ARIAD Pharmaceuticals, Inc. (ARIA) and Gen Ilac, a leading Turkish pharmaceutical company focused on the supply of orphan drugs for the treatments of rare diseases, today announced that ARIAD has granted Gen Ilac exclusive rights to distribute Iclusig® (ponatinib) in Turkey for patients with Philadelphia-positive leukemias.
Gen Ilac was granted the exclusive right to sell Iclusig as an investigational product in Turkey on a named-patient basis and will provide associated medical affairs and regulatory support. ARIAD retains the option to file for marketing authorization at a later date and, if approved, to hold the Marketing Authorization for Iclusig in Turkey. Gen Ilac has the exclusive right then to market and commercialize the product upon approval.
“This agreement with Gen Ilac furthers our mission to provide Iclusig to patients in geographies beyond our core commercial footprint,” said Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. “We are excited by Gen Ilac’s experience and proven capabilities in this area, which makes them an ideal partner to introduce Iclusig to patients and physicians in Turkey.”
“We are excited by our partnership with ARIAD and the hope it provides to refractory CML patients in Turkey,” said Abidin Gulmus, chief executive officer of GEN ILAC. “This partnership aligns well with our company mission and our expertise in providing treatments in the field of hematology.”
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.
About Gen Ilac
GEN ILAC A.C, is a leading specialty pharmaceutical company headquartered in Ankara, Turkey. Gen Ilac represents innovative pharmaceutical and biotechnology companies, serving the medical community and patients in specific therapeutic areas of neurology, oncology, hematology and endocrinology. Gen Ilac has long-term collaborations with a number of international companies, including Biogen, Ipsen, PTC, Orphan Europe and others. Gen Ilac is taking a leading role in Turkey bringing novel treatment options to patients with difficult-to-treat or rare conditions.
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visithttp://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc. in the U.S. and is trademarked in Turkey.
This press release contains forward-looking statements, each of which are qualified in their entirety by this cautionary statement. Any statements contained herein which do not describe historical facts, including, but not limited to, statements regarding: our mission to provide access to Iclusig in geographies outside of our core commercial footprint; our partnership with Gen Ilac; and the therapeutic potential of Iclusig, are forward-looking statements that are based on management’s expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, but are not limited to ARIAD’s ability to manufacture and supply Iclusig to Gen Ilac; the ability of Gen Ilac to perform the contracted services; our ability to obtain regulatory, pricing and reimbursement approval for Iclusig in Turkey, including as a result of regulatory developments and the level of any such pricing and reimbursement approvals; safety issues related to Iclusig; Gen Ilac’s ability to successfully distribute, market, promote and sell Iclusig in Turkey; the timing and scope of any marketing authorization for Iclusig in Turkey; third-party reimbursement; the timing and success of sales of Iclusig in Turkey; the costs associated with ARIAD’s development and manufacturing, commercial and other activities; the adequacy of our capital resources and the availability of additional funding; and those additional factors detailed in ARIAD’s public filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.