Orion Corporation Orion Pharma has entered into a licensing agreement with Population Council, an international, nonprofit U.S. -based organization, providing Orion Pharma worldwide exclusive rights to develop, manufacture, market, sell, and sublicense the synthetic progestin Nestorone, for hormone replacement therapy (HRT) as a transdermal product other than patch. Nestorone is a new chemical entity that is not on the market with any indication in the United States, Europe, or Japan. The compound is an important addition to Orion Pharma's HRT portfolio. Orion is continuing the development in Phase 2 of a gel preparation containing Nestorone in combination with estrogen, for registration in the U.S. and Europe.
Orion Pharma has been studying Nestorone for several years and has reached a positive proof of concept. The results so far indicate that, unlike most progestins, Nestorone effectively penetrates the skin, exerts good progestational effects and is well tolerated.
Currently, there are no gel preparations available combining estrogen and progestin in the same product. Tablet formulations are predominant for HRT in most markets, but during the past ten years, estrogen, and lately also progestin, has become popular in transdermal form.
Nestorone is a registered compound. The basic patent has expired, whereas transdermal compositions containing Nestorone are patented by the Population Council. These patents provide protection until 2014 in the U.S. and until 2011 in Europe.
Steadily growing market
Ageing women are increasingly relying on HRT for relieving the often very uncomfortable symptoms of menopause. The essential treatment component is estrogen. For non-hysterectomised women, addition of cyclic or continuous progestin to estrogen is recommended to prevent endometrial hyperplasia and to reduce the risk of endometrial carcinoma that is associated with estrogen-only treatments.
About 25 million women worldwide pass through menopause every year, and by 2030, the world population of menopausal and post-menopausal women is projected to increase to 1.2 billion, with 47 million new cases each year. According to IMS World Review, the 1998 world market for HRT preparations was about 3.1 billion USD in ex-factory prices. The combined estrogen-progestin treatments accounted for 1 billion USD.
HRT is one of Orion Pharma's core therapy areas
HRT represents a remarkable business for Orion Pharma, contributing about 25 million euros to last year's net sales, and has been constantly increasing. Orion's HRT product portfolio currently comprises five different preparations based on Orion's own research: Divina, Divitren, Divigel, Indivina, and Diviseq, the two latter ones having received their first national marketing authorisations some months ago. Progestin is included in all of them except Divigel which is a transdermally applied estrogen gel preparation. Divina, Divitren and Indivina are also indicated for the prevention of osteoporosis.
Orion Pharma, a research-oriented pharmaceuticals division, is the core of the Orion Group, Finland's leading company for pharmaceuticals and healthcare products. With net sales of 2,6 billion FIM Orion Pharma accounted for almost one half of the Orion Group net sales and for close to three-fourths of the Group operating profit in 1999. Orion Pharma is the leader in the Finnish pharmaceutical market with a 19% share. Orion Pharma operates through its subsidiaries in nine European countries. Original proprietary drugs account for an increasing share of Orion Pharma's sales. The research focus is on HRT, CNS, cardiology, and respiratory diseases. More about Orion on homepage www.orion.fi.
Population Council is an international, nonprofit U.S.-based organisation concerned with reproductive health, population, and social policy issues around the world. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Through its Center for Biomedical Research, the Council develops and tests innovative products that respond to the reproductive health needs of women and men.