Adherex Technologies purchased all remaining options from GlaxoSmithKline for failed cancer drug eniluracil. With an upfront fee of $1 million, the company will thus assume full responsibility for its development.
“Adherex has sought since 2004 to acquire the rights to eniluracil, which we believe represents a major pharmaceutical and therapeutic opportunity,” remarks William P. Peters, M.D., Ph.D., chairman and CEO of Adherex. “Today's agreement brings the development and commercialization of eniluracil under our control and provides the flexibility for Adherex to develop the product alone or to collaborate or partner with other parties as we feel most appropriate.”
Adherex is now required to pay GSK the same development and sales milestone payments and sales royalties as agreed in the original July, 2005 development and license agreement. However, GSK no longer has the option to buy back the product. Adherex has the ability to partner and/or sublicense the product to third parties.
Eniluracil enhances the effect of the chemotherapy drug 5-fluorouracil (5-FU). It is an oral dihydropyrimidine dehydrogenase inhibitor that improves the therapeutic value of 5-FU by making it orally active with fewer side effects as well as potentially more effective.
GSK's stopped development of eniluracil after Phase III trials testing it in combination with 5-FU failed. Adherex believes that the reason for the failure was an unexpected dose- and schedule-dependent drug interaction that resulted in the inhibition of 5-FU's activation into an effective anticancer agent.
"While GSK's initial Phase III trials with the product failed, we now have data to support each element of our hypothesis as to why those trials failed," says Dr. Peters. "We expect to complete our Phase I dose-escalation trial in North America shortly and intend to begin our Phase II trial in breast cancer promptly thereafter. We also have a Phase I/II trial in hepatocellular cancer ongoing in Asia."