HRA Pharma's Partner, PregLem, The Wholly Owned Subsidiary Of Gedeon Richter Plc, Receives Positive CHMP Opinion For Uterine Fibroids Treatment
HRA Pharma announces that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), has issued a positive opinion recommending a marketing authorization for Esmya (ulipristal acetate) for pre operative treatment (3months) of moderate to severe symptoms in patients with uterine fibroids. Subject to approval by the European Commission, PregLem, a wholly owned subsidiary of Gedeon Richter, is expected to receive a marketing authorization for Esmya valid for all European Union Member States in early 2012.
In European studies, ulipristal acetate has been shown to be an effective and safe treatment for uterine fibroids (myoma), a condition that affects millions of women worldwide. The condition is the most common type of non-cancerous hormone-dependent tumour of the female reproductive system.
The CHMP positive opinion is based on a comprehensive quality, preclinical and clinical data package which has been under evaluation as a part of the EMA centralised procedure since late 2010. The European Commission will now review the recommendation in order to grant a community marketing authorisation which will be valid throughout the European Union.
Erin Gainer, CEO of HRA Pharma underlined, "HRA Pharma has a declared mission to ensure that women worldwide have as much access to progressive healthcare as possible and the CHMP's opinion moves us and our partners closer to achieving this goal. We are keen to bring the product to market in other territories across the world and continue to seek partners with a commitment to women's health in Asia, Pacific, Latin America and Africa".
Erik Bogsch, CEO of Gedeon Richter Plc. commenting on the positive opinion said: "Richter is dedicated to bring to market innovative, patient-friendly treatment like Esmya that will improve and simplify the treatment of patients with fibroids", said Erik Bogsch, Managing Director of Gedeon Richter Plc. "We are encouraged by this positive opinion from the CHMP and we shall do our best to make Esmya available to physicians and patients in Europe during 2012 and later on in Russia, in other CIS republics and also in China."
Ernest Loumaye, CEO of PregLem, added, ‘We have developed ulipristal acetate to produce this new chemical entity as a treatment for uterine myoma, a condition which affects approximately 40% of women between the ages of 35 and 55, including 24 million women in Europe. Uterine myoma significantly impairs women's quality of life, often leading to hysterectomy and we are delighted that we're now one step closer to providing an effective treatment."
HRA Pharma has licensed the development rights of the ulipristal acetate molecule for benign gynaecological disorders to PregLem, a wholly owned subsidiary of Gedeon Richter Plc. Richter is itself an expanding multinational pharmaceutical company which acquired PregLem in October 2010 as part of its growth strategy and as a result, procured the marketing and distribution rights for Esmya in the European Union and North America in addition to China, Russia and other CIS countries. HRA Pharma retained the worldwide rights to the compound in other countries worldwide.
Shin Poong Pharma in South Korea and Aska Pharmaceutical in Japan also partner HRA Pharma and hold these rights in their respective markets.
About uterine fibroids
Uterine fibroids are the most common type of non-cancerous hormone-dependent tumor of the female reproductive system. The condition affects between 20-50% of women, and is most common in women between the ages of 35 and 50. Symptomatic uterine fibroids are characterized by excessive uterine bleeding, pain, anemia or infertility. There are no effective, well tolerated medications available. Treatment most frequently consists of surgery and interventional radiology.
About HRA Pharma
HRA Pharma is a privately-held European pharmaceutical company that designs products, devices and supporting services in niche areas of health and makes them available to doctors and patients worldwide. The company targets therapeutic gaps in the areas of reproductive health and endocrinology, and uses innovative marketing solutions and socially-conscious programmes, such as contraception education in developing countries, to promote healthy management of drugs and diseases. Headquartered in Paris, France and with offices throughout Europe, HRA Pharma has built a strong network of R&D, manufacturing, distribution and NGO partners which enables it to satisfy critical patient needs and improve patient health in over 50 countries across the globe. For more information, visit www.hra-pharma.com.
About Richter Plc
Gedeon Richter Plc., headquartered in Budapest/Hungary, is a major pharmaceutical company in Hungary and one of the largest in Central Eastern Europe, with an expanding direct presence in Western Europe in the field of gynaecology. Richter's consolidated sales was approximately EUR 1 billion (USD 1.3 billion) while its market capitalization amounted to EUR 2.9 billion (USD 3.8 billion) in 2010. The product portfolio of the Company covers almost all important therapeutic areas, including cardiovascular, central nervous system and gynaecology. The Company has the largest R&D unit in Central Eastern Europe. Original research activity focuses exclusively on CNS disorders with main clinical targets being schizophrenia, anxiety, chronic pain and depression. With its widely acknowledged steroid chemistry expertise the Company is also a significant player in the female healthcare field worldwide. For more information, visit www.richter.hu
About PregLem
PregLem is a Swiss speciality biopharmaceutical company, dedicated to the development and commercialization of a new class of drugs for women's reproductive health conditions. PregLem has an experienced senior management team, with a proven track record in developing, registering and commercializing reproductive health products. The company is owned by Gedeon Richter, a leading multinational pharmaceutical company headquartered in Budapest, Hungary. For more information, visit www.Preglem.com
SOURCE: HRA Pharma