( 12 ) United States Patent
`Comiskey et al .
`
`( 10 ) Patent No . :
`( 45 ) Date of Patent :
`
`US 9 , 919 , 024 B2
`* Mar . 20 , 2018
`
`US009919024B2
`
`( 72 )
`
`( * ) Notice :
`
`( 54 ) FORMULATIONS OF GUANYLATE
`CYCLASE C AGONISTS AND METHODS OF
`USE
`( 71 ) Applicant : SYNERGY PHARMACEUTICALS ,
`INC . , New York , NY ( US )
`Inventors : Stephen Comiskey , Doylestown , PA
`( US ) ; Rong Feng , Langhorne , PA ( US ) ;
`John Foss , Doylestown , PA ( US ) ;
`Kunwar Shailubhai , Audubon , PA
`( US )
`( 73 ) Assignee : SYNERGY PHARMACEUTICALS ,
`INC . , New York , NY ( US )
`Subject to any disclaimer , the term of this
`patent is extended or adjusted under 35
`U . S . C . 154 ( b ) by 0 days .
`This patent is subject to a terminal dis
`claimer .
`( 21 ) Appl . No . : 15 / 467 , 648
`( 22 ) Filed :
`Mar . 23 , 2017
`Prior Publication Data
`( 65 )
`US 2017 / 0202904 Al Jul . 20 , 2017
`Related U . S . Application Data
`( 63 ) Continuation of application No . 14 / 845 , 644 , filed on
`Sep . 4 , 2015 , now Pat . No . 9 , 610 , 321 , which is a
`continuation of application No . 14 / 661 , 299 , filed on
`Mar . 18 , 2015 , now abandoned , which is
`a
`continuation of application No . 13 / 421 , 769 , filed on
`Mar . 15 , 2012 , now Pat . No . 9 , 616 , 097 , which is a
`continuation - in - part
`of
`application
`No .
`PCT / US2011 / 051805 , filed on Sep . 15 , 2011 .
`( 60 ) Provisional application No . 61 / 383 , 156 , filed on Sep .
`15 , 2010 , provisional application No . 61 / 387 , 636 ,
`filed on Sep . 29 , 2010 , provisional application No .
`61 / 392 , 186 , filed on Oct . 12 , 2010 .
`Int . Cl .
`A61K 38 / 10
`A61K 4738
`A61K 47 / 12
`A61K 45 / 06
`A61K 9 / 00
`CO7K 7 / 08
`CO7K 7 / 64
`A61K 9 / 16
`A61K 9 / 48
`U . S . CI .
`???
`
`( 51 )
`
`( 52 )
`
`( 2006 . 01 )
`( 2006 . 01 )
`( 2006 . 01 )
`( 2006 . 01 )
`( 2006 . 01 )
`( 2006 . 01 )
`( 2006 . 01 )
`( 2006 . 01 )
`( 2006 . 01 )
`. . . A61K 38 / 10 ( 2013 . 01 ) ; A61K 9 / 0053
`( 2013 . 01 ) ; A61K 9 / 1623 ( 2013 . 01 ) ; A61K
`9 / 1652 ( 2013 . 01 ) ; A61K 9 / 1676 ( 2013 . 01 ) ;
`A61K 9 / 4858 ( 2013 . 01 ) ; A61K 9 / 4866
`( 2013 . 01 ) ; A61K 45 / 06 ( 2013 . 01 ) ; A61K 47 / 12
`( 2013 . 01 ) ; A61K 47 / 38 ( 2013 . 01 ) ; CO7K 7 / 08
`( 2013 . 01 ) ; CO7K 7 / 64 ( 2013 . 01 )
`
`25
`
`( 58 )
`
`( 56 )
`
`Field of Classification Search
`None
`See application file for complete search history .
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`Primary Examiner — Satyanarayana R Gudibande
`Assistant Examiner — Jia - Hai Lee
`( 74 ) Attorney , Agent , or Firm — Cynthia A . Kozakiewicz ;
`Ivor Elrifi
`( 57 )
`ABSTRACT
`The invention provides low - dose formulations of guanylate
`cyclase - C ( “ GCC " ) agonist peptides and methods for their
`use . The formulations of the invention can be administered
`either alone or in combination with one or more additional
`therapeutic agents , preferably an inhibitor of cGMP - depen
`dent phosphodiesterase or a laxative .
`16 Claims , 6 Drawing Sheets
`
`MYLAN - EXHIBIT 1001
`
`

`

`US 9 , 919 , 024 B2
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