SAN FRANCISCO Jan 13 Eli Lilly & Co said on Monday it had reacquired rights to an experimental treatment for migraine headaches it had licensed to another company three years ago, based upon promising new data from a completed mid-stage trial of the medicine.
The injectable drug, a monoclonal antibody called LY2951742, was discovered by Lilly but was licensed in 2011 to Arteaus Therapeutics, a privately held drugmaker created specifically to test the drug's potential in preventing migraines.
It works by blocking a protein fragment called calcitonin gene-related peptide (CGRP) that is released when sensory nerves are activated by stimuli such as certain foods, stress or lack of sleep. In turn, CGRP causes blood vessels to dilate and nerves to become inflamed, both of which have been linked to migraines.
Lilly research chief Jan Lundberg, who helped discover the characteristics of CGRP thirty years ago as a researcher in Sweden, said it had taken that long for a medicine to emerge that may counter the peptide without causing serious side effects.
"We will do what we can to accelerate development of this drug because it involves a big patient population," who were poorly served by standard treatments, Lundberg said.
If approved, it would become Lilly's first migraine medicine. The Indianapolis company has long been a big player in neuroscience, however, with its Prozac and Cymbalta treatments for depression, Zyprexa for schizophrenia and experimental treatments for nerve pain and Alzheimer's disease.
Data from the three-month Phase II study were not released, but David Grayzel, chief executive of Arteaus, said LY2951742 had met all its safety and efficacy goals.
"Nine million people in the United States, 80 percent of whom are women, have frequent migraine episodes," Grayzel said in an interview at the annual JP Morgan Healthcare Conference in San Francisco. "And LY2951742 would be the first drug, if approved, to be developed specifically for migraine prevention."
Financial terms of the deal to return drug rights to Lilly were not disclosed, but Lilly said it would incur a related fourth-quarter charge of about $57 million.
In smaller Phase I trials, there was no significant difference in side effects between those taking LY2951742 and patients given placebos.
By contrast, leading current treatments called triptans, which include generic forms of GlaxoSmithKline's Imitrex (sumatriptan), cause cardiovascular side effects that make them inappropriate for many patients and for long-term use.
Lilly said it aims to conduct Phase III trials to determine if LY2951742 can help patients who have frequent cases of migraines, meaning those having between four and 14 episodes a month.
Although injections of the drug were given every other week in the recent mid-stage trial, Lilly said it strongly believes less-frequent dosing will ultimately be possible because of the drug's long half-life.
Arteaus was formed in 2011 upon acquiring rights to Lilly's CGRP antibody, with an $18 million investment from healthcare investment firm OrbiMed and Atlas Venture, an early-stage venture capital firm that invests in life science companies.
The licensing deal was part of Lilly's strategy to spread the risk of drug development. Several other experimental Lilly drugs are also being tested in "proof of concept" studies being conducted by private start-up companies.
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