Eli Lilly and Co. built its pharmaceutical empire on insulin, antidepressants and cancer treatments. But if CEO David Ricks has his way—and the Food and Drug Administration gives its blessing—the next big push will come in pain treatments, a whole new area for the 142-year-old drugmaker.
Pain medications are the “next chapter of growth” for Lilly, Ricks told investors in January at the J.P. Morgan health care conference in San Francisco.
First up is a migraine treatment called galcanezumab. Earlier this month, Lilly presented data from late-stage clinical trials that it said showed the experimental drug significantly reduced the number of monthly migraine headache days in patients who previously failed to respond to multiple preventive therapies.
The FDA is now reviewing galcanezumab, a once-monthly, self-administered, non-opioid injection drug. An FDA decision is expected in the third quarter.
Lilly is also developing other pain meds, including lasmiditan and tanezumab.
Lasmiditan is an oral treatment for acute migraine headaches. Lilly researchers discovered it and later licensed it to biotech firm CoLucid International in 2005 to develop. In 2017, Lilly bought CoLucid for $960 million, bringing lasmiditan back in house.
The other drug, tanezumab, is an injectable, non-opioid medication for people with arthritis and chronic back pain. The drug was discovered by Rinat Neuroscience Corp., a San Francisco biotech start based in San Francisco. Pfizer bought Rinat in 2006 and entered a joint agreement with Lilly in 2013 to jointly development and commercialize the drug.
If the FDA approves any or all of the pain meds, it could give Lilly a big push into a brand-new treatment area. As the opioid epidemic rages out of control, with more than 1 million Americans a year swamping hospitals for overdose treatments, doctors and public health officials are clamoring for non-opioid pain medications.
Opioids are a dangerous, highly addictive category of pain killers that includes hydrocodone, morphine and fentanyl. A non-opioid pain medication could ring up billions of dollars in sales.
Tanezumab works by inhibiting a protein called nerve growth factor, or NGF, and thus preventing pain signals from hitting the brain.
Analysts have said that a successful NGF inhibitor could become a blockbuster, meaning it could ring up more than $1 billion a year in annual sales.
But the field is littered with setbacks. AstraZeneca and AbbVie both discontinued development of NGF inhibitors within the past decade after results didn’t measure up to expectations.