Galderma Announces Positive Phase 2 Results for its Proprietary Liquid Formulation of an Investigational Botulinum Toxin and Approval of New State-of-the-Art Manufacturing Facility

- Results Demonstrate Safety and Long-Term Efficacy of QM1114 in 350 patients for the Treatment of Glabellar Lines

- Galderma Received Manufacturing License for its New Facilities at their Center of Excellence in Uppsala, Sweden

- Galderma Poised to Advance to Phase 3 Testing

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Oct 09, 2019, 08:07 ET

LAUSANNE, Switzerland, Oct. 9, 2019 /PRNewswire/ -- Galderma, a global leader in skin health focused on developing innovative aesthetic solutions, recently announced the Phase 2 clinical trial results for its novel ready-to-use investigational botulinum toxin, QM1114. The multicenter, randomized, double-blind, placebo-controlled study successfully demonstrated the safety and efficacy of Galderma's liquid formulation of botulinum toxin type A for the treatment of glabellar lines (frown lines). The Phase 3 clinical trial program will begin soon to support regulatory submissions globally.¹

"As a physician, I need to be confident that innovation in aesthetic treatment is the result of scientific rigor. I am encouraged by the results of the Phase 2 QM1114 study, which demonstrated initial safety and efficacy at all doses with high patient satisfaction," said Dr. Joel Cohen*, Director of AboutSkin Dermatology and DermSurgery in Colorado, and investigator in the Phase 2 clinical trial. "It is exciting to see the development of a new toxin formulation that can offer convenience and the potential to eliminate the need for reconstitution in my practice."

Derived from Galderma's proprietary strain of Clostridium botulinum bacteria and manufactured using an animal-origin free process, QM1114 has been designed and developed specifically for use in aesthetics. The QM1114 liquid formulation reduces preparation time needed in clinic and has the potential to increase accuracy, as it is ready-to-use, in contrast with current treatments that require reconstitution before administration. Market research suggests that on average, over 70 percent of injectors do not delegate the reconstitution process because they 'do not feel comfortable with someone else doing it.'²

Additionally, Galderma recently received a manufacturing license from the Swedish Medical Products Agency (MPA) for a new state-of-the-art manufacturing facility at the Center of Excellence, located in Uppsala, Sweden.³ This new facility, built to the highest quality standards, is designed exclusively to meet the production and safety requirements of QM1114. It will also ensure that Galderma can meet increasing worldwide demand as the company's innovative aesthetics pipeline grows.

"Innovation is at the core of our business and our investment is backed by a trusted legacy of creating unique solutions that meet our customer needs," said Alexandre Brennan, Global Head of Aesthetics, Galderma. "We are proud to be leaders in toxin research, and with these studies for a novel liquid formulation of botulinum toxin type A, we are building on our aesthetics heritage by advancing new treatments at our Center of Excellence in Sweden."

Pivotal Phase 3 trials for Galderma's liquid formulation of botulinum toxin type A for the treatment of glabellar lines are expected to begin soon and enroll approximately 1,500 subjects.

Galderma's investment in the development of QM1114 is evidence of the company's ongoing commitment to advancing the field of medical aesthetics through innovative solutions that create positive impact for aesthetics providers and their patients.

About Galderma's investigational drug, a liquid formulation of botulinum toxin type A for the treatment of glabellar lines
Using Galderma's proprietary strain of Clostridium botulinum bacteria and an animal-origin free manufacturing process, this botulinum toxin type A is a novel liquid toxin formulation. Clinical data have demonstrated its safety and efficacy in the treatment of glabellar (frown) lines in more than 350 patients in a Phase 2 study.

About Galderma
Galderma, the world's largest independent global skin health company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven innovative solutions for the skin. For more information, please visit www.galderma.com.

Contacts
Sébastien Cros
Head of Corporate Communications
[email protected]

Isabella Laihorinne Smedh
Head of PR & Communications, Aesthetics
[email protected]
+46761811713

Victoria Smurro
Marina Maher Communications
[email protected]
212.485.6816

References

Cohen J.L., [Evaluation of QM1114, a novel ready-to-use liquid botulinum toxin, in aesthetic treatment of glabellar lines] oral presentation at the 24th World Congress of Dermatology, Milan, 15 June 2019.
Data on file.
Manufacturing Plant Approval.

*Clinical Trial Investigator

USMP/DYS/0222/0919(1)

SOURCE Galderma