Gedeon Richter acquires Marketing Authorisation for the first and only transdermal contraceptive patch licensed in the UK

Gedeon Richter acquires Marketing Authorisation for the first and only transdermal contraceptive patch licensed in the UK

London, United Kingdom, 8 December 2021 – Gedeon Richter UK Ltd. (“Gedeon Richter”) today announced that it has become Marketing Authorisation holder for Evra®, a once-weekly contraception for women of fertile age, and the only transdermal contraceptive patch licenced in the UK. Gedeon Richter acquired the rights from Janssen Pharmaceutica NV (“Janssen”), a wholly owned subsidiary of Johnson & Johnson, and the deal continues to strengthen the company’s position as a major player in providing women’s healthcare solutions. 

“The addition of a patch to our existing contraceptive delivery methods such as oral contraceptives, emergency contraceptives and our intra-uterine system, enables us to proudly offer a wide selection of family planning solutions to women in the UK,” said Tamas Neubauer, Managing Director UK and Ireland, Gedeon Richter. “The acquisition emphasises our commitment to providing healthcare professionals and women with greater choice in contraception. As one of only a few companies in the world to offer a comprehensive gynaecological portfolio, we have years of experience in women’s healthcare and won’t rest until women can.”

The National Institute for Health and Care Excellence (NICE) contraception guidelines state that women in the UK should be offered a choice of all contraceptive methods available, and provided the method of contraception that is most acceptable to them, as long as it is not contraindicated.

“Collaborative decision-making should help women choose a method that fits their individual circumstances, reducing the risk of dissatisfaction, misuse or non-use,” said Dr Ali Kubba, a London based specialist in contraception and reproductive health. “It is vitally important that companies recognise the importance of contraceptive choice, and bring a broad range of effective products to the market which make a difference to women’s health and fit with their differing lifestyles.”      

When used correctly, Evra® is over 99% effective at preventing pregnancy. The hormonal patch can be worn discreetly, and the convenience and simplicity offered versus daily oral contraceptives has been shown to provide high satisfaction rates among women. The once-weekly application results in high compliance. Evra® is a square patch that must be applied to the lower abdomen, buttocks, upper torso, or outer upper arm. Each patch is worn for seven days before being replaced, for three weeks. The fourth week is treatment free.

The safety and tolerability of Evra® have been analysed in a comparative study (812 patch, 605 oral contraceptives) and pooled analysis (3,330 patch) for up to 13 treatment cycles. With the exception of application site reactions, dysmenorrhea (pain associated with menstruation), and breast symptoms*, the incidence of adverse events with Evra® is comparable to oral contraceptives. Headache was the most frequently reported adverse event in the comparative study, occurring in 22% of the patch group compared to 22% in the oral contraceptive group.

*Breast symptoms include breast discomfort, engorgement and pain.