By Mary Welch

Ontogeny Inc. has regained the rights to develop and commercialize hedgehog protein products from partner Biogen Inc.

Hedgehog proteins are a class of novel human proteins that are responsible for inducing the formation or regeneration of tissues.

"We had a very good relationship with Biogen since 1996," said Doros Platika, the company's president and CEO. "However, there was a deadline of July 1 for Biogen to decide whether to develop the proteins or not. Biogen reviewed its portfolio, and with the deadline for a decision looming, decided to return the rights to us in favor of later-stage products. The clinical trials for the indication we were working on - diabetic neuropathy - would be very long and complex. From our understanding, their decision had nothing to do with the efficacy of the compounds and the program."

A decision to develop the proteins internally or with a partner will come after Ontogeny completes a merger slated for July 31.

"After the merger, we will have every reason to move forward and will have the financial resources as well," he said. "We have already had interest from other companies to partner as well as from investors. This is a tremendous asset and deciding what to do next will be one of the first decisions Curis will make."

Ontogeny, based in Cambridge, Mass., is expected to consummate its merger at the end of the month with Creative BioMolecules Inc., of Hopkinton, Mass., and Reprogenesis Inc., also of Cambridge. The combined company will be known as Curis Inc., and will be based in Cambridge.

The first hedgehog protein could reach Phase I trials next year, Platika said. An independent panel reviewing the preclinical data said that the findings were "very compelling," he said. "The protein appears to be efficacious in relevant models of diabetic neuropathy as well as other neurological disorders. We expect to publish this data in the next six to eight months. We are fortunate to be given this jewel, this asset, back."

The collaboration with Cambridge, Mass.-based Biogen could have reached $90 million had it been completed. Biogen initially invested $6 million in Ontogeny to cover two years of research and then agreed to pay up to $27 million in potential license fees and milestone payments for each of the three proteins. (See BioWorld Today, July 22, 1996, p. 1.)

Platika would not disclose how much privately held Ontogeny has received from Biogen, other than to note that it is "north of $20 million. However, in addition to the financial arrangements, which were significant, we benefited from the extensive involvement from the company and its scientists in the program. They added significantly to the project, including testing proteins in various models."

The hedgehog family of proteins - Sonic, Indian and Desert - are involved in areas of the central nervous system, bone and cartilage, fertility, cancer and organs. The Sonic hedgehog protein was being tested for diabetic neuropathy. Ontogeny's goal is to use the inducing molecules to repopulate cells where they are absent or out of balance. Although hedgehog proteins are not part of the superfamily of TGF-beta factors, they interact during the embryonic stage of human development and are responsible for giving structure and form to the tissues and organs of the body.

No Comments