ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Angelini Pharma, through the Austrian subsidiary CSC Pharmaceuticals, today announced that ARIAD has granted Angelini exclusive rights to commercialize Iclusig ® (ponatinib) for the indications approved by the European Medicine Agency (EMA) in Central and Eastern Europe. These countries include Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia. With this distributorship in place, Iclusig will be available to patients with resistant and intolerant Philadelphia-positive leukemias in more than 23 countries in Europe. Under the terms of the agreement, ARIAD will remain the Marketing Authorization Holder of Iclusig, and ARIAD will manage this distributorship out of its European headquarters in Lausanne, Switzerland. Angelini will be responsible for sales and marketing, medical affairs, regulatory and reimbursement support. Angelini will book sales of Iclusig while ARIAD will supply packaged drug to Angelini. An upfront payment to ARIAD and milestones associated with commercial launches will total approximately $7.3 million. Additionally, Angelini will provide ARIAD with a substantial share of Iclusig sales in the region. "With this agreement, we continue to move towards having Iclusig available to patients in geographies outside of our own commercial footprint," said Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. "Angelini will be an important partner for us in this region where, according to the EMA, there are approximately 8,000 patients living with chronic myeloid leukemia (CML) who may become resistant or intolerant to other approved tyrosine kinase inhibitors. Angelini has the experience and geographic reach to market and distribute Iclusig in Central and Eastern Europe." ARIAD received Marketing Authorization Approval for Iclusig from the European Medicine Agency in July 2013. The commercial launches of Iclusig in these Central and Eastern European countries are expected to begin in 2015. "By partnering with ARIAD, we will be able to provide this important cancer medicine to patients in Central and Eastern Europe who have difficult-to-treat CML or Ph+ ALL and few options available to them," said Gianluigi Frozzi, CEO of Angelini Pharma Division. "We look forward to a successful collaboration with ARIAD and to making Iclusig available to refractory CML and Ph+ ALL patients."
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. About Angelini Angelini is a privately-held, mid-sized international manufacturer and marketer of pharmaceutical and healthcare products in the pharmaceutical and mass-market sectors. Founded in Italy in 1919, the group employs about 4,000 people. The pharmaceutical sector is the core business of the group, representing over 50% of the company's €1.4 billion 2013 revenue. Angelini has branches in Italy, Spain, Austria, Portugal, Poland, Czech Republic, Slovak Republic, Hungary, Romania, Bulgaria, Slovenia, Croatia, Greece, Turkey, Russia, USA, Pakistan; its products are available in over 60 countries through an extensive network of licensees and strategic agreements with local pharmaceutical companies. At an international level, the company focuses mainly on pain relief, inflammation, CNS, anti-infectives, gynecology and has a strong position in the OTC market. The R&D department is currently focused on pain/inflammation, CNS and infectious diseases areas. In the latter, R&D is active with program in discovery, including private-public projects with New Chemical Entities, as well as clinical programs with already marketed products fully developed in Europe by Angelini. Angelini also operates in Personal Care and Machinery sectors, in joint venture with Procter & Gamble, and in Perfumery and Winegrowing. About ARIAD 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). 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 Angelini with Iclusig; the ability of Angelini to perform the contracted services, such as obtaining pricing and reimbursement approval for Iclusig in central and eastern European countries; Angelini's ability to distribute, promote, market and sell Iclusig in those countries; the reimbursed price levels obtained; the use of Iclusig for patients under named patient access schemes in those countries; and the timing and success of sales of Iclusig in those countries. 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.