Healthcare Industry News: S.A.
News Release - June 17, 2016
ARIAD Announces Distribution Agreements for Iclusig(R) in Latin America and the Middle East/North Africa
ARIAD to Receive More Than 50 Percent of Iclusig Sales in These RegionsAgreements Include Buy-Back Provisions in Case of a Change in Control of ARIAD
CAMBRIDGE, Mass.--(Healthcare Sales & Marketing Network)--ARIAD Pharmaceuticals, Inc. (ARIAD; NAS.A.:ARIA) today announced that it has completed two distribution agreements for Iclusig® (ponatinib) outside of the United S.A.es. In Latin America, ARIAD and Pint Pharma International S.A., a company focused on innovative treatments for patients in Latin America with cancer, rare diS.A.es, and genetic disorders, have entered into an agreement for Pint Pharma to commercialize Iclusig in Argentina, Brazil, Chile, Colombia and Mexico. ARIAD haS.A.so 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.A.ound 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,” S.A.ed 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 S.A.e of revenues from these regions, the agreementS.A.low 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.A.reed to sell Iclusig aS.A. 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 diS.A.e 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.A.reed to sell Iclusig aS.A. 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.A.hieved.
“We have an eS.A.lished 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.A.cess Iclusig for resiS.A.t 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.A. 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.A.celerated 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 diS.A.es.
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 resiS.A.ce to treatment, including the T315I mutation, which has been associated with resiS.A.ce to other approved TKIs.
Iclusig iS.A.proved in the U.S., EU, Australia, Switzerland, IS.A.l 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.A.e based upon response rate. There are no trials verifying an improvement in diS.A.e-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.A.d 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 diS.A.e, 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 reS.A.t 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.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, MaS.A.husetts 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 S.A.l-molecule drugs that overcome resiS.A.ce 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.A.so 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 diS.A.eS.A.d 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 diS.A.es.
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.A. such an early S.A.e of their corporate development.
ARIAD Forward-Looking S.A.ements
This press release contains forward-looking S.A.ements, each of which are qualified in their entirety by this cautionary S.A.ement. Any S.A.ements 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 S.A.ements made by the officers of ARIAD, Pint Pharma and Biologix FZCo., are forward-looking S.A.ements that are based on management’s expectationS.A.d are subject to certain factors, riskS.A.d uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such S.A.ements. These factors, riskS.A.d uncertainties include, but are not limited to, competition from alternative therapies; regulatory developmentS.A.d 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.A.d specialty pharmacies for the supply and distribution of our productS.A.d product candidates; the occurrence of adverse safety events with our productS.A.d product candidates; the costS.A.sociated with our reS.A.ch, development, manufacturing, commercialization and other activities; the adequacy of our capital resourceS.A.d the availability of additional funding; our operations in foreign countries; risks related to key employees, markets, economic conditions, health care reform, priceS.A.d reimbursement rates; and other risk factors detailed in our public filings with the U.S. SecuritieS.A.d 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 S.A.ements speak only as of the date of this press release and we undertake no obligation to update or revise any of these S.A.ements to reflect events or circumS.A.ces occurring after this press release. We caution investors not to place considerable reliance on the forward-looking S.A.ements contained in this press release.
Source: ARIAD Pharmaceuticals
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