drugset / Press release

Daewoong Pharmaceuticals announces the result of phase 3 clinical trial in US on Nabota

2016-04-08 · Daewoong Pharmaceutical Co. LTD. · original daewoong.co.kr ↗

Daewoong Pharmaceuticals announces the result of phase 3 clinical trial in US on Nabota Daewoong’s partner Alphaeon presents the result of phase 3 clinical trial at ASAPS Nabota soon to be released in US On April 7, US and European partner to Daewoong Pharmaceuticals, Alphaeon announced the result of phase 3 clinical trials of the two ‘DWP-450’, botulinum toxin developed by Daewoong Pharmaceuticals, at the ‘2016 American Society of Aesthetic Plastic Surgery’ held in Las Vegas. ‘DWP-450’ is the drug code name for Daewoong’s ‘Nabota’ in the US clinical trials. Daewoong Pharmaceuticals is planning to apply of US FDA approval by the end of this year, aiming to release the product by 2017. ASAPS is an internationally authoritative event in the field of cosmetic surgery participated by many renowned plastic surgeons worldwide. Dr. Paul Laurence, clinical trial expert at Alphaeon, published the result on ‘DWP-450’ under the name ‘Quick Hits” What’s Happening in Filters and Neuromodulators’, heightening anticipation on the outstanding efficacy of Nabota. According his presentation, ‘DWP-450’ successfully achieved its primary effectiveness evaluation variables when conducted two randomized, double blind, placebo-controlled phase 3 clinical trials (EV001 and EV002). When injected according to GLS index, the wrinkles improved by 2 stages out of 4 after 30 days. The results were attained from both doctors and volunteers; the response rates were 67.5% for EV001 and 70.4% for EV002. In both trials, the experimental group displayed much better results. For more details, go to www.clinicaltrials.gov. In addition to this presentation, Alphaeon held three other sessions widely promoting its business model and prospects to potential clients. J. Christomer Marmo, Ph.D., president of Alphaeon Beauty, said, “This result is a significant one that can impact the licensing process. I hope it functions as a lever for the innovative business platform provided to plastic surgeons.” CMO Rui Avelar, MD, said, “Achieving a major variable in this study signifies the efficacy of DWP-450. We are positive about the results from the other trial.” Daewoong Pharmaceuticals already signed over 7,000 billion won export contracts to over 60 countries, with products already released in Thailand and Philippines. In 2013, Daewoong Pharmaceuticals signed a distribution contract with Evolus for distributing abour 3,000 billion won worth of its botulinum toxin to North America and Canada. Later, Evolus was acquisitioned by Strathspey Crown which is a parent company to Alphaeon; and with an exclusive distribution right for the botulinum toxin, Alphaeon will present the result of the clinical trial in 5 other European countries. After licensing process, Nabota is planned to be released in US and EU by 2017. *Photo 1 : On April 7, US and European partner to Daewoong Pharmaceuticals, Alphaeon announced the result of the two phase 3 clinical trials of ‘DWP-450’, botulinum toxin developed by Daewoong Pharmaceuticals, at the ‘2016 American Society of Aesthetic Plastic Surgery’ held in Las Vegas. *Photo 2 : 'Nabota', a botulinum to?xin medication developed by Daewoong Pharmaceuticals

The release as fetched from its publisher. daewoong.co.kr ↗