`
`·~~.
`+.t ..... ~.t<ll!
`
`~~~ © ~ 0 f!J ~ ~
`w OEC 2 3 2004 w
`
`B
`t:'l.;Y;::;:;::;:::::=::::.::::=::=:l
`-
`
`PlND 69.852
`
`B iogen Idee
`Attention: Nadine D. Cohen, Ph.D.
`Senior Vice President,-Regulatory Affairs
`14 Cambridge Center
`·
`Cambridge, MA 02142
`
`Public Health Servipe
`
`Food. and Drug AdiT)inistration.
`Rockville, MD ,20857 ·
`
`Please r.e.fer to your Pre-Inv~stig.atiQnal New Qrug Application (PIND) file for BGOOO-I 2 for
`psoriasis.
`
`We also refer-to the meeting ·betvv.een repre-sentativ-es of your firm and the FDA ori November 23.
`2004. The purpose of the meeting w~s to di.scuss the pre-clinical and early c}jnieal pJans.
`
`The official mi.hutes of that meeting are enclosed. You are responsible· for notifying us of any
`significant differences in. understan.ding r~garding the me~ting outcomes.
`
`lfyou hav-e ~ny !{ue~ious,-pl~ase contact Frank C:ross, Regul~tory Project Manager, at (301)
`827-2020.
`'
`
`Sincerely,
`
`{Se~ appended electronic signaJUr i! page/
`
`Jon&than Willdn, M.D.
`Division Dir~ctor
`Division ofDermatologic and Dental Drug
`Products
`OfficeofDrug Evaluation V
`Center for Drug Evaluation and Research_
`
`Enclosure
`
`Page 1 of16
`
`Biogeo Exhibit 2290
`Coalition v. Biogeo
`IPR2015-01993
`
`
`
`Time: 9:30 a.m.
`
`Location: 8300
`
`PIND 69,852 11/23/04 mcetmg
`
`Meeting Date: November 23, 2004
`Meeting 10# 14024
`
`BGOOOI2
`
`Indication: Treatment of psoriasis
`
`Sponsor: Biogen Idee
`
`Pre-IND Meeting
`
`Meeting Chair: Jonathan K. Wilkin, M.D.
`
`Meeting Recorder (CSO/Projcct Manager): Frank H. Cross, Jr., M.A., CDR
`
`FDA Attendees, titles and offices:
`
`Jonathan K. Wilkin, M.D., Division Director, DDDDP, HFD-540
`Jonca Bull, M.D., Office Director, ODEV, HFD-105
`Ramesh Sood, Ph.D .. Chenlistry Team Leader, DNDCHI, HFD-830
`Norman See, Ph.D., Pharmacologyffoxicology Reviewer, DDDDP, HFD-540
`Raman Bnweja, Ph.D., Clinical PharmacologyiBiopharmaceutics Team Leader, DPEIII, HFD-880
`Lei Zhang, Ph.D., Clinical Pharmacology/Biopharmaceulics Reviewer, DPEIII. HFD-880
`Markham Luke, M.D., Ph.D., Clinical Team Leader, DDDDP, HFD-540
`Denise Cook, M.D., \-ledical Officer, DDDDP, HFD-540
`Joseph Porres, M .D ., PhD ., Medical Officer, DDDDP, HFD-540
`Mohamed Alosh, Ph.D., Biostatistics Team Leader, DBIU, HFD-725
`Matt Soukup, Ph.D,, Biostatistics .Reviewer, DB III, HFD-725
`Frank H. Cross, M.A., CDR, Senio.r Regulatory Management Officer, DDDDP, HFD-540
`
`Sponsor Attendees, titles and offices:
`
`2
`
`Page 2 of16
`
`
`
`FIND 69:85E 1.1.32;
`inccting
`PJN.D 69,852 11/23/04 meeting
`
`
`
`3
`
`Page 3 of16
`Page 3 of 16
`
`
`
`
`
`Page 4 of16
`
`Page 4 of 16Page 4 of 16
`
`
`
`
`
`
`
`Page 5 of 16Page 5 of 16
`
`Page 5 of 16
`
`
`
`
`
`
`
`Page 6 of 16Page 6 of 16
`
`Page 6 of 16
`
`
`
`
`
`
`
`Page 7 of 16Page 7 of 16
`
`Page 7 of 16
`
`
`
`
`
`
`
`Page 8 of 16Page 8 of 16
`
`Page 8 of 16
`
`
`
`
`
`
`
`Page 9 of 16Page 9 of 16
`
`Page 9 of 16
`
`
`
`
`
`
`
`Page 10 of 16Page 10 of 16
`
`Page 10 of 16
`
`
`
`
`
`
`
`Page 11 of 16Page 11 of 16
`
`Page 11 of 16
`
`
`
`PIND69,852 11/23(()4 .m~eting
`
`Sponsor's Question 9 from 0C;tobei' 21 , 2004, Brieii:ng Package: ·~noes the FDA agree that
`~x.posu~e at 240 mgiid provides the supportive d~tuequir:ed to. register the 240 mg"bid dpse?"
`
`Agency:
`
`If the sponsor is referring to safety data, certainly safety data collected at the higher dose can be
`extrapolateddoVYnwardto a lower dose. However, the same canno~ ~e said for .efficacy. In order
`to. get approval' for the higher .do;;e (24.0 mg·tid.), there must he significant efficacy demonstrated
`over the lower dose (240 mg bid) without an adverse effect on safety. The spollSor ts referred ·to
`the lCH E4 guidance.
`
`Page 12 of16
`
`
`
`
`
`
`
`Page 13 of 16Page 13 0f 16
`
`Page 13 of 16
`
`
`
`
`
`
`
`Page 14 of 16Page 14 0f 16
`
`Page 14 of 16
`
`
`
`
`
`
`
`Page 15 of 16Page 15 0f 16
`
`Page 15 of 16
`
`
`
`
`
`
`
`Page 16 of 16Page 16 of 16
`
`Page 16 of 16
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
