Mayne Pharma and Mithra announce TGA approval of the oral contraceptive NEXTSTELLIS®

ADELAIDE, Australia, November 30, 2021 / PRNewswire / – Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are pleased to announce that the Therapeutic Goods Administration (TGA) has launched the novel combined oral contraceptive NEXTSTELLIS. has admitted® (14.2 mg estetrol and 3 mg drospirenone tablets). Mayne Pharma expects the commercial launch of NEXTSTELLIS by mid-2022, supported by market training for healthcare professionals from January 2022.

NEXTSTELLIS was developed by Mithra Pharmaceuticals and is the first contraceptive pill of its kind to contain a new low-impact estrogen – Estetrol (E4) and the tried and tested progestin – drospirenone (DRSP). E4 is a natural estrogen that is produced by the human body during pregnancy and is now obtained from a plant source. With a new chemical unit (NCE), NEXTSTELLIS receives 5 years of market exclusivity.

The Australian contraceptive market is rated at 125 million AUD with the market for short-acting combined (estrogen and progestin) oral contraceptives worth more than 65 million AUD[1].

The CEO of Mayne Pharma, Mr. Scott Richards called: “We are excited to introduce NEXTSTELLIS to the Australian market. It has been 10 years since Australian women had to consider a new birth control hormone with their doctor. NEXTSTELLIS is an effective, safe and well-tolerated pill with excellent cycle control and has.” showed little impact on certain parts of the body. Mayne Pharma is committed to women’s health and brings innovative products to market to meet the needs of Australian and American women. ”

Sexual Health Doctor, Dr Terri Foran, called: “Combined oral contraceptives are still the most widely used method of hormonal contraception Australia And every doctor knows that every woman reacts differently to contraceptive hormones. This is why it is so important that we have a range of birth control options so that we can personalize that choice. Today we have a wide range of progestins available, but the choice of estrogen has been limited to ethinylestradiol or estradiol. Taking another form of estrogen, estetrol (E4), opens up the possibility that more women will find a combination that suits them. Research shows that estetrol is more selective in its effects on various hormonally receptive tissues in the female body. While it has the desired genital system effects necessary for an effective combined contraceptive, it appears to have potentially less liver and breast effects. ”

Mithras CEO Mr. Leon Van Rompay called: “After the USA, Canada and Europe, we are pleased about this additional approval for our innovative contraceptive, which confirms a commercial launch on a third continent. This fourth major approval this year fits our schedule perfectly and allows us to cover more than 80% of the target area. This again shows the strong expertise of our teams and the strength of our cooperation with Mayne Pharma, which gives the commercial introduction of NEXTSTELLIS the highest priority. ”

About Mayne Pharma

Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on using its drug delivery expertise to commercialize branded and generic drugs to provide better, safer, and more accessible drugs to patients. Mayne Pharma also provides contract engineering and manufacturing services to more than 100 customers worldwide. Mayne Pharma has a 40 year history of innovation and success in developing new oral drug delivery systems and these technologies have been successfully marketed in numerous products that continue to be marketed around the world. Mayne Pharma has two locations in Salisbury, Australia and Greenville, United States of America with expertise in formulating complex oral and topical dosage 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 bringing new opportunities through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products that offer greater efficacy, safety and convenience, and meet the needs of women throughout their lifespan. Mithra is exploring the potential of the unique native estrogen, Estetrol, in a variety of uses in women’s health and beyond. Mithra also develops and produces complex therapeutics in the fields of contraception, menopause and hormone-dependent cancers. On its Mithra CDMO technology platform, it offers partners a full spectrum of research, development and special production. Mithra is active in more than 100 countries around the world, employs around 300 people and is headquartered in Liège, Belgium.


NEXTSTELLIS was developed by Mithra and is a new, patented combined oral contraceptive with 14.2 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is an estrogen naturally produced during pregnancy that is obtained from a plant source. In two Phase 3 clinical studies in 3,632 women, NEXTSTELLIS was shown to be safe and effective, and met its primary endpoint of pregnancy prevention. It also produced positive results on a variety of secondary endpoints showing excellent cycle control, bleeding patterns, safety and tolerability, and low rates of side effects.

Mayne Pharma has a 20 year license and supply agreement in the US and Australia for NEXTSTELLIS.

NEXTSTELLIS is a registered trademark of a third party.

[1] IQVIA, MAT sales December 2020

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