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Apatinib, designated as European orphan drug..'Speeding' licensing-out to market
HLB announced on Mar 2nd that the target cancer drug Apatinib has been designated as an orphan drug for gastric cancer by the European Commission (EU) on Mar 1st (local time), which was developed and currently under a clinical trial by HLB’s subsidiary LSKB (LSK Biopharma).
In the European Union (EU), Apatinib has secured the right to market exclusively for a period of at least 6 years and up to 10 years with benefits such as expedited examination, fee reduction, etc., after completing the clinical trial.
It is generally known that the review process for orphan drugs in Europe is more difficult than the US Food and Drug Administration (FDA).
According to HLB, Apatinib is expected to be able to compete with Avastin (8.5 trillion won annual revenue), Herceptin (7.7 trillion won) or Cyramza (7 hundred billion won).
Both Avastin and Herceptin are injections and treatment costs are quite high, while Apatinib is oral use and only about one-tenth of the cost of existing injection anticancer drugs. According to Korea Health Industry Development Institute(KHIDI) and Health Technology Transfer Center(HTTC), gastric cancer treatment market is expected to be 11 billion dollar market scale by 2030.
As a result, Apatinib is expected to have momentum in the process of licensing-out negotiations and final commercialization, with surging sales in China already on the market and global phase 3 launch, followed by receiving orphan drug designation in Europe.
Meanwhile, Apatinib made 140 billion won as a gastric cancer treatment in China in 2016. Phase 3 clinical trial is in the process for added indication for lung cancer, liver cancer or more. Furthermore, Apatinib is undergoing phase 2 trials for a monotherapy in treating esophageal cancer and 1st-2nd line combination chemotherapy in treating gastric, lung, and esophageal cancer.
Apatinib’s Global phase 3 clinical trials plans to have 459 patients enrolled in the study at 95 sites in 12 different countries. The researchers' meeting (IM) and study initiation gathering (SIV) in each country are almost finished, and patient registration will begin soon, the company said. Upon completion of the Phase 2 clinical trial for colorectal cancer, it will be submitted to Korean and European licensing authorities for clinical approval.
Academic world has high expectations for Apatinib’s success. In april 2016, well known international journal “Nature Review” published an article titled “Targeted therapy: Apatinib- new third line option for refractory gastric or GEJ cancer” and discussed its potential for improved overall survival compared to other traditional treatment such as Avastin.