Bryn Pharma LLC, a privately held pharmaceutical company dedicated to finding a better way for patients and caregivers to treat anaphylaxis, announced today that pharmaceutical industry veteran Sandy Loreaux has been appointed CEO, effective immediately. David Dworaczyk, Ph.D., is transitioning from the CEO role and will stay on as a senior advisor and head of R&D, Regulatory, and production efforts as Bryn works toward the completion and filing of the NDA for the company’s lead candidate, investigational epinephrine nasal spray, UTULY™.

Pivotal trial results demonstrate that UTULY has quick uptake, with higher and more sustained epinephrine levels than the current standard of care, the epinephrine autoinjector (EpiPen).

“Over the past 5-plus years, we’ve been a development-stage company focusing on UTULY’s NDA submission and 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. We appreciate David’s dedication, development expertise, scientific acumen and continued insights as he leads the completion and filing of UTULY’s NDA submission. Now we must evolve into a commercial-stage company. Sandy’s extensive pharmaceutical commercialization and leadership experience will be instrumental to Bryn as we advance UTULY. While Sandy has already made significant contributions to Bryn as a member of our Board of Directors, her day-to-day involvement comes at a critical time to guide us through a successful launch,” said Steven Hartman, Co-Founder and Chairman of the Board of Directors.

“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. “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.”

Ms. Loreaux has over 25 years of experience in the pharmaceutical industry. Over the course of her career, she has worked across multiple therapeutic areas, including allergy and the epinephrine autoinjector space. She most recently led Covis Pharma’s U.S. Operations as U.S. President. Sandy joined Covis after serving as Senior Vice President and General Manager, U.S. Critical Care for Mallinckrodt Pharmaceuticals. She has led multiple market access organizations and has served as SVP, Head of Market Access at Mallinckrodt Pharmaceuticals and SVP, Head of Market Access, and Commercial Operations at Bausch Health. Ms. Loreaux spent the first 19 years of her career at Sanofi and its legacy companies in various roles of increasing responsibility across medical affairs, sales, marketing and market access. Ms. