Evolus is a medical aesthetics company whose lead product candidate is an injectable purified botulinum toxin type A complex that would compete with Botox, the lead product from Allergan’s (NYSE: AGN) stable. Evolus disclosed that it had filed its S-1 for a $75 million IPO.
The company is being spun out of its parent, ALPHAEON, which has funded all operations to date. According to the filing, ALPHAEON is a technology company focused on providing healthcare products and services, including patient financing services.
As a measure of the size of the potential market, Allergan reported revenues from Botox alone of $2.8 billion in 2016 and $2.3 billion through the first nine months of 2017.
Evolus has completed the clinical development program for its DWP-450 botulinum toxin candidate for the treatment of moderate to severe glabellar lines (frown lines) between the eyebrows, in the US, European Union and and Canada. The company expects to hear from the FDA by May 15, 2018, for completion of its review of Evolus’ Biologics License Application (BLA). Additionally, the company expects to hear from the European Medicines Agency in the second half of 2018 on its Marketing Authorization Application in the EU. Evolus has also submitted a New Drug Submission (NDS) to Health Canada, which was accepted for review and is awaiting decision.
The company has successfully completed a five-study clinical development program in the US, EU and Canada to meet the respective regulatory requirements of the jurisdictions. The program, which was developed in consultation with the FDA and European regulatory bodies, included three multicenter, randomized, controlled, single dose Phase III studies and two open label, multiple dose, long-term Phase II studies. Over 2,100 adult male and female subjects with moderate to severe glabellar lines at maximum frown participated in the program. All three Phase III studies successfully met their respective primary endpoints.
Evolus has an exclusive distribution license to market DWP-450 from Daewoong Pharmaceuticals, the Korean pharmaceutical manufacturer, for aesthetic indications in the US, EU, Canada, Australia, Russia, Commonwealth of Independent States and South Africa, as well as co-exclusive distribution rights with Daewoong in Japan. The company also has an option to exercise a similar license in these territories for therapeutic indications by the end of 2018, which it has assigned to and is currently holding in trust for ALPHAEON. DWP-450 will be manufactured by Daewoong in a recently constructed facility in Korea that is designed with the intention of complying with FDA and EMA current Good Manufacturing Practice requirements. Evolus also has the option to negotiate first with Daewoong to secure a distribution license for any product that Daewoong directly or indirectly develops or commercializes that is classified as an injectable botulinum toxin (other than DWP-450) in a territory covered by the license.