!
!
EPIRUS!Biopharmaceuticals!Expands!Biosimilar!Pipeline!and!Capabilities!Through!Acquisition!of!Bioceros!!
!
• Combined!...
!
webcast!at!least!10!minutes!early!to!ensure!adequate!time!to!register.!!The!webcast!will!be!archived!on!EPIRUS’!
website...
!
!
For!investor!inquiries:!
Tom!Shea,!EPIRUS!Biopharmaceuticals!
+19617960093471!
tshea@epirusbiopharma.com!
!
Source:!EP...
of 3

Press Release 9Sept2015

Published on: Mar 4, 2016
Source: www.slideshare.net


Transcripts - Press Release 9Sept2015

  • 1. ! ! EPIRUS!Biopharmaceuticals!Expands!Biosimilar!Pipeline!and!Capabilities!Through!Acquisition!of!Bioceros!! ! • Combined!companies’!product!pipeline!targets!reference!biologics!with!sales!of!$29!billion!in!2014! • Pipeline!expanded!to!include!biosimilars!to!Soliris®,!STELARA®!and!SIMPONI®!!! • Capabilities!enhanced!to!accelerate!product!development!and!optimize!quality!and!yields! ! Boston,! MA! –! (GlobeNewswire)! –! September! 9,! 2015! 99! EPIRUS! Biopharmaceuticals,! Inc.! (Nasdaq:EPRS),! a! biosimilar!company!focused!on!the!global!development!and!commercialization!of!biosimilar!monoclonal!antibodies! (mAbs),!today!announced!an!agreement!for!the!acquisition!of!Bioceros!Holding!B.V.,!enabling!EPIRUS!to!expand!its! biosimilar!pipeline!and!vertically!integrate!product!development!capabilities.!!! ! Bioceros!is!a!privately9held,!Netherlands9based!biopharmaceutical!R&D!company!focused!on!the!development!of! mAbs!and!generation!of!GMP9ready!cell!lines.!Over!the!past!decade,!Bioceros!has!developed!numerous!biosimilar! cell! lines! from! its! proprietary,! well9characterized! CHO! platform! (CHO BC ®) i .! ! Bioceros’! staff! of! scientists,! fully9 equipped!labs!and!bioreactor!capabilities!have!been!designed!for!the!development!of!monoclonal!antibodies!and! protein!therapeutics,!with!a!focus!on!biosimilars.! ! From! the! Bioceros! platform,! EPIRUS! will! expand! its! pipeline! with! the! addition! of! three! preclinical! product! candidates:! BOW080,! a! proposed! biosimilar! to! eculizumab! (reference! biologic! Soliris®);! BOW090,! a! proposed! biosimilar! to! ustekinumab! (reference! biologic! STELARA®);! and! BOW100,! a! proposed! biosimilar! to! golimumab! (reference!biologic!SIMPONI®).!!Soliris®,!marketed!by!Alexion!Pharmaceuticals,!is!currently!indicated!to!treat!ultra9 rare! blood! disorders,! including! paroxysmal! nocturnal! hemoglobinuria! (PNH)! and! atypical! hemolytic! uremic! syndrome! (aHUS).! ! SIMPONI®! and! STELARA®! are! marketed! by! Janssen! Pharmaceuticals! and! indicated! in! inflammatory!and!immune!mediated!disorders.!!!! ! These!three!new!pipeline!assets!represent!a!global!growth!opportunity!for!EPIRUS!in!targeting!reference!biologics! with!estimated!2020!peak!sales!of!$12!billion ii .!!The!platform!also!enables!future!pipeline!growth!opportunities!for! EPIRUS.!!The!anticipated!filing!dates!for!the!three!new!pipeline!products!are!2020!for!BOW080,!2021!for!BOW090! and!2022!for!BOW100.!!! ! “Building! a! focused,! sustainable! and! profitable! biosimilar! business! requires! capabilities! for! efficient! pipeline! growth.!!With!this!in!mind,!we!are!excited!to!welcome!Bioceros!and!their!world9class!capabilities!and!expertise,”! said!Amit!Munshi,!president!and!chief!executive!officer,!EPIRUS!Biopharmaceuticals.!!