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news.ARIAD Pharmaceuticals has completed the sale of its European operations to Incyte and entered into the previously announced license agreement for Incyte to exclusively license Iclusig (ponatinib) in Europe and other select countries.
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ARIAD transferred all rights to its EU operations to Incyte, which has acquired all shares of ARIAD Pharmaceuticals (Luxembourg) S.a.r.l., the parent company of ARIAD’s European subsidiaries responsible for the commercialization of Iclusig in the licensed territory, for a payment to ARIAD at the closing of approximately $140 million (subject to customary post-closing adjustments).
In addition, Incyte has now been granted an exclusive license to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.
"With the closing of this transaction, we have completed a key outcome from our strategic review," stated Paris Panayiotopoulos, president and chief executive officer of ARIAD.
"This agreement puts ARIAD in a strong financial position. It will allow us to focus our resources on our promising R&D initiatives and our efforts to achieve the full commercial potential of Iclusig and brigatinib, if approved, in the highly valuable U.S. market, while also maintaining future strategic flexibility through the buy-back provision for the licensed Iclusig rights."
In connection with the closing of the Incyte transaction, the previously disclosed amendments to ARIAD’s royalty financing agreement with PDL BioPharma, Inc. (PDL), entered into on May 9, 2016, became effective.
ARIAD and PDL agreed to amend the agreement to, among other things, include net sales of Iclusig made by Incyte in the calculation of net sales under the PDL agreement and to restructure ARIAD’s option to receive additional funding so that ARIAD may require PDL to fund up to an additional $40 million (instead of the original $100 million) in July 2017, rather than between January and July 2016.
Baker & McKenzie LLP represented ARIAD in the Incyte transaction, and Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. represented ARIAD in the PDL transaction.
About Iclusig (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.
Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.
In the U.S., Iclusig is a kinase inhibitor indicated for the:
Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.