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Evolus Inc. is (almost) ready for its close-up.
Newport Beach-based Evolus (Nasdaq: EOLS) this month said positive data in a head-to-head trial that compared its Jeuveau against Allergan PLC superstar Botox, “are compelling and reinforce the clinical performance of Jeuveau,” Evolus Chief Executive Officer David Moatazedi said in a statement.
He said Jeuveau’s launch is imminent—just weeks away.
Results of the Phase III duel in Europe and Canada were published in the April issue of Aesthetic Surgery Journal.
Jeuveau, the company’s first product, is a botulinum toxin drug designed to act similarly to Botox in treating moderate to severe frown lines.
Annual Botox sales rose 12% to $907 million for Allergan (NYSE: AGN). Botox dominates the cosmetic facial injectable market with a 70% share compared to rivals Galderma SA’s Dysport, which has 21%, and Merz Pharmaceuticals LLC’s Xeomin at 9%, according to data from Goldman Sachs.
Evolus received FDA approval of its toxin in February and believes it has a good shot at cracking this market. The drug was licensed from South Korea’s Daewoong Pharmaceutical Co. as “the first new neurotoxin [to launch in the U.S.] in nearly a decade,” according to Rui Avelar, Evolus chief medical officer and head of R&D.
The company has filed for European approval of the drug, which will be marketed as Nuceiva.
Evolus shares have doubled in the past year to a $725 million market cap but are still dwarfed by Allergan’s $50 billion. Botox, Dysport and Xeomin are approved for both aesthetics and therapeutic indications and Evolus plans to differentiate its product by focusing solely on cosmetic use.
The company told the Business Journal in an earlier interview that Jeuveau is aimed at younger female buyers.
TherOX Gets FDA Nod
TherOx Inc. received FDA premarket approval of its SuperSaturated Oxygen Therapy device, designed to deliver blood to heart attack patients.
It’s intended to be applied immediately after a blocked coronary artery has been opened by percutaneous coronary intervention (PCI), or stenting.
The Irvine-based medical device maker said the challenge with PCI is the procedure for many patients doesn’t do enough to prevent dead or damaged tissue caused by lack of oxygen. This heightens risks of future complications such as heart failure or death.
“SuperSaturated Oxygen is the only therapy shown in a pivotal randomized trial to reduce infarct size in patients with large anterior myocardial infarction, offering the potential to further improve outcomes in these high-risk patients despite successful primary angioplasty,” said Dr. Gregg Stone, professor of medicine at Columbia University Medical Center.
The therapy combines highly oxygenated saline with the patient’s blood.
TherOX’s device, indicated for patients who suffer the most serious kind of heart attacks, “provides interventional cardiologists with the first and only FDA-approved treatment beyond PCI to save damaged heart muscle in heart attack patients,” the company said in a statement.
Healthcare Accelerator Launched
Consulting vets Frank Ripullo and Nancy Kailas co-founded Excelerant Consulting LLC to help firms get their products to market.
Ripullo and Kailas, managing partners, each have more than 25 years of experience and previously founded and ran healthcare consulting firms—Ripullo with Laguna Niguel-based Essential Healthcare Management in 2007 and Kailas at Chicago-based Healthcare Supplier Solutions in 2005—before merging. The new company is based in Scottsdale, Ariz., with hubs in Orange County and Chicago.
Ripullo said Excelerant has longstanding relationships in group purchasing organizations, regional purchasing coalitions and integrated delivery networks. These entities, which help healthcare providers like hospitals and nursing homes negotiate purchasing contracts, are increasingly important to device makers; providers rely on them to manage the complex system of purchasing.
Masimo Gets New CE Mark
Irvine-based Masimo Corp. (Nasdaq: MASI) received European CE Mark approval of its Next Generation Sedline brain function monitoring for pediatric patients aged one to 18 years. The device, which helps clinicians monitor the state of the brain under anesthesia, received FDA clearance for adults in January last year. It is not currently cleared for pediatric patients in the U.S.