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The Drama Is Over For Ariad Phamaceuticals’ Orphan Drug Iclusig (Ponatinib)

December 17, 2012

On December 14, 2012, the FDA following priority review, gives Accelerated Approval of Ariad Pharmaceuticals’ orphan drug Iclusig (Ponatinib) for the treatment of Chronic Myeloid Leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic Leukemia (Ph+ALL).  The approval comes more than 3 months before the FDA PDUFA date of March 27, 2013. The approval provides CML patients with another option if they are not responding to other drugs.

Per the New York Times article, analysts did not expect Iclusig’s label to contain a black boxed warning about the side effects of blood clots and liver toxicity. As a result of this, Ariad Pharmaceuticals’ shares sank 21% on December 14, 2012.

Facts about Iclusig

  1. Ariad Pharmaceuticals 1st drug to reach the market
  2. Tablet taken once a day
  3. Wholesale price of approximately $115,000/year/patient – 15% higher than drug’s competitors
  4. Per Ariad’s Chief Executive, the expected annual sales is to reach $600 – $800 by 2017 – 2018
  5. < 5 years to bring drug from start of clinical development to FDA approval
  6. Approval comes more than 3 months before the FDA PDUFA date of March 27, 2013
  7. Expected to be available within about 2 weeks to patients through select specialty pharmacies
  8. Establishment of ARIAD PASS (Patient Access and Support Services).

Iclusig’s Orphan Drug Competitors Approved Of By The FDA In 2012 :

  1. Pfizer’s orphan drug Bosulif (Bosutinib) for CML
  2. Teva Pharmaceutical’s orphan drug Synribo (Omacetaxine Mepesuccinate) for CML
  3. Talon Therapeutics’ orphan drug Marqibo for Ph+ALL.


Ariad Pharmaceuticals December 14, 2012 News Release

Ariad Pharmaceuticals Pipeline December 14, 2012 article titled, “Ariad sinks on safety warnings with US drug approval”

FDA December 14, 2012 News Release

New York Times Business December 14, 2012 article titled, “FDA gives early approval to drug for rare leukemia”

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

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