Results from large-scale real-world safety study for oral combination contraception pill, Zoely® (NOMAC-E2), submitted to European Medicines Agency

LONDON, UK – 27 April 2021. Theramex, a global company specialised in women’s health, announced today that they submitted results from the post-authorisation safety study (PASS) for Zoely® (NOMAC-E2) to the European Medicines Agency (EMA).¹ NOMAC-E2 (which combines nomegestrol acetate [2.5mg] and 17β-estradiol [1.5mg]), contains oestrogen with an identical structure to the one naturally produced by women.²

The prospective, non-interventional controlled cohort study, one of the largest of its kind, known as PRO E2, was designed to compare the risks of using NOMAC-E2 versus combined oral contraceptives containing levonorgestrel (COC-LNG).^1,3 The study, conducted by ZEG-Berlin, was required by the EMA and initiated in 2014 (following a precursor study, CELINA, initiated in 2012) and closed in Dec 2020.¹ The results reflect real world practice in more than 100,000 women from across Australia, Austria, Colombia, France, Germany, Hungary, Italy, Mexico, Poland, Russia, Spain, and Sweden.³

Theramex CEO Robert Stewart commented: “The strength of this study further underscores our confidence in Zoely® as an effective and reliable first-line birth-control option for all eligible women.”

Professor Luis Iñaki Lete, Department of Gynecology, University Hospital Araba, Vitoria, Spain commented: “As clinicians, real-world evidence and ongoing safety monitoring is increasingly important to the decisions we make on a day-to-day basis for our patients. Studies of this size help guide our clinical practice.”

NOMAC-E2 has previously been shown to induce significantly less change in the overall activity of the coagulation system in a study comparing it with levonorgestrel/ ethinylestradiol.⁴

Ends

Notes to Editor:

About the PASS study

A post-authorisation safety study (PASS) is a study that is carried out after a medicine has been authorized to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures.

This study aimed to compare the risks of using NOMAC-E2 versus COC-LNG in a study population that is representative of the actual users of the individual preparations.¹

About Zoely® (estradiol hemihydrate, nomegestrol acetate)

Nomegestrol acetate is a highly selective progestogen derived from the naturally occurring steroid hormone, progesterone. Nomegestrol acetate has a strong affinity for the human progesterone receptor and has an anti-gonadotropic activity, a progesterone receptor-mediated anti-oestrogenic activity, a moderate anti-androgenic activity, and is devoid of any oestrogenic, androgenic, glucocorticoid or mineralocorticoid activity.²

Theramex was granted the exclusive licence and supply agreement for the product, a patented oral contraceptive that was subsequently commercialised in over 50 markets on a global basis by Teva in Jan 2020. MSD retains rights in the United States and Canada.⁵

About Theramex

Theramex is a leading, global speciality pharmaceutical company dedicated to women and their health. With a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis, we support women at every stage of their lives. Our commitment is to listen and understand our patients, serve their needs, and offer healthcare solutions to help improve their lives. Our vision is to be a lifetime partner for women and the healthcare professionals who treat them, by providing innovative and effective solutions that care for and support women as they advance through each stage of their lives.

www.theramex.com

Contacts:

Andrew Bradley, Head of Communications, Theramex / andrew.bradley@theramex.com / 07864 167962

Helen Rae / Makara Health / helenrae@makarahealth.com / +44(0)7503 652311

References:

1. ClinicalTrials.gov identifier: NCT01650168
2. Zoely® SMPC.  Available at: https://www.medicines.org.uk/emc/product/3038/smpc. Last accessed April 2021.
3. Reed S et al, A‘Real-World’ study population of NOMAC-E2 users and COC-LNG users: Baseline characteristics from the multinational PRO-E2 study. Pharmacoepidemiol Drug Saf. 2020;29(Suppl. 3):4
4. Gaussem, P et al. Thromb Haemost 2011;105:3
5. https://www.prnewswire.co.uk/news-releases/theramex-acquires-commercial-rights-for-oral-contraceptive-zoely-845938454.html