Entrance to Pfizer’s office in Cambridge, Massachusetts
Pfizer was not involved in the initial stages of developing and commercializing new migraine drugs that target new protein targets associated with chronic diseases.By inking Commercialization Agreement In cooperation with Biohaven Pharmaceuticals, the pharmaceutical giant has now acquired a portion of the market and has access to the next generation of such therapies.
The two companies announced an agreement on Tuesday involving the global commercialization of Biohaven’s oral migraine drug Nurtec, and the treatment of migraine in a nasal spray formulation that is still under development. The transaction gives Pfizer the right to sell these drugs worldwide, except in the United States where Biohaven reserves rights. Pfizer will advance US$500 million to Biohaven, of which US$150 million in cash, and a 25% premium of US$350 million to purchase shares of the biotech company.
Biohaven, headquartered in New Haven, Connecticut, can receive up to $740 million in milestone payments from Pfizer, as well as royalties from the pharmaceutical giant to sell migraine treatments. These sales may begin soon. Nurtec is currently undergoing regulatory review in other institutions in Europe and around the world.
Nurtec is part of a class of drugs that block calcitonin gene-related peptide (CGRP), a protein associated with migraine attacks. The first CGRP inhibitor was developed as an antibody drug for injection. CGRP blocking antibodies from Amgen, Eli Lilly and Teva Pharmaceutical were approved by the FDA as a preventive treatment for migraine in 2018. The injection interval of these drugs ranges from once a month to once every three months.
Oral drugs represent the next generation of CGRP therapy. Ubrelvy is a drug developed by Allergan (now part of AbbVie) and is the first oral CGRP to enter the market after its launch FDA approved in 2019 As a treatment for acute migraine. In the nine months ended September 30, Ubrelvy’s sales were 369 million U.S. dollars, compared to 60 million U.S. dollars in the same period in 2020. September, another AbbVie’s oral drug Qulipta is approved by the FDA for migraine prevention.
U.S. Food and Drug Administration Nurtec approved Last year as a treatment for acute migraine; regulatory approval for migraine prevention occurred in May. Biohaven continues to see strong market absorption of small molecule drugs.In its published Financial results for the third quarter of 2021 On Tuesday, the company reported that the drug’s revenue was $136 million; for the nine months ended September 30, revenue was $272.5 million. Biohaven stated in its financial report that it expects the market for oral CGRP inhibitors to be between US$4 billion and US$5 billion in the United States alone.
The next Biohaven migraine therapy is another CGRP blocking small molecule zavegepent. The drug is being developed as a nasal spray. In September, encouraging data from the Phase 2/3 trial of the drug was announced at the International Headache Association-European Headache Federation Joint Conference. Biohaven reported that the preventive effect of the drug was observed as early as the first week of treatment. These effects persisted after 12 weeks. In addition, the company reported that an open-label study showed that the drug has preventive benefits when taken as needed to treat acute migraine attacks.
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