Incyte and GENESIS Pharma Announce a Commercialization Agreement for Iclusig® (ponatinib) in Greece

Incyte Biosciences International Sàrl, a European subsidiary of Incyte Corporation, and GENESIS Pharma S.A., a leading Greek pharmaceutical company, today announced that Incyte has granted GENESIS Pharma exclusive rights to commercialize Iclusig^® (ponatinib) in Greece. Under the terms of the agreement, GENESIS Pharma will be responsible for sales and marketing, medical affairs, and regulatory and reimbursement support for Iclusig in Greece.

“The agreement with GENESIS Pharma will expand the availability of Iclusig to patients in geographies beyond our current European footprint,” said Jonathan Dickinson, Incyte’s General Manager, Europe. “We look forward to collaborating with GENESIS Pharma, whose oncology and hematology experience makes them an ideal partner to enable patient and physician access to Iclusig in Greece.”

In Europe and other select ex-U.S. countries, Iclusig is approved for the treatment of adult patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant or intolerant to specific second generation tyrosine kinase inhibitor (TKIs); or who have the T315I mutation.

“We are very happy to announce our partnership with Incyte. For us, it is another step forward to delivering our mission to provide innovative hematology treatments to patients in Greece,” said Constantinos Evripides, Chief Executive Officer of GENESIS Pharma. “Once available, Iclusig will add to the broad portfolio of treatments for patients with rare and difficult to treat hematological diseases that GENESIS Pharma commercializes in Greece. We are very pleased to have another leading international pharmaceutical company, like Incyte, recognize our expertise and high quality standards, and place its trust in us.”

According to the European Medicines Agency’s orphan drug designation¹ and the HAEMACARE project², there are approximately 1,000 CML and Ph+ ALL patients in Greece.

GENESIS Pharma has submitted a pricing application for Iclusig in Greece; the application is currently under review by the Greek Ministry of Health. Pending their approval, the commercial launch of Iclusig is expected to occur in the first half of 2017.

About Iclusig ^®  (ponatinib) tablets

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.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or for the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Incyte has an exclusive license from ARIAD Pharmaceuticals, Inc. to develop and commercialize Iclusig in the European Union and 28 other countries, including Switzerland, Norway, Iceland, Turkey, Israel and Russia.

Iclusig^® is a registered trademark of ARIAD Pharmaceuticals, Inc.

About Incyte

Incyte Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. Headquartered in Wilmington, Delaware, Incyte also has offices in Switzerland and nine other European countries. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

About GENESIS Pharma

GENESIS Pharma was among the first pharmaceutical companies in Europe specialized in biopharmaceutical products and is currently the largest among Greek companies specializing in branded innovative medicines, mainly in the therapeutic areas of Oncology, Hematology, CNS, Gastroenterology and Nephrology. The company has created a strong product portfolio that includes high-tech pharmaceutical products for severe and rare diseases, through long standing strategic alliances for the broader region of Southeast Europe with some of the leading multinational pharmaceutical companies committed to cutting edge R&D.

For further information please visit www.genesispharma.com.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: whether the collaboration with GENESIS Pharma will be successful in expanding access for patients in Greece to Iclusig; whether the Greek Ministry of Health will approve the pricing application for Iclusig; and the expected timing of the commercial launch of Iclusig in Greece. These forward-looking statements are based on the Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including risks detailed from time to time in the Incyte’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2016. The Company disclaims any intent or obligation to update these forward-looking statements.

¹ Public summary of opinion on orphan designation, Committee for Orphan Medicinal Products, European Medicines Agency, 2 March 2010, http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2010/03/WC500075158.pdf

² Sant et al. Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project. Blood 2010 116:3724-3734

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Contact information

Incyte Contacts
Media
Catalina Loveman
+1 302-498-6171
cloveman@incyte.com
or
Investors
Michael Booth, DPhil
+1 302-498-5914
mbooth@incyte.com
or
GENESIS Pharma Contact
Vicky Karra
Corporate Affairs Manager
+30 210 87 71 500
vkarra@genesispharma.com