Oncology and Critical Care Therapy Area includes drugs used in the treatment of urological diseases and cancer, as well as treatments used in intensive care. The drugs used in the treatment of cancer and intensive care have a long history in Orion, and the R&D experts are at the top of their field. Originally, the research focused in the development of products related to hormone replacement therapy (Divigel, Diviseq, Divitren, Indivina) and intensive care (Simdax, Precedex). Fareston was Orion's first proprietary drug for the treatment of cancer.
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Currently, the main focus of the research in the Therapy Area is nuclear receptors (targeting hormonal cancers).
By numerous partner collaborations the research has been extended to other cancer types and supportive treatments for cancer patients. |
Orion is developing novel drugs for the treatment of cancer. The cancer research in Orion focuses mainly on receptors located in the cell nucleus. These receptors mediate hormonal effects in the body. Especially drug candidates affecting male sex hormone receptors are actively studied. These kinds of drugs have favourable effects, for example on muscle mass and bones, but not the unfavourable effects of enlarging the prostate. Such drugs can be developed for instance for the treatment of prostate cancer.
Development of the androgen receptor antagonist intended for the treatment of advanced cases of prostate cancer has moved to clinical phase trials in Europe in the first quarter of 2011 in collaboration with the US company Endo Pharmaceuticals Inc. An extensive cooperation agreement with Endo on the research, development and productisation of cancer drugs is a promising start for our research and development work in 2011.
Orion is actively reconstructing its cancer product portfolio also by acquiring development and marketing rights for patent-protected drugs. In year 2008 Orion signed a licensing agreement for European-wide marketing rights of Vantas® with Endo Pharmaceuticals Inc., a US-based company. Vantas is a novel, long-lasting hormonal implant for the treatment of advanced prostate cancer. The product was launched in the US in 2004. A Mutual Recognition Procedure for European approvals is currently under way in several countries, based on the marketing authorisation granted by Denmark in 2005.
Partnership with the Indian-based Aurigene Inc. aim at the development of novel cancer drugs. Partnership with Aurigene engages in early research on molecules related to cancer.
Orion has licensed out development of toremifene (a selective estrogen receptor modulator) to GTx Inc., located in the US. Toremifene is developed for the prevention of bone fractures, for the treatment of other side effects of androgen deprivation therapy, and also for the prevention of prostate cancer in high risk men. Marketing authorisation process of toremifene for the treatment of side effects of androgen deprivation therapy is currently under way in the US. A Phase III clinical study for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia (PIN) is currently ongoing.
In addition, in-licensing of various molecules for treatments of cancer and supportive treatment for cancer patients are under way. Orion has started partnership with Rëcro Pharma, a US-based company. The aim of the partnership is to develop new administration dosage forms and indications for dexmedetomidine.
Drugs in urology
Orion is actively reconstructing its product portfolio by in-licensing products also for urology. Kentera® (oxybutynin) is a treatment for overactive bladder (OAB). It is sold by Orion under license from the Italian company Recordati S.p.A. in a territory covering the Nordic countries and Switzerland. Kentera is indicated for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with unstable bladder. Kentera is the only non-orally administered product approved for OAB in Europe. It has no anticholinergic side effects, and it is dosed bi-weekly.
Drugs in intensive care
For patients in intensive care, Orion has developed an intravenously administered product dexmedetomidine used as a sedative. Orion markets dexmedetomidine in the EU markets mainly through its own organisation and under the tradename dexdor®. The product received an EU wide marketing authorisation in September 2011.
On markets outside Europe, dexmedetomidine is available under the tradename Precedex®. The US based Hospira Inc. markets the product in the US, Japan and several other countries outside Europe under Orion's licence.
Midex and Prodex research programs
Before the marketing authorisation application for Dexdor was posted for the European authorities, Orion conducted two Phase III clinical studies on dexmedetomidine. A total of 1000 patients were recruited into these studies comparing dexmedetomidine with currently used midazolam (the Midex program) and propofol (the Prodex program) as a sedative for patients in intensive care.
The results of the research carried out on dexmedetomidine show that the sedative is as efficient as the well-established comparators midazolam and propofol. In comparison with midazolam, dexmedetomidine also shortened the duration of respirator treatment.
Read more about the trials:
Midex
Prodex
Simdax® for acutely decompensated heart failure
Orion has developed intravenously administered levosimendan drug (tradename Simdax) for the treatment of acutely decompensated heart failure in intensive care and cardiac monitoring wards. The product is available in many countries. Orion has marketing rights for Simdax in all regions of the world except Latin America. Orion markets the product in Europe mainly through its own organisation and in other countries with the help of partners.
Updated
Nov 14th 2011