In a normal world posting positive pivotal data in an indication that clearly separates you from the competition would be a surefire way to boost a share price. These, however, are not normal times, and Biohaven saw its shares slide 7% yesterday after reporting that Nurtec ODT had scored a hit in the tricky migraine prevention setting.
The uncertainty that the Covid-19 pandemic is throwing up has made investors scrutinise company announcements more closely than normal. And, despite showing a significant difference over placebo in the incidence of monthly migraine, the 0.8-day reduction Nurtec ODT mustered was shy of the one-day minimum some analysts had been looking for.
Same, same, but different
With three other CGRP migraine drugs already on the market, having prevention data is a key differentiator for Nurtec, marking it out as the only drug that has shown an impact on migraine treatment and prevention alike. The asset is also one of the few oral treatments, something that Biohaven is bound to talk up alongside the prevention data.
The company hopes to move quickly in terms of regulatory submissions, and said it was already working on a submission for the prevention setting. FDA and EMA filings are expected by the mid-year and, if these are successful, approval could come next year.
Haste is wise given that the Covid-19 pandemic, which has already started to hit clinical trial timelines, could at some point disrupt the functions of regulatory bodies.
New model sales army
Even without formal approval in prevention, doctors could become aware of the new data. The pill was approved on February 27 in an acute setting and marketing has commenced.
Still, this was four weeks after the first confirmed US Covid-19 case. The social distancing and lockdown measures now in place are almost certain to blunt the product's prospects this year: current sales forecasts sit at $59m this year.
But even that Covid-unadjusted number might be overly generous given that the acute CGRP market has turned out to be smaller than expected. Part of this has been due to the availability of cheap generic triptans and issues around reimbursement, which initially saw some companies give away their products.
Sales have failed to ramp up since then, even with price concessions and patient-access programmes. The number of players in the CGRP market and the proximity of their initial launches also ensured that payers benefited from the fierce competition between the makers.
With these existing headwinds Biohaven’s attempts to launch in an environment where a sales force is either on lockdown or prohibited from visiting physicians has been made even harder.
As such, the company is relying on a virtual launch strategy, which has seen it use remote meeting technology to provide education programmes to KOLs and doctors. The company is also employing webinars and accessing the growing telemedicine market to spread the word, alongside direct-to-consumer TV and social media adds.
In these constantly evolving times the rest of the market will be watching to see if Biohaven’s virtual approach proves to be a model worth replicating.
|Calcitonin gene-related peptide (CGRP) antagonists|
|WW sales ($m)|
|Rimegepant||Biohaven Pharmaceutical Holding||Filed||-||59||385||893|
|Vazegepant||Biohaven Pharmaceutical Holding||Phase III||-||-||-||15|
|Nurtec ODT||Biohaven Pharmaceutical Holding||Marketed||-||-||-||-|
|Atogepant||Merck & Co||Phase III||-||-||-||-|