The new drug application by Orion Pharma for a triple combination tablet for Parkinson's disease is under review by the European Agency for the Evaluation of Medicinal Products (EMEA), the pharmaceutical regulatory authority for the EU countries. On 26 August, Orion Pharma announced the filing of a corresponding application with the U.S. Food and Drug Administration (FDA). The new pharmaceutical preparation combines the Parkinson's medicines, levodopa /carbidopa with entacapone in one tablet. Marketing authorisations both in the EU and the U.S. are anticipated in the latter half of 2003. Accordingly, the new treatment option could become available in the U.S. in late 2003 and in the EU in early 2004.
Levodopa is the most effective and widely used treatment of Parkinson's disease. Entacapone and carbidopa enhance the effect of levodopa by inhibiting two of its metabolising enzymes, COMT (catechol-0-methyltransferase) and DDA (dopa-decarboxylase). The rationale of putting the three active compounds into one tablet is to offer a convenient and more manageable means of administering the substances that belong together. The composition of three active ingredients in one tablet provides a more continuous delivery of levodopa whereby the benefits of the levodopa treatment are prolonged. Improved patient compliance could also be achieved as the number of tablets taken daily will decrease.
Three different strength combinations of the product are being registered, designed for use either as a stand-alone therapy or in combination with other Parkinson's disease therapies.
Entacapone, one of the three substances in the tablet, is a new proprietary medicine developed by Orion Pharma. It has been available so far under trade names Comtess (sold by Orion) and Comtan (sold by Novartis) and has been used as an adjunct to levodopa preparations. Since its introduction in 1998 in Europe and in 1999 in the U.S., inhibition of the COMT enzyme has been widely adopted by neurologists as a novel approach to relieve the symptoms of Parkinson's disease patients treated with levodopa.
Orion Pharma has a marketing agreement for the combination tablet with Novartis. A milestone payment of USD 3 million will be paid by Novartis to Orion Pharma based on the EU filing of the new drug application. A payment of USD 10 million was triggered by the U.S. filing.
Orion Pharma has marketing exclusivity for the combination product in Germany, the UK and Ireland, the Nordic and the Baltic countries, and some other areas. Moreover, Orion has the option to co-promote or co-market the triple combination in the USA, the largest single market, and in France, Spain, Italy and ten other countries.
Risto Miettunen, President, Orion Corporation, Orion Pharma, phone +358 10 429 4299,
gsm +358 50 429 4299
gsm +358 50 429 4299
Orionintie 1, 02200 Espoo
Corporate communications and investor relations:
Anne Allo, Corporate VP, Communications and IR
Phone +358 10 429 3735
Fax +358 10 429 2801