Washington Editor

Under a provision in its August 2006 deal with MedImmune Inc., Infinity Pharmaceuticals Inc. has decided to regain the development and worldwide commercialization rights for its Hedgehog cell-signaling pathway inhibitor program, including its lead candidate IPI-926.

The original agreement stated that if either firm was acquired by a company that had a competing product discovery program, the acquiring company would either shut down its program, sell it or negotiate an arrangement under which it would be allowed to continue to work on its program, explained Infinity CEO Steven Holtzman.

London-based AstraZeneca plc, which has a development program targeting the Hedgehog pathway, acquired Gaithersburg, Md.-based MedImmune this past summer in a $15.2 billion cash deal, he noted. (See BioWorld Today, April 24, 2007.)

Since any compounds developed through AstraZeneca's Hedgehog pathway program would potentially compete with Infinity's products, the two firms agreed that it was best if Cambridge, Mass.-based Infinity regained the full rights to its program, Holtzman told BioWorld Today. "We felt that it was better than putting them all together and having multiple programs going on."

There was "nothing negative" about the arrangement, he maintained, adding that his firm "liked" AstraZeneca's program and "they liked our program." But, he said, "we would prefer first and foremost that we have ours back."

In exchange for the full rights to the program, Infinity is waiving the noncompetition clause contained in the original deal with MedImmune that applies to AstraZeneca's independent work in the Hedgehog pathway.

Under the new pact, MedImmune will continue to fund its 50 percent share of development activities for IPI-926 through May 2008, Holtzman said. After that, Infinity will own 100 percent of the rights to its Hedgehog pathway program, including IPI-926, on a royalty-free basis.

"There's no milestones payable to them, and there's no royalties payable to them, or vice versa," he said. "We have the right to develop [the Hedgehog program] ourselves or re-partner it. There's no right of first negotiation whatsoever. It's ours, full stop."

Holtzman said his firm expects to initiate its first clinical trial of IPI-926 in humans in 2008.

In preclinical studies, the molecule showed potent and selective inhibition of the Hedgehog pathway, which is believed to play a central role in allowing the proliferation and survival of certain cancer-causing cells, such as pancreatic, prostate, small-cell lung and breast and certain brain cancers.

The agreement also calls for Infinity to have the right to opt-in to certain Hedgehog programs being developed by AstraZeneca, including equal worldwide profit-sharing and U.S. co-promotional rights, Holtzman said.

The company will have the right at any time from now until AstraZeneca initiates a Phase III pivotal registration trial to opt-in to the programs, he said, adding that his firm must pay the large drug maker an undisclosed fee to do so.

Under the terms, if AstraZeneca sells its Hedgehog pathway program, Infinity's opt-in rights will be attached to the sale, Holtzman explained.

The acquisition provision in the original 2006 agreement had been "reciprocal," he said. "If we had been acquired by someone, MedImmune would have the same rights, so it's not that we picked their pocket," Holtzman added that both firms view the new arrangement as a "win-win" situation.

The new pact with AstraZeneca does not affect the collaboration between Infinity and MedImmune to jointly develop novel inhibitors of heat-shock protein 90 (Hsp90).

That deal, which was a separate agreement formed in August 2006, but had terms similar to the Hedgehog pathway collaboration, will continue unchanged, including Infinity's right to equal worldwide profit-sharing and U.S. co-promotional rights, he said. (See BioWorld Today, Aug. 29, 2006.)

The companies are developing IPI-504, an Hsp90 molecule that has demonstrated evidence of biological activity in both gastrointestinal stromal tumors and in non-small-cell lung cancer. They are planning to launch a Phase II trial of IPI-504 as a single agent in additional tumors, and start at least one combination study before the end of 2007.

Infinity said it expects to end 2007 with greater than $100 million in cash and short-term investments.

Shares of Infinity (NASDAQ:INFI) rose 7 cents Monday to close at $9.92.