Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext 
Brussels: MITRA) are very pleased to announce the Therapeutic Goods 
Administration (TGA) has approved the novel combined oral contraceptive 
NEXTSTELLIS(R) (14.2 mg of estetrol and 3 mg drospirenone tablets). Mayne 
Pharma anticipates the commercial launch of NEXTSTELLIS by mid-2022 supported 
by healthcare professional market education from January 2022.

Developed by Mithra Pharmaceuticals, NEXTSTELLIS is a first-of-its-kind 
contraceptive pill containing a new low impact estrogen - estetrol (E4) and the 
proven progestin - drospirenone (DRSP). E4 is a natural estrogen produced by 
the human body during pregnancy, now derived from a plant source. Containing a 
new chemical entity (NCE), NEXTSTELLIS will receive 5 years of market 
exclusivity.  

The Australian contraceptive market is valued at A$125 million with the 
short-acting combined (estrogen and progestin) oral contraceptive market worth 
over A$65 million[1]. 

Mayne Pharma's CEO Mr Scott Richards said: "We are pleased to be introducing 
NEXTSTELLIS to the Australian market. It has been 10 years since Australian 
women have had a new contraceptive hormone to consider with their doctor. 
NEXTSTELLIS offers an effective, safe and well-tolerated pill with excellent 
cycle control and has demonstrated low impact on certain parts of the body. 
Mayne Pharma is committed to women's health and launching innovative products 
to meet the needs of Australian and American women." 

Sexual Health physician, Dr Terri Foran, said: "Combined oral contraceptives 
continue to be the most widely used method of hormonal birth control in 
Australia and every clinician knows that each woman responds differently to 
contraceptive hormones. This is why it is so important that we have a range of 
contraceptive options so we can individualise that choice. Today we have a wide 
range of progestins available, but the choice of estrogen has been limited to 
ethinylestradiol or estradiol. Having another estrogen, estetrol (E4), opens up 
the possibility that more women will be able to find a combination that suits 
them. Research indicates that estetrol is more selective in its impact on 
various hormonally receptive tissues in the female body. While it has the 
desired effects on the genital system necessary for an effective combined 
contraceptive, it appears to have potentially less effect on the liver and the 
breast." 

Mithra's CEO Mr Leon Van Rompay said: "After the US, Canada and Europe, we are 
delighted to receive this additional approval for our innovative contraceptive, 
confirming a commercial launch on a third continent. This fourth major approval 
obtained this year, is perfectly in line with our schedule, allowing us to 
cover more than 80% of the targeted territory. This further demonstrates the 
strong expertise of our teams and the strength of our collaboration with Mayne 
Pharma, which makes NEXTSTELLIS' commercial launch a top priority." 

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, safe 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. Mithra explores the potential of the unique native 
estrogen Estetrol in a wide range of applications in women health and beyond. 
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 300 staff members and is 
headquartered in Liège, Belgium. www.mithra.com

About NEXTSTELLIS(R)

Developed by Mithra, NEXTSTELLIS is a novel, patent-protected combined oral 
contraceptive pill containing 14.2 mg estetrol (E4) and 3 mg drospirenone 
(DRSP). E4 is a naturally produced estrogen during pregnancy, that's derived 
from a plant source. In two phase 3 clinical studies conducted in 3,632 women, 
NEXTSTELLIS was shown to be both safe and effective and met its primary 
endpoint of pregnancy prevention. It also delivered positive results on a 
variety of secondary endpoints that demonstrated excellent cycle control, 
bleeding pattern, safety and tolerability, and low rates of adverse reactions.

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

Source: Mayne Pharma