Biologix – Incyte Partnership in the Middle East - North Africa region
Biologix FZ LLC and Incyte Sign Exclusive Supply and Distribution Agreement for Tafasitamab and Pemigatinib in the Middle East and North Africa Region.
DUBAI, UAE April 1st, 2022 – Biologix FZ LLC has entered into an exclusive agreement with Incyte (Nasdaq:INCY), a global biopharmaceutical company, whereby, upon local regulatory approval, Biologix will promote and distribute tafasitamab (sold as Monjuvi® in the United States and Minjuvi® in Europe) and pemigatinib (Pemazyre®) in certain countries throughout the Middle East and North Africa (MENA) region. Under the terms of the agreement, Biologix will also be responsible for managing named-patient requests received from physicians lawfully and ethically permitted to prescribe tafasitamab and pemigatinib for patients prior to commercial availability in MENA where local regulations allow.
Tafasitamab in combination with lenalidomide is approved in the United States and Europe 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). DLBCL is the most common type of non-Hodgkin lymphoma *.
Pemigatinib is approved in the United States, Europe and Japan for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Cholangiocarcinoma is the most common cancer of the bile duct. FGFR2 fusions or rearrangements have been observed in 10-16% ** of patients with intrahepatic cholangiocarcinoma, whereas the incidence in patients with extrahepatic cholangiocarcinoma is rare.
About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In Europe, Minjuvi® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.
Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S., and marketed by Incyte under the brand name Minjuvi® in ex-U.S. markets.
XmAb® is a registered trademark of Xencor, Inc.
About Pemigatinib
Pemigatinib (Pemazyre®) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a FGFR2 fusion gene, worsening after cancer chemotherapy.
In Europe, Pemazyre received conditional approval, for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3, which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.
Pemazyre is marketed by Incyte in the United States, Europe and Japan.
Pemazyre is a trademark of Incyte.
About Biologix
Biologix, a privately owned pharmaceutical company organized and existing under the laws of the United Arab Emirates (UAE), was incorporated in the Dubai Airport Free Zone in September 2002 as a regional distributor and promoter of pharmaceutical specialties in the Middle East & North Africa (MENA) countries. Biologix provides end to end services from the pre-registration phase including named patient supply, medical and disease awareness activities, to registration, promotion, cold chain distribution, tender management, market access programs, pharmacovigilance and product safety, as well as the administration of risk management plans, on behalf of its partners.
References
* Globocan 2020
** Jain A et al. JCO Precision Oncology 2018 :2, 1-12
DLBCL: Diffuse Large B-Cell Lymphoma
ASCT: Autologous Stem Cell Transplant
FGFR-2: Fibroblast Growth Factor Receptor 2
