`
`October 21, 2004
`
`Jonathan K. W ilkin, M.D.
`Division Director
`,Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Dermatologic & Dental Drug Products, HFD-540
`9201 Corporate Blvd.
`Rockville, MD 20850
`
`Attn: Ms. Sandy Childs
`
`RE: BG00012 Type B Meeting Briefing Document
`
`Dear Ms. Childs,
`
`Reference is made to the Type B meeting request submitted August 27, 2004, and to the
`meeting scheduled for November 23, 2004. In anticipation of the meeting and as
`requested in the facsimile from the Agency on September H. 2004, Biogen Idee is
`II
`II
`
`Should you have any questions regarding thi~ request, please contact • • • • • at
`(617) 679-6459 ..
`
`ent,
`Senior Vice
`Phone (617) 679-3783
`Fax (617) 679-31 70
`
`Biogen Idee 14 Cambridge Center Cambridge, MA 02142 Phone 6 17 679 2000 www.bio9enidec.com
`
`Page 1 of 15
`
`Biogen Exhibit 2288
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`1 INTRODUCTION ... : ......................... , ....................................... ; ............................................ 7
`2 PROPOSED AGENDA AT THE MEETING AND ATTENDANCE ............................... 10
`3 PROPOSED QUESTIONS AND ISSUES FOR DISCUSSION WITH THE
`AGENCY .............................................. ; .......................................... : ....................................... 11
`3.1 Non-clinical ......................... : .......................................................................... , ............. 11
`3.2 Clinical ...... , ................................................................................................................. 11
`
`63
`
`63
`
`Page 2 of 15
`
`
`
`TABLE OF CONTENTS
`
`63
`
`63
`
`Page 3 of 15
`
`
`
`TABLE OF CONTENTS
`
`63
`
`63
`
`Page 4 of 15
`
`
`
`TABLE OF TABLES
`
`Page
`
`63
`
`63
`
`Page 5 of 15
`
`
`
`TABLE OF TABLES
`
`63
`
`Page 6 of 15
`
`
`
`TABLE OF FIGURES
`TABLE OF FIGURES
`
`Page
`Page
`
`
`
`Page 7 of 15
`
`63
`
`63
`
`Page 7 of 15
`
`
`
`I
`
`.
`
`;
`
`. I
`
`!
`
`63
`
`63
`
`Page 8 of 15
`
`
`
`63
`
`63
`
`Page 9 of 15
`
`
`
`63
`
`63
`
`Page 10 of 15
`
`
`
`2
`
`PROPOSED AGENDA AT THE NEETING AND ATTENDANCE
`
`Table 2-1
`
`Agenda
`
`Table 2-2
`
`List of Attendees from Blogen Idee
`
`63
`
`63
`
`Page 11 of 15
`
`
`
`3
`
`PROPOSED QUESTIONS AND ISSUES FOR DISCUSSION WITH THE
`AGENCY
`
`3.1
`
`Non-clinical
`
`1.
`
`2.
`
`Does the FDA agree that preclinical studies already completed are sufficient to
`support the initiation of the proposed Phase 3 clinical trials?
`
`FDA agree to accept the NDA filing
`· based on a
`2-year rat carcinogenicity study and accept the 2-
`year mouse carcinogenicity study during review? NOTE: The mouse 2-year
`study is anticipated to be available 8 months after submission of the NDA.
`
`63
`
`63
`
`Page 12 of 15
`
`
`
`In addition to the specific questions regarding the proposed Phase 3 protocol, Biogen Idee
`is seeking the Agency's input O)l the following questions:
`
`6.
`
`Does the FDA agree that two additional Phase 3 studies, in addition to available
`Phase 1, Phase 2, and Phase 3 data, is sufficient to support registration of
`BG00012 drug product for 'the treatment of moderate to severe psoriasis'?
`
`63
`
`63
`
`63
`
`Page 13 of 15
`
`
`
`8.
`
`9.
`
`Does the FDA agree that the overall safety exposure, as provided in section 7, is
`sufficient to support registration ofBG00012 drug product?
`
`Does the FDA agree that exposure at 240 mg tid provides the supportive data
`required to register the 240 mg bid dose?
`
`63
`
`63
`
`Page 14 of 15
`
`
`
`4
`
`PROPOSED INDICATION
`
`The overall clinical development plan for BG00012 drug product as described in Section
`7.4 has been designed to provide support for the following indication:
`
`BG00012 drug product is indicatedfor the treatment of moderate to severe
`psoriasis.
`
`63
`
`63
`
`Page 15 of 15
`
`
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
