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Jazz Pharmaceuticals Enters Into Agreement with TerSera Therapeutics LLC for Prialt

Hamilton, Bermuda – July 2, 2018 – In a filing with the Bermuda Stock Exchange (“BSX”), Jazz Pharmaceuticals plc (Nasdaq: JAZZ) whose Secured Loan Notes are listed on the BSX announced that it had entered into agreement with TerSera Therapeutics LLC for Prialt. The full filing stated:

 

DUBLIN, June 29, 2018 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced a definitive agreement to sell its rights related to Prialt® (ziconotide) intrathecal infusion to TerSera Therapeutics LLC (TerSera) for $80 million in cash at closing. The transaction is expected to close in the third quarter of 2018 and is subject to the satisfaction of customary closing conditions.  As part of the transaction, TerSera will offer employment positions to a majority of the Jazz employees dedicated to Prialt.

 

Prialt is the only FDA approved, non-opioid agent indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted.  Jazz recorded $27 million in net product sales for Prialt in 2017.

 

“This transaction allows us to focus resources on our core therapeutic areas of sleep medicine and hematology/oncology,” said Daniel Swisher, President and Chief Operating Officer of Jazz Pharmaceuticals.  “Given TerSera’s strong track record and focus on the business, we’re confident they will continue to educate medical professionals about and ensure full access to this important medicine for patients.”

 

“We are excited about acquiring Prialt and welcoming a team of seasoned professionals to support the future growth of this product as we continue to serve patients who can benefit from this therapy,” said Ed Fiorentino, Chairman and Chief Executive Officer of TerSera. “It is vitally important to ensure non-opioid alternatives are available for patients for the management of their severe chronic pain.”

 

Advisors

JazzPharmaceuticals’financial advisor forthetransaction is MTSHealthPartners, L.P.

 

AboutJazz Pharmaceuticals

JazzPharmaceuticalsplc(Nasdaq:JAZZ)isan international biopharmaceutical company focusedon improvingpatients’lives byidentifying, developingand commercializing meaningfulproductsthat addressunmet medical needs.Thecompanyhasa diverseportfolio ofproducts andproductcandidates with a focusin theareas ofsleep andhematology/oncology.Intheseareas, JazzPharmaceuticalsmarketsXyrem®(sodiumoxybate) oral solution,Erwinaze®(asparaginaseErwiniachrysanthemi),Defitelio®(defibrotidesodium) and Vyxeos®(daunorubicin and cytarabine)liposomeforinjection in the U.S. andmarkets Erwinase®and Defitelio®(defibrotide) in countriesoutside the U.S.  For country-specificproductinformation,please visit  http://www.jazzpharmaceuticals.com/products.For moreinformation,pleasevisit http://www.jazzpharmaceuticals.com/andfollow us onTwitter at@JazzPharma.

AboutTerSera TherapeuticsLLC

TerSera Therapeutics LLCacquires, developsandmarketsspecialtypharmaceuticalproductswithafocusonselect therapeuticareas.Itsmissionistoprovideproductswhichtrulymake adifference forpatients.  For moreinformationabout TerSeraTherapeutics, please visit www.tersera.com.

"SafeHarbor"StatementunderthePrivateSecuritiesLitigationReformActof1995

Thispressreleasecontainsforward-looking statements,including, but notlimited to,statementsrelatedtothe anticipatedsaleofJazzPharmaceuticals’rightsrelatedto Prialtand the timingthereof, JazzPharmaceuticals’strategy,andother statementsthatarenot historicalfacts. Theseforward-looking statementsare basedonJazzPharmaceuticals' current plans,objectives,estimates, expectationsand intentionsand inherently involve significant risksanduncertainties.Actual resultsandthetiming ofeventscould differ materiallyfrom thoseanticipated in suchforward-looking statementsasaresult oftheserisksanduncertainties, which include,withoutlimitation, risksand uncertaintiesassociated with:JazzPharmaceuticals’ability to close thetransaction ontheproposed termsandschedule, including risksanduncertaintiesrelatedtothesatisfaction ofclosingconditions;disruptionto JazzPharmaceuticals’businessasaresult ofthetransaction; and other risksand uncertaintiesaffecting thecompany,including those describedfrom timetotimeunderthe caption "RiskFactors" and elsewhere in JazzPharmaceuticalsplc'sSecurities andExchangeCommissionfilingsandreports(Commission File No.001-33500),includingthecompany'sQuarterlyReport on Form10-Qforthe quarter ended March31, 2018 andfuturefilingsandreportsbythe company.Other risksand uncertainties of which JazzPharmaceuticalsisnotcurrentlyawaremayalso affect thecompany'sforward-looking statementsand maycauseactual resultsandthe timing ofeventsto differ materiallyfrom those anticipated.

The forward-looking statementshereinaremadeonlyas ofthe date hereoforas ofthedatesindicated in the forward-looking statements,eveniftheyaresubsequentlymade available byJazzPharmaceuticalson itswebsite or otherwise.  Jazz Pharmaceuticalsundertakes noobligationtoupdate orsupplement any forward-looking statementstoreflectactualresults,newinformation,future events,changes in itsexpectationsorothercircumstancesthatexistafterthe date asofwhich theforward-looking statementsweremade.

AboutPrialt

Prialtreceived FDA approval in2004,andisindicatedfor themanagementofseverechronicpainin adultpatientsforwhomintrathecal (IT) therapy iswarranted,and who areintolerantoforrefractoryto other treatment, suchas systemicanalgesics, adjunctive therapies,or ITmorphine.

 

IMPORTANT SAFETY INFORMATION:

Prialt is contraindicated inpatientswitha preexisting historyofpsychosis.  Severepsychiatric symptomsand neurological impairment mayoccurduring treatmentwithPrialt.Monitorallpatientsfrequentlyforevidence of cognitive impairment,hallucinations, orchanges inmoodorconsciousness.Discontinue Prialt therapyin the eventof seriousneurological orpsychiatricsignsorsymptoms.

 

WARNINGS AND PRECAUTIONS

  Cognitive and neuropsychiatricadversereactionsCognitive impairment and severeneuropsychiatricsymptoms mayoccurwith Prialt use

  Meningitisand otherinfections -Patients, caregivers,and healthcareprovidersmustbe awareofthe signsand symptoms ofmeningitis,includingbutnotlimitedtofever,headache,stiffneck,alteredmentalstatus(e.g., lethargy, confusion,disorientation), nausea or vomiting, andoccasionallyseizures.

  Reduced level ofconsciousness- Patientsmaybecomeunresponsive or stuporouswhilereceivingPrialt

  Elevation ofserum creatinekinasePatientstakingPrialtmayexperience elevations in creatinekinase.Monitorserum CK in patientsundergoingtreatmentwith Prialtperiodically

  Withdrawal from opiates:Patientsmustnotbe abruptly withdrawn fromopiatesandmustbegraduallytapered overafewweeksandreplacedwith apharmacologicallyequivalentdose oforal opiates

 

Pleaseclickhere to see thefull PrescribingInformationforPrialt, includingBOXEDWarning.

JazzPharmaceuticalsContacts:

Investors:

KatheeLittrell

VicePresident,Investor RelationsIreland, +3531 6347887

U.S., +1650 4962717

Media:

JacquelineKirby

VicePresident,CorporateAffairs&GovernmentRelationsIreland, +3531 6972141

TerSera Therapeutics LLC Contact:

Media:

MarkLeonard

+1847651 9682or mark@reachthenextlevel.com