale.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties that could cause VioQuest's actual results and experiences to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as anticipates, expects, plans, believes, intends, and similar words or phrases. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that VioQuest will receive any proceeds in connection with a sale or other disposition of its Chiral Quest division, or that the FDA will approve VioQuest's planned NDA submission relating to VQD-001 for the treatment of leishmaniasis, and even if approved, there is no assurance that VioQuest will be able to successfully commercialize VQD-001 for the treatment of leishmaniasis or any other indication. Other risks and uncertainties include the possibility that the results of clinical trials will not support VioQuest's claims, the possibility that VioQuest's development efforts relating to its product candidates, including VQD-001 and VQD-002, will not be successful, the inability to obtain regulatory approval of VioQuest's product candidates, VioQuest's reliance on third-party researchers to develop its product candidates, its lack of experience in developing and commercializing pharmaceutical products, and the possibility that its licenses to develop and commercialize its product candidates may be terminated. Additional risks are described in VioQuest's Annual Report on Form 10-KSB for the year ended December 31, 2005. VioQuest assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Contact information: Diane Perry VP, Investor Relations & Public Relations diane.perry@vioquestpharm.com 917-834-7526 or 908-766-4455
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20070117/NYW085LOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comVioQuest Pharmaceuticals, Inc.CONTACT: Diane Perry, VP, Investor Relations & Public Relations,diane.perry@vioquestpharm.com, or +1-917-834-7526, or +1-908-766-4455
