ARIAD Pharmaceuticals, Inc. (ARIAD; NASDAQ:ARIA) today announced that it has completed two distribution agreements for Iclusig® (ponatinib) outside of the United States. In Latin America, ARIAD and Pint Pharma International S.A., a company focused on innovative treatments for patients in Latin America with cancer, rare diseases, and genetic disorders, have entered into an agreement for Pint Pharma to commercialize Iclusig in Argentina, Brazil, Chile, Colombia and Mexico. ARIAD has also entered into a separate agreement with Biologix FZCo., a leading distributor of specialty pharmaceuticals in the Middle East region, for Biologix to commercialize Iclusig in the Middle East and North Africa (MENA), including in Saudi Arabia, the Gulf Coast Countries, Lebanon, and selected other countries in the region.
“Our new distribution agreements for Latin America and the Middle East and North Africa markets demonstrate our commitment to bringing Iclusig to patients around the world who are in need of this important medicine for refractory CML and Ph+ ALL, while continuing to focus our commercial resources on the U.S. market,” stated Hugh Cole, chief business officer of ARIAD. “We believe that our new partners in these geographies have the local expertise and commitment to successfully commercialize Iclusig in their markets. In addition to providing a significant share of revenues from these regions, the agreements allow future strategic optionality for ARIAD by including provisions for the buy-back of these Iclusig rights by an acquirer of ARIAD in case of a change in control of ARIAD.”
Agreement with Pint Pharma
Pint Pharma has received exclusive rights to commercialize Iclusig following regulatory approval in Argentina, Brazil, Chile, Colombia and Mexico (the “Territory”), with the potential of adding other Latin American countries in the future. ARIAD and Pint have agreed to collaborate to submit marketing authorization approvals in the countries in the Territory. In addition, Pint has agreed to sell Iclusig as an investigational product on a named patient basis in certain countries in the territory where permitted prior to regulatory approval.
In exchange for these rights, ARIAD will receive upfront and potential regulatory milestone payments totaling $15 million. ARIAD will also receive more than 50 percent of net product sales in the Territory through a product supply transfer price.
“Over the past few years, we have focused on bringing important oncology and rare disease treatments to Latin American countries,” said David Muñoz, chief executive officer of Pint Pharma. “Together with ARIAD, we plan to work to secure regulatory and reimbursement approvals for Iclusig to be available to refractory Philadelphia-positive leukemia patients in need of new treatment options in the Territory.”
The terms of the distribution agreement include an option for an acquirer of ARIAD to buy-back the rights to Iclusig in the Territory following three years from the effective date of the distribution agreement by making specified payments.
Agreement with Biologix FZCo.
Biologix has received exclusive rights to commercialize Iclusig in Bahrain, the Kingdom of Saudi Arabia, Kuwait, Oman, Qatar, the United Arab Emirates, Lebanon, and several other countries in the region. In the initial phase of the agreement, Biologix has agreed to sell Iclusig as an investigational product on a named patient basis in certain countries in the territory where permitted prior to regulatory approval, and thereafter to commercialize Iclusig in those countries in which regulatory approval is achieved.
“We have an established oncology and hematology portfolio with extensive experience in the Middle East, Gulf Coast and North Africa,” said Selim Ghorayeb, chief executive officer of Biologix. “Looking ahead to our partnership with ARIAD, we are dedicated to bringing that experience to help appropriate patients access Iclusig for resistant forms of CML and Ph+ ALL.”
Under the terms of the distribution agreement, ARIAD will receive more than 50 percent of net product sales in the territory through a product supply transfer price. The agreement also includes an option for an acquirer of ARIAD to buy-back the rights to Iclusig in the territory following three years from the effective date of the distribution agreement by making specified payments.
About CML and Ph+ ALL
CML is characterized by an excessive and unregulated production of white blood cells by the bone marrow due to a genetic abnormality that produces the BCR-ABL protein. After a chronic phase of production of too many white blood cells, CML typically evolves to the more aggressive phases referred to as accelerated phase and blast crisis. Ph+ ALL is a subtype of acute lymphoblastic leukemia that carries the Ph+ chromosome that produces BCR-ABL. It has a more aggressive course than CML and is often treated with a combination of chemotherapy and tyrosine kinase inhibitors. The BCR-ABL protein is expressed in both of these diseases.
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.
Limitations of use:
Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY
See full prescribing information for complete boxed warning
• Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
• Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
• Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts is focused on discovering, developing and commercializing precision therapies for patients with rare cancers. ARIAD is working on new medicines to advance the treatment of rare forms of chronic and acute leukemia, lung cancer and other rare 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).
About Pint Pharma
Pint Pharma is a private specialty pharma company which benefits from specialized leaders with extensive experience in the pharmaceutical sector and whom are based strategically throughout Latin America and Europe. Pint Pharma has also a long track record of developing strong relationships with global pharmaceutical and healthcare companies. Pint Pharma has the ambition to become a leading Latin American company delivering innovative treatments to patients with cancers, rare diseases and genetic disorders.
About Biologix FZCo.
Biologix FZCo. is incorporated in the Dubai Airport Free Zone as a regional promoter of specialty pharmaceutical products. Biologix is focused on oncology-hematology, cardiology, central nervous system, and rare diseases.
Biologix FZCo. mission is to accelerate the availability in the MENA markets of innovative therapies that would not be normally available until much later due to the focus of their manufacturers on the larger markets of North America, Europe and Japan. Biologix enables a win-win outcome for patients who would miss on an effective treatment and for manufacturers who would not access the MENA markets at such an early stage of their corporate development.
ARIAD Forward-Looking Statements
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, the ability of Pint Pharma and Biologix FZCo. (collectively, the “Distributors”) to perform the contracted services, such as obtaining regulatory approvals for Iclusig in their respective territories; the Distributors’ ability to distribute, promote, market and sell Iclusig in their respective territories; the timing and scope of regulatory approvals obtained in the covered territories; the timing and success of sales of Iclusig in the territories; and the statements made by the officers of ARIAD, Pint Pharma and Biologix FZCo., 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, competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products; our reliance on the performance of third-party manufacturers and specialty pharmacies for the supply and distribution of our products and product candidates; the occurrence of adverse safety events with our products and product candidates; the costs associated with our research, development, manufacturing, commercialization and other activities; the adequacy of our capital resources and the availability of additional funding; our operations in foreign countries; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in our 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.