Milan, 24 octobre 2008 - Recordati annonce la signature d'un nouveau contrat avec Kowa Pharmaceutical Europe Co. Ltd. (Wokingham, Royaume-Uni, "KPE"), une filiale de la société pharmaceutique japonaise Kowa Co. Ltd. (dont le siège social est situé à Nagoya, Japon), pour la commercialisation et la vente de pitavastatin en France, en Espagne, au Portugal, en Grèce, en Irlande, à Chypre, en Turquie, en Russie et dans les pays de la CEI, ainsi qu'en Italie. Pitavastatin est une nouvelle "statine" pour le traitement de l'hypercholestérolémie. La demande de dossier d'approbation a été soumise par KPE à la fin août dans 7 des pays de l'UE couverts par le contrat en utilisant la procédure décentralisée (DCP). La demande d'approbation dans les pays restants relèvera de la responsabilité de Recordati.
Pitavastatin is already successfully on the market in Japan and in Korea, and in these countries it has reached a 10% market share. Launch by Recordati in the territories covered by the new agreement is expected to take place as from the second half 2010.
Pitavastatin is a competitive inhibitor of the enzyme HMG-CoA reductase. It decreases cholesterol synthesis, LDL and VLDL. These effects are concentration-dependent. In controlled clinical trials involving more than 1,600 patients, it has been shown that pitavastatin is more effective than other statins, since its affinity for the HMG-CoA enzyme is stronger.
The metabolism of pitavastatin is in minimal portion mediated by the co-enzyme CY-P (2C9 and 2C8), therefore, the potential risk for interactions with drugs that are metabolised by the same pathway is minimal. Pitavastatin is mainly excreted by the gastrointestinal tract, and a only <3% through the kidney, therefore, there is no evidence of accumulation after multiple doses of the drug.
The high bioavailability and long half-life of pitavastatin ensure the prolonged effect of the statin and support the rationale for a once-daily dosing.
Several clinical trials have shown that the treatment with pitavastatin induces a decrease in LDL-Cholesterol (the "bad" cholesterol) and a trend increase in HDL-Cholesterol (the "good" cholesterol). This has been observed in controlled studies, even in high-risk patients. When tested in long-term treatment protocols, pitavastatin showed a prolonged beneficial effect. In particular, over a 60-week period the stable reduction in LDL-C was maintained and the HDL-C concentrations continued to increase.
The safety profile of pitavastatin was extensively evaluated in controlled clinical trials versus placebo and other statins, also in elderly and diabetic patients. The adverse events observed with pitavastatin were generally mild and transient.
The effects of pitavastatin on both LDL-cholesterol reduction and HDL-cholesterol increase should be regarded as highly relevant, since it is known that their coexistence may reduce the relative risk of cardiovascular complications.
"This agreement with KPE represents an important opportunity for Recordati to extend its presence in the cardiovascular area, and in particular to be present in a significant way in the market for anti-cholesterol treatments, the most important therapeutic class in the global pharmaceutical market", declared Giovanni Recordati, Chairman and CEO. "The statins market in the 8 largest of the 21 countries covered by the agreement was worth E 2.8 billion in 2007 and is expected to grow further in the future, particularly in emerging markets such as Turkey, Russia and the C.I.S. countries. Pitavastatin is an innovative drug with an improved clinical profile over the statins currently in use which will allow us to reach interesting market shares in a very competitive drug class".
Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, isin IT 0003828271), dedicated to the research, development, manufacturing and marketing of pharmaceuticals, with headquarters in Milan, Italy, operations in the main European countries, and a total staff of over 2,400. A European field force of over 1,300 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati's current and growing coverage of the European pharmaceutical market makes it a partner of choice for new product licenses from companies which do not have European marketing organizations. Recordati is committed to the research of new drug entities within the cardiovascular and urogenital therapeutic areas in which its research TEAM has proven scientific competence and a track record of discovery and development of original drugs, the most recent of which, lercanidipine, a latest generation calcium channel blocker for the treatment of hypertension, is the company's leading product. Consolidated revenue for 2007 was E 628.4 million, operating income was E 131.5 million and net income was E 84.9 million.
Kowa Company, Ltd is a privately-held Japanese corporation headquartered in Nagoya. Since its establishment as a textile wholesaler in 1894, Kowa has grown into a multinational company with about 40 affiliates around the world and has built a strong position in developing, manufacturing, marketing and trading products within a variety of businesses. Kowa started pharmaceutical business in 1947 and has since built a strong presence in the discovery, development, manufacturing and marketing of prescription and OTC drugs in Japan and other Asian countries. Kowa is also active in the EU and US through its clinical development programs at Kowa Research Europe (Wokingham, UK) and Kowa Research Institute (North Carolina, US). For sales and marketing, Kowa Pharmaceutical Europe has taken responsibility in EU; in US, Kowa inaugurated Kowa Pharmaceuticals America (Alabama, US) as its commercial base in September 2008. Pitavastatin is expected to become the first Kowa product to be commercialized through KPE in collaboration with Recordati in EU and through KPA in US.
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Marianne Tatschke Claudio Rossetti (Echo Comunicazione d'Impresa)
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