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This procedure involves a small, lighted telescope called a hysteroscope being placed into the cervix through the uterus. Saline solution is injection into the uterus expanding the uterine cavity and allowing the investigation of the uterus.


About Richter and PregLem SA

PregLem Holding SA, the wholly owned subsidiary of Richter, is a Swiss speciality biopharmaceutical company, based in Geneva, dedicated to the development and commercialization of a new class of drugs for women’s reproductive health conditions.

In February 2012, PregLem announced full results of PEARL I and II studies on the use of ulipristal acetate (Esmya®) in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
In the following months, the company filed for the initial marketing authorization by the European Commission, which was successfully granted.

In May 2015, Gedeon Richter Plc. announced that the European Commission (EC) has granted an extension to initial indication – an approval for the intermittent use of Esmya® 5mg in the long-term management of uterine fibroids (myomas). This decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 23 April 2015 and is applicable for all Member States in the European Economic Area.

The recent approval provides an opportunity for women to benefit from long-term medical management of uterine fibroids and potentially avoid surgery.

The approval is based on the assessment of two long-term Phase III studies, PEARL III extension and PEARL IV, involving 132 and 451 patients respectively, both designed to evaluate the efficacy and safety of ulipristal acetate (Esmya®) as a long-term treatment of uterine fibroids.

Visit Gedeon Richter Corporate Website

An expanding product portfolio

The Richter brand is known all over the world. The Richter Group produces about two hundred pharmaceutical products in more than 400 presentations. The product portfolio covers almost all important therapeutic areas, including gynaecology, central nervous system and cardiovascular. Thanks to its internationally acknowledged expertise in steroid chemistry, Richter is a leading player in the field of gynaecology worldwide. Furthermore, the biotechnological facilities, among them a new plant in Hungary, will help the Company expand its product portfolio with products offering high added value.

Development of generic drugs and chemical processes as well as biotechnology

labo richter

Innovation has been a defining element of Richter’s strategy since its establishment. Today, with a 1000-strong research and development team in Hungary, the company boasts the Central-Eastern European region’s largest centre for pharmaceutical research. Original research focuses on CNS disorders, with main clinical targets being schizophrenia, anxiety, chronic pain and depression, as well as the treatment of benign gynaecological conditions. Richter is also engaged in the development of generic drugs and chemical processes as well as biotechnology. When compared with other firms in Central Eastern Europe, Richter spends the highest ratio, on average 10 per cent of its revenue, on R&D.

A 112-year-old company present in more than thirty countries


It was in 1901 that the company’s founder, pharmacist Gedeon Richter obtained a license to produce medicines. He bought “Sas” pharmacy, still today owned and operated by the company, and started small-scale pharmaceutical production. The young pharmacist always recognized and took advantage of new opportunities, laid great emphasis on innovation, product quality and international relations. Today, Richter is present in more than thirty countries thanks to its five production sites, thirty representative offices, thirty-five commercial subsidiaries and wholesale joint ventures.

About Gedeon Richter

Headquartered in Hungary, Gedeon Richter Plc. is one of the largest pharmaceutical multinationals in Central Eastern Europe, with an expanding direct presence in Western Europe in the field of gynaecology. On a mission to improve the quality of human life, the company’s objective is to deliver advanced and affordable medicines to the public.

Risk factors

While there is no clear consensus and limited literature regarding predisposing risk factors for development of uterine fibroids, risk of uterine fibroids has been associated with such factors as age, ethnicity, family history, reproductive factors, lifestyle and medical conditions, and use of exogenous sex steroids10.

Women are most likely to be diagnosed with fibroids during their forties; however, it is not clear whether this is due to an increased formation or increased fibroid growth secondary to hormonal changes during this time10.

Fibroids are more common in Black women than Caucasian women, and in fact are estimated to be 2-3 times higher in women of African descent compared to European descent, however the incidence reported may be due to health access, method of diagnosis or verification of self-reported diagnosis20,21.

Although no specific gene has been identified as the cause of non-syndromic fibroids, there is convincing evidence of the role of heredity as a risk factor for uterine fibroids 22. Furthermore, it appears that fibroids with familial prevalence behave differently from those that occur sporadically in families, lending weight to the argument that fibroids are not a uniform pathological condition13.

Several studies have shown that reproductive factors including age at menarche, parity, pregnancy, interval since last term pregnancy and levels of endogenous hormones are associated with uterine fibroids13, 23-30.

Lifestyle and medical conditions, including non-smoker status, a diet rich in red meat and obesity have all been linked with an elevated risk of uterine fibroids 10, 13, 23, 31-36.


The true prevalence of uterine fibroids is often underestimated, as women who do not come into contact with healthcare professionals are not captured in the incidence statistics. However it is known that incidence increases with age 8.

Uterine fibroids are the most common benign tumours in women of reproductive age with a clinically relevant prevalence in 20-40% of women during their reproductive years2, although they are rare in teenagers. They are more common in Black women than Caucasian women, and in fact are estimated to be 2-3 times higher in women of African descent compared to European descent18.

Around 25% of these women will have symptoms that impact activities of daily life or require treatment19.

Prevalence of uterine fibroids in Europe

Figure illustrating Prevalence of uterine fibroids9


Figure illustrating Prevalence of uterine fibroids9