RESEARCH TRIANGLE PARK, N.C.—In a deal between Adherex and GlaxoSmithKline (GSK) penned in July, Adherex received an exclusive license to the oncology product eniluracil for all indications, while GSK gained an option to license Adherex's lead biotechnology compound, ADH-1.
ADH-1 targets N-cadherin, a molecule present on certain tumor cells and on the blood vessels that feed tumors, and is expected to be useful in treating a wide variety of cancers where N-cadherin is expressed, including breast, lung and ovarian cancers and melanoma.
"Adherex has been looking for some time to get a collaboration with major pharma around our ADH-1 compound," says Dr. Robin Norris, the president and chief operating officer of Adherex. "At the same time, we, as a company, have been looking for later-stage drugs which might be appropriate for us to license and develop, and eniluracil seemed perfect for that, in part because we have a very strong network of oncology experts on our scientific advisory board."
Under the agreement, GSK retains options to buy back eniluracil at various points in time during its development. If GSK exercises any of its options on eniluracil, Adherex will receive development and sales milestone payments of up to approximately $120 million in aggregate, plus up to double-digit royalties, varying on when—and if—such an option is exercised. In the absence of a buy-back by GSK, Adherex would be free to develop eniluracil alone or with other partners and would pay GSK development and sales milestone payments and double-digit royalties.
For its part in the trade-off of products, Adherex agreed to grant to GSK an option to receive a worldwide, exclusive license for ADH-1, which in its initial Phase I trial demonstrated encouraging evidence of anti-tumor activity. ADH-1 is now in Phase Ib/II and Phase II trials. If GSK exercises the ADH-1 option and negotiates a license agreement with Adherex, Adherex would receive up-front, development and sales milestone payments of up to approximately $100 million in aggregate, plus double-digit royalties.
"Either of these licensing deals would be of major importance for Adherex alone, but the combination is a transforming event for the company," says Dr. William P. Peters, chairman and chief executive officer of Adherex. "The in-licensing of eniluracil provides Adherex with potential blockbusters on both sides of our business."
According to Adherex and GSK, eniluracil may enhance the therapeutic value of 5-FU—one of the most commonly used oncology drugs in the world—by making the drug orally active with fewer side effects. The drug is currently administered via a 48-hour intravenous infusion.
Norris adds that the use of 5-FU in combination with eniluracil may also offer the opportunity to broaden the types of cancers in which 5-FU has been shown to be active. He predicts eniluracil may be back in Phase III trials as early as 2007.
