Pfizer and Biohaven Pharmaceuticals | October 04, 2022
Pfizer Inc. announced the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd., the maker of NURTEC® ODT 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 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 for intranasal spray for the acute treatment of migraine under U.S. Food and Drug Administration review, with a Prescription Drug User Fee Act goal date in 1Q 2023
"We are proud to build on Pfizer’s legacy of delivering breakthrough medicines for patients living with complex pain disorders. 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.
Aamir Malik, Executive Vice President, Chief Business Innovation Officer, Pfizer
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. 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”.
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 and sensitivity to light.
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.
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.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.
BUSINESS INSIGHTS, PHARMACY MARKET
TherapeuticsMD, Inc. | December 05, 2022
TherapeuticsMD, Inc. an innovative, leading women’s healthcare company, announced that it has entered into definitive agreements to license its products to an affiliate of Mayne Pharma Group Limited an ASX-listed specialty pharmaceutical company focused on commercializing novel and generic pharmaceuticals, for commercialization in the United States. In addition, TXMD has agreed to sell certain assets to Mayne Pharma to allow Mayne Pharma to commercialize the products.
At closing of the transaction, TXMD will receive an upfront cash payment of $140.0 million for the license grant and sale of certain assets, plus an additional approximately $13.1 million, subject to customary adjustments, for acquired net working capital. In addition, TXMD will receive a 20-year royalty stream tied to Mayne Pharma’s net sales of the products. The upfront payment to be made by Mayne Pharma, along with cash on hand, will allow TXMD to repay its outstanding indebtedness with Sixth Street Partners and to redeem its outstanding preferred equity, with TXMD continuing as a pharmaceutical royalty company with the potential to create value for stakeholders over time from the resulting net cash flows.
"After completing a thorough evaluation of several strategic alternatives, our Board of Directors concluded that this transaction with Mayne Pharma would create the most value for TherapeuticsMD’s stakeholders. This transaction will allow us to repay in full our debt to Sixth Street Partners and redeem our preferred stock from Rubric Capital Management, while also establishing a future royalty revenue stream for our common shareholders. We believe that Mayne Pharma has the experience necessary to fully realize the promise of our products as we work together to improve patient care.”
The Honorable Tommy Thompson, Executive Chairman of TherapeuticsMD
Upon completion of the transaction, which is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Act of 1976, Mayne Pharma will be responsible for development, regulatory filings, manufacturing, and commercialization of the Products.
TXMD will receive an upfront payment of $140.0 million for the sale of the assets and the grant of the licenses, plus a payment of approximately $13.1 million for the acquisition of net working capital, subject to certain customary adjustments.
In addition, Mayne Pharma will make one-time, milestone payments to the Company of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million. Further, Mayne Pharma will pay to the Company royalties on net sales of all licensed Products in the United States at a royalty rate of 8.0% on the first $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the closing. The royalty rate will decrease to 2.0% on a Product-by-Product basis upon the earlier to occur of the expiration or revocation of the last patent covering a Product and a generic version of a Product launching in the United States. Mayne Pharma will pay to the Company minimal annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject to certain further adjustments.
In connection with entering into the transaction, the lenders and administrative agent under the Company’s Financing Agreement with Sixth Street Partners have agreed to extend the maturity date of the Financing Agreement to December 31, 2022, allowing the Company to complete the transaction with Mayne Pharma on or before that date. The maturity date of the Financing Agreement may be further extended to January 31, 2023, upon payment of an amendment fee, in the event the definitive agreements in connection with the transaction remain in effect and the waiting period under the HSR Act has not expired or terminated.
The Company will retain its existing licensing agreements with Knight Therapeutics, Inc. and Theramex HQ UK Limited.
The transaction is not subject to any financing conditions and is expected to close at the end of 2022, pending satisfaction of customary closing conditions.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. TherapeuticsMD’s products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. TherapeuticsMD is committed to advancing the health of women and championing awareness of their healthcare issues.
Emerald Health Pharmaceuticals | October 14, 2022
Emerald Health Pharmaceuticals Inc. a clinical-stage biopharmaceutical company developing a new class of medicines to treat neurodegenerative, autoimmune and other diseases, today announced the publication of a scientific article in the peer-reviewed Journal of Neuroinflammation highlighting additional data supporting the unique mechanism of action of EHP-101, the company’s first-in-class drug candidate for the treatment of systemic sclerosis and multiple sclerosis.
Titled “A cannabidiol aminoquinone derivative activates the PP2A/B55α/HIF pathway and shows protective effects in a mouse model of traumatic brain injury”, the paper was co-authored by Eduardo Muñoz, MD, PhD, EHP’s Chief Scientific Officer. The publication demonstrates that VCE-004.8, the active pharmaceutical ingredient of EHP-101, is a highly specific activator of the B55a subunit of the protein phosphatase, thus activating the hypoxia-inducible factor (HIF) pathway. This first-in-class activator of the HIF pathway via modulation of B55a provides a new mechanism to treat diseases where vascular integrity is compromised. Therefore, these findings support the use of EHP-101 for the treatment of SSc and MS, and illustrate the potential of VCE-004.8 for acute disorders including traumatic brain injury and stroke.
“The results of Dr. Muñoz’s work, as published in this prestigious journal, validate EHP-101’s unique ability to address key disease factors associated with the complex pathophysiology of fibrotic and demyelinating diseases such as SSc and MS through complementary specific mechanisms of action,”
Alain Rolland, Pharm.D., Ph.D., COO of EHP
EHP is currently conducting a Phase 2a clinical study to evaluate the safety, tolerability, and preliminary efficacy of EHP-101 in SSc patients. The Company has also met the regulatory requirements to start a Phase 2 clinical trial of EHP-101 for MS.
About Emerald Health Pharmaceuticals Inc.
Emerald Health Pharmaceuticals is developing novel product candidates for the treatment of CNS, autoimmune, and other diseases. The Company has two families of patented new chemical entities that have been created through rational drug design to affect validated receptors and pathways in the body which are pertinent to targeted
diseases. Its first drug product candidate, EHP-101, is in a Phase 2a study for the treatment of systemic sclerosis, a severe form of scleroderma, and has met regulatory requirements to start a Phase 2 study for multiple sclerosis. EHP-101 has received Orphan Drug Designation in the US and EU, as well as Fast Track status by the US FDA for systemic sclerosis.
The Company’s second product candidate, EHP-102, is in non-clinical development with IND-enabling studies and is focused on treating Parkinson’s disease and Huntington’s disease. EHP-102 has received Orphan Drug Designation in the US and EU for Huntington’s disease.