ARIAD Pharmaceuticals, Inc. 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.”

Pint Pharma has received exclusive rights to commercialize Iclusig following regulatory approval in Argentina, Brazil, Chile, Colombia and Mexico (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.

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.

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.

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 US, 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.

Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.