“Together,!we!will!continue! working! to! improve! patient! access! to! important! cost9effective! medicines! worldwide.! Our! combined! biosimilar! pipeline! targets! reference! biologics! with! sales! of! $29! billion,! which! we! estimate! to! be! a! biosimilar! market! opportunity!of!more!than!$9!billion.”! ! “Having!worked!with!EPIRUS!as!a!partner!over!the!last!several!years,!we!believe!strongly!in!the!Company’s!vision! and!their!ability!to!execute,”!said!Bram!Bout,!Ph.D.,!chief!executive!officer!and!chairman!of!the!management! board,!Bioceros.!!“With!our!proven!track!record,!our!team!brings!substantial!cell!line!and!process!development! experience,!representing!a!strong!asset!for!EPIRUS.”!! ! Under!the!terms!of!the!agreement,!EPIRUS!has!acquired!Bioceros!for!a!total!consideration!of!$14.1!million!in!cash! and!stock!payable!in!installments!over!a!one9year!period.! ! Conference!Call!and!Webcast!Information:!! EPIRUS’!leadership!team!will!host!a!conference!call!and!webcast!today,!September!9,!2015!at!9:00!a.m.!Eastern! Time,!to!discuss!these!recent!corporate!developments.!!To!access!the!conference!call,!please!dial!19855963893957! (United!States)!or!19224963391318!(International).!!The!conference!ID!is!32375668.!!The!webcast!can!be!accessed! on!EPIRUS’!website!at!http://ir.epirusbiopharma.com/events.cfm.!!Please!connect!to!either!the!conference!call!or!
  • 2. ! webcast!at!least!10!minutes!early!to!ensure!adequate!time!to!register.!!The!webcast!will!be!archived!on!EPIRUS’! website!for!a!period!of!three!months.!! ! About!EPIRUS!Biopharmaceuticals! EPIRUS! Biopharmaceuticals! (Nasdaq:EPRS)! is! a! biopharmaceutical! company! building! a! focused,! sustainable! and! profitable!biosimilar!business.!!EPIRUS’!goal!is!to!improve!patient!access!to!important,!cost9effective!medicines! worldwide.! ! EPIRUS'! current! pipeline! of! biosimilar! product! candidates! includes:! BOW015! (infliximab,! reference! biologic! Remicade®);! BOW050! (adalimumab,! reference! biologic! Humira®);! BOW070! (tocilizumab,! reference! biologic!Actemra®) iii ;!BOW080!(eculizumab,!reference!biologic!Soliris®);!BOW090!(ustekinumab,!reference!biologic! STELARA®);!and!BOW100!(golimumab,!reference!biologic!SIMPONI®).!!The!reference!products!for!these!candidates! together!generated!approximately!$29.2!billion!in!global!sales!for!2014,!according!to!EvaluatePharma®.!!EPIRUS! has! developed! distinct! strategies! to! penetrate! the! global! market,! leveraging! partnerships! to! optimize! value! retention!over!the!long!term.!!For!more!information!visit!EPIRUS’!website!at!www.epirusbiopharma.com.!! ! ForwardGLooking!Statements! Various!statements!in!this!release!are!forward9looking!statements!within!the!meaning!of!the!Private!Securities! Litigation!Reform!Act!of!1995.!!In!addition,!when!or!if!used!in!this!document,!the!words!“may,”!“could,”!“should,”! “anticipate,”!“believe,”!“estimate,”!“expect,”!“intend,”!“plan,”!“predict”!and!similar!expressions!and!their!variants,! as!they!relate!to!EPIRUS!or!its!management,!may!identify!forward9looking!statements.!!EPIRUS!cautions!that!these! forward9looking! statements! are! subject! to! numerous! assumptions,! risks,! and! uncertainties,! which! change! over! time.!Important!factors!that!may!cause!actual!results!to!differ!materially!from!the!results!discussed!in!the!forward9 looking! statements! or! historical! experience! include! risks! and! uncertainties,! including! the! failure! by! EPIRUS! to! secure!and!maintain!relationships!with!collaborators!and!single9source!contract!manufacturers;!risks!relating!to!in9 house! cell! line! and! process! development! activities:! risks! relating! to! clinical! trials;! risks! relating! to! the! commercialization,!if!any,!of!EPIRUS’!proposed!product!candidates!