Mithra plans to submit Myring for US and EU approval in Q2 2017

January 24, 2017 News BioVox

Mithra Pharmaceuticals today announces that it intends to submit its combined hormonal contraceptive vaginal ring, Myring, for marketing approval in both Europe and the United States in Q2 2017.

This follows the completion of two successful studies in Europe and the US demonstrating that Myring is bioequivalent to the branded versions of NuvaRing®, sold in both markets.

Valérie Gordenne, CSO of Mithra Pharmaceuticals, said: “Following completion of successful bioequivalence studies in both Europe and the United States, we are on track to submit Myring for regulatory approval in both markets in the second quarter of 2017. We are also working on submissions in other markets.”

François Fornieri, CEO of Mithra Pharmaceuticals, said: “This is yet another important step in the
development of Myring and we believe that we are on track to sign a commercialisation deal in 2017,
both in the US, as well as in other territories. Additionally, this is great news for Mithra’s CDMO, our
integrated R&D and manufacturing platform, where we will be producing Myring. This fundamental
step shows that Mithra is successful in developing complex therapeutic solutions alongside Estetrol
(E4), which recently also reported positive results.”

Mithra has conducted two studies of bioequivalence involving 42 subjects. The studies are required
to confirm the effectiveness and the safety of the product with a view to completion of the marketing
authorization applications in Europe and the U.S.

Read more news about Mithra Pharmaceuticals

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