A program of highly selective fibroblast growth factor receptor inhibitors is at the heart of a discovery deal announced June 9 between Johnson & Johnson/Janssen Pharmaceutica and Astex, a privately held U.K. firm, Astex CEO Harren Jhoti told "The Pink Sheet" DAILY.

Astex's two-year-old FGFR inhibitor program is highly selective for the FGF protein alone, Jhoti said in an interview. Other compounds hit FDFR, but they also hit several other targets, which brings side effects that include hypertension.

The program is still at the lead optimization stage, but "given interest in this target, we were able to command pretty significant financials," the exec said.

Under the terms of the deal with Ortho Biotech Oncology Research & Development, Janssen's R&D arm, Astex receives upfront payments, cash and equity payments and research funding of $37.4 million over two years. The total involves a "reasonable split" between equity, upfront and research funding, Jhoti said.

The Oxford, U.K., firm also is in line for downstream development and regulatory milestones related to the FGF program, as well as payments related to candidates Astex identifies against two oncology targets provided by Janssen in a second layer of the deal.

While the focus is on Astex's FGFR program, which J&J has tied up with the arrangement, Janssen also wants the company to use its proprietary fragment-based drug discovery technology to identify leads against the two undisclosed proteins, Jhoti explained.

Astex receives tiered, double-digit royalties on sales of FGFR inhibitor products and additional royalties on new products generated under the other programs. Total payments, including royalties, could amount to over $500 million.

The firm will develop compounds up to the preclinical stage at which point J&J has an option to "bring them to their shop" and continue to develop them into the clinic, Jhoti said. J&J is fully responsible for preclinical and clinical development.

It is too early to say what tumor types will prove most vulnerable to FGFR inhibitors, Jhoti said, noting that FGF is the most mutated protein in the cancer genome. One possible use is as a second-tier therapy for patients whose cancers have become resistant to vascular endothelial growth factor inhibitors, such as Roche/Genentech's Avastin (bevacizumab).

"There is plenty of data indicating [tumors] do that by upregulating FGF activity, so this could be one potential application - to treat patients with a FGFR inhibitor who become resistant to VEGF inhibitors," he said.

The deal also includes a mechanism whereby Astex can bring assets back in-house for further development, should J&J not exercise its option.

Astex has three compounds of its own in development that it plans to take into Phase I/II trials. Novartis owns an option on one, but the other two are unpartnered.

-Shirley Haley (s.haley@elsevier.com)

J&amp;J Inks Potential $500M Deal With Astex

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