Medis, Axantis, Source Orphan Drugs from India’s Lupin

Mumbai-based global pharma major Lupin, signed a distribution agreement with Slovenia-based Medis for Lupin’s orphan drug NaMuscla® (mexiletine).

Medis will commercialize NaMuscla® for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in Central and Eastern European countries, namely Croatia, Czech Republic, Hungary, Slovakia, and Slovenia in the first phase. Lupin will commercialize the drug in Germany, France, and the U.K.

NDM disorders are a group of rare, inherited neuromuscular disorders characterized by the inability to relax muscles following voluntary contraction. NaMuscla® is the first and only licensed product for NDM designated orphan drug status. It received EU marketing authorization in December 2018.

In other news, Lupin and Axantia, holding company of Pharma International – Jordan, and Med City Pharma – Saudi Arabia, entered into a License, Supply and Technology Sharing Agreement for Pegfilgrastim in the Middle East and North Africa.

Axantia will register, distribute, and market biosimilar Pegfilgrastim in certain territories including Saudi Arabia, certain GCC countries, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria.

Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy.

Last updated: December 26th, 2025