Monumental Year Ahead For Korean Pharmas As New US Approvals Eyed
Executive Summary
2019 could be a monumental year for the South Korean pharma industry, as several new drug assets await the green light from the US FDA.
The South Korean pharma industry could be in for some pleasant surprises this year as several new pipeline drugs are slated to receive approvals from the US FDA or reveal their potential through key results from global Phase III trials.
If the first revolution in the Korean pharma/biotech sector was major out-licensing deals, and the second was global biosimilar leadership, the third major stage will be the first launches of drugs with global potential, according to Kiwoom Securities.
"In the end, South Korea needs a global blockbuster drug. We may be able to witness this process in 2019," said the brokerage in a recent research report.
SK First To Develop, Launch, Market New Drug In US?
SK Biopharmaceuticals Co. Ltd. will be at the center of attention this year, as two of its new drug candidates are now undergoing the regulatory approval process in the US.
SK Group's new drug development arm, which focuses on developing novel CNS medicines, filed an NDA for its anti-epileptic drug cenobamate to the FDA in late 2018 and could receive an approval late this year.
Through its US subsidiary SK Life Science, SK Biopharmaceuticals is seeking to not only take the product through the regulatory process but also to market it by independently, rather than seeking an out-licensing deal. If it successfully receives the approval, it will become the first Korean pharma firm to develop, launch and market an in-house developed new drug alone in a major global market. (Also see "Committing To Drug Development In World's Biggest Market: SK's Story" - Scrip, 13 Mar, 2018.)
SK Biopharmaceutical's sleep disorder drug candidate SKL-N05 (solriamfetol), which was licensed out to Jazz Pharmaceuticals PLC, is also undergoing regulatory review in the US, and the FDA's possible approval is expected in the first quarter.
Hanmi’s Poziotinib, Rolontis Set For US Approval
Hanmi Pharmaceutical Co. Ltd. is another company that could see some major approvals in global markets this year, although this time for drugs licensed out to overseas partners.
Although poziotinib, which is licensed out to Spectrum Pharmaceuticals Inc., did not get a Breakthrough Therapy Designation from the US FDA based on Phase II data in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 20 mutations, Spectrum said its overall development plan and timeline for an NDA filing based on the first cohort of the ZENITH20 trial remains unchanged.
The open-label, single-arm, multi-center global Phase II study is evaluating more than 300 NSCLC patients with EGFR or HER2 exon 20 insertion mutations. (Also see "Spectrum To Test Poziotinib's Potential As First Line Treatment Of Exon 20 Mutant NSCLC " - Scrip, 19 Sep, 2018.)
In late 2018, Spectrum also submitted a BLA with the US FDA for Rolontis (eflapegrastim), which is also in-licensed from Hanmi. (Also see "Spectrum Gears Up To File Rolontis, Stresses Patient Access " - Scrip, 2 Jul, 2018.)
The application is supported by data from two identically designed Phase III clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of Rolontis in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive cytoxic chemotherapy.
Phase III Outcomes For ViroMed, SillaJen
Late-stage pipelines at biotechs ViroMed Co. Ltd. and SillaJen Inc. will also be under the spotlight, as ViroMed is set to unveil the outcome of its US Phase III clinical trial for VM202 in painful diabetic peripheral neuropathy (PDPN), and SillaJen is expected to disclose interim results from a global Phase III trial of Pexa-Vec for hepatocellular carcinoma.
VM202 is a proprietary gene therapy targeting four different indications - PDPN, peripheral arterial disease, coronary artery disease, and amyotrophic lateral sclerosis.
The first US Phase III clinical in PDPN will end in the first half of 2019 and results are likely to be available in the latter half. As of June 21, 2018, 448 patients (94% of the planned total) had been randomized and 210 had completed the nine-month follow-up. The second US Phase III study, also in PDPN, is expected to be completed in 2020 or 2021. (Also see "ViroMed's Plasmid DNA Facility Buy Addresses Key Potential US Regulatory Hurdle" - Scrip, 23 Jul, 2018.)
SillaJen is expected to complete global Phase III studies with Pexa-Vec, an oncolytic virus-based immunotherapy,for hepatocellular carcinoma (Also see "BIO Korea 2016: SillaJen On Maximizing Value Of Pexa-Vec" - Scrip, 13 Apr, 2016.)), and to get results from a Phase Ib combination study being conducted with Regeneron Pharmaceuticals Inc.
Pexa-Vec (JX-594, pexastimogene devacirepvec) is the most advanced product candidate from the private South Korean biotherapeutics firm’s proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The therapy is based on the Wyeth strain of vaccinia virus and works through various mechanisms including direct cell lysis, adaptive immune response, and vascular shutdown. It is the first engineered oncolytic virus with demonstrated effective intravenous delivery to tumors.
GC Pharma, formerly known as Green Cross Corp., holds rights in South Korea, while Lee's Pharmaceutical Holdings Ltd. has licensed rights in China, Hong Kong and Macau, and Transgene SA in the EU, while SillaJen retains rights in all remaining territories.
Additional Licensing Deals After JPM?
The JP Morgan Healthcare Conference this week is also being keenly monitored for additional licensing deals between Korean companies and global pharmas, which have picked up speed in general in recent months.
Yuanta Securities noted that Hanmi's triple agonist for obesity/non-alcoholic steatohepatitis (NASH) is poised to complete a Phase I trial in the first half of this year, making it one of the anticipated candidates for a out-licensing deal, given that it has the only weekly formulation among competitors from other company such as Novo Nordisk AS and Sanofi.
How Korean biosimilars perform in the US market will also be closely watched this year, amid increasing competition in this and other global markets, further evidenced by AbbVie Inc.'s decision to cut the price of original Humira (adalimumab). (Also see "AbbVie Defends Humira With Aggressive Discount In First EU Tender " - Scrip, 1 Nov, 2018.)
Tax Incentives For Overseas Trials
Regulatory wise, South Korea's drug ministry has vowed to continue its efforts this year to speed up the launch of innovative drugs and cutting edge medical devices, as well as to improve the predictability and transparency of the approval process.
The government plans to provide tax incentives related to the R&D cost of Phase III overseas clinical trials, while stepping up efforts to establish digital healthcare bases.
From the editors of PharmAsia News.