In October 2010 we acquired PregLem a Swiss based, specialty pharmaceutical company engaged in the development of a new class of drugs for the treatment of benign gynaecological conditions. PregLem focuses on women’s reproductive medicine with significant unmet medical needs, such as uterine fibroids (myoma), endometriosis, infertility and post surgical abdominal adhesions. PregLem currently has five projects in clinical and pre-clinical development. 
Its most advanced product, PGL4001 Esmya™ (ulipristal acetate), completed Phase III clinical trials in June 2010 for the treatment of uterine myoma, a common benign tumor in women of reproductive age. Ulipristal acetate is a first-in-class, orally active selective progesterone receptor modulator which reversibly blocks the progesterone receptors in target tissues. A European MAA filing for Esmya™ was made in December 2010. This strategic move further increases Richter’s exposure to specialty pharma, based on its widely acknowledged steroid chemistry expertise and complements Richter’s existing Women’s Health franchise.

At the end of 2010 the clinical portfolio was the following:

Based on our long term almost 50 year experience in the area of classical fermentation, combined with molecular biological knowledge, a strategic decision was made by the management in 2006 to start recombinant biotechnological activities at the Company. The Hamburg based Richter-Helm biologics, established jointly with Helm AG, carries out development and manufacturing of microbial proteins. In addition, a biotechnology laboratory and pilot plant in Budapest became operational in 2009. Meanwhile a greenfield investment which was commenced in Debrecen in 2008, progresses according to plans. This facility will enable us to produce the most complex mammalian cell products from 2012 onward. These monoclonal antibodies are considered to be one of the most up to date areas of pharmaceutical therapies.

The Company considers it essential to establish partnerships to facilitate the development and marketing of new molecules. We join forces with academic and university institutions in the early phase of our research activities, while we make efforts to establish cooperation with other pharmaceutical companies when it comes to the development of molecules in clinical phases. In this regard partnerships with the US-based Forest Laboratories and with the Japanese Mitsubishi-Tanabe Pharmaceuticals have contributed substantially to the Company’s research activity. In particular Richter’s experience in preclinical trials has complemented well with Forest’s experience in clinical trials. In December 2010 Richter and Mochida Pharmaceutical Co. Ltd. signed a comprehensive and long term license and collaboration agreement in 
respect of the development and marketing of Richter’s biosimilar product portfolio. Together with Mochida’s contribution it establishes the presence of biosimilar products developed and manufactured by Richter on the Japanese market.

Generic development work in several therapeutic areas continued in 2010 at the Parent company and at its two subsidiaries in Poland and Romania, all of which is coordinated by the Director of Development. The Group’s target is to launch at least 5-7 new generic and branded generic products per year on its traditional markets, i.e. Hungary, CEE and CIS. Licensing-in activity increasingly contributes to the continuous development of the Group’s product portfolio. Process 
development activities and bioequivalence studies on several active pharmaceutical ingredients and finished products continued during the year.

As a result of the Group’s development activity we further enhanced during 2010 our female healthcare product portfolio.

Several products developed in-house were introduced during 2010, namely the cardiovascular rosuvastatin containing cholesterol lowering product, in the following countries – in Hungary, in the Czech Republic, in Poland, in addition in Slovakia and in Bulgaria (under different brand names). 

The Group reported in 2010 a 15.1 percent increase in its spending on research and development which totalled 
HUF 27,126 million (EUR 98.3 million), representing 9.9 percent of consolidated sales. 

Licence-in