Earnings Release • Dec 5, 2011
Earnings Release
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Company!announcement No.!25/2011
Copenhagen,!5!December!2011 J!Zealand!Pharma!A/S!(NASDAQ!OMX!Copenhagen:!ZEAL),!a!Danish! biopharmaceutical!company!dedicated!to!the!discovery!and!development!of!innovative!peptide!drugs,! announces!that!new!results!on!lixisenatide!(Lyxumia®)!will!be!presented!by!the!company's!partner! Sanofi!at!the!International!Diabetes!Federation's!21st!World!Diabetes!Congress,!5!–!8!December!2011!in! Dubai,!United!Arab!Emirates.!Lixisenatide!is!an!investigational!new!GLPJ1!agonist!for!onceJdaily!dosing,! discovered!by!Zealand!Pharma!and!developed!by!Sanofi!for!the!treatment!of!Type!2!diabetes.!
In!a!poster!session!today!at!2:00!J!3:00!pm!Dubai!local!time!(11:00!am!J!12:00!noon!CET),!Sanofi!will! present!three!posters!with!titles!and!conclusions!as!follows:!!
Conclusion: Lixisenatide!QD!had!a!significantly!greater!postJprandial!glucose!lowering!(PPG)!effect!than! liraglutide!QD!in!patients!with!Type!2!diabetes!(J129%!versus!J41%,!respectively),!accompanied!by! significant!decreases!in!insulin,!CJpeptide!and!glucagon!and!a!better!gastroJintestinal!tolerability!profile.
*!This!is!a!4Jweek!Phase!II!study
Conclusion:!AddJon!treatment!with!lixisenatide!(onceJdaily)!provided!a!marked!significant!improvement! in!postprandial!glycemic!control!over!24!weeks!in!Type!2!diabetes!patients!insufficiently!controlled!on! SU ± metformin.!Lixisenatide!also!reduced!glucagon!and!proJinsulin!and!thus!improved!glucose! homeostasis.
The!GetGoalJS!study!is!part!of!the!GetGoal!Phase!III!clinical!program!with!lixisenatide,!and!positive!topJ line!results!from!the!study!were!reported!by!Sanofi!and announced!by!Zealand!Pharma!in!April!2011! (Company!Announcement!no.!5/2011,!12!April!2011).
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"Comparison!of!the!OnceIDaily!GLPI1R!Agonists!Lixisenatide!and!Liraglutide!on!Prandial!Carbohydrate! Utilization!in!Animal!Models"!(Abstract!DI0737)
Conclusion:!In!the!present!animal!studies,!lixisenatide!and!liraglutide!had!a!different!impact!on!postJ prandial!carbohydrate!utilization,!with!lixisenatide!having!a!stronger!prandial!effect!than!liraglutide. This!potent!effect!of!lixisenatide!on!postJmeal!glucose!control!might!result!in!improvement!of!glucose! control!in!Type!2!diabetes,!allowing!more!patients!to!reach!their!HbA1c!target!with!body!weight!loss.
Further,!in!two!oral!presentations!scheduled!for!presentation!at!the!congress!on!Thursday,!8!December! at!10:45J12:45!local!time!(7:45J9:45!CET),!Sanofi!will!present!results!from!two!studies!under!the!GetGoal! Phase!III!program!with!lixisenatide:!topJline!results!from!the!GetGoalJM!study!and!additional!results! from!the!GetGoalJF1!study!,!from!which!study!positive!topJline!results!were!reported!by!Sanofi!at!EASD! 2011!and!announced!by!Zealand!Pharma!midJSeptember!2011!(Company!Announcement!no.!15/2011,! 12!September!2011).!The!two!oral!presentations!are!titled!as!follows:!
"Efficacy!and!safety!of!lixisenatide!QD!morning!and!evening!injections!versus!placebo!in!T2DM! inadequately!controlled!on!metformin!(GetGoalIM)"!(Abstract!OI0591)
"LongIterm!(up!to!2!years)!safety!of!lixisenatide!once!daily!versus!placebo!in!T2DM!insufficiently! controlled!on!metformin!(GetGoalIF1)"!(Abstract!OI0595)
In!November!2011,!the!European!Medicines!Agency!(EMA)!accepted!Sanofi's!marketing!authorization! application!filed!for!lixisenatide!(Lyxumia®).!Submission!for!regulatory!approval!of!lixisenatide!in!the! United!States!is!expected!in!Q4!2012.!
