Axsome Therapeutics to Purchase Sunosi® from Jazz Prescription drugs, Increasing Axsome’s Management in Neuroscience

Article content material

Sunosi is the primary and solely dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) authorised by the FDA to enhance wakefulness in adults residing with extreme daytime sleepiness related to narcolepsy or obstructive sleep apnea

Acquisition accelerates Axsome’s transformation into a world industrial entity forward of potential near-term launches of AXS-05 in main depressive dysfunction (MDD) and AXS-07 in migraine

Extremely synergistic with Axsome’s current neuroscience portfolio and Digital Centric Commercialization™ (DCC) platform

Article content material

Anticipated long-lived exclusivity for Sunosi with potential for important further indications

Instantly income producing, and anticipated to be breakeven to working plan in 2023, and considerably accretive thereafter

Firm to host convention name at present at 8:00 AM ET

NEW YORK, March 28, 2022 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical firm creating novel therapies for the administration of central nervous system (CNS) problems, at present introduced that the Firm has entered right into a definitive settlement to amass Sunosi® (solriamfetol) from Jazz Prescription drugs (NASDAQ: JAZZ). Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to enhance wakefulness in grownup sufferers with extreme daytime sleepiness (EDS) as a result of narcolepsy or obstructive sleep apnea (OSA).

Article content material

Upon closing, the transaction will speed up Axsome’s transition to a world industrial entity, leverage Axsome’s first-in-class Digital Centric Commercialization™ platform forward of potential near-term launches of AXS-05 in despair and AXS-07 in migraine, and strengthen Axsome’s industry-leading neuroscience portfolio.

Sunosi was authorised by the U.S. Meals and Drug Administration (FDA) in 2019 and by the European Medicines Company (EMA) in 2020. Sunosi is the primary and solely DNRI authorised to deal with EDS in adults residing with narcolepsy or OSA. Sunosi internet gross sales have been $57.9 million in 2021, representing year-over-year development of 104%. Along with additional development potential within the present indication for Sunosi, there are alternatives to pursue new high-value indications in psychiatry and neurology.

Article content material

“This acquisition instantly transforms Axsome into a world industrial entity, upon closing, and accelerates our development as a premier biopharmaceutical firm centered on delivering doubtlessly life-changing medicines to individuals residing with critical CNS situations,” mentioned Herriot Tabuteau, MD, Chief Government Officer of Axsome. “Sunosi has demonstrated clinically significant efficacy, possesses a novel mechanism of motion, and has generated constructive affected person and doctor suggestions. We’re excited by its important development potential and wonderful strategic match with the Axsome portfolio. Moreover, the addition of Sunosi augments and accelerates our industrial preparedness forward of the potential near-term launches of our two current lead belongings, AXS-05 and AXS-07, and permits us to totally leverage our first-in-class Digital Centric Commercialization™ platform with three complementary belongings. We’re dedicated to making sure uninterrupted affected person entry to Sunosi through the transition interval and look ahead to constructing on the robust basis for Sunosi laid by Jazz.”

Article content material

“In assessing the general therapy panorama, we decided Axsome can be properly positioned to maximise the worth of Sunosi, each to sufferers and to Jazz. Axsome is properly positioned to leverage its complementary industrial enterprise to make sure Sunosi can successfully attain those that can profit from this vital medication,” mentioned Bruce Cozadd, Chief Government Officer of Jazz. “Additional, we consider Axsome’s observe report of scientific improvement supplies a promising basis for the exploration of Sunosi in further indications.”

Sunosi Transaction Rationale

Article content material

Article content material

Transaction Particulars

Beneath the phrases of the settlement, Axsome will obtain from Jazz worldwide industrial, improvement, manufacturing, and mental property rights to Sunosi, apart from sure Asian markets. Jazz will obtain from Axsome a complete upfront fee of $53 million, a excessive single-digit royalty on Axsome’s U.S. internet gross sales of Sunosi within the present indication, and a mid single-digit royalty on Axsome’s U.S. internet gross sales of Sunosi in future indications.

Axsome may also assume the commitments of Jazz to SK Biopharmaceuticals (SK) and Aerial Biopharma (Aerial). SK is the originator of Sunosi and retains rights in 12 Asian markets, together with China, Korea, and Japan. In 2014, Jazz acquired from Aerial worldwide rights to Sunosi excluding these Asian markets. The assumed commitments to SK and Aerial embody single-digit tiered royalties based mostly on Axsome gross sales of Sunosi, and as much as $165 million in income milestones and $1 million in improvement milestones.

