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

Rhea-AI Summary

GENESIS Pharma (GENESIS), a leading regional biopharma company operating in Europe, and Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), announce an exclusive distribution agreement for RIPRETINIB in 14 European markets in Central and Eastern Europe. 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.

Insights

Pharmaceutical Market Analyst

The exclusive distribution agreement between GENESIS Pharma and Deciphera Pharmaceuticals for RIPRETINIB in 14 European markets holds strategic significance for both entities. From a market perspective, this deal represents a pivotal expansion for Deciphera Pharmaceuticals, which has been actively seeking to widen its global commercial footprint, especially in the oncology sector. The choice of GENESIS Pharma as a partner leverages their established network and experience in commercializing specialized treatments in Central and Eastern Europe.

For GENESIS Pharma, the agreement enhances their portfolio with a product that addresses a critical need in fourth-line gastrointestinal stromal tumor (GIST) treatment. The deal not only broadens their therapeutic offerings but also strengthens their market position in the niche segment of rare diseases. The potential market uptake of RIPRETINIB can be analyzed by examining the prevalence of GIST in the specified regions and the current treatment landscape, including the penetration of kinase inhibitors like imatinib.

It's crucial to monitor the execution of this agreement, as successful commercialization hinges on effective market access strategies, pricing and reimbursement negotiations, which vary significantly across the diverse healthcare systems of the 14 countries. The long-term growth prospects for both companies will depend on their ability to navigate these complexities and deliver RIPRETINIB effectively to the market.

Oncology Medical Expert

RIPRETINIB's approval for the treatment of advanced GIST after the failure of three or more kinase inhibitors underscores its role as a critical option for patients who have exhausted other treatments. As a fourth-line therapy, RIPRETINIB provides hope for improved outcomes in a patient population with limited alternatives.

The clinical value of RIPRETINIB lies in its mechanism of action as a broad-spectrum kinase inhibitor, which targets a range of mutations driving GIST progression. This is particularly relevant for patients who have developed resistance to prior therapies, a common challenge in the management of GIST. The partnership between GENESIS Pharma and Deciphera Pharmaceuticals could enhance patient access to this innovative therapy, which is an important consideration in the overall management and prognosis of GIST.

Understanding the clinical profile of RIPRETINIB, including its efficacy, safety and tolerability, is essential for healthcare providers in the region. This knowledge will be pivotal for integrating the drug into existing treatment protocols and for informing patient selection, ultimately impacting patient outcomes and quality of life.

 

ATHENS, Greece--(BUSINESS WIRE)-- 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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FAQ

What is the exclusive distribution agreement announced by GENESIS Pharma and Deciphera Pharmaceuticals, Inc.?

GENESIS Pharma and Deciphera Pharmaceuticals, Inc. have announced an exclusive distribution agreement for RIPRETINIB in 14 European markets in Central and Eastern Europe.

What is the approved use of RIPRETINIB in the European Union?

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.

Who is the Senior Vice President, Head of International at Deciphera Pharmaceuticals?

Ms. Margarida Duarte is the Senior Vice President, Head of International at Deciphera Pharmaceuticals.

Who is the Managing Director of GENESIS Pharma?

Mr. Constantinos Evripides is the Managing Director of GENESIS Pharma.