Why Lilly Still Faces An Uphill Battle Vs. Amgen In Preventing Migraines
A migraine prevention treatment from Eli Lilly (LLY) faces an uphill battle against Amgen (AMGN) which, late Thursday, had strong results from long-term studies of its approved medicine.
Both Amgen and Lilly have migraine prevention drugs called anti-CGRPs. These drugs work by blocking a specific peptide associated with migraines. Amgen’s drug, Aimovig, grabbed approval in May, but Lilly’s is fast approaching approval, likely in September.
Although Allergan‘s (AGN) Botox is well known as a treatment for wrinkles and facial lines, it has other uses in excessive sweating, urinary incontinence and to prevent migraines. On Wednesday, Lilly showed that its drug, called Emgality, can benefit patients for whom Botox didn’t prevent migraines.
But RBC Capital Markets analyst Kennen MacKay doesn’t expect the study to “substantially impact positioning in the marketplace.”
“We do find the post-Botox analysis to provide a unique perspective and marketing point for Emgality with the physicians who have established familiarity with Botox and the estimated 50% of patients that may step through Botox to CGRP therapy,” he said in a report.
On the stock market today, Lilly advanced 1% at the closing bell, to 85.49. Amgen sank 0.1%, to 183.34. Shares of pharmaceutical and biotech companies each rose a fraction.
Lilly Tackles Migraine Prevention
Late Wednesday, Lilly said Emgality benefited some patients for whom Botox didn’t work to prevent migraines.
Lilly tested its anti-CGRP at 120-milligram and 240-milligram doses in patients who failed on Botox as a migraine prevention treatment. On average, 41.3% and 47.5%, respectively, saw their migraine days per month cut in half.
“These data are compelling given that Botox is a commonly used agent in the prophylactic treatment paradigm for migraine, and could potentially be required as a step-through therapy prior to treatment with the CGRP class,” RBC’s MacKay said.
But Lilly will continue to face an uphill battle against Amgen, MacKay said. U.S. officials approved Aimovig in May. The drug already has an established safety and effectiveness profile. It also beat rivals Lilly, Teva Pharmaceutical (TEVA) and Alder Biopharmaceuticals (ALDR) to market.
“We expect that Aimovig will continue to benefit from their first-to-market status,” he said.
Amgen Works To Prevent Migraines
But MacKay doesn’t expect Aimovig to completely fill the revenue hole Amgen faces amid a growing list of challenges for its legacy products. Notably, three of Amgen’s drugs are facing potential competition from biosimilars, nearly identical drugs.
Further, Amgen partners with Novartis (NVS) on Aimovig, meaning it will have to share sales.
Amgen is more bullish, though. The biotech released results on Wednesday of a survey of 11,000 patients who experience at least four migraines per month. Six in 10 respondents said they missed at least a week of work each month due to migraines.
Effective migraine prevention could help ease an estimated $ 22 billion annually in economic cost, Amgen said. About half of that is due to lost productivity. Additional data show patients are often reluctant to admit suffering from a migraine.
This suggests the “already extremely large market could see potential upside beyond the incident and prevalent populations estimated in medical literature, as well as the numbers underpinning assumptions in our model,” MacKay said.
MacKay estimates that there are 2.4 million chronic and 4.3 million episodic migraine patients in the U.S.
“However, despite potential for the migraine market to be significantly larger vs. established literature, we see (Amgen’s) base business erosion creating a significant/challenging revenue hole to fill, especially given Aimovig revenues are shared with partner Novartis,” he said.
Long-Time Aimovig Studies
Late Thursday, Amgen said Aimovig was tested for a year in chronic migraine patients. The biotech also took an interim look at data three years into an ongoing five-year study in episodic migraine patients. Researchers tested patients at doses of 140 milligrams and 70 milligrams.
On average, patients saw their migraine day per month decline by a respective 10.5 days and 8.5 days. Monthly migraine days declined by half for 67% and 53% of patients, respectively. Those days also dropped by three-quarters in 42% and 27% of patients, respectively.
Just 13% of patients on the 14-milligram dose and 6% of patients on the 70-milligram dose had no migraine days.
“These data showing sustained (effectiveness) and consistent safety and tolerability of Aimovig over an extended period of time are important for migraine patients and their clinicians to know,” Stewart Tepper, professor of neurology at Geisel School of Medicine at Dartmouth Medical School, said in a prepared statement.
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