Mayne geeft wat extra info in hun 2020 AGM Results: enkele belangrijke citaten :
NEXTSTELLIS (E4/DRSP), is the Company’s most significant near-term pipeline opportunity. The product is a novel oral contraceptive which contains a new estrogen called Estetrol or E4 in combination with a progestin, drospirenone. If approved, E4 will be the first new estrogen introduced in the US for contraceptive use in 50 years. E4 is a low-impact estrogen with a unique mechanism of action that offers potential advantages over other estrogens used in contraception. The Company’s strategic development partner, Mithra Pharmaceuticals, has studied this product in more than 4000 women in Phase II and Phase III trials. The phase III trials met efficacy end-points and demonstrated good bleeding control – which is a clear expectation of women using an oral contraceptive. Further, a phase II trial importantly showed a favourable effect on certain markers associated with blood clotting, which is one of the known risks with many contraceptives. NEXTSTELLIS has also shown a neutral effect on weight gain. Being a native estrogen, NEXTSTELLIS has the potential to have a lower adverse impact on the environment and this could also be a key differentiator against other contraceptives on the market today.
Mayne Pharma has the distribution rights for NEXTSTELLIS in the US and Australia. The product is currently pending at a number of regulatory agencies around the world including the US, Europe, Canada and Australia. In September, we had a mid-cycle review meeting with the FDA and we were pleased that no substantive issues and no major safety concerns were raised. We have another important meeting with the FDA in early 2021 at which time we expect clarification on all major review matters as we close in on our target action date set in April 2021.