- Libtayo (cemiplimab) is a leading PD-1 inhibitor that has
shown efficacy in the treatment of certain patients with cutaneous
squamous cell carcinoma, advanced basal cell carcinoma, advanced
non-small cell lung cancer and advanced cervical cancer, and is
approved by regulatory authorities in more than two dozen countries
for various indications
- Medison and Regeneron will work together to continue
patient access to this important therapy in select
markets
ZUG, Switzerland, Jan. 8, 2024 /PRNewswire/ -- Medison
Pharma ("Medison"), a global pharma company focused on
providing access to highly innovative therapies to patients in
international markets, announced today their exclusive
multi-national agreement with Regeneron Ireland DAC, a wholly owned
subsidiary of Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN), a leading biotechnology
company that invents, develops and commercializes life-transforming
medicines for people with serious diseases, to commercialize
Libtayo® (cemiplimab), a fully human monoclonal antibody targeting
the immune checkpoint receptor PD-1 on T cells, in select European
markets and additional markets around the world.
Libtayo was invented in laboratories at Regeneron, which
acquired exclusive worldwide development, commercialization, and
manufacturing rights to the medicine from Sanofi in July 2022. Medison and Regeneron will work
together with all stakeholders and regulatory authorities to
facilitate a seamless transition of commercialization activities to
Medison during the first half of 2024.
Libtayo, which was invented using Regeneron's proprietary
VelocImmune® technology, is currently
approved by regulatory authorities in more than two dozen
countries, including by the European Medicines Agency (EMA).
In select markets, it is approved as monotherapy treatment for
certain patients with advanced basal cell carcinoma (BCC), as
monotherapy treatment for certain patients with advanced cutaneous
squamous cell carcinoma (CSCC), as both monotherapy or in
combination with chemotherapy for certain patients with advanced
non-small cell lung cancer (NSCLC) and/or as monotherapy treatment
for certain patients with recurrent or metastatic cervical cancer.
Libtayo is a leading and first-in-class PD-1 inhibitor approved for
the treatment of two non-melanoma skin cancers and is considered
standard of care in these indications.
"Our multi-regional commercial platform is a great fit for
Regeneron's go-to-market plan and another great opportunity for
Medison to facilitate access to highly innovative therapies for
people suffering from rare and severe diseases," said Meir
Jakobsohn, Founder and Executive Chairman of Medison. "Regeneron's
selection of Medison is yet another testimony of the unique value
that our multi-regional solution can generate for innovative
biotech companies wishing to focus on selected markets."
"We are proud to partner with Regeneron," said Gil Gurfinkel, CEO of Medison. "Our
one-of-a-kind centralized, unified commercial platform, with single
alliance management across multiple markets and regions, is of
great value to more and more leading biotech companies. Our
platform enables biotech companies to transform numerous complex
and fragmented markets and regions into a unified territory."
About Libtayo
Libtayo is a fully human monoclonal antibody targeting the
immune checkpoint receptor PD-1 on T cells and was invented using
Regeneron's
proprietary VelocImmune® technology. By
binding to PD-1, Libtayo has been shown to block cancer cells from
using the PD-1 pathway to suppress T-cell activation. In
the U.S. and other countries Libtayo is indicated in
certain patients with advanced BCC, advanced CSCC and advanced
NSCLC, as well as in advanced cervical cancer in the European
Union, Canada and Brazil. As
of July 1, 2022, Libtayo is developed
and marketed globally by Regeneron. Outside of the U.S., the
generic name for Libtayo is cemiplimab.
The extensive clinical program for Libtayo is focused on
difficult-to-treat cancers. Libtayo is currently being investigated
in trials as a monotherapy, as well as in combination with either
conventional or novel therapeutic approaches for other solid tumors
and blood cancers. These potential uses are investigational, and
their safety and efficacy have not been evaluated by any regulatory
authority.
Select Approved Indications for Libtayo
Libtayo is a cancer medicine used in adults to treat:
- a type of skin cancer called cutaneous squamous cell
carcinoma (CSCC) when the cancer is locally advanced (has spread
nearby) or metastatic (has spread to other parts of the body). It
is used in patients who cannot have surgery or treatment with
radiation to cure their disease;
- a type of skin cancer called basal cell carcinoma (BCC) when
the cancer is locally advanced or metastatic. It is used in
patients who cannot tolerate treatment with a type of medicine
called a 'hedgehog pathway inhibitor (HHI)' or whose disease has
worsened after such treatment;
- a type of lung cancer called non-small cell lung cancer (NSCLC)
when the cancer is locally advanced and cannot be treated with
chemotherapy (medicines to treat cancer) and radiation therapy, or
when the cancer is metastatic. It is used either alone in patients
whose tumours have a protein called PD-L1 in more than 50% of cells
and no mutations in the genes EGFR, ALK and ROS1 involved in the
development of NSCLC, or together with platinum-based chemotherapy
in patients whose tumours have PD-L1 in at least 1% of the cells
and no mutations in the EGFR, ALK and ROS1 genes;
- cervical cancer that has come back (recurrent) or is
metastatic. It is used in patients whose disease has progressed
during or after treatment with platinum-based chemotherapy.
It is not known if Libtayo is safe and effective in
children.
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
For additional information, please
contact:
Medison
Pharma
Inbal Chen, Corporate Communications
M: +972 54 440 0784
E: inbalc@medisonpharma.com
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