Orion Corporation announced today that it has signed an agreement with the French company Innothéra S.A to acquire back the exclusive sales and distribution rights for its proprietary hormone replacement therapy products Divina and Duova (in most other countries is known as Indivina) in France. Orion Pharma will begin to market and sell Divina as soon as the marketing authorisation transfer has been approved by the French Drug Regulatory Agency. Duova is planned to be launched in early summer after the French reimbursement authorities have concluded the price approval process.
During the first months following the agreement Orion Pharma will lease sales force from Innothéra to detail Divina and Duova to French physicians. Thereafter Orion Pharma will use its own sales force for detailing the product to specialists. Divina wholesales in 2001 in France were EUR 6.7 million.
By the agreement Orion Pharma strengthens the hormone replacement therapy product portfolio of its French subsidiary Orion Pharma S.A. which in the coming years intends to become a significant player on the French market in this therapy area. The retrieval of the marketing rights of Divina and Duova is in line with Orion Pharma's current strategy according to which the company intends to market its proprietary products to specialists in those countries where it has a subsidiary or a marketing organisation. The Orion Pharma S.A. portfolio includes an estrogen gel, Delidose (Divigel), which is already on the market, and Diviseq tablet, which will be launched later this year. If needed, Orion Pharma S.A. will use outsourcing arrangements to detail its products to general practitioners.
Divina is a biphasic estrogen-progestin combination product. Estrogen and progestin are administered sequentially, and the product mimics the natural one month menstrual cycle. The treatment can be started as soon as menopausal symptoms appear. Divina has been shown effective in alleviating menopausal symptoms and in prevention of osteoporosis. The addition of progestin protects the endometrium against hyperplasia. Divina is marketed widely in Europe, Australia, South America and South-East Asia.
Indivina is an estrogen-progestin combination treatment that is taken daily. Indivina eliminates menstrual bleedings and has been shown to be effective in alleviating menopausal symptoms and in prevention of osteoporosis. The product is safe to the endometrium. The dose of both estrogen and progestin can be adjusted to meet the patient's individual needs. Indivina has been launched in Sweden, the UK, Ireland, Finland, Germany, Denmark, the Czech Republic, Lithuania, Latvia, Russia and Switzerland. In the Netherlands, Luxembourg, Belgium, France, Spain, Iceland Portugal, Austria and Italy it will be launched in the near future.
Diviseq is a new, triphasic estrogen-progestin combination preparation. In Diviseq estrogen is given continuously throughout the 28-day cycle. Sequential dosing of estrogen and progestin mimics the natural one-month hormonal cycle. Diviseq is indicated for postmenopausal women and for women in early menopause. The product is approved in Finland, Germany, Norway, Denmark, Austria, France, Ireland, Portugal, Switzerland, Italy and Spain. Additional registrations within the EU are in progress through the Mutual Recognition process.
Divigel is an opalescent estrogen gel that is applied on the skin. The daily dose is packed in a sachet, which secures an exact dosing. Divigel can be started as soon as the first menopausal symptoms occur. It can be given continuously for women who have had a hysterectomy. If the uterus is intact, regular addition of progestin is required. Efficacy of Divigel is comparable to the oral and to other transdermal preparations. Skin irritations with Divigel are rare compared to patches. Moreover, the treatment is invisible. Divigel is marketed in Finland, Sweden, Denmark, Iceland, the Netherlands, Germany, Italy, Ireland, United Kingdom, Switzerland, Australia, Brazil, and Russia.