Article content material

Financing

Axsome expects to finance the transaction through its current $300 million time period mortgage facility with Hercules Capital, Inc.

Closing Situations

The transaction has been unanimously authorised by Axsome’s Board of Administrators, and is topic to customary closing situations, together with the expiration or termination of the ready interval underneath the Hart-Scott Rodino Antitrust Enhancements Act of 1976. The transaction is structured to be accomplished in sequential closings for the U.S. and ex-U.S. territories. Topic to the satisfaction or waiver of the closing situations, the businesses anticipate the U.S. transaction to shut within the second quarter of 2022, and the ex-U.S. transaction to shut inside 60 days following the U.S. transaction shut.

Article content material

Further Data

Axsome intends to file a Kind 8-Ok with the SEC on the identical day as this press launch. The disclosure on this press launch is topic to any further particulars contained in such Kind 8-Ok. Buyers and stockholders are inspired to learn the Kind 8-Ok.

Convention Name Data

Axsome will host a convention name and webcast at present at 8:00 AM Jap to debate the acquisition of Sunosi. To take part within the dwell convention name, please dial (844) 200-6205 (toll-free home) or (929) 526-1599 (worldwide) and use the convention ID 015166. The dwell webcast will be accessed on the “Webcasts & Displays” web page of the “Buyers” part of the Firm’s web site at axsome.com. A replay of the webcast can be obtainable for roughly 30 days following the dwell occasion.

Article content material

Advisors

DLA Piper LLP acted as authorized counsel to Axsome.

About Sunosi® (solriamfetol)

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor proven to enhance wakefulness in adults residing with extreme daytime sleepiness (EDS) as a result of narcolepsy or obstructive sleep apnea (OSA). Sunosi obtained U.S. Meals and Drug Administration approval on March 20, 2019 to enhance wakefulness in grownup sufferers with EDS related to narcolepsy or OSA and was designated a Schedule IV medication by the U.S. Drug Enforcement Company on June 17, 2019. SK Biopharmaceuticals Co., Ltd., the discoverer of the compound, maintains rights in 12 Asian markets, together with Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the US.

Article content material

Vital Security Data

SUNOSI (solriamfetol) is offered in 75 mg and 150 mg tablets and is a federally managed substance (C-IV) as a result of it comprises solriamfetol that may be a goal for individuals who abuse prescription medicines or road medication. Preserve SUNOSI in a secure place to guard it from theft. By no means give or promote your SUNOSI to anybody else, as a result of it might trigger loss of life or hurt them and it’s in opposition to the legislation. Inform your physician in case you have ever abused or been depending on alcohol, prescription medicines, or road medication.

Earlier than taking SUNOSI, inform your physician about your whole medical situations, together with for those who:

Article content material

What are the attainable negative effects of SUNOSI?

SUNOSI could trigger critical negative effects, together with:
•  Elevated blood stress and coronary heart price. SUNOSI may cause blood stress and coronary heart price will increase that may improve the danger of coronary heart assault, stroke, coronary heart failure, and loss of life. Your physician ought to verify your blood stress earlier than and through therapy with SUNOSI. Your physician could lower your dose or let you know to cease taking SUNOSI for those who develop hypertension that doesn’t go away throughout therapy with SUNOSI.
•  Psychological (psychiatric) signs together with nervousness, issues sleeping (insomnia), irritability, and agitation. Inform your physician for those who develop any of those signs. Your physician could change your dose or let you know to cease taking SUNOSI for those who develop negative effects throughout therapy with SUNOSI.

Article content material

The most typical negative effects of SUNOSI embody:
•        headache
•        decreased urge for food
•        issues sleeping
•        nausea
•        nervousness

These usually are not all of the attainable negative effects of SUNOSI. Name your physician for recommendation about negative effects.

You’re inspired to report destructive negative effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch, or name 1-800-FDA-1088.

Please discover full prescribing data right here: https://pp.jazzpharma.com/pi/sunosi.en.USPI.pdf

About Obstructive Sleep Apnea and Extreme Daytime Sleepiness

Obstructive sleep apnea, generally known as sleep apnea, is a extremely prevalent illness (as excessive as 14% in males and 5% in girls) through which extreme daytime sleepiness is a serious presenting grievance in lots of instances. Optimistic Airway Stress (PAP) remedy, with its most typical type being Steady Optimistic Airway Stress (CPAP), has been proven to be an efficient remedy for sleep apnea that regularly leads to enchancment in extreme daytime sleepiness in lots of sufferers; nevertheless, not all sufferers tolerate CPAP remedy and amongst those that tolerate CPAP, utilization is extremely variable. Extreme daytime sleepiness could persist in individuals with sleep apnea regardless of utilizing CPAP.

