Mayne Pharma poised to enter world’s largest pharmaceutical market
Mayne Pharma Group Limited (ASX:MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) announced on Thursday morning that the former has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA), seeking marketing authorisation for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy.
Two phase 3 clinical studies of E4/DRSP including more than 4400 women from various global regions have demonstrated very positive outcomes for efficacy and safety in a product that has achieved a desirable bleeding profile and excellent tolerability.
If approved by the FDA, E4/DRSP is expected to be made available to patients in the US market in the first half of calendar 2021.
Given US sales of combined hormonal contraceptives are more than US$4 billion per annum, there is the potential for this drug to generate substantial revenues for Mayne Pharma.
E4/DRSP is a novel, next generation oral contraceptive containing Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.
E4 is a naturally occurring estrogen that is produced by the human foetal liver during pregnancy.
Targeting 2021 launch
Following more than 20 years of research and development, Mayne Pharma’s development and manufacturing partner Mithra can synthesise E4 at scale through a complex plant-based production process.
Commenting on this development, Mayne Pharma chief executive Scott Richards said, “The NDA filing is a major milestone for Mayne Pharma and our development partner Mithra Pharmaceuticals.
‘’We are now one step closer to making this new oral contraceptive that we believe to be safe, effective and well-tolerated available to American women.
‘’We confirm our earlier stated goal of bringing this product to market in the first half of calendar 2021.”
Should the group meet this target, it will be well-placed to achieve the sharp uptick in earnings per share that are forecast to occur in fiscal 2022.
Consensus forecasts currently indicate that earnings per share will increase from 1.9 cents in fiscal 2021 to 5.6 cents in 2022, with the latter implying a seemingly conservative forward PE multiple of just over six relative to Wednesday’s closing price of 34.5 cents.
With COVID-19 having a significant impact on retail sales in the US, investors are likely to be looking to identify companies that generate income from non-discretionary areas such as contraception.
This may account for the substantial rebound of about 70% in Mayne Pharma’s share price since it bottomed out at 19.5 cents on 19 March.