[Seoul = Healthkoreanews] Kanarb Developed by BoRyung Pharm on the Bases of New Working Mechanism which was the first Korean genuine new antihypertensive (No. 15) having Fimasartan kalium three hydrate as an active ingredient. This will be marketed in both the domestic and international market during the first semester in this year.
This new one seemed to be recognized in the world market as a world new drug. The clinical study data were exposed at the International Society of Hypertension of Vancouver to about three hundred worldly medical scholars and other thousand participants including Dr. Anthony Heagerty, distinguished medical society chairperson and Dr. Lisheng Liu, the chairperson of the Chinese Society of Hypertension. The BoRyung R & D staff was very much surprised at the keen attention by most of the medical doctors and participants in the meeting.
The antihypertensive, Kanarb originated in Korea was developed purely by BoRyung Pharm of which the active ingredient was ‘Fimasartan K’. This new drug was born by the dedicated leadership of Mr. Kim, Seung-Ho, Chairperson of BoRyung Pharm that was called a living history of Korea Pharmaceutical Industry.
The market size of Korea antihypertensives in 2010 was estimated to 1.4 thousand billion Won which reached 15.4 % of the the total domestic pharm production, 1.2 trillion Won. Most of 228 GMP pharm companies produced this kind of antihypertensives.
But most antihypertensives produced domestically are the generics made with imported APIs and only a small portion of them are selfdeveloped as a complex types. Furtherless, the original such as amlodipine besylate of ARB(angiotension receptor blocker) gave rise to Norvasc (Pfizer/90 million Won in 2010) which represented the main stream of antihypertensives along with CCB(calcium channel blocker).
The professional survey organizations including IMS estimated the world antihypertension market as 40 billion dollars with patients of 200 million. Among them, ARB occupied 28 % and CCB had 27 % portion which are from foreign origins.
Made a high assessment by thousands of professionals in effectiveness and stability on Kanarb in the International Society of Hypertension in Vancouver.
When the world market gets increased, the current Korean pharm industries can not catch up the foreign pharm companies without any new innovative drugs.
The world market size of the preion drugs in 2010 is about 650 billion dollars of which the preion portion of the antihypertensives takes 40 billion dollars of 6.15%.
Kanarb of BoRyung at this moment means a golden egg like Norvasc. BoRyung has a timely chance to step up to the world pharm market.
What’s Kanarb? This is the medicine successfully developed for 12 years since 1998.
This medicine is the only one through the phase 3 as a domestic antihypertensive. The clinical data have been presented at the symposium of the International Society of Hypertension with the title of ‘A new Approach of Hypertension Assessment’. The Canadian clinical report (Sep. 2010) exposed the clinical data of BoRyung’s Kanarb of which Fimasartan was the active ingredient in comparison of Losartan.
Massive Clinical Study with 2,000 Patients in 60 General Hospitals of Korea.
The symposium was proceeded into 3 sessions. Prof. No, Yong-Moo(Director of Sejong General Hospital), Prof. Oh, Byung-Hee (Medical School of SNU), and Chief Director, Lee, Myung-Mook of Korea Society of hypertension (Director of Ilsan General Hospital) took parts of presiders. The clinical results presented each other by Prof. Park, Jung-Bae (Jeil General Hospital), Prof. Kim, Gi-Shik (Medical School of Gye Myung University), Prof. Choi, Dong-Joo (Medical School of SNU).
Launching in the Upper Semester – Sales Prediction of 200 billion during the coming 3 years in Korea. The symposium participant, Mr. Heagerty, Chairperson of the International Society of Hypertension and Mr. Liu, Chairperson of the Chinese Society of Hypertension made a high evaluation on the clinical data of Kanarb. And also other scientist confirmed that the data was trustable and the new drug would be recognized as a world innovative drug.
The scholars in the symposium evaluated the Kanarb as follows; ▶able to make a complex with AT1 receptor selectively and efficiently. ▶absorbable quickly and not easily cumulative ▶quickly active and controllable for 24 hours ▶shows prominent blood pressure down within 1-2 weeks after administration ▶quicker effect compared with other ARB drugs and better stability. And also estimated excellent in effectiveness, stability and pharmacokinetics. It was the first time that abroad professionals evaluated a Korean new drug, Kanarb very high in the International Symposium.
BoRyung Pharm showed a positive attitude in both clinical process and PMS plans.
▶The clinical study included more than 2,000 patients over 60 general hospitals and preserved the recognizable level toward the world market as a new antihypertention drug. ▶The PMS will be planned to perform 3 years with 5,000 patients using 35 billion Won after launching. This plan is the first and most cases as a domestic new drug which will defeat the clinical PMS plan of the multinational innovative new drug.
BoRyung will seem to meet the 2nd golden age with this ambitious Kanarb since the launching of Yong Kak San and Gelfos.
In draws <1>, <2> and <3>, Kanarb showed significant excellences in blood pressure controls in comparison with other antihypertensives. The medication dose of Losartan was 50-100 mg while that of Fimasartan was 60-120 mg.
Compared results from the phase 2 clinical studies of ambulatory blood pressure monitoring between Fimasartan and Valsartan. The group administered with 60 mg once a day showed a stable blood pressure drop in both SBP and DBP, which represented more blood pressure dropping effect than that of the reference group with Varsartan.
<Chart 2>
In the phase 3 clinical study for the FDA approval, the experimental group showed the statistically significant blood pressure drop compared to the reference group from 4 weeks through 12 weeks of the end point. At the point of the 12th week in the aspect of DBP change, the Fimasartan group showed -11.26 and 7.53 mmHg while the Losartan group showed -8.56 and 7.72 respectively (p<0.0001). At the same point of the 12th week, the DBP blood pressure drop change indicated 2,70 mmHg between the groups of Fimasartan and Losartan, and also DBP change showed the significant changes in the two points (p=0.0002). Therefore, it was confirmed that the Fimasartan group showed the superior DBP blood pressure drop to the Losartan group at the 12th week.
<Chart 3>
The Fimasartan group was confirmed to be superior SBP blood pressure drop to the group of Losartan and From the base line, the SBP changes at the 4th, 8th and 12th weeks showed -13.61, -17.84 and 17.57 mmHg, respectively for the Fimasartan group in the mean time, -10.51, -13.54 and -14.21 mmHg for the Losartan group. Respectively. The differences between two groups were statistically significant (p-value <0.0001). Also, the differences between two groups in the SBP changes at the 4thm 8th and 12th week turned out to be statistically significant. <Republic of Korea medical journal>
