Mayne Pharma Group Limited (ASX: MYX) is pleased to announce it has entered 
into an exclusive long-term license and supply agreement with Mithra 
Pharmaceuticals SA (Mithra) to commercialise E4/DRSP, a combined oral 
contraceptive, in Australia. 

E4/DRSP is a novel, next generation oral contraceptive containing Estetrol (E4) 
15 mg and drospirenone (DRSP) 3 mg. E4 is a naturally occurring estrogen that 
is produced by the human foetal liver during pregnancy. 

The product is expected to be filed with the Therapeutic Goods Administration 
(TGA) in 2020 with potential launch in the second half of calendar 2021. On 
approval, the product is expected to receive five years of data exclusivity 
from the TGA as it is a new chemical entity. Additionally, Mayne Pharma has the 
option to obtain a license to register and launch E4/DRSP in New Zealand.

Mayne Pharma's CEO Scott Richards said, "We are very pleased to have extended 
our license for E4/DRSP, an innovative oral contraceptive, for the Australian 
market. E4/DRSP has a unique mode of action that has shown promising results in 
two phase 3 clinical studies conducted in 4,400 women with positive outcomes in 
efficacy and safety and also showed good bleeding profile, cycle control and 
tolerability." 

"This is the third transaction we have completed with Mithra who is also our 
partner for generic NUVARING(R) and E4/DRSP oral contraceptive in the US 
market. We look forward to working closely with the Mithra team on the 
commercialisation of these key pipeline products over the next 18 months as 
well as exploring further opportunities to deepen our relationship in the 
women's health therapeutic category." 

The Australian contraceptive market is valued at A$130m according to IQVIA with 
the short acting combined (estrogen + progestin) hormonal oral contraceptives 
estimated at A$70m with approximately 14m units sold annually[1]. 

Mithra's CEO, Mr Francois Fornieri said, "We are delighted to have further 
strengthened our strategic relationship with Mayne Pharma to now bring E4/DRSP 
to the Australian market. Mayne Pharma has extensive commercial capabilities 
and infrastructure to support the launch in Australia and will be able to 
leverage from launching the product in the US, the world's largest 
pharmaceutical market, which is targeted for the first half of calendar 2021." 

[1] IQVIA, MAT Sales and units, Dec 2019. A single unit is equivalent to one 
28-day cycle.
 

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.

Mayne Pharma Australia in-licenses pharmaceutical products from international 
partners in a number of therapeutic areas including women's health such as 
MONUROL® (fosfomycin trometamol) for the treatment of acute urinary tract 
infections in females. 

MONUROL(R) and NUVARING(R) are registered trademarks of third parties.

Source: Mayne Pharma