David!H.!Solomon,!President!&!CEO,!Tel:!+45!2220!6300
Hanne!Leth!Hillman,!Vice!President!for!IR!&!Corporate!Communication,!!!!!!!!!!!!! Tel:!+45!5060!3689,!email:[email protected]
Lixisenatide,!a!glucagonJlike!peptideJ1!(GLPJ1)!agonist!for!onceJdaily!dosing,!is!in!development!for!the!treatment!of! patients!with!Type!2!diabetes!mellitus.!Lixisenatide!was!discovered!by!Zealand!Pharma!and!has!been!licensed!to! Sanofi.!Lyxumia®!is!the!intended!trademark!of!lixisenatide.!Lixisenatide!is!not!currently!approved!or!licensed! anywhere!in!the!world.
GLPJ1!is!a!naturallyJoccurring!peptide!that!is!released!within!minutes!of!eating!a!meal.!It!is!known!to!suppress! glucagon!secretion!from!pancreatic!alpha!cells!and!stimulate!insulin!secretion!by!pancreatic!beta!cells.!GLPJ1! receptor!agonists!are!in!development!as!an!addJon!treatment!for!Type!2!diabetes!and!their!use!is!endorsed!by!the!
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Zealand!Pharma!announces!new!results!on!lixisenatide (Lyxumia®)!for!Type!2!diabetes!presented!by!Sanofi!at!21st!World! Diabetes!Congress
European!Association!for!the!Study!of!Diabetes!(EASD),!the!American!Diabetes!Association!(ADA),!the!American! Association!of!Clinical!Endocrinologists!and!the!American!College!of!Endocrinology.
The!GetGoal!Phase!III!clinical!program!provides!data!for!lixisenatide!in!adults!with!Type!2!diabetes!treated!in! monotherapy,!with!various!oral!antiJdiabetic!agents!or!in!combination!with!basal!insulin.!The!GetGoal!program! started!in!May!2008!and!has!to!date!enrolled!more!than!4,500!patients.!So!far!topJline!results!have!been!reported! for!the!GetGoalJX,!GetGoalJL,!GetGoalJL!Asia,!GetGoalJMono,!GetGoalJS!and!GetGoalJF1!studies,!all!supporting! potential!efficacy!and!safety!for!lixisenatide.!Further!Phase!III!results!are!expected!in!2011!and!2012.
Zealand!Pharma!A/S!is!a!public!(NASDAQ!OMX:!ZEAL)!biopharmaceutical!company!based!in!Copenhagen,!Denmark! with!a!mature!and!growing!clinical!pipeline!of!innovative!peptide!based!drugs.!The!company's!lead!product!is! lixisenatide!(Lyxumia®!1)),!a!onceJdaily!GLPJ1!agonist!for!the!treatment!of!Type!2!diabetes,!discovered!by!Zealand! Pharma!and!licensed!to!Sanofi.!In!November,!Sanofi!filed!for!marketing!authorization!for!lixisenatide!(Lyxumia®) in! Europe.!Submission!for!regulatory!approval!of!lixisenatide!in!the!U.S.!is!expected!in!Q4!2012.!Zealand!Pharma!also! has!a!collaboration!with!Boehringer!Ingelheim!covering!glucagon/GLPJ1!dual!agonists,!including!ZP2929!for!the! treatment!of!diabetes!and!obesity,!and!a!license!agreement!with!Helsinn!Healthcare!on!elsiglutide,!a!clinical!stage! GLPJ2!drug!for!the!treatment!of!chemotherapyJ!and!radiotherapyJ!induced!diarrhea.
Zealand!Pharma!specializes!in!the!discovery,!optimization!and!development!of!novel!peptide!drugs,!and!all!drug! candidates!in!its!pipeline!have!been!identified!through!the!company's!own!drug!discovery!activities.!Zealand! Pharma's!products!target!disease!areas!where!existing!treatments!fail!to!adequately!serve!patient!needs!and! where!the!market!potential!for!improved!treatments!through!the!use!of!peptide!drugs!is!high.!For!further! information:!www.zealandpharma.com.
Note!1)!Lyxumia®!is!the!intended!trademark!for!lixisenatide
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