[THE INVESTOR] The US Food and Drug Administration has rejected Daewoong Pharmaceutical’s application seeking approval of its botulinum toxin Nabota, also known as DWP-450, the company said on May 17.
Daewoong shares fell 3.86 percent after the Korean drug maker revealed that its US partner Evolus had received a complete response letter from the health regulator on May 15 which will delay its entry to the key market.
“Daewoong and Evolus will refile an application at the earliest possible time with supplementary documents. The review is expected to take several months,” the Korean firm said in a statement.
It had submitted a biologic license application for Nabota, a treatment for glabellar lines in adult patients, in May 2017 hoping to bring the wrinkle treatment to the US by end-2018.
Nabota, Daewoong’s key pipeline asset for its initiative to reinforce overseas business, was widely expected to be the first botulinum toxin developed by a Korean company to enter the US while other local peers like Hugel and Medytox are gearing up to make inroads into the world‘s largest botulinum toxic market.
“The best case scenario for Nabota will be to get approval nine months later. Previously, we expected the approval would come in August, but we have revised it to the first quarter of next year due to the issuance of complete response letter,” said Shin Jae-hoon, an analyst at eBEST Investment & Securities.
In a separate statement, US biotech firm Evolus said deficiencies cited by the FDA were isolated to items related to chemistry, manufacturing, and controls processes and “no deficiencies were related to clinical or non-clinical matters.”
Although the anti-wrinkle injection has faced a setback, it also made regulatory progress as Daewoong received a favorable inspection report of its manufacturing facilities in Korea, which were purpose built for production of the treatment. Production sites are required to pass the FDA’s inspection for a potential drug to receive approval.
In 2013, Daewoong signed an exclusive license deal with Evolus to export Nabota to the US and Europe. The deal was worth 300 billion won (US$278 million) based on the five-year export value.
By Park Han-na (firstname.lastname@example.org)