Daewoong seeks FDA approval for botulinum toxin
[THE INVESTOR] Daewoong Pharmaceutical’s botulinum toxin Nabota is expected to hit the US market by the end of 2018, fueling competition among rivals amid a near monopoly of Allergan.
The Korean drug maker’s US distribution partner Alphaeon said on May 17 it submitted a biologic license application for the Botulinum toxin Type A, with the US Food and Drug Administration seeking approval for the treatment of adult patients with frown lines. It generally takes about a year to clear the regulatory hurdle.
“Submission of the BLA within three years of the first study enrollment speaks of our experience, drive and commitment. We are excited to move one step closer to its commercial launch,” Chris Marmo, president of Beauty for Alphaeon, said in a press release.
According to the California-based biotech firm, a total of 1,500 adult male and female subjects participated in phase 2 and 3 clinical programs of the wrinkle smoother.
If successful, Nabota will 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.
Daewoong is hoping to begin shipping Nabota to the US in the second half of 2018 after receiving the FDA’s Current Good Manufacturing Practices certification for its new plant, located in Hyangnam, Gyeonggi Province, that will produce the wrinkle treatment. The CGMPs is required for drugs and most biological products to be legally marketed in the US.
Currently, the US botulinum toxic market, worth US$1.5 billion, is dominated by Allergan with a whopping 85 percent market share.
Korea’s Hugel is aiming to get final regulatory approval from US authorities for its own-developed Botulax later next year, while Medytox, which has partnered with Allergan, will begin phase 3 clinical trials for its liquid-injectable product Innotox later this year.
By Park Han-na (firstname.lastname@example.org)