GAITHERSBURG, Md.--(BUSINESS WIRE)--Wellstat Therapeutics Corporation announced today that it has granted Named Patient supply rights and an option to obtain marketing rights in the European Union for the company’s investigational drug uridine triacetate to the specialist healthcare company BTG International Inc. for use as an antidote to overexposure to the chemotherapy drug 5-fluorouracil (5-FU) due to dosing errors or impaired clearance of 5-FU from the body. Wellstat previously granted BTG marketing rights to uridine triacetate for treatment of 5-FU overexposure in the U.S., however Wellstat retained commercialization rights for this indication outside of the U.S. and E.U. and for all other potential uses of uridine triacetate.
Under the terms of the agreement Wellstat will be responsible for development and regulatory filings and for product manufacture. Wellstat will receive from BTG an upfront payment, a payment upon option exercise, and transfer pricing payments based on manufacturing costs and a significant percentage of net sales.
While uridine triacetate has not yet received marketing approval, to support pre-approval demand, BTG will make the product available in the E.U. on a Named Patient supply basis. Uridine triacetate will continue to be available to patients in the U.S. under an expanded access protocol and emergency use INDs. The compound has been granted orphan drug designation both in the United States and outside the U.S.
“Expanding our relationship with BTG will increase medical awareness of 5-FU overexposure, an important unmet medical need, and help supply uridine triacetate on a Named Patient basis in the E.U.,” said David M. Wohlstadter, Vice President of Licensing and Business Development for Wellstat. “In entering into this new agreement, BTG further demonstrated its commitment to addressing patient needs in oncology and antidote therapies. We look forward to further development and commercialization of uridine triacetate in territories outside the U.S. and E.U. as well as in other indications worldwide.”
Louise Makin, BTG’s Chief Executive Officer, commented: “We’re delighted to extend our partnership with Wellstat into Europe. These new commercial rights for uridine triacetate complement our existing named patient activities for Voraxaze® and DigiFab® in Europe, and reflect our growing expertise in medical toxicology and oncology antidotes.”
In use as a cancer drug for decades, 5-FU is a mainstay of various treatment regimens for solid tumors including those of the colon, 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 of the mucous membranes lining the digestive tract). Overexposure to 5-FU can lead to severe myelosuppression, gastrointestinal hemorrhage, septic shock, multiple organ failure, and death.
The incidence of 5-FU overexposure is low though difficult to quantify. Overexposure may result because patients vary in their capacity to break down 5-FU and eliminate it from the body and because infusions pumps can malfunction or be misprogrammed.
About uridine triacetate
Uridine triacetate is an investigational drug currently under development for use as a treatment for overexposure to 5-FU due to dosing errors or impaired clearance of 5-FU from the body. It is an orally active prodrug of uridine, meaning that uridine triacetate is converted to uridine in the body. Once uridine triacetate is converted to uridine it reduces the incorporation of 5-FU metabolites particularly into non-cancerous cells. Because of the poor bioavailability of oral uridine, however, and because of complications associated with intravenously administered uridine, uridine itself is not a clinically viable treatment for 5-FU overexposure. Studies have demonstrated that uridine triacetate delivers about eight-fold more uridine into the bloodstream than does oral administration of uridine itself.
Wellstat is also investigating the potential use of uridine triacetate when given after high dose 5-FU administration to cancer patients, as well as for the potential treatment of neurodegenerative and mitochondrial disorders. Uridine triacetate does not have marketing approval for any indication.
Wellstat Therapeutics Corporation is a privately-held biopharmaceutical company located in Gaithersburg, Maryland. 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. Wellstat Therapeutics is part of the Wellstat group of companies. For more information, please visit the website at http://www.wellstat.com
BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. The company is seeking to acquire new products to develop and market to specialist physicians, and is building a sustainable business financed by revenues from sales of its own marketed products and from royalties and milestone payments on partnered products. For further information about BTG please visit our website at www.btgplc.com
Jeremiah Hall, 415-349-5016