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NEXTSTELLIS® oral contraceptive has been nominated for the 2022 prix galien usa award for best pharmaceutical agent

  • Written by PR Newswire

ADELAIDE, Australia, Aug. 2, 2022 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are pleased to announce NEXTSTELLIS® (drospirenone and estetrol tablets) has been nominated for the 2022 Prix Galien USA Award for Best Pharmaceutical Agent.

NEXTSTELLIS® is the first and only contraceptive pill containing a new low impact[1] estrogen, estetrol (E4), and a progestin, drospirenone. E4 is a natural estrogen produced by the human body during pregnancy and in NEXTSTELLIS® it is derived from a plant source. E4 is the first new estrogen introduced in the US in more than 60 years.

The Prix Galien was created in France in 1970 to reward innovative treatments and technologies that improve human health[2]. It is seen as an influential event to those interested in pharmaceutical development and is widely considered the industry's highest accolade for pharmaceutical research and development.

The Prix Galien USA Awards Ceremony to be held in October 2022 awards prizes for Best Pharmaceutical Agent, Best Biotechnology Product, and Best Medical Technology approved by the FDA in the past five years. The Prix Galien USA Awards Committee is comprised of 10 renowned leaders from the biomedical industry and academia, including two Nobel Laureates, and is responsible for evaluating the nominees.

About Mayne Pharma

Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on commercializing novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines. Mayne Pharma also provides contract development and manufacturing services to 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.[1] 

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.[2] 

About the Galien Foundation

The Galien Foundation fosters, recognises and rewards excellence in scientific innovation to improve the state of human health. Our vision is to be the catalyst for the development of the next generation of innovative treatments and technologies that will impact the state of medical practice and save lives. The Foundation oversees and directs activities in the US for the Prix Galien, an international awards program dedicated to progress through innovative medicines development, with chapters in 14 countries and Africa. The Prix Galien was created in 1970 by Roland Mehl in honor of Galien, the father of medical science and modern pharmacology. Worldwide, the Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical research.[3]


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 NEXTSTELLIS® tablets. 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 a predictable bleeding pattern with good safety and tolerability, as well as low rates of adverse reactions. 

NEXTSTELLIS® is a registered trademark of Estetra SRL, a Mithra Pharmaceuticals affiliates company.

[1] Based on its selectivity, potency, pharmacokinetics, mechanism of action and impact on the liver



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