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Exelixis, Orphan Drug Cometriq, And The J.P. Morgan Healthcare Conference

January 11, 2013

On Wednesday, January 9, 2013, 2:00 PM PST/5:00 PM EST, Exelixis gives a presentation at the J.P. Morgan Healthcare Conference in San Francisco. The presentation is given by Exelixis’ President & CEO, Michael Morrissey.

Here are a few highlights from the presentation for the launch of orphan drug Cometriq (Cabozantinib) for the treatment of Medullary Thyroid Cancer (MTC) :

1) Commercial launch of newly approved Cometriq :

– FDA approval in November 2012 for treatment of MTC

– Boxed warning for GI & non-GI perforations and fistulas, and hemorrhage

– Commercial manufacturing & distribution in place

– 3 dosing strengths for daily dosing

– Flat pricing of $9,900/28-day supply or approximately $118,800/patient/year

– Provides reimbursement support

– 5 sales representatives across US

– Estimation of 500 – 700 MTC eligible patients in US

2) Additional indications are being pursued to build the Cometriq franchise:

– Advance COMET trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

– Initiate pivotal trials for Renal Cell Carcinoma (RCC) & Hepatocellular Carcinoma (HCC).

FDA Historical Events For Cometriq

1) Receives FDA Orphan Drug Designation (ODD) on November 29, 2010

2) Submits Rolling New Drug Application (NDA) in May 2012

3) Receives FDA Priority Review on July 30, 2012 and assigning of November 29, 2012, for the PDUFA date

4) Removal from FDA Oncologic Drug Advisory Committee (ODAC) Meeting scheduled for November 8 – 9, 2012, on August 29, 2012

5) Approval on PDUFA date of November 29, 2012.

Exelixis on November 29, 2012 , announces that the European Medicines Agency (EMA) accepts for review the Marketing Authorization Application (MAA) for Cometriq for MTC.

References January 9, 2013 article titled, “Exelixis’ CEO Presents at JP Morgan 31st Annual Healthcare Conference (Transcript)” December 4, 2012 article titled, “Exelixis’s Promising Pipeline Of Drugs”

Cabozantinib Clinical Trial Information

Cometriq Website Video titled, “Dr. Ezra Cohen Discusses The Cabozantinib EXAM Trial”

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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