Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US

ADELAIDE, Australia, June 24, 2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021.

Developed by Mithra Pharmaceuticals SA (Mithra), E4/DRSP is a novel combined oral contraceptive pill containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is produced by the human foetal liver during pregnancy. 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.

The NDA submission includes results from two phase 3 clinical studies conducted in more than 3,725 women aged 16 to 50 years.

If approved, E4/DRSP would be the first contraceptive product containing E4 and the first new estrogen introduced in the US for contraceptive use in approximately 50 years. US sales of combined hormonal contraceptives are more than US$4 billion per annum, with 10 million US women using combination (estrogen + progestin) oral pills, patches or vaginal rings^[1]. 

Mayne Pharma's CEO Scott Richards said, "This is another important milestone for E4/DRSP and brings us one step closer to providing women in the US with a new contraceptive that we believe will be effective, safe and well-tolerated. We look forward to working with the FDA and Mithra during the ongoing review of our application. In parallel, we continue to advance our US commercial strategy and infrastructure to ensure we are well positioned to support the potential launch of E4/DRSP in the first half of calendar 2021."

Mayne Pharma recently extended its strategic relationship with Mithra to also bring E4/DRSP to the Australian market and plans to file the product with the Therapeutic Goods Administration (TGA) this calendar year.

About Mayne Pharma

Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialise branded and generic pharmaceuticals, offering patients better and more accessible medicines. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide.

Mayne Pharma has a 40-year track record of innovation and success in developing new oral drug delivery systems and these technologies have been successfully commercialised in numerous products that continue to be marketed around the world.

Mayne Pharma has two facilities based in Salisbury, Australia and Greenville, USA with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and poorly soluble compounds.

About Mithra

Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women's Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra's goal is to develop products offering better efficacy, safety and convenience, meeting women's needs throughout their life span. Its three lead development candidates are built on Mithra's unique native estrogen platform, Estetrol (E4): E4/DRSP, a new era in oral contraception, PERINESTA®, the first complete oral treatment targeting perimenopause and DONESTA®, the next-generation hormone therapy.

Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO. Active in more than 100 countries around the world, Mithra has an approximate headcount of 250 staff members and is headquartered in Liège, Belgium. Further information can be found at www.mithra.com.

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SOURCE Mayne Pharma