CRCP

Migraines affect over 37 million Americans, according to the Migraine Research Foundation (MRF).1Migraine-related pain is the third most prevalent illness in the world.1According to the Global Burden of Disease study, migraines are the second leading cause of disability worldwide.1A recent market research study (n=150) of Neurologists, Headache Specialists and Primary Care Physicians revealed that 93% of clinicians treating migraine have moderate to extremely high unmet needs for alternatives to triptan therapy.2Elyxyb® (celecoxib oral solution) profile is preferred by physicians to address migraine attacks that often involve throbbing, nausea, sensitivity to light and sound, and other symptoms that can last extended periods of time often ranging from 4 to 72 hours.1 PALO ALTO, Calif., Nov. 22, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that the key product attributes of ELYXYB® meet the high unmet needs of clinicians treating patients with acute migraine, with and without aura, in adults, based on the results from a recent market research study. A recent market research study (n=150) of Neurologists, Headache Specialists and Primary Care Physicians revealed that 93% of clinicians treating migraine have moderate to extremely high unmet needs for alternatives to triptan therapy.2 Clinicians stated their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy, and those who have contraindications to triptan use. ELYXYB’s product profile mapped with a high degree of certainty to these stated unmet needs. In clinical studies, patients treated with ELYXYB® demonstrated pain relief in as little as 15 minutes, and significant pain relief compared to placebo within 45 minutes in nearly 50% of patients. Approximately 34% of patients were pain free at two hours.3 Notably, these data are well differentiated from two other new oral migraine medications of a different class, calcitonin gene-related peptide (CGRP) receptor antagonists. Recent data from a post hoc analysis presented at the Brain Week Conference in Las Vegas showcased that ELYXYB® had higher pain freedom rates from 60 minutes through 3 hours post-dose compared to ubrogepant 100 mg and rimegepant 75 mg.4 As a low-dose COX-2 inhibitor, ELYXYB was safe and well-tolerated in large Phase III clinical studies of 1,253 patients.3 The most common adverse reaction was dysgeusia (3% of patients on ELYXYB vs 1% on placebo).3 Unlike triptans, ELYXYB is not contraindicated in patients with cardiovascular conditions.5 For more information on ELYXYB, including Full Prescribing Information, refer to the Exhibits hereto and visit ELYXYB.com. Exhibit A Exhibit B Exhibit C About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex is uncompromising in its focus to become the global pain management leader committed to social, environmental, economic, and ethical principles to responsibly develop pharmaceutical products to maximize quality of life. Results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. Scilex participated in the type C meeting for purposes of pre-NDA discussion with the FDA and reached agreement on a path forward to file an NDA for SP-102 (SEMDEXA™) in Lumbosacral Radicular Pain (Sciatica) with the FDA. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with moderate to severe pain. Scilex launched its first commercial product ZTlido® in October 2018, in-licensed a commercial product Gloperba® in June 2022, and launched its third FDA-approved product Elyxyb™ in April 2023. It is also developing its late-stage pipeline, which includes a pivotal Phase 3 candidate, and one Phase 2 and one Phase 1 candidate. Its commercial product, ZTlido® (lidocaine topical system) 1.8%, or ZTlido®, is a prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with post-herpetic neuralgia, which is a form of post-shingles nerve pain. Scilex in-licensed the exclusive right to commercialize Gloperba® (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex in-licensed the exclusive rights to commercialize Elyxyb® (celecoxib oral solution) in the U.S. and Canada, the only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. Scilex launched Elyxyb® in April 2023, and is planning to commercialize Gloperba® by 2024, and is well-positioned to market and distribute those products. Scilex’s three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status; SP-103 (lidocaine topical system) 5.4%, a Phase 2 study, triple-strength formulation of ZTlido®, for the treatment of chronic neck pain, with FDA Fast Track status. We received our SP-103 Phase 2 top-line results in August 2023 and the trial achieved its objectives characterizing safety, tolerability and preliminary efficacy of SP-103 in acute low back pain associated with muscle spasms. SP-103 was safe and well-tolerated. Increase of lidocaine load in topical system by three times, compared with approved ZTlido, 5.4% vs. 1.8%, did not result in signs of systemic toxicity or increased application site reactions with daily applications over one month treatment. We will continue to analyze the SP-103 Phase 2 trial data along with a recently completed investigator study of ZTlido in patients with chronic neck pain which also has showed promising top-line efficacy and safety results. Scilex is planning to initiate Phase 2/3 trial in chronic neck pain in 2024; and SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia that has completed multiple Phase 1 trial programs and is expected to initiate Phase 2 trials in 2024. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding ELYXYB®’s potential to further expand Scilex’s non-opioid portfolio and its potential to address high unmet needs in treating acute migraine, the findings of the recent market research study, the potential market size for U.S. oral migraine drugs and for pain management therapeutics, Scilex’s plans to initiate a Phase 2/3 trial in chronic neck pain in 2024 and plans to initiate Phase 2 trials in 2024 for SP-104, Scilex’s belief that it is well positioned to continue its growth over the next several years, Scilex’s long-term objectives and commercialization plans, Scilex’s potential to attract new capital, future opportunities for Scilex, Scilex’s future business strategies, the expected cash resources of Scilex and the expected uses thereof; Scilex’s current and prospective product candidates, planned clinical trials and preclinical activities and potential product approvals, as well as the potential for market acceptance of any approved products and the related market opportunity; statements regarding ZTlido®, Gloperba®, ELYXYB®, SP-102 (SEMDEXA™), SP-103 or SP-104, if approved by the FDA; Scilex’s development and commercialization plans; and Scilex’s products, technologies and prospects. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks that Scilex may not achieve the results expected from the commercialization of ELYXYB®; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials for SP-102, SP-103 or SP-104 may not be successful; risks that the prior results of the clinical trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks set forth in Scilex’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com References Anita Gupta: https://blogs.webmd.com/pain-management/20231120/managing-migrainesData on file. Scilex Holding CompanyLipton RB, et al. J Pain Res 2021; 14:549-560.Tepper, SJ, Serrano D, Chan EK. Pain Freedom With Celecoxib Oral Solution, Ubrogepant, and Rimegepant Through 4 Hours Postdose: Post Hoc Analysis in the Acute Treatment of Migraine. Poster presented BRAINWeek September 6, 2023; Las Vegas, NV.ELYXYB package insert. SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2023 Scilex Holding Company All Rights Reserved. Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/7738cbba-5a4e-4390-a3a5-89a48791e0dc https://www.globenewswire.com/NewsRoom/AttachmentNg/dbea46c6-4b53-48ee-adba-9dba94586a9f https://www.globenewswire.com/NewsRoom/AttachmentNg/5003c08d-5712-405c-b213-a3486884f01d