(such!as!marketing,!regulatory,!product!liability,! supply,! competition,! and! other! risks);! dependence! on! the! efforts! of! third! parties;! dependence! on! intellectual! property;!risks!related!to!the!loss!of!any!of!EPIRUS’!key!management!personnel;!risks!that!EPIRUS!may!lack!the! financial!resources!and!access!to!capital!to!fund!proposed!operations!and!other!factors!that!are!described!in!the! “Risk! Factors”! and! “Management’s! Discussion! and! Analysis! of! Financial! Condition! and! Results! of! Operations”! sections!of!EPIRUS’!annual!report!on!Form!109K!for!the!fiscal!year!ended!December!31,!2014!and!quarterly!reports! on! Form! 109Q! for! the! quarters! ended! March! 31,! 2015! and! June! 30,! 2015,! which! are! on! file! with! the! SEC! and! available!on!the!SEC’s!website!at!www.sec.gov.!In!addition!to!the!risks!described!above!and!in!EPIRUS’!annual! report!on!Form!109K,!quarterly!reports!on!Form!109Q,!current!reports!on!Form!89K!and!other!filings!with!the!SEC,! other! unknown! or! unpredictable! factors! also! could! affect! EPIRUS’! results.! There! can! be! no! assurance! that! the! actual!results!or!developments!anticipated!by!EPIRUS!will!be!realized!or,!even!if!substantially!realized,!that!they! will! have! the! expected! consequences! to,! or! effects! on,! EPIRUS.! Therefore,! no! assurance! can! be! given! that! the! outcomes!stated!in!such!forward9looking!statements!and!estimates!will!be!achieved.!! ! All!written!and!verbal!forward9looking!statements!attributable!to!EPIRUS!or!any!person!acting!on!its!behalf!are! expressly!qualified!in!their!entirety!by!the!cautionary!statements!contained!or!referred!to!herein.!EPIRUS!cautions! investors!not!to!rely!too!heavily!on!the!forward9looking!statements!EPIRUS!makes!or!that!are!made!on!its!behalf.! The!information!in!this!release!is!provided!only!as!of!the!date!of!this!release,!and!EPIRUS!undertakes!no!obligation,! and!specifically!declines!any!obligation,!to!update!or!revise!publicly!any!forward9looking!statements,!whether!as!a! result!of!new!information,!future!events!or!otherwise.! ! Contact!Information:! ! For!media!inquiries:! Mike!Devine,!FleishmanHillard!! +19617969290507!! michael.devine@fleishman.com!!
  • 3. ! ! For!investor!inquiries:! Tom!Shea,!EPIRUS!Biopharmaceuticals! +19617960093471! tshea@epirusbiopharma.com! ! Source:!EPIRUS!Biopharmaceuticals,!Inc.! !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! i!CHOBC!is!a!registered!trademark!of!Bioceros!Holding!B.V.! ii!As!reported!by!EvaluatePharma!(data!pulled!August!2015)! iii!Remicade!is!a!registered!trademark!of!Johnson!and!Johnson!(www.jnj.com);!Humira!is!a!registered!trademark!of!AbbVie! (www.abbvie.com);!Actemra!is!a!registered!trademark!of!Chugai!Seiyaku!Kabushiki!Kaisha!Corp.,!a!member!of!the!Roche!Group! (www.gene.com);!!Stelara!is!owned!and!marketed!by!Centocor!Ortho!Biotech!Inc,!a!wholly!owned!subsidiary!of!Johnson!&!Johnson;! Simponi!is!marketed!by!Janssen!Biotech!Inc;!Soliris!is!a!registered!trademark!of!Alexion!Pharmaceuticals,!Inc.!!

Related Documents