- Acquisition of next-generation Kv7 channel activators for target indications including epilepsy, pain disorders and affective disorders
- BHV-7000 is the lead asset from Kv7 channel platform and is potentially a best-in-class potassium channel activator with a profile suggestive for low-dose efficacy, reduced GABA activity, and a wide therapeutic index
- Biohaven anticipates entering BHV-7000 into the clinic in 2022 initially for the treatment of focal epilepsy
NEW HAVEN, Conn., Feb. 25, 2022
NEW HAVEN, Conn., Feb. 25, 2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN; the "Company" or "Biohaven") announced today that it has entered into a definitive agreement to acquire Channel Biosciences, LLC, a subsidiary of Knopp Biosciences LLC, and its Kv7 channel targeting platform – adding the latest advances in ion-channel modulation to Biohaven's growing neuroscience portfolio. The Kv7 platform has been developed and refined for over a decade by a team with deep experience in ion channel science led by Michael Bozik, M.D., and Steven Dworetzky, Ph.D. Both leaders, along with members of their scientific team, are anticipated to join Biohaven as part of the transaction, further bolstering the discovery and translational expertise at Biohaven Labs.
The lead asset, BHV-7000 (formerly known as KB-3061), is a potent activator of Kv7.2/Kv7.3, key subunits involved in neuronal signaling and in regulating the hyperexcitable state in epilepsy. The acquisition of BHV-7000 and the Kv7 channel-targeting series demonstrates Biohaven's continued commitment to neurology and to meeting the unmet needs of these patients. Biohaven intends to bring BHV-7000 to the clinic in 2022, with focal epilepsy as the lead indication for development.
Vlad Coric, M.D., Chief Executive Officer and Chairman of the Board of Biohaven, stated, "With this transaction, we have added one of the most innovative and exciting therapeutic targets for epilepsy to Biohaven's portfolio. This technology platform is poised to deliver new treatment options for patients suffering from epilepsy and, if ultimately approved, will be synergistic with our existing commercial sales force already calling upon neurologists who also may treat patients with seizures. We are excited to welcome Mike, Steven and members of the Kv7 team into the Biohaven family and look forward to working with them to accelerate this platform to benefit patients."
Michael Bozik, M.D., Chief Executive Officer of Channel Biosciences and its parent, Knopp Biosciences, commented, "Kv7 modulators have demonstrated clear efficacy in the clinic but have been limited by off-target effects. Our team has developed a portfolio of what we believe are potentially best-in-class Kv7 modulators to deliver novel therapies across several different indications. We are proud that Biohaven recognizes the potential of this platform—Biohaven was the clear partner of choice, given their demonstrated leadership in neurology and excellence in both developing and commercializing paradigm-shifting treatments for patients."
Epilepsy affects approximately 3.5 million Americans, or more than 1.2% of adults and 0.6% of children, and more than 50 million patients worldwide, according to the World Health Organization. It is the fourth most common neurological disorder, and many patients struggle to achieve seizure freedom, with more than a third of patients requiring two or more medications to manage their epilepsy. While the use of anti-seizure medications is often accompanied by dose-limiting side effects, BHV-7000 is specifically designed to target potassium channels without engagement of GABA receptors. The lack of GABA activity potentially gives BHV-7000 a wide therapeutic window and is expected to result in an improved side effect profile, limiting the somnolence and fatigue so often seen in patients receiving anti-seizure medications. By adding BHV-7000 to its pipeline, Biohaven aims to bring this novel potassium channel modulator as a solution to patients who remain uncontrolled on their current regimen.
Irfan Qureshi, M.D., Vice President of Neurology at Biohaven, commented, "The Kv7 channel platform is highly complementary to Biohaven's existing neurology pipeline and expands our potential to serve patients. We know Kv7 is a clinically validated target for focal epilepsy, and BHV-7000's unique profile is particularly exciting. Preclinical data suggest it offers the potential for significant reductions in seizure frequency without the troublesome side effects associated with other anti-seizure medications."
Members of the Channel Biosciences' scientific team will join and complement the discovery expertise at Biohaven Labs, adding world-leading ion channel scientists and driving its mission for bringing novel medicines to patients facing neurologic and neuropsychiatric diseases. This team includes CEO Dr. Bozik, a neuroscience clinician who was part of the leadership team at Bristol Myers Squibb that brought Abilify through to New Drug Approval, and Chief Scientific Officer, Steven Dworetzky, Ph.D., who cloned and discovered the KCNQ 2, 3, and 5 genes (now called Kv7.2, 7.3, and 7.5), and who has authored numerous patents and publications in this area.
Dr. Dworetzky commented, "The selection of BHV-7000 as the lead asset to enter the clinic is based upon its superior potency for Kv7.2/Kv7.3 and wide therapeutic margin compared to other compounds. We are excited to join Biohaven to accelerate clinical development of BHV-7000 and other drug candidates from our ion channel platform."
Terms of the Arrangement
In consideration for the transaction, Biohaven will make an upfront payment comprised of $65 million in Biohaven common shares and $35 million in cash to Knopp Biosciences. Biohaven has also agreed to make additional success-based earnout payments (i) up to $325 million based on BHV-7000 developmental and regulatory epilepsy milestones through approvals in the US, EU and Japan, (ii) up to an additional $250 million based on developmental and regulatory milestones for the Kv7 pipeline development in other indications and additional country approvals, and (iii) up to $562.5 million in scaled, commercial annual sales-based milestones of BHV-7000, the total of which will be achieved when annual sales exceed $3 billion. Biohaven has also agreed to make scaled royalty payments for BHV-7000 and the pipeline programs, starting at high single digits and peaking at low teens for BHV-7000 and starting at mid-single digits for the pipeline programs.
Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's Neuroinnovation™ portfolio includes FDA-approved NURTEC® ODT (rimegepant) for the acute and preventive treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.
About Knopp Biosciences LLC
Knopp Biosciences is a privately held, Pittsburgh-based drug discovery and development company focused on delivering breakthrough treatments for immunological and neurological diseases with high unmet need. Knopp's clinical-stage oral small molecule, dexpramipexole, is in development for eosinophilic asthma. Knopp's preclinical Kv7 platform is directed to small-molecule treatments for epilepsy and neuropathic pain. Please visit www.knoppbio.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "may" and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about BHV-7000 and Kv7 as a target for the treatment of epilepsy, pain disorders and affective disorders. Biohaven may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements, and the conditions to the obligations of Biohaven and Channel Biosciences to consummate the transaction may not be satisfied, the transaction may not close at all or on the terms expected, and if the transaction closes, Biohaven's plans to integrate the acquired business into Biohaven may not be successful. You should not place undue reliance on Biohaven's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2021, and Biohaven's subsequent filings with the Securities and Exchange Commission. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.
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