RALEIGH — Pharmaceutical industry veteran Sandy Loreaux is the new CEO of Raleigh-based Bryn Pharma, the company announced this week.
Loreaux has replaced Dr. David Dworaczyk, who will remain at Bryn as a senior advisor and head of R&D, according to the press release.
Bryn is best known for its investigational epinephrine nasal spray, UTULY™, which could become an alternative to the commonly-prescribed EpiPen.
The EpiPen is a handheld device used to treat life-threatening allergic reactions, or anaphylaxis, by automatically injecting a pre-measured dose of epinephrine. It was FDA approved in 1987 and has become the go-to prescribed solution for those with known allergies who might need quick access to epinephrine.
But in recent years, the cost of an EpiPen has skyrocketed, and current and former manufacturers of the EpiPen have paid big in class-action lawsuits—EpiPen marketer Mylan settled a $264 price-gouge deal last summer, and Pfizer and Mylan settled a $345 deal in 2021.
Meanwhile, some studies show that less than half of patients diagnosed with anaphylaxis carry their auto-injector with them.
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According to information on the Bryn Pharma website, trial results indicate that the needle-free UTULY solution could provide “quicker uptake” than the EpiPen.
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“Over the past 5-plus years, we’ve been a development-stage company focusing on UTULY’s NDA submission and approval,” said Steven Hartman, Bryn Pharma Co-Founder and Chairman of the Board of Directors, in the press release. (Submitting a new drug application, or NDA, is the formal step of asking the FDA to consider a drug for marketing approval.)
“David’s efforts have brought us from an idea of building a non-needle, easy to use, easy to carry emergency epinephrine delivery device to being on the cusp of filing our NDA,” said Hartman.
Hartman also shared in the press release that Dworaczyk will continue leading the completion of the NDA filing.
“Now we must evolve into a commercial-stage company,” said Hartman. “Sandy’s extensive pharmaceutical commercialization and leadership experience will be instrumental to Bryn as we advance UTULY.”
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Loreaux was first appointed to the Bryn Board of Directors last November.
According to the press release, Loreaux has over 25 years of experience in the pharmaceutical industry and recently served as US President of Covis Pharma. A pharmacist by training, her professional background includes roles at Covis Pharma, Mallinckrodt Pharmaceuticals, and Bausch Health.
Loreaux is also the mother of twin boys who were diagnosed with life-threatening food allergies as infants.
“Sandy and I share both a connection and a commitment to the food allergy community as mothers of children with life-threatening food allergies,” said Bryn Co-Founder Michelle Lobel in the press release. “Early treatment during anaphylaxis can be life-saving, but patients and caregivers often hesitate due to fear of needles. We have been diligently working to bring a quick-acting needle-free epinephrine alternative to market. Sandy’s stellar combination of passion and expertise at the helm of Bryn will help us bring this vision to life.”
Loreaux also shared the news on LinkedIn.
“I am excited to announce that I am joining Bryn Pharma as Chief Executive Officer,” she wrote in the post. “As a mother of 2 boys with life threatening food allergies, I am thrilled to be leading an organization committed to improving the standard of care for emergency medical treatment.”
