In an effort to get into a three-way battle between major drug makers belonging to the all-new CGRP migraine class, the tiny Biohaven Pharmaceutical has released detailed data for its own candidate, according to which a group analysts could achieve blockbuster status.
Biohaven already has its new application for rhyme drug at the FDA counter. In March, she bought a priority examination voucher in hopes of bringing it to market faster. Unlike other CGRP injections, namely Amgen and Novovis Aimovig, Teva Ajovy and Eli Lilly's Emgality, rimegepant is an oral medication.
In a phase 3 study of 1,186 patients who tested the ability of the drug to treat acute migraine, approximately 19.6% of patients with rimegepant were completely painless two hours after taking the tablet, compared with 12.0% in the placebo group, according to data recently published in the New England Journal of Medicine. The difference was statistically significant, researchers discovered.
Currently, Aimovig, Ajovy and Emgality are engaged in a three-way battle. Aimovig leads the rankings with a competitive advantage. But in what will likely be the next two years, oral CGRP are poised to capture more than half of the total market share, Piper Jaffray analyst Christopher Raymond's team said on Thursday. with more than 100 high-volume headache specialists.
Of course, Biohaven also considers the potentially larger market – because of the higher frequency of treatments – of migraine prevention. The results of a phase 3 trial testing rhimegepant as a preventive treatment for migraine are expected in the fourth quarter.
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According to the results of the survey, Raymond estimates that oral PRCPs could mobilize $ 4 billion just for prevention. The doctors surveyed believe that Biohaven can capture almost half, which, according to Raymond, is well above the estimated amount of more than one billion dollars by his team.
Considering a higher conversion rate in orals, Raymond's team reduces Aimovig's revenue forecast from $ 1.40 billion to $ 1.21 billion in 2025.
However, Randall Stanicky, an analyst at RBC Capital, acknowledged that "a significant niche in the oral CGRP market," warned of the potential hurdles outlined in an April issue addressed to customers. A member of the public, Stanicky, questioned, pointed out that the effectiveness of oral drugs is "a game-changer" and worries that compliance with oral drugs would probably be worse compared to products. injectables. "In addition, the pricing is to be monitored given the availability of many other low-cost oral options for acute migraine," said the RBC analyst.
The list of enemies of Rimegepant is not limited to injectable CGRP. Allergan, who could soon become AbbVie after a gigantic fusion deal, is also developing a CGRP oral reagent. The FDA has accepted the company's new drug application, with a decision expected by the end of the year. And the race is about to be the first oral presentation now that Biohaven has cut the rimegepant replay time by four months with the coupon.
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Allergan is obviously the most experienced marketing specialist: his botox seems to resist migraine as the anti-CGRP class gains ground. But Biohaven is ready to roll. In April, he hired William "BJ" Jones as commercial director of migraine and common illnesses. Jones has joined Takeda and has commercial experience that includes the Excedrin Migraine, Farxiga Diabetes Drug, Pradaxa anticoagulant and Abilify antipsychotic launches. In addition, Biohaven launched a "Demand More" campaign on Thursday, outlining patient expectations for migraine treatment.
And Biohaven may not need to run rimegepant alone. Jefferies analyst Michael Yee had previously said Biogen could consider acquisitions after his big flop of aducanumab Alzheimer's, and Biohaven was on the list of possible targets. Then, in April, Bloomberg announced that the company based in New Haven, Connecticut, was actually exploring options, including a potential sale, after attracting the interest of potential bidders. Raymond, of Piper Jaffray, in his note, suggested to Amgen to resolve the Aimovig dispute with Novartis as soon as possible "and to seriously consider acquiring Biohaven to gain access to rhyme and eliminate what appears to be a growing competitive threat. ".