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IR NEWS LETTER
IR News Letter - Pre-NDA Meeting, JV with Neopharma and Paul Chen (10/01/2019)
1. Pre-NDA Meeting with FDA
Our subsidiary, Elevar, is planning to have a Pre-NDA meeting with the FDA on October 24. At this meeting, we will discuss the FDA's approval of new drugs for the 3rd gastric and 4th gastric cancer treatments. The details will be explained as follows.
Clinical patients in the ANGEL study are divided into 3rd line+ and 4th line +. Of the 460 clinical patients, 186 patients were 4th line+ and 274 patients were 3rd line+. The mix is 40% and 60% for 4th line+ and 3rd line, respectively.
1) OS (Overall Survival)
-3rd line+ indicators show 5.8 mo vs.5.1 mo, the p-value did not reach a statistically significant number, p <0.05, which was discussed in the June 27 Topline presentation.
-However, 4th line+ indicators show 6.3 mo vs. 4.7 mo, the p-value was 0.0195, which was statistically very significant.
2) Clinically significant PFS (Progression Free Survival)
PFS was 2.8 mo vs. 1.8mo (p-value <.0001)for 3rd line+ and 3.5 mo vs. 1.7mo for 4th line+(p <.0001), both statistically and clinically significant results were obtained.
3) Side effects (drug safety), an important consideration in other drug approvals, have proven to be excellent. Considering the safety of terminal cancer patients, the confirmation of safety is very important.
4) It is noteworthy that there was complete response (complete disappearance of the tumor), especially in patients with late gastric cancer.
5) Based on the data above, we will discuss the 3rd line and 4th line drug approvals with FDA. The 4th line is expected to have the new drug approval license because it has sufficient statistical and clinical significance. The 3rd line also aims to receive new drug approval by demonstrating clinical and statistically significant PFS and improvements compared to existing drugs.
In recent years, the FDA has focused on quality of life, focusing on PFS, as the OS has a high potential for contamination. FDA guidelines discuss that FDA would consider other data such as PFS. This is a comprehensive opinion of our internal and external experts and consulting firms.
2. Elevar and Neopharma signed JV agreement
On Thursday, September 26, Elevar and Neopharma signed JV agreement.
After investing a 50:50 stake between Elevar and Noepharma to establish a JV in the United Arab Emirates, the company plans to establish a sales network for Rivoceranib, a targeted anticancer drug, and conduct clinical trials for other pipelines and export Korean pharmaceuticals to the Middle East.
Neopharma is run by B.R. Shetty, the founder of NMC healthcare, the world's fourth largest hospital chain. We are expecting great synergies with Neopharma through this JV, as it is a global pharmaceutical company that vertically integrates from API manufacturing, pharmaceutical sales to sales network.
We will announce the master plan after the establishment of JV.
3. Dr. Paul Chen joined Elevar as a board member
CEO of the Advenchen Research Institute, Paul Chen, the molecule developer of the targeted anticancer drug, Rivoceranib for Elevar and Aitan for China’s Jiangsu Hengrui Medicine Co. Ltd., joined the board of directors of Elevar, a subsidiary of HLB.
Mr. Paul Chen, an ex-senior researcher and principal investor of Amgen, has been developing various new drug candidates since he founded the Advanced Research Institute in 2003. In particular, the targeted anticancer drug Rivoceranib is a new drug candidate developed by Mr. Paul Chen. After developing Rivoceranib, he moved all rights of Rivoceranib to Jiangsu Hengrui Medicine Co. Ltd. for China and to Eleva (formerly LSKB) for global regions outside China.
In his 36 years of experience in the pharmaceutical industry, his experiences are so deep from his discovery of new drug candidates to preclinical and clinical development. We believe he will be a great help for HLB’s Bio business.