Welcome to Biotech Analysis Central Daily News, a daily news report and analysis about what has happened lately in the biotech industry.
Evoke Pharma Tumbles After Preliminary NDA Review
News: Recently, Evoke Pharma (EVOK) tumbled by 51% on the announcement that the FDA was not satisfied with the information it received in its initial NDA review for Gimoti. Specifically, the biotech received what is known as a multi-disciplinary review (DR) letter from the FDA. The basic premise is that this letter is given to a company in the preliminary stages of review to state what parts of the NDA are not sufficient enough for potential approval. Evoke Pharma will try to address the issues noted in the DR letter from the FDA before the April 1, 2019, PDUFA. The biotech is uncertain that it will get all the information to the FDA before the final review.
Analysis: I believe that Evoke Pharma can address these issues over a long period of time. However, I don't think that it will be able to obtain FDA approval by the expected PDUFA date. Had the DR letter only stated one minor deficiency, then it could have been possible. The issue is that the letter had multiple issues that were noted. The three issues raised in the application were: Chemistry, clinical package, and clinical pharmacology. What this means is that Evoke Pharma will likely get a Complete Response Letter (CRL) from the FDA for Gimoti. That means the stock will likely trade lower again and investors will sustain additional losses.
ImmunoGen Fails To Advance Ovarian Cancer Drug From Pipeline
News: Recently, ImmunoGen (IMGN) announced results from its phase 3 study using its drug mirvetuximab soravtansine to treat patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer. It was announced that the primary endpoint failed to meet in either the entire patient population or for those with high levels of FRα expression. The primary endpoint was looking for progression free survival (PFS). The biotech will continue to analyze the rest of the data and see if anything else positive can be extrapolated from the study. There were no safety issues noted, and the drug was highly tolerable for the patients.
Analysis: There might be a path forward here, but I remain skeptical for a few reasons. For starters, I don't like the overlapping statistical analysis that was utilized for this study. In essence, ImmunoGen used a statistical method known as the Hochberg procedure. The reason why it did so was because this method is easier to analyze the results from two overlapping populations from the study. In my opinion, using this procedure to analyze data didn't instill any confidence in trial design from the beginning. Typically, I have seen biotechs target the primary endpoint for the entire population. Then if the primary endpoint doesn't hit, there is an analysis done to see if a sub-population benefited from therapy.
In this instance, the biotech implemented this Hochberg procedure to overlap immediately to see if either population benefited with treatment of mirvetuximab soravtansine in terms of PFS. With this statistical analysis, if the p-value in either subset population in terms of the primary endpoint were > 0.05, then the p-value in the other population had to be < or = to 0.025 in order for the study to be statistically significant. The trial design was not strong to begin with. Then, there is the question about moving forward with the drug. This option may be possible in monotherapy, but not highly likely. Then there is the possibility to explore it in terms of combination therapies. ImmunoGen believes that it can still make this drug work by combining it with other cancer drugs. I remain skeptical for now, until tangible evidence is laid out to the contrary to support this notion. The good news is that the biotech has $295 million in cash on hand and several other early stage products in the pipeline.
Eli Lilly's Good Fortune With Emgality
News: Recently, Eli Lilly (LLY) announced that it had obtained Priority Review for its supplemental Biologics License Application (sBLA) for Emgality as an injection for preventative treatment of episodic cluster headaches in adults. The FDA gave Emgality priority review based on a successful phase 3 study. It seems that this drug is doing very well. That's because the FDA also granted Emgality with a Breakthrough Therapy Designation.
Analysis: The priority review is good in that it allows for a speedy review of a drug that may be more suitable compared to others to treat a serious condition. In this case, I must say this was highly appropriate. The reason why I state that is because cluster headaches are painful for the patient to begin with. However, episodic cluster headache is even worse. These patients have pain attacks that can last from as early as only seven days up to one year. Then there are periods in between such a time frame where there is no pain for roughly one month in between. Any way you look at it, this is terrible quality of life for these patients. That's very rough, but why did the FDA consider Emgality for both Priority Review and Breakthrough Therapy designation? That answer is quite simple really; it's because there are no FDA approved drugs for the prevention of episodic cluster headaches.
If Eli Lilly receives FDA approval for this indication, it will be the first as a preventative measure for this patient population. My final point is the addressable market size. Out of all the cases of patients with cluster headaches, about 80% or more are of the type of being classified as episodic cluster headaches. That gives Eli Lilly the ability to expand Emgality for a larger market opportunity.
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