Medison Pharma [https://www.medisonpharma.com/] (“Medison”), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, today announced the addition of new markets to its multi-territorial agreement with Immunocore Holdings plc [https://www.immunocore.com/] (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 multi-territorial agreement to help seek regulatory authorization and commercialize Immunocore’s KIMMTRAK(R) (tebentafusp -tebn) for the treatment of unresectable or metastatic uveal melanoma, a rare and aggressive form of melanoma that affects the eye, which covers Canada, twenty markets across Central Eastern Europe and Israel, will now extend to Australia and New Zealand.
MEDISON Logo (PRNewsfoto/Medison Pharma)
KIMMTRAK has been approved by both by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), where it is the first and only treatment approved in the E.U. to treat patients with unresectable or metastatic uveal melanoma.
“We are delighted to deepen our partnership with Immunocore and proud to further grow the reach of their breakthrough treatment, as part of our mission that knows no borders,” said Meir Jakobsohn, Founder and CEO of Medison. “We believe that every patient, wherever they are in the world, deserves a fair chance to receive lifesaving, highly innovative therapies. By adding new countries and continents, we are continuing in our efforts to turn our mission into a reality.”
“It can be challenging for biotechs to commercialise in a large number of countries, often resulting in delayed access to highly innovative therapies in many areas of the world. Medison’s global platform is designed to address this challenge,” said Gil Gurfinkel, VP Corporate Development at Medison. “Immunocore’s novel therapy for unresectable or metastatic uveal melanoma and our ability to treat patients suffering from this rare and aggressive form of cancer in additional countries is a win-win outcome of our partnership.”
Medison’s expansion of its commercial presence to Australia and New Zealand is the latest addition to its geographic growth, enabling Medison to capitalize on growing market opportunities for its commercial partners.
Medison is further enlarging its footprint in Europe with a new office location for its international headquarters in Zug, Switzerland, and operations in Greece and Cyprus, which enlarge its European offering of Central Eastern Europe, the Baltic states, and Balkans. In Canada, the team is also growing and recently moved into larger office space in downtown Toronto.
With this latest growth, Medison increases its commercial presence across 25 locations around the world. Medison is hiring across all locations 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.
Medison is also an active investor in disruptive healthcare technologies and provides its partners with exposure to innovation in biotech and digital health. To learn more visit www.medisonpharma.com.
About KIMMTRAK(R) (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.
KIMMTRAK is a prescription medicine used to treat HLA-A*02:01¨Cpositive 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, 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.
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 (¡Ý30%) 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 (¡Ý50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.
Please see full Prescribing Information [https://ir.immunocore.com/static-files/4e58e85c-de58-4b36-8076-f14cf1cbe206], including BOXED WARNING for CRS.
Corporate Communications Lead
Source: Medison Pharma