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GENESIS Pharma Announces Expansion of Commercialization Agreement with Incyte
25/10/2022
GENESIS Pharma Announces Expansion of Commercialization Agreement with Incyte

The expanded agreement includes two new orphan-designated cancer medicines in 11 markets in Southeast Europe    

25 October 2022 –GENESIS Pharma, a leading regional biopharma company operating in the broader region of Southeast Europe, today announced an expansion of the exclusive supply and distribution agreement with Incyte Biosciences International Sàrl, continuing their successful six year collaboration for ponatinib. The expanded agreement includes the commercialization of two new, orphan-designated, cancer medicines as well as the geographical extension of the agreement to include 11 markets: Greece, Cyprus, Croatia, Slovenia, Malta, Serbia, North Macedonia, Bosnia and Herzegovina, Kosovo, Albania and Montenegro.

Under the terms of the expanded supply and distribution agreement, Incyte has granted GENESIS Pharma exclusive rights in these markets to, upon local market approval, commercialize pemigatinib, a cancer monotherapy for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy[1], and tafasitamab, a cancer medicine used in combination with lenalidomide followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT)[2].

Mr. Constantinos Evripides, Managing Director of GENESIS Pharma stated: “During the last six years we have been working together with Incyte to ensure patient access for ponatinib in Greece and the wider southeast European region. This successful cooperation and our shared commitment and expertise in rare hematological and oncology diseases have paved the way for us to expand our agreement to include two promising new treatments that are now added to our broad portfolio of rare malignancies. It is an honor that a leading company such as Incyte has placed its trust in our company and its people.”

About Cholangiocarcinoma
Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor[3,4]. In Europe, the incidence of cholangiocarcinoma ranges between 6,000 – 8,000[5,6]. FGFR2 fusions or rearrangements occur almost exclusively in intrahepatic cholangiocarcinoma, where they are observed in 10-16 percent of patients[7,8,9].

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, comprising 40% of all cases[10], and is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs[11]. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter[12]. In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL[13,14,15].

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REFERENCES
 
_________________ About Cholangiocarcinoma
1 Pemigatinib EU Summary of Product Characteristics
Banales JM, et al. Nat Rev Gastroenterol Hepatol. 2016;13:261‒280.
Uhlig J, et al. Ann Surg Oncol. 2019;26:1993–2000.
Kirstein MM, Vogel A. Visc Med 2016; 32: 395-400.
6 Countries factored include: UK, Germany, France, Spain, Italy, Switzerland, Denmark, Finland, Poland and Austria
7 Graham RP, et al. Hum Pathol. 2014;45:1630‒1638.
Ang C. J. Gastroenterol Hepatol. 2015;30:1116‒1122.
9 Ross JS et al. The Oncologist. 2014;19:235–242.
_________________ About Diffuse Large B-cell Lymphoma (DLBCL)
2 Tafasitamab EU Summary of Product Characteristics
10 Cancer Research UK. Diffuse large B cell lymphoma. Available at https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/diffuse-large-B-cell-lymphoma. Accessed: 20/10/2022
11 Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209–16. doi.org/10.1016/j.beha.2018.07.014.
12 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253–265. doi.org/10.3747/co.26.5421.
13 DRG Epidemiology data.
14 Kantar Market Research (TPP testing 2018).
15 Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.