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Vertex Pharmaceuticals, Orphan Drug Kalydeco, And 2012 Financial Results

January 29, 2013

On Tuesday, January 29, 2013, Vertex Pharmaceuticals has a conference call to report 4th Quarter and year end 2012 financial results, and updates on development programs.

Here are a few highlights from the conference call for Kalydeco (Ivacaftor) for the treatment of Cystic Fibrosis (CF) :

–  Net product revenue of $171.6 million for Kalydeco for 2012

–  Sales rose from $49 million in the 3rd Quarter to $58.5 million in the 4th Quarter 2012 as the drug is launched in several European markets (sales growth is constrained by the fact that Kalydeco only currently treats approximately 4% of CF patients – those with the G551D mutation)

–  Forecast of Kalydeco sales in 2013 of $280 – $320 million

–  On January 6, 2013, at the J.P. Morgan Healthcare Conference, Vertex Pharmaceuticals provided a detailed update on the status of the CF Development Program

–  Additional updates to the CF Development Program for the combination therapy of VX-809 + Ivacaftor for CF patients with 2 copies of the F508del Mutation (which will be aimed at a far greater portion of CF patients) :

  1. Receives FDA Breakthrough Therapy Designation
  2. Completion of an end-of-Phase 2 meeting with FDA
  3. Submission to FDA of a proposed design for a pivotal Phase 3 program for the combination therapy which is expected to begin in the 1st Quarter 2013, pending regulatory approval.

References

CNBC.com article titled, “Vertex pposts loss as hepatitis C drug sales plunge”

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

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