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Mayne Pharma opened an oral solid-dose commercial manufacturing facility (Credit: gmpnews)
Mayne Pharma Group Ltd (ASX: MYX) caught the attention of eager investors today by rising up to 19% this morning to $0.64 per share following an exciting announcement made by the company. Mayne Pharma is a specialty pharmaceutical company based in South Australia with expertise in commercialising branded and generic drugs. The firm also provides development and manufacturing contracts to an international client base and excels within its industry through this global distribution network. Mayne Pharma has held a proven track record of developing new oral drug delivery systems and successfully marketed capsule and tablet compounds to partners in North America, Europe, and Asia; where its subsidiary facilities are located.
In what has been touted as a landmark contract, this morning Mayne Pharma Group Ltd announced to investors that it’s phase 3 clinical study enrolling more than 3,700 women have been completed and approved, pending a 2021 calendar year launch of a new oral contraceptive in the United States. The group signed a 20-year exclusive supply and license agreement with partner Mithra Pharmaceuticals in order to commercialise the next generation contraceptive composed of a unique compound of Estetrol (E4) and drospirenone (DRSP). The development of which can now be produced at scale, following 20 years of research and development by Mithra Pharmaceuticals.
The two companies have been partners since 2017 and Mayne Pharma CEO Scott Richards hails the agreement as “transformational” for their portfolio, further enhancing the potential of their US assets such as NUVARING. Mayne Pharma’s announcement cites the US contraceptive market as being valued at US$5.4 billion (A$8 billion) with 10 million American women using short-acting combined hormonal contraceptives. Leveraging Mayne Pharma’s presence in the North American market, the venture is expected to exceed US$200 million (A$298 million) in sales and generate a positive EBITDA in FY21 following approval by the US Food and Drug Administration.
This announcement has been welcomed news to investors following Mayne Pharma’s disappointing FY19 results, reporting a net debt of A$280.4 million due to worsening net loss of up to 110% to A$280.8 million with a gross profit increase of 13% to A$289.9 million. Mayne Pharma management commented that competitive pressures in the US generic drugs market had caused challenges for the business. The new agreement, however, aims to ease earnings volatility and better align the company with their principal focus of building sustainable channels for growth.
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