[Seoul = Healthkoreanews] ‘Kanarb®’(Fimasartan), as Angiotensin II Receptor blocker(ARB), the most largely used class among all antihypertensive drugs, has its mechanism of action to reduce blood pressure through interrupting the combination between receptors and enzymes causing high blood pressure. Boryung has successfully completed Phase III at 24 local hospitals at the end of 2009 and new drug application has been officially approved by KFDA on Sep. 9, 2010. ‘Kanarb®’ has been launched since March 1st 2011 as the 15th new drug in Korea and at the same time the first new antihypertensive drug in Korea.
During 12 years of research period starting from the year 1998, the total investment cost reaches KRW 50 Billion, among them KRW 3.5 Billion supported by Ministry or Heath as a national project. If we take into consideration the candidate synthesis period from1992, the total period spent to develop this new drug is 18years.
Antihypertensive market is the largest market in Korea as well as in the world and our new drug, ‘Kanarb®’ has a quite significant meaning because it is a big challenge to the largest market as a Korean new drug. The total value of local Antihypertensive market is KRW 1.4 Trillion and the ARB class accounts for nearly half of the market in sales revenue. The annual growth rate of local antihypertensive market is 9%, but the ARB class is growing so sharply to reach 23% in the recent 3 years. Total value of global market is USD 36 Billion (KRW 42 Trillion) and also over 50% of the market is occupied by ARB class
Presently there are 7 ARBs on the Korean market : Losartan (‘Cozzar’, MSD), Valsartan (‘Diovan’ Novartis), Olmesartan(‘Olmetec’, Daiichisankyo) etc. and Valsartan is ranking no. 1 market share with the value of KRW 110 Billion including its combination drugs. All of them have been developed by not local pharmaceutical companies but foreign multinational companies. Of course, there were some local companies who tried to develop antihypertensive drug but, they gave up in the process of deveopment due to diverse difficulties such as inmarketability and low clinical results, etc.
Boryung will continuously invest in developing its diuretic combination in phase III at aim to launch in 2013 and CCB combination which is under development will be launched by 2014 in order to double its competitiveness in Antihypertensive market.
Boryung signed license-out agreement having a potential value of USD 22.6 Billion with Stendhal, a Mexican pharmaceutical company, for exclusive distribution of ‘Kanarb®’. Especially, entering Mexican market with our own brand ‘Kanarb®’, it could be an opportunity to globalize our brand and it has more important meaning more than a simple export business of the finished product.
Taking this opportunity, Boryung will promote ‘Kanarb®’ as a new global drug by extending the market all over the world.
The substance name of ‘Kanarb®’, ‘‘Fimasartan’’, is listed in INN (International Nonproprietary Name) of WHO in Jan. 2006 and it has obtained 32 compounds and process patents in 17 countries throughout Japan, Australia, 6 European countries, Mexico, Russia, etc., starting its patent application in USA in 2001,
It has advantage to enter global market since its pre-clinical and phase I clinical trials have been conducted and completed in Europe. Currently, Boryung design to export ‘Kanarb®’ toward USA, China, India, Europe etc. through diverse routes.
Considering the import substitution effect of the existing 7 ARBs, license-out and export, ‘Fimasartan’ will be a blockbuster able to create the sales scale of the trillion KRW in the global market. <Republic of Korea medical journal>
