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~ CSL Behring Obtains Absolute All-around Rights to Beforehand and Commercialize uniQure’s Differentiated Gene Analysis Applicant for Hemophilia B ~
~ uniQure Acceptable to Accept Added Than $2 Billion, Including $450 Actor in Upfront Cash, $1.6 Billion in Anniversary Payments, and Double-Digit Royalties Ranging Up to a Low-Twenties Allotment of Net Sales ~
~ Acceding Leverages CSL Behring’s All-around Hematology Capabilities and Basement to Account Hemophilia B Patients Common ~
~ Transaction Expected to Enable uniQure to Strategically Aggrandize and Beforehand Activity and Belvedere ~
~ uniQure to Host Appointment Alarm Today, June 24, 2020, at 5:30 p.m. EDT ~
LEXINGTON, Mass. and AMSTERDAM, June 24, 2020 (GLOBE NEWSWIRE) — uniQure N.V. (NASDAQ: QURE), a arch gene analysis aggregation advancing transformative therapies for patients with astringent medical needs, today appear that uniQure and CSL Behring accept entered into a licensing acceding accouterment CSL Behring with absolute all-around rights to etranacogene dezaparvovec, uniQure’s investigational gene analysis for patients with hemophilia B. Etranacogene dezaparvovec consists of an AAV5 viral agent accustomed a gene cassette with the patent-protected Padua alternative of Factor IX (FIX-Padua). Beneath the acceding of the agreement, uniQure will accept a $450 actor upfront banknote acquittal and be acceptable to accept up to $1.6 billion in payments based on authoritative and bartering milestones. uniQure will additionally be acceptable to accept tiered double-digit royalties in a ambit of up to a low-twenties allotment of net artefact sales arising from the collaboration.
The accord leverages CSL Behring’s able all-around ability and bartering basement in hematology to beforehand admission of etranacogene dezaparvovec to hemophilia B patients about the world.
“We are captivated to access into this commercialization and authorization acceding with CSL Behring, an ideal bartering accomplice with all-around ability and decades of ability in hemophilia,” declared Matt Kapusta, arch controlling administrator of uniQure. “We accept that through this arrangement, we are alluringly positioned to bear globally our avant-garde gene analysis to the better cardinal of hemophilia B patients as bound as possible.”
“The transaction represents a above anniversary in the development of etranacogene dezaparvovec and, back closed, we apprehend that it will accommodate uniQure with cogent banking assets to beforehand and aggrandize our activity of gene analysis candidates, anchored by AMT-130 in Huntington’s disease, and to beforehand added in our arch gene analysis accomplishment and technology belvedere to abutment activity growth,” he added.
As a CSL Bound (ASX:CSL;USOTC:CSLLY) company, CSL Behring is a all-around biotherapeutics baton carrying lifesaving medicines to patients with attenuate and austere diseases. A all-around baton in alleviative bleeding disorders, CSL Behring has been carrying innovations for the hemophilia accommodating association for added than 30 years. The aggregation appear added than $1 billion in sales of hemophilia-related medicines in 2019.
“Our eyes with hemophilia B patients is to action transformational analysis paradigms that advice chargeless them from the constant accountability of this disease,” said CSL’s CEO and Managing Director Paul Perreault. “With added than three decades of accouterment lifesaving innovations for the all-around bleeding disorders community, we are able-bodied positioned to aerate the abeyant account of this therapy. Upon approval, we accept this next-generation analysis will be awful commutual to our absolute best-in-class hemophilia B artefact portfolio with an alternating best-in-class analysis option.”
Under the acceding of the agreement, uniQure will be amenable for the achievement of the HOPE-B cardinal study, accomplishment action validation, and the accomplishment accumulation of etranacogene dezaparvovec until such time that these capabilities are transferred to CSL Behring. Analytic development and authoritative activities performed by uniQure beneath the acceding will be reimbursed by CSL Behring. CSL Behring will be amenable for authoritative submissions and commercialization of etranacogene dezaparvovec.
The closing of the transaction is accidental on achievement of analysis beneath antitrust laws in the United States, Australia and the United Kingdom.
Accelerate Build-out of Avant-garde Gene Analysis Activity and Platform
uniQure expects that the acceding will accommodate added basic to decidedly beforehand and aggrandize its activity of avant-garde gene therapies, including advancing the Phase I/II abstraction of AMT-130 in Huntington’s disease, initiating IND-enabling studies of AMT-150 in spinocerebellar anarchy blazon 3, selecting a beforehand applicant in Fabry ache and advanced added accepted and new candidates for axial afraid arrangement disorders and attenuate liver-directed diseases. Regarding AMT-130, uniQure afresh appear the acknowledged achievement of the aboriginal two accommodating procedures in the Phase I/II abstraction and anticipates announcement aboriginal assurance abstracts in the added bisected of 2020 and antecedent ability abstracts in 2021.
uniQure affairs to abide to advantage its arch gene analysis platform, including the Company’s abysmal ability with AAV5, to beforehand potentially best-in-class gene therapies. AAV5-based gene therapies accept been approved to be safe and able-bodied acceptable in a aggregation of analytic trials, including uniQure trials conducted in hemophilia B and added indications. No accommodating advised in analytic trials with uniQure’s AAV5 gene therapies has accomplished any cytotoxic T-cell-mediated allowed acknowledgment to the capsid. Additionally, preclinical and analytic abstracts appearance that AAV5-based gene therapies may be applicative treatments in patients with above-mentioned antibodies to AAV5, thereby potentially accretion accommodating accommodation for treatment. uniQure additionally may seek to in-license or access added artefact candidates that adjust with its analysis and development strategy.
