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Unimpeded by Allergan's Botox Dominance, Amgen/Novartis' Aimovig, Teva's Ajovy, and Eli Lilly's Emgality Use at the Patient Level is More Robust Within the Episodic Migraine Segment Than Physicians Are Aware of

Teva's Ajovy may be most at risk by the future availability of orally dosed anti-CGRP therapies, including Biohaven's rimegepant and Allergan's atogepant, while Allergan's Botox will remain insulated from anti-CGRP class pressure, according to the inaugural Spherix Global Insights audit of the US migraine prevention market

EXTON, Pa., Sept. 11, 2019 /PRNewswire/ -- Contributing physicians appear to underestimate their use of the anti-calcitonin gene-related peptide (CGRP) therapies in patients with episodic migraine. Neurologists and migraine specialists self-reported that less than half of their patients currently on Amgen/Novartis' Aimovig, Teva's Ajovy, or Eli Lilly's Emgality were diagnosed with episodic migraine at the time of the decision to prescribe the brand. However, data captured from 1,016 patients currently treated with an anti-CGRP and/or Allergan's Botox as part of Spherix's inaugural RealWorld Dynamix™: Migraine Prevention (US) audit service showed that the majority of anti-CGRP-treated patients were initiated on their current brand while diagnosed with episodic, often low frequency (<10 monthly migraine days), migraine. A similar dynamic exists for Botox, although the misalignment between physicians' perception and actual treatment patterns is not quite as stark, likely attributed to the brand's label restricted to chronic migraine prevention.

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The episodic migraine segment represents the greatest market expansion opportunity for the anti-CGRP brands, due to higher patient volume and historically low treatment rate. Spherix real-world data indicate that anti-CGRP uptake in this segment may be stronger than managing physicians and other secondary data sources suggest. As a result, anti-CGRP marketers could only benefit competitively by highlighting available clinical data supporting brand use among patients with less severe current migraine disability who are at risk of migraine chronification.

At this time, Novartis appears to be the only company with an ongoing Phase 4 clinical program aimed at supporting such messaging with the head-to-head HER-MES trial (NCT03828539) evaluating Aimovig to topiramate in patients with episodic migraine. With two-thirds of the audit patients treated with concomitant topiramate still on one of the branded versions of the molecule (i.e., Janssen's Topamax, Supernus' Trokendi XR, Upsher-Smith's Qudexy XR), a positive readout of the HER-MES trial in mid-2020 would be influential in shifting payer support and physician prescribing patterns towards even greater Aimovig use in this large segment.

Botox, the current market leader for chronic migraine prevention among the injectable options, won almost all cases where the brand was considered an appropriate therapeutic option. In comparison, stressing strong within-class competition, individual anti-CGRP brands were prescribed in only about half of cases where the brand was considered a viable option. Along with efficacy and tolerability, positive long-term safety perceptions and patient requests played a significantly greater role in the selection of Botox over other potential competitors.

As an example, when Emgality lost out to Botox for a potential new patient start, patient request for Botox was influential in almost half of the lost opportunities. As one managing physician described the Botox selection process: "The patient had friends receiving botulinum toxin injections and it had helped them. They were uncomfortable with newer medications on the market due to lack of safety data." When Botox did lose to an anti-CGRP therapy, preference for the subcutaneous administration method and better convenience expectations were typically the reasons for the preferential selection of the monoclonal antibody.

Among the pipeline anti-CGRP therapies in late-stage clinical development, specifically Alder BioPharmaceutical's eptinezumab, Biohaven Pharmaceutical's rimegepant, and Allergan's atogepant, most US neurologists and migraine specialists already project at least moderate use for the prevention of migraine upon approval. Assuming availability at the time of the current brand selection, audit patients who were considered very likely candidates for rimegepant, an oral CGRP receptor antagonist dosed once every two or three days, instead of their current preventive therapy are significantly more likely to be prescribed Ajovy and less likely to be prescribed Botox compared to noncandidates. This pattern suggests that oral anti-CGRP therapies may put a disproportionate amount of pressure on the Teva brand, which is already struggling in the face of the current injectable anti-CGRP therapies. Regardless of the pipeline agent and/or the route of administration, Botox appears to remain insulated from the competitive pressure from the expanding anti-CGRP class in the migraine prevention market.

About RealWorld Dynamix™
RealWorld Dynamix™: Migraine Prevention (US) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,000 patients currently treated with an anti-CGRP and/or Botox. 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 first annual audit published in August 2019.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages its own independent data and expertise to provide strategic guidance so biopharma stakeholders can make decisions with confidence.

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

For more information contact:
Kristen Henn, Neurology Franchise Insights Analyst
Email: info@spherixglobalinsights.com
www.spherixglobalinsights.com

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