SYS-CON MEDIA Authors: Sematext Blog, Trevor Parsons, Elizabeth White, Pat Romanski, Yeshim Deniz

News Feed Item

FDA Accepts Investigational New Drug Application For ALPHAEON's Neurotoxin EVOSYAL

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.

ALPHAEON Corporation. For more information, please visit www.alphaeon.com

"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.

Press Contact:
Jenna Mons, Vice President of Marketing and Communications
Tel: 949-284-4523
Email: [email protected]

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

Logo - http://photos.prnewswire.com/prnh/20140728/130500

SOURCE ALPHAEON Corporation

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Log data provides the most granular view into what is happening across your systems, applications, and end users. Logs can show you where the issues are in real-time, and provide a historical trending view over time. Logs give you the whole picture. Logentries, a log management and analytics service built for the cloud, has announced a new integration with Slack, the team communication platform, to enable real-time system and application monitoring. Users of both services can now receive real-...
Over the past year, Datical has had amazing success with our flagship product, Datical DB. We’ve seen multiple visionary, sector-leading companies select Datical DB to drive their Application Schema changes. Now that the number has grown rapidly over the past year, we can begin to see patterns in why customers choose Datical DB. One of them turns out to be pretty emblematic of our other customers. So, let's examine the reasons why they chose to adopt Datical DB.
Entuity®, a provider of enterprise-class network management solutions, today announced that it solidifies its position as a market leader through global enterprise customer acquisitions and a refined channel strategy. In 2014, Entuity increased new license revenues in EMEA by over 75 percent, and LATAM by over 125 percent as customers embraced Entuity for its highly automated solution and unified architecture. Entuity’s refined channel strategy focuses on even deeper strategic alignment with ke...
CloudBees, Inc., has announced a $23.5 million financing round, led by longtime CloudBees investor Lightspeed Venture Partners. Existing investors Matrix Partners, Verizon Ventures and Blue Cloud Ventures also participated in the round. The latest funding announcement follows earlier rounds of $4 million, $10.5 million and $10.8 million, bringing the total investment in CloudBees to just under $50 million since the company’s inception in 2010. Previous venture investment rounds were led by Ma...
We are all here because we are sold on the transformative promise of The Cloud. But what good is all of this ephemeral, on-demand infrastructure if your usage doesn't actually improve the agility and speed of your business? How must Operations adapt in order to avoid stifling your Cloud initiative? In his session at DevOps Summit, Damon Edwards, co-founder and managing partner of the DTO Solutions, will highlight the successful organizational, process, and tooling patterns of high-performing c...
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Technology is enabling a new approach to collecting and using data. This approach, commonly referred to as the "Internet of Things" (IoT), enables businesses to use real-time data from all sorts of things including machines, devices and sensors to make better decisions, improve customer service, and lower the risk in the creation of new revenue opportunities. In his General Session at Internet of @ThingsExpo, Dave Wagstaff, Vice President and Chief Architect at BSQUARE Corporation, discuss the ...
"ElasticBox is an enterprise company that makes it very easy for developers and IT ops to collaborate to develop, build and deploy applications on any cloud - private, public or hybrid," stated Monish Sharma, VP of Customer Success at ElasticBox, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Agility is top of mind for Cloud/Service providers and Enterprises alike. Policy Driven Data Center provides a policy model for application deployment by decoupling application needs from the underlying infrastructure primitives. In his session at 15th Cloud Expo, David Klebanov, a Technical Solutions Architect with Cisco Systems, discussed how it differentiates from the software-defined top-down control by offering a declarative approach to allow faster and simpler application deployment. Davi...
Cloud Expo 2014 TV commercials will feature @ThingsExpo, which was launched in June, 2014 at New York City's Javits Center as the largest 'Internet of Things' event in the world.
Cloud Technology Partners on Wednesday announced it has been recognized by the Modern Infrastructure Impact Awards as one of the Best Amazon Web Services (AWS) Consulting Partners. Selected by the editors of TechTarget's SearchDataCenter.com, and by votes from customers and strategic channel partners, the companies acknowledged by the Modern Infrastructure Impact Awards represent the top providers of cloud consulting services for AWS including application migration, application development, inf...
“Will Jaya is a direct source for server integration and storage solutions. If you are looking for any specific configurations for a project we can help you configure based on your needs and requirements," explained Netty Goya, CEO of Will Jaya, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
“We help people build clusters, in the classical sense of the cluster. We help people put a full stack on top of every single one of those machines. We do the full bare metal install," explained Greg Bruno, Vice President of Engineering and co-founder of StackIQ, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
In this demo at 15th Cloud Expo, John Meza, Product Engineer at Esri, showed how Esri products hook into Hadoop cluster to allow you to do spatial analysis on the spatial data within your cluster, and he demonstrated rendering from a data center with ArcGIS Pro, a new product that has a brand new rendering engine.