IRVINE, Calif., Sept. 4, 2014 /PRNewswire/ -- ALPHAEON® Corporation, a leader in lifestyle healthcare and subsidiary of Strathspey Crown Holdings LLC, announced today that the U.S. Food and Drug Administration (FDA) accepted the Investigational New Drug (IND) application to conduct clinical studies for EVOSYAL, an advanced Botulinum toxin Type A neurotoxin that was acquired by ALPHAEON last October, as part of the acquisition of Evolus Inc.
"The product development team is very pleased that the research presented in the IND application was accepted by the FDA without questions, permitting the initiation of the clinical study to support safety and efficacy of this excellent product," said Del Stagg, PhD, ALPHAEON VP of Regulatory.
"EVOSYAL represents the state-of-the-art in both consistent manufacturability and potency as a 900 kDa neurotoxin molecular complex with high purity, both of which we believe will aid in achieving precise, predictable and long-lasting patient outcomes," said John Gross, MD, Chief Scientific Officer for Evolus.
"FDA acceptance of our IND and clinical program is a critical milestone towards FDA approval and a testament to the strength of ALPHAEON's clinical development team," said ALPHAEON Beauty President, J. Christopher Marmo PhD. "This approval is a key step in bringing U.S. consumers new best-in-class aesthetic products."
According to the ASPS®, Botulinum toxin Type A was injected for cosmetic purposes more than 6 million times last year, accounting for over 2 billion dollars of consumer spend annually, which was a 3 percent increase from the previous year. ALPHAEON expects the initial clinical trial to be fully enrolled by the end of 2014.
About ALPHAEON Corporation
ALPHAEON Corporation is a lifestyle healthcare company committed to partnering with board-certified physicians to bring to market and develop highly innovative technologies and services that promote patient wellness, beauty and performance. Ensuring access to leading advancements in lifestyle healthcare, the company fosters deep relationships with leading specialty physicians so patients look their best, feel their best and know they are receiving the best in lifestyle healthcare. For more information, please visit www.alphaeon.com.
About Strathspey Crown
Strathspey Crown is a growth equity firm specializing in lifestyle healthcare. Strathspey Crown uniquely partners with board certified physician specialists to bring to market highly innovative technologies and services in the self-pay sector. The firm is founded in partnership with physician investors across three key medical specialties: plastic surgery, ophthalmology and dermatology. For more information visit www.strathspeycrown.com.
About Evolus, Inc.
Evolus Inc., founded in 2012, is headquartered in Santa Barbara, California. The company has a robust and experienced R&D team with international neurotoxin manufacturing, clinical and regulatory experience. Key management includes Chief Executive Officer J. Christopher Marmo, Ph.D., who previously led Allergan's Medical's Global R&D organization and Chief Scientific Officer John Gross, MD, who chairs the Injectable Safety Coalition. On September 30, 2013, Evolus entered a partnership with Daewoong Pharmaceuticals, the leading Korean pharmaceutical manufacturer, to manage the clinical tests and regulatory approvals of Daewoong's neurotoxin in the United States and other international markets.
Jenna Mons, Vice President of Marketing and Communications
ALPHAEON® is a registered trademark of Strathspey Crown LLC
EVOSYAL is a trademark of Strathspey Crown LLC
ASPS® is a registered trademark of the American Society of Plastic Surgeons
TEOSYAL® is a registered trademark of TEOXANE
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SOURCE ALPHAEON Corporation