"""" 0
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Astelin Day
`Life Cycle Plan
`November 1, 2002
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX01871176
`
`WOYJCI)jJ!lSl!q!4Xd
`
`- 1-
`U) m ·~
`LL. -
`... ,
`0
`LL. ::I:
`i= ><
`0
`z w
`><
`T""
`:3 <( 1-
`-
`....1
`a..
`a.. 0::
`1-
`
`1
`
`CIP2054
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Astelin Day
`Life Cycle Plan
`November 1, 2002
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX01871176
`
`WOYJCI)jJ!lSl!q!4Xd
`
`- 1-
`U) m ·~
`LL. -
`... ,
`0
`LL. ::I:
`i= ><
`0
`z w
`><
`T""
`:3 <( 1-
`-
`....1
`a..
`a.. 0::
`1-
`
`1
`
`CIP2054
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`Agenda
`
`1) Review of Detailed
`Proposals and Discussion
`
`45 Min.
`
`2) Breakout Session Instruction
`
`3) Breakout
`What else do we want?
`Supply source/packaging?
`Trademarks/specifications?
`Studies directed specifically
`toward target messages?
`
`60 Min.
`
`4) Reconvene and Report Back
`
`30 Min.
`
`5) Prioritize and Next Steps
`
`30 Min.
`
`N
`0
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-a.
`
`R. Spivey/
`D. Fink
`
`D. Fink
`
`All
`
`D. Fink/
`R. Spivey
`
`D. Fink/
`R. Spivey
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`2
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871177
`
`2
`
`
`
`M
`0
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`AstelirP
`
`Projects
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`3
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871178
`
`3
`
`
`
`-.::t
`0
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Packaging Configuration Projects
`
`• Pediatric packaging
`
`• V-Bottom bottle/ cap configuration - trade
`(30.0 ml)
`
`• V-Bottom bottle/pump configuration- trade
`(30.0 ml)
`
`• V-Bottom bottle- sample (5 ml)
`
`• Calmar- Albert pump
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`4
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871179
`
`4
`
`
`
`II)
`0
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Pediatric Packaging
`
`• Single 17 ml flat-bottom bottle
`
`• Current VP3 Valois pump
`
`• Straight-forward; high probability of success
`
`• Timing influenced by whether ''value added''
`materials are included
`
`• Cost is minimal
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`5
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871180
`
`5
`
`
`
`CD
`0
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`V-Bottom Bottle/Cap Configuration- Trade
`[~l!IJJ~l
`
`• Back-up strategy for ''pump on'' plan for new
`V-bottom bottle
`
`• High likelihood of success
`
`• Requires development of data, submission,
`and approval by FDA
`
`• Available in 18 - 24 months
`
`• Cost is relatively small
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`6
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871181
`
`6
`
`
`
`.......
`0
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`V-Bottom Bottle/Pump Configuration -
`Trade (.lflm~l
`
`• Current, planned configuration for new V(cid:173)
`bottom bottle
`
`• Requires additional engineering efforts to
`periect pump placement
`
`• In addition, particulates may be an issue
`
`• Available in 6 - 9 months
`
`• Cost is estimated at $350 - 400k
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`7
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871182
`
`7
`
`
`
`00
`0
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`V-Bottom Bottle -Sample (5 mL}
`
`• Already approved by FDA
`
`• Issues similar to 30 ml V-bottom bottle
`
`• Available in 6 - 9 months
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`8
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871183
`
`8
`
`
`
`0')
`0
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Colman- Albert Pump
`
`• Qualification of back-up pump supplier
`
`• Moderate likelihood of success
`
`• Available in 18 - 24 months
`
`• Cost is approximately $2.5 million
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`9
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871184
`
`9
`
`
`
`0
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Formulations Projects
`
`• Astelin/ steroid combination
`
`• Taste masking- meet current
`specifications
`
`• New optimized formulation
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`10
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871185
`
`10
`
`
`
`""""
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Astelin/Steroid Combination
`
`• High degree of technical difficulty
`
`• Need to reconcile combination of
`sol uti on I suspension
`
`• Dosing differences
`
`• 4- 5 years to develop; $75 million
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`11
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871186
`
`11
`
`
`
`N
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Taste Masking- Meet Current
`
`• Multiple attempts made but all altered
`specifications
`
`• No feasibility to make modifications
`without extensive product
`characterization and some clinical trials
