Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 972

Opposition re #856 MOTION in Limine No. 13: Exclude Evidence and Argument Regarding Roche's FDA Filings and Communications Withheld Throughout Fact Discovery filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A)(Toms, Keith)

Case 1:05-cv-12237-WGY

Document 972-2

Filed 09/03/2007

Page 1 of 2

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN INC. Plaintiff, v. F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GmbH, and HOFFMANN-LA ROCHE INC. Defendants. ) ) ) ) ) ) ) CIVIL ACTION No.: 05-CV-12237WGY ) ) ) ) ) )

Exhibit A

DECLARATION OF KRISHNAN VISWANADHAN IN SUPPORT OF ROCHE'S OPPOSITION TO AMGEN'S MOTION IN LIMINE TO EXCLUDE EVIDENCE AND ARGUMENT REGARDING ROCHE'S FDA FILINGS AND COMMUNICATIONS THAT IT WITHHELD THROUGHOUT FACT DISCOVERY I, Krishnan Viswanadhan, declare as follows: 1. I am the Director of Drug Regulatory Affairs at Hoffmann-La Roche Inc.

("Roche"). I have been an employee of Roche since 2002. My educational background includes a B.S. in pharmacy and a Pharm.D. from Rutgers University. My duties include acting as a contact with the Food and Drug Administration (the "FDA") regarding the review of Roche's Biologics License Application ("BLA") for MIRCERA and the Investigational New Drug Applications ("IND") in Renal Anemia. 2. information. 3. I have been asked to provide information regarding: (a) Safety Update: September I make this declaration based upon my own personal knowledge and company

1, 2006 Clinical Cutoff; (b) Cardiac Adjudication Report; and (c) Special Safety Report for MIRCERA. 1

Case 1:05-cv-12237-WGY

Document 972-2

Filed 09/03/2007

Page 2 of 2

4.

Each of the above referenced documents includes interim data from two clinical

studies that are presently ongoing. I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed this 29th day of August 2007 at Basel, Switzerland. /s/_ Krishnan Viswanadhan______ Krishnan Viswanadhan CERTIFICATE OF SERVICE I hereby certify that this document filed through the ECF system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF) and will be delivered to Amgen's trial counsel by electronic mail in the manner requested in the August 29, 2007, letter of Renee DuBord Brown to Thomas F. Fleming. Paper copies will be sent to those indicated as non registered participants on September 4, 2007. /s/ Keith E. Toms Keith E. Toms
03099/00501 731027.1

2