In addition, uniQure affairs to added strengthen its proprietary gene analysis belvedere by accretion its accomplishment accommodation to abutment a ample pipeline, including artefact candidates for diseases with beyond prevalence, as able-bodied as beforehand added in new technologies to beforehand the efficacy, assurance and account of its gene therapies to patients.
As allotment of uniQure’s accomplishment to focus on those gene analysis programs that accept the greatest abeyant to beforehand patients’ lives and accomplish abiding amount for shareholders, uniQure affairs to de-prioritize its analysis affairs of AMT-180 for patients with hemophilia A.
Moelis & Aggregation acted as a banking adviser to uniQure in this transaction.
Conference Alarm Today at 5:30 p.m. EDT
uniQure will host a appointment alarm today, June 24, 2020, at 5:30 p.m. Eastern Daylight Time. The appointment alarm may be accessed by dialing (877) 870-9135 for calm callers and 44 020 719 283 38 for all-embracing callers. The passcode for the alarm is 9499239. Please specify to the abettor that you would like to accompany the “uniQure Appointment Call.” The appointment alarm will be webcast alive beneath the broker relations area of uniQure’s website at www.uniQure.com and will be archived there afterward the alarm for 90 days.
uniQure is carrying on the affiance of gene analysis – distinct treatments with potentially alleviative results. We are leveraging our modular and accurate technology belvedere to rapidly beforehand a activity of proprietary gene therapies to amusement patients with hemophilia B, Huntington’s disease, Fabry disease, spinocerebellar anarchy Blazon 3 and added diseases. www.uniQure.com
uniQure Forward-Looking Statements
This columnist absolution contains advanced statements. All statements added than statements of absolute actuality are advanced statements, which are generally adumbrated by acceding such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look advanced to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and agnate expressions. Advanced statements are based on management’s behavior and assumptions and on advice accessible to administration alone as of the date of this columnist release. These advanced statements include, but are not bound to, whether the parties will auspiciously complete the analysis beneath applicative antitrust laws or contrarily abutting the transaction, whether uniQure will accept the upfront banknote acquittal or any of the banking allowances of the agreement; whether the accord will account Hemophilia B patients worldwide, whether the parties to the acceding will authorize a new accepted of affliction for patients with hemophilia B, whether uniQure will be able to beforehand or aggrandize its activity of avant-garde gene therapies or its technology platform, including advancing the Phase I/II abstraction of AMT-130 in Huntington’s disease, initiating IND-enabling studies of AMT-150 in spinocerebellar anarchy blazon 3, selecting a beforehand artefact applicant for Fabry disease, or advanced accepted or added candidates for axial afraid arrangement disorders and added abiogenetic diseases, whether uniQure will advertise aboriginal assurance abstracts from its Phase I/II abstraction of AMT-130 in the added bisected of 2020 and antecedent ability abstracts in 2021 or ever, whether uniQure will beforehand best-in-class gene therapies, whether uniQure will in-license or access added artefact candidates, whether uniQure will aggrandize its accomplishment accommodation to abutment a ample pipeline, such as artefact candidates for diseases with beyond prevalence, and whether uniQure will access enabling technologies that beforehand the ability or assurance of its gene therapies. uniQure’s absolute after-effects could alter materially from those advancing in these advanced statements for abounding reasons, including, after limitation, risks associated with the appulse of the advancing COVID-19 communicable on our Aggregation and the added abridgement and bloom affliction system, our analytic development activities, analytic results, accord arrangements, authoritative oversight, artefact commercialization and bookish acreage claims, as able-bodied as the risks, uncertainties and added factors declared beneath the branch “Risk Factors” in uniQure’s Annual Report on Form 10-Q filed on April 29, 2020. Given these risks, uncertainties and added factors, you should not abode disproportionate assurance on these advanced statements, and uniQure assumes no obligation to amend these advanced statements, alike if new advice becomes accessible in the future.
FOR INVESTORS: FOR MEDIA: Maria E. Cantor Chiara Russo Tom Malone Direct: 339-970-7536 Direct: 617-306-9137 Direct: 339-970-7558 Mobile: 339-223-8541 Mobile: 617-680-9452 Mobile: 617-306-9137 [email protected] [email protected] [email protected]
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