Mithra announces FDA update

In the letter, Mayne has been requested to provide additional data to support the application. This additional data is not normally requested for generic products. Mithra is not concerned by the additional queries and expect to have the necessary data to be able to answer the FDA before yearend.

As a consequence, there is expected to be a delay in US, which will be clarified once the responses to the additional queries have been submitted to the FDA. The overall 10 year business plan is not expected to be impacted as the competitive landscape has evolved reflecting the complexity of the ring development. There is currently only one independent generic NuvaRing® competitor in the US. NuvaRing remains the largest contraceptive sold in the US with sales of more than US$920m.

Mithra, together with Mayne, has also recently participated in a mid-cycle review meeting with the FDA regarding the New Drug Application (NDA) for Estelle (NEXTSTELLIS™) to prevent pregnancy. The FDA did not raise any substantive issues at the meeting and indicated that no major safety concerns have been noted at this point in their review.

Outside of the FDA update, Myring™ is ready for regulatory submission in Canada, and a bioequivalence study has just been launched in China. These additional filing dossiers provide for the production of Myring™ at the Mithra CDMO.

Mithra continues to have a solid cash position and funding facilities to cover working capital needs.

François Fornieri, Chief Executive Officer of Mithra Women’s Health, commented: “We are very surprised by this unexpected setback, especially considering that we are already commercialized in the largest European countries, and soon expect to be commercialized also in the rest of Europe. Marketing Authorization processes are also pending for Latam, Australia and N. Africa. Together with Mayne Pharma, our commercial partner, we expect to have the necessary data to be able to answer the FDA before year-end in order to bring Myring™ to the American market, a market that has increased 25% over the last four years2 . Mithra has also licensed Myring™ to industry leaders in ten international markets, including the United States, Austria, Czech Republic, Russia, Denmark, Chile, Australia/New Zealand, the MENA territories , the Argentinean/Uruguay/Dominican Republic zone and Germany. All these contracts provide for the production of Myring™ at the Mithra CDMO, which has tripled its production capacity to meet the expected market increase. The commercial manufacturing process has been successfully launched in early 2019 and will continue in the second half of the year for the commercial batches for the European market. No questions or comments have been raised by FDA with regard to Mithra CDMO, which provides comfort regarding robustness of manufacturing process. At the same time, I am pleased that Mayne considers that the mid-cycle review by the FDA for Estelle (Nextstellis) went smoothly and that no major concerns were raised, and that the timing should be respected.”

Mayne Pharma’s CEO Scott Richards said, “We are confident we can address the issues raised in the letter in a timely manner. Pleasingly, the FDA has indicated that Mayne Pharma and its development partner Mithra have an acceptable manufacturing process for generic NUVARING. Furthermore, the market opportunity continues to be highly attractive with only one independent generic approved and an addressable market of US$920m1 .” The NEXTSTELLIS mid-cycle review meeting with the FDA provided us with some insights into the review process so far, and we are pleased that no significant issues and no major safety concerns were raised. This meeting marks the halfway point of the NEXTSTELLIS NDA review process, and with approximately six months until the PDUFA date, we continue to advance our US commercial strategy and infrastructure to support the potential launch of this novel contraceptive in the first half of calendar 2021.”