WEP Clinical, the specialist pharmaceutical services company, announces that it has signed an exclusive supply agreement with Wellstat Therapeutics Corporation, the US biopharmaceutical company, to supply Vistogard in the EU and Australia on a Named Patient basis.
Vistogard is FDA approved to treat overdose and early onset, severe, or life-threatening toxicities from chemotherapy drugs 5-fluorouracil (5-FU) or capecitabine.
The partnership focuses on supplying countries in the EU and Australia using Named Patient supply routes to enable healthcare professionals to access Vistogard, for patients who have no other treatment options available to them.
This new relationship with Wellstat continues to build on WEP Clinical’s growing portfolio of Expanded Access Programs, Named Patient Programs and the global supply of unlicensed medicines. It will allow more healthcare professionals across the world to access medicine.
Jas Khera, Managing Director, of WEP Clinical, said:
“This is a significant agreement for WEP Clinical. It not only expands our ever-growing portfolio of life saving medicines but clearly demonstrates the value of our business in providing access to medicines throughout their lifecycle – from Expanded Access Programs and Named Patient Programs through to Commercial medicine.”
Healthcare professionals can obtain details about Vistogard by emailing firstname.lastname@example.org or calling 0044 207 887 2235
For more information, please contact:
Jas Khera, Managing Director, WEP Clinical on 0044 208 004 8190
About VISTOGARD (uridine triacetate) oral granules
VISTOGARD (uridine triacetate) is an orally administered drug approved by the FDA to treat patients following an overdose of 5-fluorouracil (5-FU) or capecitabine or in patients exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of 5-FU or capecitabine administration. VISTOGARD received orphan drug designation from the FDA as an antidote in the treatment of 5-FU poisoning and from the European Medicines Agency (EMA) as a treatment for 5-FU overdose. In Europe, under a named patient program, VISTOGARD is currently provided to patients at risk of excess 5-FU toxicity due to overdose and patients exhibiting severe toxicities to 5-FU within 96 hours of 5-FU administration.
For more information please visit www.vistogard.com.
About 5-Fluorouracil (5-FU)
5-FU is on the World Health Organization’s List of Essential Medicines, a compilation of the most important medications needed in a basic health system. Because 5-FU is administered in different doses and schedules as a frequent component of standard chemotherapy regimens for a variety of cancers, patients can experience dramatically different patterns of toxicity.
Used in combination with other chemotherapy agents and/or radiation, 5-FU has been for decades a mainstay of various treatment regimens for solid tumors, including those of the colon, pancreas, stomach, esophagus, breast, and head and neck. The drug is most commonly administered by infusion pump at or near what is considered the maximum tolerated dose. Expected side effects of 5-FU include myelosuppression (a reduction in white-blood-cell counts and thus increased risk of infection), diarrhea, nausea, vomiting, and mucositis (a painful inflammation and ulceration of the mucous membranes lining the digestive tract). Overexposure to 5-FU can lead to severe myelosuppression, gastrointestinal hemorrhage, septic shock, multiple organ failure, cardiac and neurological complications, and death.
Capecitabine is readily absorbed from the gastrointestinal tract. In the liver, a 60kDa carboxyesterase hydrolyzes much of the compound to 5’-deoxy-5-fluorocytidine (5’-DFCR). Cytidine deaminase, an enzyme found in most tissues, including tumors, subsequently converts 5’-DFCR to 5’-deoxy-5-fluorouridine (5’-DFUR). The enzyme, thymidine phosphorylase (dThdPase), then hydrolyzes 5’-DFUR to the active drug 5-FU. Many tissues throughout the body express thymidine phosphorylase. Some human carcinomas express this enzyme in higher concentrations than surrounding normal tissues.
About Wellstat Therapeutics
Wellstat Therapeutics Corporation is a privately-held biopharmaceutical company located in Rockville, Maryland, USA. Wellstat Therapeutics is committed to discovering, developing and commercializing products that will provide new and improved treatments for patients in the fields of oncology and metabolic, neurometabolic and neurodegenerative diseases. For more information, please visit the website at http://www.wellstattherapeutics.com. Wellstat Therapeutics is part of the Wellstat group of companies (http://www.wellstat.com)
About WEP Clinical
Established in 2008, WEP Clinical is a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available. We have offices located in RTP, North Carolina, London, United Kingdom, Lisbon, Portugal and Dublin, Ireland and possess all the necessary licenses allowing us to meet drug access and distribution needs across all regions, worldwide.
We are passionate about helping those in need.
For more information, please visit www.wepclinical.com