Eli Lilly (LLY) announced that it had achieved a positive outcome in its phase 3 study that used Emgality as a preventative treatment for patients with chronic and episodic migraines. The company is off to a decent start in sales for Emgality, but this latest outcome might help it to increase market share. It won't be easy though, because there are multiple competitors in the very same space. What this latest positive outcome does for patients is that it gives them an alternative option, especially when so many other preventative therapies have failed.
Phase 3 Data Provides Solid New Option For Patients
The phase 3 trial was known as CONQUER. This late-stage study recruited patients with chronic and episodic migraines. Emgality was given to these patients to act as a preventative treatment for them. However, one thing to note is that this was a population of patients who had failed on two or four prior standard-of-care (SOC) treatments. Why would these patients want to try Emgality? Well, for starters, some of these patients that had gone through SOC treatments couldn't tolerate them. It must be understood that it's not just all about the efficacy of the product. If the patient's body can't handle the side effects or the drug causes internal problems, then one would be forced to stop regardless of efficacy. Then, of course, the second reason would be lack of efficacy. As noted above, some had even gone through 4 prior SOC treatments and still didn't get the relief they were looking for. Both of my points are proven in that about 40% of international patients who take migraine preventative treatments have a history of failure or switching. That means Emgality could offer a substantial new option for them. In terms of efficacy, it's pretty straight forward that Emgality had met the primary and all key secondary endpoints. The phase 3 study recruited a total of 462 patients. This involved two sets of patients with a certain type of migraine.
- About 193 patients with chronic migraines
- About 269 patients with episodic migraines
It was noted that, at baseline, these patients had a median of 13.2 monthly migraine headache days. They were randomized to receive either Emgality or placebo for 3 months of treatment. The primary endpoint was to evaluate the change from baseline between Emgality or placebo in terms of monthly migraine headache days. This primary endpoint was easily met. Emgality was able to reduce monthly migraine headache days by about 4.1 days. On the flip side, placebo was only able to reduce this measure by 1.0 day. This change from baseline in favor of Emgality was statistically significant with a p-value of p<0.0001.
The item to note about Eli Lilly with Emgality is that it still trails behind other competitors in the very same space that also have CGRP drugs. These would be Amgen (AMGN) and Novartis (NVS) with Aimovig and Teva (TEVA) with Ajovy. These products have been performing better, but that makes sense considering that Emgality was the 3rd product to be approved to market for the migraine space. It's not trailing that much though, and I believe that there is still quite some time until it is known which company will end up being highly competitive compared to others. Sales for Emgality were reported to be $33.8 million in Q2 2019, compared to Amgen which reported sales of $83 million in the same time period. The space is about to get more crowded as Alder BioPharmaceuticals (ALDR) has its migraine prevention drug Eptinezumab up for FDA review at the moment. This will only serve to increase competition.
Eli Lilly is on the right track with Emgality. It is nice to see that patients will have an alternative treatment option. As I highlighted above, about 40% of those treated have a history of failing on treatment or switching over. The biggest risk is that there are a lot of competitors in the migraine space. This will make it a challenge for Eli Lilly to sell its migraine drug. On the flip side, it wasn't the first to come to market. That means if it can deliver on sales in the coming quarters, it might start to make a run. Thus far, sales are on the low end at $33.8 million in the 2nd quarter of 2019. It will need to do a solid marketing effort if it intends to de-throne Amgen/Novartis or Teva. I believe there is room for all players involved anyways. Especially, if you consider that the market for migraine drugs is expected to be $8.7 billion by 2026. The downside is that insurers have been reluctant to pay for these CGRP class type of drugs, considering they cost $7,000 to $8,000 per year. This is another risk, in that Doctors may choose to stick to cheaper alternatives that may not work as well. The future of this market depends on pricing and marketing in an effort to force a switch to CGRP drugs. It won't be easy, but thus far generating millions of dollars for such prevention migraine drugs is the first key to being successful. This just needs to be followed through on in the coming years.
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