Pfizer Inc. (NYSE: PFE) announced 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: Rimegepant: 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 Zavegepant: 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 Pfizers 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."(1) 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 Biohavens 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". About Migraine Worldwide, more than one billion people suffer from migraine, which predominately affects women.(1) Findings from the 2019 Global Burden of Disease study indicate that migraine is one of the worlds leading causes of disability.(2) 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).(3) About Rimegepant 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. Please click here for full Prescribing Information . About Zavegepant 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. 1. Ashina et al, Lancet; 2021; 397:1485-95 2. Steiner et al, The Journal of Headache and Pain; 2020; 21:137 3. Ferrari et al, Nature Review Disease Primers; 2022; 8(1):2

NEW HAVEN, Conn., Sept. 29, 2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. ( NYSE: BHVN) today announced results from a focused analysis of treatment with verdiperstat in the HEALEY ALS Platform Trial in amyotrophic lateral sclerosis (ALS). The HEALEY ALS Platform Trial, the first-ever platform trial in ALS, is designed as an adaptive trial to evaluate multiple investigational treatments simultaneously, thus accelerating the development of effective and breakthrough treatments for people living with ALS. Verdiperstat did not statistically differentiate from placebo on the prespecified primary efficacy outcome, disease progression measured by the ALS Functional Rating Scale-Revised and survival, nor the key secondary efficacy measures during the 24-week study period. Initial analysis of safety data was consistent with the overall profile of verdiperstat from prior clinical trial experience. Additional analyses are ongoing, and complete study results will be presented at an upcoming scientific meeting. Irfan Qureshi, M.D., Senior Vice President of Neurology at Biohaven, stated, "We are incredibly grateful to our collaborators at the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, HEALEY ALS Platform Trial study investigators, and the ALS community – especially people with ALS and their families –– who made the trial possible. While we are disappointed that verdiperstat did not demonstrate efficacy for ALS, Biohaven remains committed to developing treatments for people who suffer from neurodegenerative diseases." About ALS ALS is a progressive, life-threatening, and rare neuromuscular disease that affects approximately 30,000 people in the United States. The median age of onset is 55 years and average survival is 3-5 years after onset of first symptoms. ALS is characterized by the loss of motor neurons in the brain, brainstem, and spinal cord that leads to progressive muscle weakness and difficulties in speaking, swallowing, and breathing. There are currently limited treatment options and no cure for ALS. About Biohaven Biohaven is a global 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 (EMA-approved as Vydura™ (rimegepant) for the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month) and a broad pipeline of late-stage product candidates across five distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral sclerosis; Kv7 Ion Channel Activators (Kv7) for focal epilepsy and neuronal hyperexcitability, and myostatin inhibition for neuromuscular diseases. More information about Biohaven is available at www.biohavenpharma.com.