Pfizer Inc. (NYSE: PFE) announced today the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the maker of NURTEC® ODT (rimegepant), an innovative migraine therapy approved for both acute treatment and prevention of episodic migraine in adults.
The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) receptor antagonists including:
- Approved in the United States under the trade name NURTEC® ODT, in adults for both the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine
- Approved in the European Union under the trade name VYDURA® for both the acute treatment of migraine with or without aura in adults and the preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month
- New Drug Application (NDA) for intranasal spray for the acute treatment of migraine under U.S. Food and Drug Administration (FDA) review, with a Prescription Drug User Fee Act (PDUFA) goal date in 1Q 2023
- A portfolio of pre-clinical CGRP assets
“We are proud to build on Pfizer’s legacy of delivering breakthrough medicines for patients living with complex pain disorders,” said Aamir Malik, Executive Vice President, Chief Business Innovation Officer, Pfizer. “The success of NURTEC® ODT coupled with Biohaven’s CGRP pipeline will strengthen Pfizer’s innovative Internal Medicine pipeline through 2030, and beyond. Combined with Pfizer’s global reach, this acquisition increases our potential to bring new treatment options to patients with migraine – a disease which affects over 1 billion people worldwide.”i
Pfizer acquired all of the outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash, for a total transaction consideration of approximately $11.6 billion. As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer.
Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN), distributing Biohaven Ltd.’s shares to Biohaven’s shareholders. Biohaven Ltd., a new company that retained Biohaven’s non-CGRP development stage pipeline compounds, holds the Kv7 ion channel activators, glutamate modulation, and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure assets excluded from the Pfizer acquisition. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 3% of Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York Stock Exchange under the ticker “BHVN”.
For additional background on the acquisition, please read the announcement press release here.
Worldwide, more than one billion people suffer from migraine, which predominately affects women.i Findings from the 2019 Global Burden of Disease study indicate that migraine is one of the worlds leading causes of disability.ii Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).iii
Rimegepant targets a key component of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name Nurtec® ODT for the acute treatment of migraine in adults in February 2020 and for the preventive treatment of episodic migraine in adults in May 2021. Nurtec® ODT is taken orally as needed, up to once daily for acute treatment, and every other day for preventive treatment. The maximum dose in a 24 hour period is 75 mg.
NURTEC® ODT U.S. IMPORTANT SAFETY INFORMATION
Contraindications: Hypersensitivity to Nurtec® ODT or any of its components.
Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue Nurtec® ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.
Adverse Reactions: The most common adverse reactions were nausea (2.7% in patients who received Nurtec® ODT compared to 0.8% in patients who received placebo) and abdominal pain/dyspepsia (2.4% in patients who received Nurtec® ODT compared to 0.8% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with Nurtec® ODT.
Drug Interactions: Avoid concomitant administration of Nurtec® ODT with strong inhibitors of CYP3A4 or strong or moderate inducers of CYP3A. Avoid another dose of Nurtec® ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4 or potent inhibitors of P‑gp.
Use in Specific Populations: Pregnancy: It is not known if Nurtec® ODT can harm an unborn baby. Lactation: The transfer of rimegepant into breastmilk is low (Hepatic impairment: Avoid use of Nurtec® ODT in persons with severe hepatic impairment. Renal impairment: Avoid use in patients with end-stage renal disease.
Nurtec® ODT is indicated in adults for the:
- acute treatment of migraine with or without aura
- preventive treatment of episodic migraine
Please click here for full Prescribing Information.
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from the NOJECTION® Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The FDA has accepted for review a New Drug Application (NDA) for zavegepant nasal spray, with a PDUFA date in 1Q 2023.