Article content material

About Narcolepsy

Narcolepsy is a critical and debilitating neurological situation that causes dysregulation of the sleep-wake cycle and is characterised clinically by extreme daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep. Narcolepsy afflicts an estimated 185,000 people within the U.S. Narcolepsy interferes with cognitive, psychological, and social functioning, will increase the danger of work- and driving-related accidents, and is related to a 1.5-fold greater mortality price.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical firm creating novel therapies for central nervous system (CNS) situations which have restricted therapy choices. Via improvement of therapeutic choices with novel mechanisms of motion, we’re reworking the strategy to treating CNS situations. At Axsome, we’re dedicated to creating merchandise that meaningfully enhance the lives of sufferers and supply new therapeutic choices for physicians. For extra data, please go to the Firm’s web site at axsome.com. The Firm could often disseminate materials, nonpublic data on the corporate web site.

Article content material

Ahead Wanting Statements

Sure issues mentioned on this press launch are “forward-looking statements”. We could, in some instances, use phrases reminiscent of “predicts,” “believes,” “potential,” “proceed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “could,” “may,” “would possibly,” “will,” “ought to” or different phrases that convey uncertainty of future occasions or outcomes to establish these forward-looking statements. Specifically, the Firm’s statements concerning tendencies and potential future outcomes are examples of such forward-looking statements. The forward-looking statements embody dangers and uncertainties, together with, however not restricted to, the anticipated closing of the transaction referenced on this press launch, the success, timing and value of our ongoing scientific trials and anticipated scientific trials for our present product candidates, together with statements concerning the timing of initiation, tempo of enrollment and completion of the trials (together with our skill to totally fund our disclosed scientific trials, which assumes no materials modifications to our at present projected bills), futility analyses and receipt of interim outcomes, which aren’t essentially indicative of the ultimate outcomes of our ongoing scientific trials, and the quantity or sort of research or nature of outcomes essential to help the submitting of a brand new drug utility (“NDA”) for any of our present product candidates; our skill to fund further scientific trials to proceed the development of our product candidates; the timing of and our skill to acquire and keep U.S. Meals and Drug Administration (“FDA”) or different regulatory authority approval of, or different motion with respect to, our product candidates (together with, however not restricted to, whether or not potential submitting points or points recognized by FDA through the substantive overview could influence the potential approvability of the Firm’s NDA submission for AXS-05 in MDD or the timing of such approval, and whether or not the FDA will agree with the Firm’s discontinuation of the bupropion therapy arm of the ADVANCE examine in accordance with the impartial knowledge monitoring committee’s suggestions); whether or not points recognized by FDA through the substantive overview could influence the potential approvability of the Firm’s NDA for AXS-07 for the acute therapy of migraine in adults with or with out aura, pursuant to our particular protocol evaluation for the MOMENTUM scientific trial; the potential for the ASCEND scientific trial, mixed with the GEMINI scientific trial outcomes, to offer a foundation for approval of AXS-05 for the therapy of main depressive dysfunction and speed up its improvement timeline and industrial path to sufferers; the Firm’s skill to efficiently defend its mental property or get hold of the mandatory licenses at a price acceptable to the Firm, if in any respect; the profitable implementation of the Firm’s analysis and improvement applications and collaborations; the success of the Firm’s license agreements; the acceptance by the market of the Firm’s product candidates, if authorised; the Firm’s anticipated capital necessities, together with the quantity of capital required for the Firm’s industrial launch of its product candidates, and the potential influence on the Firm’s anticipated money runway; unexpected circumstances or different disruptions to regular enterprise operations arising from or associated to COVID-19; and different elements, together with common financial situations and regulatory developments, not inside the Firm’s management. The elements mentioned herein may trigger precise outcomes and developments to be materially completely different from these expressed in or implied by such statements. The forward-looking statements are made solely as of the date of this press launch and the Firm undertakes no obligation to publicly replace such forward-looking statements to replicate subsequent occasions or circumstance.

Axsome Contact:
Mark Jacobson
Chief Working Officer
Axsome Therapeutics, Inc.
22 Cortlandt Road, sixteenth Ground
New York, NY 10007
Tel: 212-332-3243
E mail: mjacobson@axsome.com
www.axsome.com

References