GENESIS Pharma Announces an Exclusive Distribution Agreement with Deciphera Pharmaceuticals to Commercialize RIPRETINIB in 14 EU Markets in Central and Eastern Europe

GENESIS Pharma, a leading regional biopharma company operating in Europe, and Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, announce an exclusive distribution agreement for RIPRETINIB in 14 European markets in Central and Eastern Europe. Under the terms of the agreement, GENESIS Pharma will exclusively commercialize RIPRETINIB for the treatment of fourth-line gastrointestinal stromal tumor (GIST) in: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, and Slovenia.

RIPRETINIB is approved in the European Union for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Ms. Margarida Duarte, Senior Vice President, Head of International, Deciphera Pharmaceuticals stated: “We are excited to partner with GENESIS Pharma to distribute RIPRETINIB across Central and Eastern Europe, ensuring fourth-line GIST patients in these countries have access to this standard-of-care treatment. Deciphera is committed to commercializing RIPRETINIB globally, and our agreement with GENESIS Pharma builds upon the significant progress we have already made launching the therapy in Europe, positioning us well for continued growth as we work together to improve the lives of GIST patients”.

Mr. Constantinos Evripides, Managing Director of GENESIS Pharma stated: “We are pleased to expand the network of our international partners and honored that Deciphera recognized our expertise and track record in the commercialization of innovative biopharmaceutical products targeting severe and rare diseases. This agreement is an important step forward in expanding our geographical reach and delivering our mission to ensure that such products are made available to patients in the countries we operate. We look forward to joining forces with Deciphera to enable access to this important innovative therapy for eligible patients in Central and Eastern Europe”.

About Gastrointestinal stromal tumor (GIST)

Gastrointestinal stromal tumor (GIST) is a rare neoplasm of the gastrointestinal tract affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine¹. GIST is the most frequent sarcoma of the gastrointestinal tract, with a reported incidence of 10-15 cases per million per year². The majority of GISTs are driven by two oncogenic protein kinases, KIT and PDGFRA gain-of-function mutations. The most common primary mutations are in KIT kinase, representing approximately 80% of cases, or in PDGFRA kinase, representing approximately 5-10% of cases³. Current therapies are unable to inhibit the full spectrum of primary and secondary mutations, which drives resistance to most tyrosine kinase inhibitors (TKIs) therefore leading to disease progression⁴. Estimates for 5-year survival rate range from 48% to 90%, depending on the stage of the disease at diagnosis⁵.

About Deciphera

Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, RIPRETINIB is Deciphera’s switch-control inhibitor for the treatment of fourth-line GIST. RIPRETINIB is approved in Australia, Canada, China, the European Union, Hong Kong, Iceland, Israel, Liechtenstein, Macau, New Zealand, Singapore, Switzerland, Taiwan, the United Kingdom, and the United States. For more information, visit www.deciphera.com and follow us on LinkedIn and X (@Deciphera).

About GENESIS Pharma

GENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies. For more information, please visit www.genesispharmagroup.com.

^1. Parab TM, DeRogatis MJ, Boaz AM, Grasso SA, Issack PS, Duarte DA, Urayeneza O, Vahdat S, Qiao JH, Hinika GS. Gastrointestinal stromal tumors: a comprehensive review. J Gastrointest Oncol. 2019 Feb;10(1):144-154.
^2. Søreide K, Sandvik OM, Søreide JA, Giljaca V, Jureckova A, Bulusu VR. Global epidemiology of gastrointestinal stromal tumours (GIST): A systematic review of population-based cohort studies. Cancer Epidemiol. 2016 Feb;40:39-46.
^3. Lostes-Bardaji MJ, García-Illescas D, Valverde C, Serrano C. Ripretinib in gastrointestinal stromal tumor: the long-awaited step forward. Ther Adv Med Oncol. 2021 Jan 7;13:1758835920986498.
^4. Gajiwala KS, Wu JC, Christensen J, Deshmukh GD, Diehl W, DiNitto JP, English JM, Greig MJ, He YA, Jacques SL, Lunney EA, McTigue M, Molina D, Quenzer T, Wells PA, Yu X, Zhang Y, Zou A, Emmett MR, Marshall AG, Zhang HM, Demetri GD. KIT kinase mutants show unique mechanisms of drug resistance to imatinib and sunitinib in gastrointestinal stromal tumor patients. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1542-7.
^5. American Cancer Society. (March 1, 2023). Gastrointestinal stromal tumor survival rates. Retrieved December 21, 2023, from https://www.cancer.org/cancer/types/gastrointestinal-stromal-tumor/detection-diagnosis-staging/survival-rates.html.

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Contact information

Deciphera
Investor Relations:
Maghan Meyers
Argot Partners
Deciphera@argotpartners.com
212-600-1902

Media:
David Rosen
Argot Partners
David.Rosen@argotpartners.com
212-600-1902

GENESIS Pharma
Media:
Natalia Karahaliou
nkarahaliou@genesispharma.com
+30 210 87 71 605