In the mid 1990's our USA business was scaled up initially by signing a strategic agreement with Duramed Inc. focusing on Richter's niche specialty area, Women's Healthcare, notably on oral contraceptives, which was extended both in scope and in duration with Barr Inc., who acquired Duramed. Subsequent mergers and acquisitions did not interfere with our long-term partnerships, which over time enabled our US presence to become a renowned Women's Healthcare API supplier.
A key element of the Company's strategy has been and remains the development of its Women's Healthcare product portfolio. In accordance with this strategy, two acquisitions were concluded during 2010, both of which further strengthened the Women's Healthcare portfolio. The acquisition of PregLem enabled Richter to enhance its portfolio with ESMYA®, a first in class product initially approved for preoperative treatment of uterine fibroids in 2012 for the member states of the European Union. Subsequent indications followed in 2014 and 2015 with a two-cycle treatment and a longterm intermittent treatment, respectively. The purchase of Grünenthal's well established oral contraceptive franchise boosted both our existing gynaecological sales and also created a platform for establishing a Women's Healthcare sales network in Western Europe.
Beyond the geographical expansion, it is an important objective for us to broaden and strengthen our Women's Healthcare product portfolio via establishing collaboration agreements with companies possessing promising products or development projects.
Agreements have been signed with companies including the Australia based Acrux for an estradiol transdermal spray therapy for menopause symptoms, with Allergan to commercialise its levonorgestrel releasing Intrauterine System (IUS), as a contraceptive device, and with the US based Evestra Inc., to cofinance its innovative gynecological portfolio through clinical development.
Uterine fibroids are the most common benign, solid tumours of the female genital tract, affecting between 20 and 25 percent of women of reproductive age. The condition is characterised by excessive uterine bleeding, anaemia, pain, frequent urination or incontinence and infertility. The 3 months once-a-day oral tablet containing 5 mg ulipristal acetate is effective to stop uterine bleeding, correct anaemia and shrink fibroid volume. It improves quality of life and has no castration side effects unlike GnRH agonists.
Based on licensing agreements signed with HRA Pharma in 2011 and 2013, Richter obtained marketing rights for ulipristal acetate for the CIS and China and the territories of Latin America.
In February 2012, the European Commission (EC) granted marketing authorization to ESMYA® 5 mg tablet as pre-operative treatment of moderate to severe symptoms of uterine fibroids. Following receipt of the marketing approval, the product has been registered and launched all across Europe, in the CIS region and also by our partner Allergan (earlier Watson / Actavis) in Canada. In May 2015 the EC granted approval for the intermittent use of ESMYA® 5 mg in the long-term management of uterine fibroids providing an opportunity for women to potentially avoid surgery.
The FDA requested inclusions of US population in the clinical trial and requested modification to the indication and primary efficacy endpoint to support a US approval. In 2016 and 2017, Allergan and Richter announced positive results from both Venus I and Venus II phase III clinical trials carried out in the USA, evaluating the efficacy and safety of ulipristal acetate in women with abnormal bleeding due to uterine fibroids.
Up to 25 percent of all couples may experience problems in conceiving a child, a figure that appears to be rising partly due to the trend to delay pregnancy. The World Health Organization estimates that there are about 60 to 80 million cases of infertility around the world. Being a responsible player in the pharmaceutical universe we are aware of the importance of productiveness of the female population and we are committed to addressing women's needs.
In June 2016 Richter announced the acquisition of Finox Holding, a Swiss biotech company focused on development and commercialisation of innovative and cost effective products addressing female fertility. BEMFOLA®, a recombinant-human Follicle Stimulating Hormone (r hFSH) was developed by Finox as a biosimilar to GONAL-f®, an established reference product. BEMFOLA® is produced using recombinant DNA technology. Both BEMFOLA® and the reference product GONAL-f® are formulations of the naturally occurring hormone FSH, which plays a key role in human reproduction. The worldwide gonadotrophin market is currently worth more than EUR 2 billion (EUR 1.5 billion ex-USA) and growing at about 4% per year, mainly fuelled by couples increasingly delaying starting a family.
BEMFOLA® is supplied in a single-use, unique, state-of-the-art delivery system which results in a simple, once-a-day disposable device, allowing the patient to self-inject.
BEMFOLA® was the first biosimilar r-hFSH launched in Europe.
We offer a broad range of contraceptive options to assist women to shape their lives according to their wishes. When it comes to the choice of contraceptive methods, reliability, safety, ease of use and convenience all play a major role. Step by step we have built up a product portfolio, which contains a number of first, second, third and fourth generation oral contraceptives and emergency contraceptives providing a broad range for the female population to choose those products which fit most with their personal needs.
In January 2017 Richter signed a distribution and supply agreement with Allergan to commercialise its levonorgestrel releasing Intrauterine System (IUS), as a contraceptive device, in Western Europe and in other European countries under the trademark of LEVOSERT®. The product is already marketed by Richter for the treatment of menorrhagia in most of the Central and Eastern European countries according to an agreement established with Uteron Pharma in 2011.
The menopause is a period of natural transition that every woman eventually experiences. The decline in oestrogen production that characterises this transition period can have short and long-term implications. It is no secret that the menopause might have a negative influence on quality of life. Furthermore, oestrogen loss is closely associated with the development of osteoporosis and bone fractures. Our aim is to maintain women's health and quality of life over the long-term.
According to an established cooperation with Acrux, an Australian drug delivery company, Richter commercialises Acrux's estradiol transdermal spray therapy for female menopause symptoms in all markets outside the United States.