One of Richter’s most important niche areas is its gynaecological business. The Company has unique and long-term experience in this field dating back to when its founder, Mr. Gedeon Richter, began to experiment with steroids. This was at a time when they had complete novelty. Since then the Company has consistently utilised its pharmaceutical manufacturing facilities to undertake the required complex and lengthy processes which result in high quality gynaecological products.
Currently, Richter makes available one of the widest range of female healthcare products from any company in the world while continuing to broaden its product portfolio. A key element of the Company’s strategy has been and remains the development of its gynaecological business. This therapeutic area represented 35 percent of the Group’s pharmaceutical turnover in 2009 and increased by 14 percent in EUR terms when compared to 2008. This product group contributed substantially to the Group’s turnover on each of its international markets. Gynaecological products represented 21 percent of total CIS sales, 28 percent of turnover in the EU region and 92 percent of total US sales during 2009.
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 second and third generation oral contraceptives and emergency contraceptives providing a wide range for the female population to choose those products which fit most to their personal needs.
Usage of oral contraceptives within fertility age women has gradually increased in the Central Eastern European and CIS regions, currently 4 percent in Russia, 9 percent in Romania, 14 percent in Poland, 15 percent in Slovakia, 19 percent in Hungary and 35 percent in the Czech Republic. These levels remain relatively low compared with 33 percent in Germany, 40 percent in France and 45 percent in the Netherlands and provide room for further growth in this therapeutic area by our Company. Being one of the largest pharmaceutical players in the region of CEE and CIS, management considers these markets to be one of the major potential drivers of growth in the coming years.
In accordance with our main strategic objectives the Company continued to launch new contraceptive products on its markets during 2009.
The range of contraceptive products was one of the key drivers of growth in Hungary, in Russia, the Czech Republic and Slovakia. Richter’s main strategic partner for API sales is the US based Teva-barr, which, according to IMS statistics, is the second largest player by value on the hormonal contraceptive market in the USA. The Company supplies steroid APIs for nine of Teva-barr’s range of oral contraceptive products. Richter supplies also the emergency contraceptive PLAN b in finished form to Teva-barr and this product also showed good results in 2009. A new emergency contraceptive PLAN b ONE STEP (1.5 mg levonorgestrel 1x) developed and manufactured in finished dosage form by Richter in partnership with Teva received final FDA approval in July 2009 and was introduced on the market in the third quarter of 2009.
In addition in June 2008, Richter also signed a profit sharing agreement with barr in respect of drospirenone, and the related revenue significantly contributed to the Company’s sales levels and profitability achieved in 2009.
In January 2009 Richter signed a distribution and marketing agreement with HRA Pharma. According to the agreement Richter will market and distribute HRA Pharma’s product ELLA ® / ELLAONE ®, an innovative next generation emergency contraceptive, containing a new chemical entity, ulipristal acetate. This product was launched in Hungary and in certain CEE countries during 2009.
The menopause is a period of natural transition which every woman eventually experiences. Unfortunately the decline in estrogen production that characterises this transition can have short and long term implications. It is no secret that the menopause might have a negative influence on the quality of life. Furthermore, estrogen loss is closely associated with the development of osteoporosis and fractures. Our aim is to maintain women’s health and quality of life over the long term.
Gedeon Richter Plc. offers a wide range of HRT products and continuously expands its product portfolio. In order to meet women’s needs for using the most convenient treatments possible, we pay particular attention to keep up with the most developed technologies and formulations. As a result, during the past few years we have licensed for marketing in Hungary, in certain EU member states and some of the RoW countries two HRT patches, which ease women’s life and provide a safe and comfortable solution for their menopause problems.
Richter’s overall target is to offer a complete range of female healthcare products and in accordance with this objective we also provide treatment for gynaecological infections. In 2004 we licensed in from Kv Pharmaceuticals the antifungal GyNAZOLE-1 and the antibacterial CLINDESSE with an innovative drug delivery system. In June 2009 the two companies (Richter and Kv) entered into a further license-in agreement, which permits Richter to use Kv’s proprietary technologies. The technology transfer of the vagiSite Drug Delivery System was completed during the second half of 2009, and this enables Richter to manufacture products via this technology for both the EU and CIS regions.
In addition, in 2009 Richter licensed in from Radelkis IUD (Inter Uterine Device) a non hormonal spiral, medical device with a special composition, the registration of the product line being valid for all EU countries.