COVID-19 Pandemic in the US May Curtail Uptake of Recent Acute Migraine Market Entrants, Diminishing Specialists' Prelaunch Expectations that Biohaven's Nurtec ODT Would Challenge Allergan's Ubrelvy and Eli Lilly's Reyvow

EXTON, Pa., April 2, 2020 /PRNewswire/ -- Biohaven's Nurtec (rimegepant) orally disintegrating tablet (ODT), a calcitonin gene-related peptide (CGRP) receptor antagonist, was approved by the FDA for the acute treatment of migraine in adults on February 27^th and commercially launched on March 12^th. Fielded between February 6^th and 19^th, data from 98 migraine specialists and neurologists surveyed as part of the ongoing quarterly report series included in Spherix's RealTime Dynamix™: Migraine (US) service, found that Nurtec ODT was poised for a strong launch, based upon a broad early prescriber base and a sizeable candidate pool.

Physicians were most willing to prescribe Nurtec ODT in patients who have previously failed or were contraindicated for triptans, the standard of care for the acute treatment of migraine, consistent with the expectation that the brand would be limited by payers to patients with a demonstrated medical necessity. However, with physicians estimating that a sizeable subset of patients have had insufficient response to triptans, this limitation was not seen as a barrier to uptake, as more than one-third of patients under management were identified as appropriate candidates for Nurtec ODT. The potential success of Biohaven's new acute treatment option could have blunted recent launch trajectories of Allergan's Ubrelvy and Eli Lilly's Reyvow, as well as pull share from the triptan class.

And yet, just one week prior to approval, physicians reported very low overall awareness of and familiarity with Nurtec ODT, though Biohaven was prepared to overcome this obstacle with a solid post-launch field promotion beginning March 2^nd. Unfortunately, just days into the launch, the COVID-19 pandemic began to drastically alter the US healthcare landscape, and Biohaven switched to a virtual-only promotion approach in reaction to the escalating crisis. In the recently published Special Report: Multi-Specialty Impact of COVID-19, Spherix found that, as of March 27^th, no neurologists had received an in-person detail by any sales representative in the previous week. Instead, most had participated in an e-detail and that channel of interaction has increased compared to the prior week.

While Biohaven's pivot to webinars, remote detailing, social media, and telemedicine is the best option for increased brand awareness during this time, there is now a hesitancy among specialists to make any change to patients' migraine treatment regimens. Especially relevant with the recent explosion of new treatment options, one-quarter of neurologists surveyed in the Special Report indicated they are less likely to prescribe a migraine therapy that has been on the market for less than a year due to the ongoing COVID-19 crisis. When asked specifically by brand, more neurologists voiced a reluctance to initiate a patient on Nurtec ODT compared to Allergan's Ubrelvy. Thus, Allergan's first-to-market oral CGRP receptor antagonist, approved for the acute treatment of migraine in late December 2019, may continue its impressive launch highlighted in the current RealTime Dynamix: Migraine (US) report, building upon a mere two additional (but non-disrupted) months on the market, as well as Allergan's established and recognized leadership in migraine treatment.

The concurrent use of CGRP agents for both the acute and preventive treatment of migraine is now a real-world possibility, building upon the two CGRP receptor antagonists for acute treatment (i.e., Ubrelvy and Nurtec ODT) and the continued uptake of the subcutaneous CGRP monoclonal antibodies (mAbs) for the prevention of migraine (i.e., Amgen/Novartis' Aimovig, Teva's Ajovy, or Eli Lilly's Emgality). Almost half of physicians agree that a CGRP receptor antagonist would be effective as an acute therapy in a patient already treated with a CGRP preventive therapy.

Based upon early Ubrelvy launch uptake patterns from February, this hypothesis was already being tested in clinical practice. In fact, Ubrelvy-treated patients were more likely to be prescribed a concomitant CGRP mAb than topiramate or Allergan's Botox for the prevention of migraine. At the time, physicians seemed even more open to prescribing Nurtec ODT in such patients, with twice as many physicians extremely willing to prescribe Nurtec ODT with a concurrent CGRP preventive therapy compared to those willing to prescribe Ubrelvy.

However, unlike Ubrelvy, clinical experience using Nurtec concomitantly could make the brand a serious competitive threat to the established CGRP preventive therapies. On Monday, Biohaven announced positive topline outcomes of the pivotal trial evaluating a tablet formulation of rimegepant for the preventive treatment of migraine, and the company plans to submit an sNDA for the expanded indication by mid-year. If approved, Nurtec would be the first migraine therapy approved with dual-therapy action, offering both acute and preventive control of migraines with every-other-day dosing.

With physicians voicing a clear preference for a tablet formulation for migraine prevention (over the existing subcutaneous route of administration), clinical experience prescribing Nurtec ODT in patients treated with CGRP therapies for migraine prevention should make the transition to Nurtec monotherapy effortless. In fact, if approved for a dual migraine indication, physicians estimate that the majority of their Nurtec prescribing would be for patients requiring a migraine prevention medication. By way of one migraine specialist's opinion, "If [Nurtec's] approval is extended for prevention, I have several CGRP mAb patients who would go off injections in a New York Minute." As an infrequently-dosed oral tablet, Nurtec represents a clear competitive threat to Aimovig, Ajovy, Emgality, and, even Lundbeck's Vyepti.

Should Nurtec receive approval for the first dual-therapy label in the market, the impact of the brand on the acute and preventive segments of the migraine market will be evaluated by Spherix each year based on two large-scale patient chart audits, RealWorld Dynamix: Preventive Therapy Switches in Migraine (US) and RealWorld Dynamix: Acute Therapy Switches in Migraine (US). Capturing recent switches to or additions of relevant new migraine therapies, the audits provide key insights into what drives brand selection and where brands may be winning or losing against competitors. In addition, each audit will provide a complete picture of the acute and preventive therapy regimens being prescribed to individual patients, illuminating the degree to which CGRP therapies are being used concomitantly and which brands, if any, are being favored for such use.

About RealTime Dynamix™
RealTime Dynamix™: Migraine (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The 8^th wave of research, covering the launches of Eli Lilly's Reyvow, Allergan's Ubrelvy, Biohaven's Nurtec ODT, and Lundbeck's Vyepti in the shadow of the COVID-19 pandemic, will publish in June 2020.

About RealWorld Dynamix™
RealWorld Dynamix is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,000 patients each switched to or have added a new migraine therapy within the previous three months. The report uncovers the "why" behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. The annual report of RealWorld Dynamix™: Preventive Therapy Switches in Migraine (US), focused on preventive treatment regimen changes involving the CGRP monoclonal antibodies or Allergan's Botox, will publish in August 2020. The annual report of RealWorld Dynamix™: Acute Therapy Switches in Migraine (US), focused on acute treatment regimen changes involving the CGRP receptor antagonists or Eli Lilly's Reyvow, will publish in November 2020.

Special Report: Multi-Specialty Impact of COVID-19 is an ongoing series of weekly monitoring that evaluates the impact of COVID-19 on physicians and their practices – including, but not limited to, the utilization of telemedicine, at-risk patient groups, key concerns, support from industry, and future changes in prescribing patterns. The third report of the weekly series will publish on Monday, April 6^th.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Virginia Schobel, Neurology Franchise Head
Email: [email protected]
www.spherixglobalinsights.com

SOURCE Spherix Global Insights

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