CAMBRIDGE, Mass. & PETACH TIKVA, Israel--(BUSINESS WIRE)--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Medison Pharma Ltd, Israel's leading international marketing group for innovative pharmaceuticals, today announced that ARIAD has granted Medison exclusive rights to commercialize Iclusig® (ponatinib) in Israel in patients with Philadelphia-positive (Ph+) leukemias.
Under the terms of the agreement, ARIAD Pharmaceuticals (Israel) Ltd will be the Marketing Authorization Holder (MAH) of Iclusig in Israel, and Medison will be responsible for sales and marketing, medical affairs, regulatory support, as well as obtaining, in collaboration with ARIAD, the pricing and reimbursement approval of Iclusig.
“The agreement with Medison illustrates our ongoing commitment to provide patients access to Iclusig in geographies outside of our core commercial footprint,” said Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. “Medison is uniquely qualified to provide the complete spectrum of integrated services for Iclusig in Israel, including a proven track record with oncology and hematology products.”
ARIAD has submitted its Marketing Authorization Application for Iclusig in Israel, which is currently under review with the Israel Ministry of Health. Marketing approval and commercial launch of Iclusig are expected to occur in the second half of 2015.
“We are very pleased with our new partnership with ARIAD. It is another step in fulfilling Medison’s continuing vision to provide innovative and unique treatments to patients in Israel,” said Meir Jakobsohn, Chief Executive Officer and Founder of Medison Pharma. “One of Medison's main focuses is providing treatments in the field of hematology. ARIAD’s treatment offers new hope for refractory CML patients.”
According to the EMA’s orphan drug designation and the HAEMACARE project, there are approximately 700 patients in Israel with CML.
“Iclusig is a very effective treatment option with utmost importance to CML or Ph+ALL patients who are resistant to dasatinib or nilotinib and for those patients with the T315I BCR-ABL mutation,” said Prof. Arnon Nagler, director of hematology at Sheba Medical Center. “It is of vital importance that Iclusig be available to the Israeli market.”
About Iclusig® (ponatinib)
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.
Medison is Israel’s leading marketing group, representing innovative niche healthcare products from companies such as Biogen Idec, Amgen, Shire and Ipsen. Medison has built and maintained long-standing relations with HMOs, local medical centers and physicians. Backed by three generations of experience in the healthcare industry since 1937, Medison is uniquely qualified to provide the complete spectrum of integrated services for international companies looking to enter or expand their presence in the Israeli. Medison has an office and is very also active in Romania. For more information, visit www.medisonpharma.com.
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, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc.
This press release contains “forward-looking statements” which are based on management's good-faith 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 the Company’s ability to manufacture, and supply Iclusig to Medison; the ability of Medison to perform the contracted services, such as obtaining pricing and reimbursement approval for Iclusig in Israel; Medison’s ability to distribute, promote, market and sell Iclusig in Israel; the timing and scope of the marketing authorization, as well as the level of pricing obtained in Israel; third-party reimbursement; and the timing and success of sales of Iclusig in Israel. These factors, risks and uncertainties also include, but are not limited to the costs associated with ARIAD’s development and manufacturing, commercial and other activities; the adequacy of capital resources and the availability of additional funding; and other factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. After the date of this document, the Company does not intend to update any of the forward-looking statements to conform to actual results or to changes in the Company's expectations, except as required by law.