As a result, Adherex will assume full direction over the product's future development pursuant to the terms of the license, including the ability to partner and sub-license the product to third parties. An upfront fee of $1 million is due on closing, which is expected to occur in March 2007.
Adherex is developing eniluracil to improve the therapeutic value of 5-fluorouracil (5-FU) by making it orally active, with fewer side effects and potentially more effective. 5-FU is one of the most commonly used oncology drugs in the world. The use of 5-FU in combination with eniluracil may also offer the opportunity to broaden the types of cancer in which 5-FU has been shown to be active.
GSK's clinical development program for the combination of 5-FU and eniluracil met with success in early development. However, phase III trials failed and development was stopped by GSK.
Adherex hypothesized that the reason for the failure of the phase III trials was an unexpected dose and schedule dependent drug interaction that resulted in the inhibition of 5-FU's activation into an effective anticancer agent. Adherex's preclinical and clinical results to date have supported this hypothesis.
“Our recent data suggests eniluracil is back on track in its accelerated development plan. 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,” said William Peters, chairman and CEO of Adherex.