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Evotec, Harvard, J&J Combine in Preclinical Diabetes Alliance

By Cormac Sheridan
Staff Writer

CureBeta, the diabetes research alliance between Evotec AG and Doug Melton's lab in Harvard University's Department of Stem Cell and Regenerative Biology, has found an early taker for its preclinical portfolio of small molecules and biologics that can trigger growth of insulin-secreting pancreatic beta cells.

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is paying $8 million up front and could pay between $200 million and $300 million more in milestones for each product that is successfully commercialized. The focus will be on Type I diabetes initially.

Proceeds from the deal will be divided between Hamburg, Germany-based Evotec and Cambridge, Mass.-based Harvard, according to pre-agreed terms. "We had an agreement with Harvard, which was based on the time to commercialization," Evotec CEO Werner Lanthaler told BioWorld International.

Evotec's share of the program was set to increase as the program progressed, to take account of its increasing investment. The Janssen agreement comes at a relatively early stage in the development of the research program, however. "It's a very even split," Lanthaler said.

Less important than the timing of the deal was the approach Janssen took to the alliance. "There was significant interest from industry, but Janssen really understood we have to go for the full platform here," he said. The effort remains early stage but broadly based. "It would be completely wrong to portray any target as being in any way close to the clinic at this stage," Lanthaler said. "We've got multiple shots on goal with Janssen."

Evotec, Harvard and the Howard Hughes Medical Institute – Melton is an HHMI investigator – established the CureBeta alliance in 2011 to explore the biological mechanisms underlying beta cell replication and to find ways of modulating them. "We have built a systematic unbiased and comprehensive infrastructure for all targets," Lanthaler said. It comprises an extensive set of screens, assays and other tools, all tailor-made for probing beta cell development and maturation. "If there is an answer to [the question of] beta cell biology in diabetes, then this is it," he said.

The partners are not disclosing the precise targets or drug leads that are involved in the alliance. Melton's recently published work includes the development of a small-molecule screening system that aided the identification of a class of adenosine kinase inhibitors that could selectively increase beta cell replication in several species. That work appeared in the March 6, 2012, issue of Proceedings of the National Academy of Sciences, in a paper titled "Adenosine kinase inhibition selectively promotes rodent and porcine islet beta-cell replication."

Janssen's metabolic and cardiovascular disease group, based at J&J's New Brunswick, N.J., headquarters, will broker J&J's participation in the alliance. Melton's lab will continue to stay involved. "It's absolutely critical that Doug stays involved, and he wants to stay involved. That's the good thing here," Lanthaler said.

The CureBeta alliance also will continue its work, independently of the J&J alliance.

For Evotec, the deal broadens its footprint in diabetes. The company already has an alliance with the MedImmune subsidiary of London-based AstraZeneca plc on EVT.770, a secreted protein designed to increase beta cell mass in the pancreas, and with Ingelheim, Germany-based Boeheringer Ingelheim GmbH on an undisclosed insulin sensitizer.

Evotec also has a royalty position in DiaPep277, an immunomodulatory peptide derived from heat-shock protein 60, which Yavne, Israel-based Andromeda Biotech Ltd. and Petah Tikva, Israel-based Teva Pharmaceutical Industries Ltd. are developing.

That drug recently attained the primary endpoint of a Phase III trial and has gained FDA Orphan Drug designation for treating Type I diabetes patients with residual beta cell function.

Investors responded positively to the news. Evotec's stock (FRANKFURT:EVT) closed Tuesday at €2.48 (US$3.04), up more than 17 percent.