VioQuest Pharmaceuticals, Inc.
acquires, develops, and commercializes targeted late preclinical and early clinical stage therapies with unique mechanisms of action for oncology, viral and autoimmune disorders. A pioneer in personalized therapeutics, VioQuest has two targeted therapeutics in clinical trials: VQD-001, an inhibitor of specific protein tyrosine phosphatases, has shown compelling preclinical activity in both renal and melanoma cancers and VQD-002 which has shown to inhibit the phosphorylation of Akt which can be seen in abnormal levels in breast, ovarian, colorectal, pancreatic, and hematologic malignancies.
VioQuest’s subsidiary, Chiral Quest, a leader 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 Management Daniel Greenleaf
has been our President and Chief Executive Officer and a member of the Board of Directors since February 2005. He joined VioQuest Pharmaceuticals from Celltech Biopharmaceuticals, a European biotechnology company where he served as President of their U.S. Operations. Celltech Pharmaceuticals was sold for $2.7 billion in 2004. Prior to that, Mr. Greenleaf served as Senior Vice President of Operations for Nabi Biopharmaceuticals, a biopharmaceutical development company, from 2002 to 2003. From 1992 to 2002, Mr. Greenleaf held a series of positions of increasing responsibility at Schering-Plough Corporation, an international pharmaceutical company, including its Vice President, Marketing and Sales from 2000 to 2002.While at Schering, Mr. Greenleaf founded, built and launched Global Animal Management. Prior to Schering-Plough, Mr. Greenleaf was a navigator in the US Air Force. Mr. Greenleaf is an active member of New Jersey’s Young President Organization (YPO); is on the Board of Trustees for Biotechnology Council of New Jersey, and was recognized by PharmaVoice in 2006 as one of the industry’s “100 of Most Inspiring People.” Mr. Greenleaf holds an MBA from the University of Miami and a BA in Economics from Denison University. Lawrence Akinsanmi M.D., Ph.D.
Vice President of Clinical Operations and Regulatory Affairs joined VioQuest in October 2006 from Daiichi Medical Research Inc., where he was the Global Lead of Early Development and Senior Director of Regulatory Affairs since 2004. He previously served at senior level positions at Omnicare Clinical Research Inc., and at Immunomedics Inc. He brings more than sixteen years of both academic and industrial knowledge to VioQuest, including over ten years of oncology drug development from both large and small pharma companies including biotech and CROs. Dr. Akinsanmi also has extensive experience in supporting IND submissions and NDA filings through working with regulatory authorities worldwide including the FDA. Brian Lenz, CPA,
Chief Financial Officer,Corporate Secretary and Treasurer joined VioQuest as a controller in October 2003 and was promoted to CFO in early 2004. Prior to VioQuest, Mr. Lenz was a controller with Smiths Detection. Mr. Lenz began his career as an auditor with KPMG, LLP a “Big 4” accounting firm. Mr. Lenz holds a BS in Accounting from Rider University and received his MBA from Saint Joseph’s University. Yaping Hong, Ph.D.
,Vice President of Process Research and Development, joined Chiral Quest in May 2003. Prior to joining Chiral Quest, Dr. Hong was Director of Process Chemistry for Synthon Chiragenics from August 2001 to May 2003. From April 1993 to August 2001, Dr. Hong was employed by Sepracor Inc., eventually serving as Associate Research Fellow. Dr. Hong holds a Ph.D. in Synthetic Organic Chemistry from the University of Waterloo. Dr. Hong conducted postdoctoral work from September 1991 to March 1993 at the Massachusetts Institute of Technology, in Cambridge Massachusetts. Michael Cannarsa, Ph.D.
, General Manager, Chiral Quest, joined VioQuest from Chemi SpA, where he was President of U.S. Custom Manufacturing and Generic API businesses. He has over 15 years experience building business in Pharmaceutical Fine Chemicals. He has held senior Business Development positions and led technology acquisition efforts at Synthetech, Symyx Technologies and PPG-Sipsy. Dr. Cannarsa received his Ph.D. in Organic Chemistry from Cornell University and his bachelor’s degree from Georgetown University. Share Statistics
Shares Outstanding: 54.62M
Revenue (ttm): 3.80M LATEST NEWS VioQuest Pharmaceuticals, In Partnership with U.S. Army, Granted Orphan Drug Designation for VQD-001 (Sodium Stibogluconate) for Cutaneous Leishmaniasis
Wednesday January 17, 11:12 am ET
- VQD-001 Also in Clinical Trials for Cancer -
BASKING RIDGE, N.J., Jan. 17 /PRNewswire-FirstCall/ -- VioQuest Pharmaceuticals, Inc. (OTC Bulletin Board: VQPH - News), 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.
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
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
* 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.
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.
VP, Investor Relations & Public Relations
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