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Replies to post #193949 on Biotech Values
In 2004, Rinat launched an antibody program targeting CGRP. If it worked, the team reasoned, it would show that it was possible to treat migraines from outside the brain, by blocking CGRP only in the peripheral nervous system. That would lower the risk of the side effects often provoked by drugs that act in the brain, Pons says. In a few months, the firm developed the peptide-blocking antibody now being tested by Teva under the name TEV-48125. The antibody faced plenty of roadblocks. The Rinat team managed to launch a phase I study testing TEV-48125’s safety, but Pfizer acquired the company in 2006, and by 2011, the firm “decided that migraine was not an area it wanted to pursue,” Pons says.
Other big companies had made similar decisions at the time, Pons says. The Food and Drug Administration (FDA) has especially stringent safety standards for pain treatments, and estimates for the market value of a new migraine drug are uncertain, ranging wildly from roughly $200 million several years ago to $5 billion, making it hard for companies to commit a large amount of money to drug development.
Despite the risk, in 2013 a venture capital company called venBio bought the rights to TEV-48125 and launched a new company called Labrys Biologics and continued the antibody’s clinical development. Neuroscientist Corey Goodman, a managing partner of venBio in San Francisco, California, had until 2009 been president of the biotherapeutics division at Pfizer, where he oversaw Rinat and Pons’s team. Goodman remembered TEV-48125 was a “very good antibody,” and after recruiting more investors, Labrys kicked off two phase II trials in people with frequent migraines. The trials produced “the most beautiful phase II data I’ve ever seen,” Goodman says, with significant reductions in number of headache days over placebo, even for the most severe cases.
Teva bought Labrys in 2014 and is now racing with Alder Biopharmaceuticals, Eli Lilly, and Amgen to win FDA approval for the first migraine antibody drug. So far, the four phase II clinical trials, at least one from each firm, have produced similarly encouraging results, with up to 15% of participants experiencing complete relief, Goodman says: “I don’t think it’s too early to start talking about a cure for some patients suffering from this debilitating disease.”
One of the superresponders is 26-year-old Julia Berner, who has been getting a migraine every day since she was a little girl. Over the years, she’s tried epilepsy medications, Chinese remedies, and nerve blocks, among countless other treatments, with no success. Within a few days of receiving four shots of Teva’s thick, viscous, antibody-containing solution in the back of her arms and the skin around her hips, however, the migraines disappeared.
The difference was “mind-blowing,” she says. Berner usually spends her days avoiding any small disturbance that could make her constant, low-grade migraines more severe. After getting the antibody injections, that burden lifted. “I hadn’t realized how tired they make me,” she says. “Everyone around me noticed the change in my demeanor.”
DESPITE SUCH ANECDOTAL SUCCESSES, some migraine researchers don’t think it’s time to celebrate yet. If CGRP “really is a fundamental mechanism, you would expect a much higher proportion of patients to be completely free of attacks,” Ferrari says. Safety also concerns him because of CGRP’s natural role in dilating arteries and maintaining blood supply to the heart and brain. “Theoretically, if you block CGRP you could translate a minor stroke or cardiac ischemia … into a full blown stroke or heart attack,” he says. So far, the companies say they haven’t seen that or other significant side effects in the several thousand people who have completed phase I and II trials, but the drugs have only been administered for up to 6 months—not long enough to judge long-term effects, Bigal says.
03/27/16 8:21 PM
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