Two prestigious medical journals this month published successful results from clinical trials of Biohaven Pharmaceuticals’ new migraine treatment rimegepant, as the New Haven company awaits FDA approval to begin selling the drug.
Meanwhile, the biotech remains the target of buzz about potential M&A activity as it races to compete with other drug companies working on similar migraine treatments.
On Monday, Biohaven announced that international scientific journal The Lancet published results from a Phase 3 clinical trial of its fast-dissolving version of rimegepant.
Last week, the New England Journal of Medicine published results from a separate Phase 3 clinical trial on Biohaven’s standard tablet formulation of the drug.
New Haven BIZ reported previously announced partial data from the trials last year, but this is the first time detailed results have been published, a Biohaven spokesman said Monday.
The studies found rimegepant outperformed a placebo and that patients remained free from pain and their “most bothersome” symptom (such as nausea or light sensitivity) two hours after taking the drug. The difference between the drug and placebo was statistically significant, the company reported. The trials also showed patients tolerated the drug well with no safety concerns.
The fast-dissolving version provided pain relief more quickly than the standard tablet, according to the results.
“We are thrilled with the publication of these Phase 3 trial results of rimegepant ODT (orally dissolving tablet) in The Lancet, an international and influential scientific journal, just days after our oral tablet Phase 3 study was published in the New England Journal of Medicine,” CEO Vlad Coric, MD, said in a statement. “These results show that rimegepant ODT has the potential to meet patients’ needs by providing faster and sustained relief in a convenient form of administration.”
Biohaven also presented the data at the 2019 American Headache Society Annual Scientific Meeting in Philadelphia last week.
Biohaven is one of a handful of pharmaceutical companies developing or marketing a new class of migraine drugs known as calcitonin gene-related peptide (CGRP) receptor antagonists, which stop migraines by blocking a brain chemical that transmits pain.
They are billed as an alternative to triptans, a widely used type of migraine drug that is unsafe for some migraine sufferers because they constrict blood vessels.
Current CGRP receptor antagonists on the market are administered only by injection. Biohaven, which submitted its application to the U.S. Food & Drug Administration during the second quarter, is racing against pharmaceutical company Allergan to bring the first oral CGRP drug to market. Regulatory approval for both could come as soon as the end of this year.
In March, Biohaven paid $105 million for a priority review voucher to shorten the 10-month FDA review process for the ODT formulation of the drug by four months.
In the meantime, pharmaceutical industry trade publication FiercePharma continued to fuel speculation last week about potential M&A activity involving the six-year-old Biohaven, which has 93 employees and is based at 215 Church St.
According to the publication, Piper Jaffray analyst Christopher Raymond suggested in a note to investors that migraine-drug developer Amgen “seriously consider acquiring Biohaven to gain access to rimegepant and remove what appears to be a growing threat.”
In April, Bloomberg reported Biohaven was in talks about options, including a possible sale, after attracting interest from potential bidders, which it did not name.
Cambridge, Mass. biotech Biogen was also floated last spring as a possible suitor for the Yale spinoff. Biohaven has declined to confirm or comment on the reports.
In other news, Biohaven announced earlier this month that it enrolled its first patient in a Phase 2 trial of rimegepant for refractory trigeminal neuralgia, a neuropathic pain disorder characterized by bouts of severe facial pain. The study is taking place at Johns Hopkins Medical Center.
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Guilford-based InveniAI Corp. said it has tapped an executive from Swiss pharma giant Novartis for its board of directors as it opens a new European headquarters.
InveniAI announced it has established a headquarters in Basel, Switzerland, home of Novartis, to expand its artificial intelligence and machine learning technology globally.
The company, a spinoff of BioXcel Corp., said it appointed Novartis’ Amit Agrawal as a “key member” of its board.
Agrawal became global head of portfolio strategy and management for global drug development at Novartis last October. Before that, he was head of corporate strategy at California-based global pharmaceutical firm Amgen.
“Amit will add a broad corporate strategy perspective and bring strong biopharma experience to our board as we look to forge new partnerships,” InveniAI President and CEO Krishnan Nandabalan said in a statement.
Nandabalan called the expansion into the European Union “a milestone moment in the growth of InveniAI.”
InveniAI says it is pioneering the application of artificial intelligence and machine learning “to transform innovation across healthcare and other industries.” It specializes in AI-based drug discovery and development.
Contact Natalie Missakian at news@newhavenbiz.com
