Business Wire

GENESIS-PHARMA

12.1.2024 12:37:29 CET | Business Wire | Press release

Share
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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240111379909/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Andersen Consulting tilføjer House of Code for at styrke teknologi- og dataløsninger26.6.2026 20:01:00 CEST | Pressemeddelelse

Andersen Consulting forstærker sine kompetencer inden for teknologisk transformation gennem en samarbejdsaftale med House of Code, en global virksomhed med hovedkvarter i USA, der specialiserer sig i datadrevne platforme, automatisering og agentbaserede ai-løsninger. House of Code blev stiftet i 2001 og udvikler softwareløsninger samt yder rådgivning til energihandels- og finanssektoren med kunder, der spænder over hedgefonde, kapitalfonde og forsyningsvirksomheder. Virksomheden besidder dyb ekspertise inden for energihandel og risikostyring og hjælper organisationer med systemimplementering, forretningstransformation, dataautomatisering og ai-underbygget modernisering af arbejdsgange. Deres proprietære platform, Enterprise Platform for Integrated Compliance (EPIC), skaber en mere effektiv datastyring, automatiserer rapporteringsprocesser, forbedrer den driftsmæssige gennemsigtighed på tværs af virksomhedssystemer og skaber et fundament for opbygning af intelligente, agentbaserede arbe

Capco Recognized by OpenAI for Innovation and Responsible AI Leadership26.6.2026 20:00:00 CEST | Press release

Receives AI Governance & Risk Excellence Award at OpenAI Partner SummitCapco’s UK AI Lab wins OpenAI Codex Hackathon Global management and technology consultancy Capco, a Wipro company,has been recognized by OpenAI for both AI innovation and responsible AI leadership. Capco received the AI Governance & Risk Excellence Award at the recent OpenAI Partner Summit 2026 in San Francisco, highlighting Capco’s ability to deliver enterprise-grade AI outcomes in highly regulated environments. The award recognizes Capco’s expert advantage when helping financial services and energy organizations to scale AI with confidence, balancing innovation with strong governance to reduce risk, strengthen compliance and improve customer outcomes. This award follows Capco winning the OpenAI Codex Hackathon, where its UK AI Lab competed against more than 30 teams and over 100 participants from across the OpenAI partner ecosystem. Capco's winning entry Sentra – a consulting-led, AI-powered retail banking solutio

Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 13:30:00 CEST | Press release

If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failedAD, the most common type of eczema which affects 230 million people globally,1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5 Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids

Datroway® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 13:00:00 CEST | Press release

Recommendation based on TROPION-Breast02 phase 3 trial where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival If approved, Datroway has potential to be the first TROP2 directed antibody drug conjugate for patients in EU with a demonstrated overall survival benefit as first-line treatment Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use

DAYBU®(trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 12:49:00 CEST | Press release

-- European Commission decision expected in the coming months-- If approved, DAYBU®would become the first treatment for neurobehavioral symptoms of Rett syndrome in the European Union Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye