Summary :
Drug firm Lupin on Wednesday said it has entered into a distribution pact with Slovenia-based Medis for its orphan drug NaMuscla.
As part of the agreement, Medis will commercialise NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in Central and Eastern European countries, Lupin said in a statement.
NaMuscla is the first and only licensed product for this indication.
Lupin Pharma
Under the agreement, Medis will initially focus on the commercialisation of NaMuscla in the Central and East European countries, namely Croatia, Czech Republic, Hungary, Slovakia, and Slovenia in the first phase.
Lupin will continue commercialisation of NaMuscla in Germany, France, and the UK.
“The distribution agreement represents an important milestone for Lupin as we continue the roll out of NaMuscla across Europe. We know that collaborating with partners which are highly focused in their territories means patients receive medicines in the most efficient way,” said Thierry Volle, President EMEA, Lupin.
NDM disorders are a group of rare, inherited neuromuscular disorders which are characterised by the inability of muscles to relax following voluntary contraction.
NaMuscla reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients.
NaMuscla, which has been designated orphan drug status, received EU marketing authorisation in December 2018.
According to the US health regulator, USFDA, ‘orphan drug’ is a drug or biologic that is used for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 2 lakh people.
It is also defined as a drug or biologic that is intended for diseases or conditions affecting 2 lakh or more people, or for a vaccine, diagnostic drug, or preventive drug to be administered to 2 lakh or more people per year, where the drug will not be profitable within 7 years following the FDA approval.