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With this latest expansion, Medison's global footprint is now extended across Israel, Central and Eastern Europe, Canada, Asia-Pacific and Latin America, offering patients in international markets improved access to highly innovative therapies.
PETACH TIKVAH, Israel, Nov. 9, 2022 /PRNewswire/ -- Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, today announced the addition of South and Central America and the Caribbean markets ("Latin America") to its multi-territorial agreement with Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease.
"The expansion of our partnership with Immunocore into LATAM is a significant milestone in building our unified commercial platform in all international markets," says Meir Jakobsohn, Founder and CEO of Medison. "This in turn will allow us to fulfil our vision, ensuring that every patient in need will have fast access to highly innovative therapies in a wide range of international markets."
"Our multi-regional platform makes us the partner-of-choice for emerging biotech companies seeking to make their innovative products available in international markets for the benefit of patients suffering from severe conditions", adds Gil Gurfinkel, VP Corporate Development at Medison "and the extension of Medison's multi-territorial agreement with Immunocore and expansion to Latin America, allows for a unique pairing between Immunocore's novel therapy and Medison's ability to commercialize and provide access to highly innovative therapies in international markets. In this case, offering patients in Latin America hope in the form of a treatment for this rare and aggressive form of melanoma that affects the eye."
Immunocore's KIMMTRAK® (tebentafusp-tebn), has been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Australia Therapeutic Goods Administration (TGA) and Health Canada, and is the first and only treatment approved for patients with unresectable or metastatic uveal melanoma."
With this latest growth, Medison increases its commercial presence across Israel, Central and Eastern Europe, Canada, Asia-Pacific, South and Central America and the Caribbean countries. Medison is hiring across all markets and in key functions. To learn more about open roles, visit: https://www.medisonpharma.com/careers/
About Medison Pharma
Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets.
Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach.
To learn more visit www.medisonpharma.com
About KIMMTRAK® (tebentafusp-tebn)
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. KIMMTRAK is currently approved in 31 countries, including the United States and European Union.
USAGE
KIMMTRAK is a prescription medicine used to treat HLA-A*02:01–positive adults with uveal melanoma that cannot be removed by surgery or has spread.
IMPORTANT U.S. SAFETY INFORMATION Regarding FDA Approval
Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.
Skin Reactions
Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.
Elevated Liver Enzymes
Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.
Embryo-Fetal Toxicity
KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.
The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.
Please see full Prescribing Information, including BOXED WARNING for CRS.
Medison Contact
Inbal Chen, Corporate Communications
T: +972-54-4400784
E: inbalc@medisonpharma.com
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