GAITHERSBURG, Md.--(BUSINESS WIRE)--Wellstat Therapeutics Corporation announced today that it has granted U.S. marketing rights for the company’s investigational drug uridine triacetate to the specialist healthcare company BTG International Inc. for use as a potential treatment for accidental overexposure to the chemotherapy drug fluorouracil (5-FU) due to dosing errors or impaired clearance of 5-FU from the body. Wellstat has retained commercialization rights for treatment of 5-FU overexposure outside of the U.S. and for all other potential uses of uridine triacetate.
Under the terms of the agreement, BTG will have exclusive rights to market, sell and distribute uridine triacetate as a treatment for 5-FU overexposure in the US for up to 10 years from marketing approval. Wellstat will be responsible for completing development and regulatory filings and for product manufacture. BTG will pay Wellstat an upfront payment, milestone payments upon NDA acceptance and approval, and transfer pricing payments based on manufacturing costs and a significant percentage of net sales.
While uridine triacetate has not yet received marketing approval, it will continue to be available to patients in the US under emergency use INDs and an expanded access protocol. It is anticipated that the New Drug Application will be submitted during the first half of 2013. The compound has been granted orphan drug designation both in the United States and outside the U.S. Until approval, any inquiries or requests for uridine triacetate should be directed to Wellstat.
“We are delighted to be working with BTG to address this important unmet medical need. This transaction provides significant value to Wellstat and will help accelerate uridine triacetate’s movement towards approval and commercialization,” said David M. Wohlstadter, Vice President of Licensing and Business Development for Wellstat. “In addition, we look forward to further development and commercialization of uridine triacetate in territories outside the U.S. as well as in other indications worldwide.”
Louise Makin, BTG’s Chief Executive Officer, commented: “There is currently no available antidote for 5-FU overexposure, so uridine triacetate will meet a real need if approved. As an oncology antidote, it is an excellent fit with our existing US acute care business and will enable us to leverage the sales team and back office support infrastructure which we have already put in place.”
About 5-FU
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 and 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 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.
About Wellstat
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
About BTG
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.