October is off to a great start for Mithra, the Liège-based biopharma company specialising in the development of innovative alternatives in the area of women's health: it has recently signed a licensing and supply agreement with Mayne Pharma Group to market Estelle®, its flagship product, in the United States.
It is a fact that oral contraceptives sometimes have undesirable side effects. It is therefore for reasons of safety, but also ease of use, that today 30% of Americans do not take the pill. Fortunately, Mithra has found a solution with its oral contraceptive Estelle®, which contains DRSP and is different from other products thanks to its innovative native oestrogen, Estetrol (E4). With its unique action, E4 has a minimal impact on liver cells, in particular on coagulation parameters and haemostatic profiles. For example, the Ethinyl Estradiol present in most oral contraceptives has a negative effect on these coagulation parameters.
As you can guess, Estelle® would therefore appear to be a promising new contraceptive solution for women with a unique benefit/risk balance. Add to that the fact that Mithra has estimated the size of the current contraceptive market in the United States at US$5.4 billion, twice the size of the European market, and the Liège-based company would be crazy not to market Estelle® in the United States.
And the best partner in this regard is Mayne Pharma Group, a specialist pharmaceutical company listed in Australia and the second largest supplier of oral contraceptives in the United States. It employs just under 1,000 people and markets branded pharmaceutical products and generics, drawing on its expertise in the area of administrative methods.
In essence, the terms of the agreement between the two companies stipulate that Mithra will receive:
- A minimum amount of US$295 million (US$308.1 million discounted) in license fees, consisting of cash and share advances and milestone payments (+US$13.1 million discounted);
- a fixed price per product for supply;
- a variable price for supply based on a percentage (high, double-digit) of net sales.
Mithra will also receive advances and milestone payments in shares and cash of at least US$295 million and will also receive a transfer price made up of fixed and variable portions, based on a double-digit percentage of net sales over a 20-year period.
As part of its marketing strategy, Mayne has committed to investing several hundred million US dollars in the first five years to cover all its expenses and, if all goes well, the dedicated Estelle® team will be made up of at least 70 experienced medical representatives and 8 managers.
In addition, Mayne, Mithra and other international partners will work together closely on branding and promotional materials over the course of the next year, with a particular focus on digitisation.
We are looking forward to the next steps, but the partnership is looking very promising, as Scott Richards, CEO of Mayne Pharma, explained: "This product is expected to play a fundamental role in the area of women's health for many years to come, and fits perfectly into Mayne Pharma's portfolio of more than 20 branded generic contraceptives currently on the market, as well as products under development."
