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$920m1 .
Mithra, together with Mayne, has also recently participated in a mid-cycle review meeting with the FDA regarding the New Drug Application (NDA) for
Outside of the FDA update, Myring is ready for regulatory submission in
Mithra continues to have a solid cash position and funding facilities to cover working capital needs.
Mithra has also licensed Myring to industry leaders in ten international markets, including
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
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.'
Contact:
Tel: +32 490 58 35 23
Email: investorrelations@mithra.com
About Myring
Myring (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, combination contraceptive vaginal ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It is made of ethylene vinylacetate copolymers, and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases, in line with the originator (Nuvaring), on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. The ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed.
About Mithra
Important information
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