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`12
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871187
`
`12
`
`
`
`M
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`New Optimized Formulation
`
`• To improve taste and optimize dosing
`
`• Need to assemble taste panels to
`determine success
`
`• 3-4 years in development
`
`• Would likely cost $4.5 million
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`13
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871188
`
`13
`
`
`
`-.::t
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Clinical Programs
`
`• One spray per nostril bid (supplemental NDA)
`
`• Perennial allergic rhinitis (supplemental NDA)
`
`• Protocol 415 (follow-on to Protocol 414
`Claritin failure trial)
`
`• SAR and asthma
`
`• Somnolence/ cognitive function studies
`
`• Nasal polyps (pilot study)
`
`• Pediatric labeling (children 2 to 4 years of age)
`
`• Non-allergic asthma (NIH study)
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`14
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871189
`
`14
`
`
`
`II)
`
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`One Spray BID
`
`• New dosage regimen (current formulation)
`
`• At least 2 trials
`
`• Cost is approximately $2.5 - $3 million
`
`• New labeling by 2005
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`15
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871190
`
`15
`
`
`
`CD
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Perennial Allergic Rhinitis
`
`• New indication
`
`• High feasibility; moderate to high
`likelihood of success
`
`• Available mid-2005
`
`• Cost is approximately $3 million
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`16
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871191
`
`16
`
`
`
`.......
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Follow-up to 414
`
`• Follow-up to Claritin failure trial
`
`• Could duplicate study 414 or study different
`antihistamine (Allergen or Zyrtec)
`
`• Study completed mid-2003
`
`• Cost is approximately $2 million
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`17
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871192
`
`17
`
`
`
`()()
`
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`SAR and Asthma
`
`• Effect of Astelin on SAR symptoms in
`patients with both asthma and SAR.
`Evaluate if any impact on asthma
`symptoms •
`
`• Low-to-moderate likelihood of success
`
`• Cost is approximately $1 million
`
`• Publication available in 2004
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`18
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871193
`
`18
`
`
`
`0')
`
`"""" 0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Somnolence/ Cognitive Function Studies
`
`• Provide data for PI in Clinical Pharmacology
`section on sleep latency and/or cognitive
`function
`
`• Two studies, total of $600K
`
`• Submission in 2004, label change by end of
`2004
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`19
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871194
`
`19
`
`
`
`0
`N
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Nasal Polyps (Pilot Study)
`
`• Evaluate effect of Astelin on nasal polyps
`
`• Depends on anti-inflammatory effect
`
`• Cost is approximately $850K
`
`• Outcome is publication
`
`• Low likelihood of success
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`20
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871195
`
`20
`
`
`
`"""" N
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Pediatric Labeling (2- 4 years)
`
`• Formally requested by FDA
`
`• Lengthy enrollment process (over 2 allergy
`seasons)
`
`• Cost is approximately $700K
`
`• Could result in 6 months of exclusivity
`
`• Submit to FDA by 2005
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`21
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871196
`
`21
`
`
`
`N
`N
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Non-allergic Asthma (NIH funded)
`
`• Investigator is Dr. Jonathan Bernstein
`
`• Low-to-moderate likelihood of success
`
`• Drug supplier only (already committed)
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`22
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871197
`
`22
`
`
`
`M
`N
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Preclinical Program
`
`• Otitis media (animal model)
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`23
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871198
`
`23
`
`
`
`-.::t
`N
`0
`0
`0
`I
`II)
`0
`0
`
`"""" >< I-
`
`C..
`
`Otitis Media
`
`• Effects of antihistamine on middle ear
`effusion
`
`• Study to be conducted in rats
`
`• Publication
`
`• Drug supplier committed
`
`~neci-IJol~le
`
`/:::=::::,,::;·_;::;:·-;::,;:·~:=:.--:~· ·=· ·:·::·~· ~· :~ /:·~ .: i·=·: 'tx A::;::::~::t:·:t:~:;::;::-=··
`
`24
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`September 2fi
`/01'1
`
`MEDA_APTX01871199
`
`24
`
`
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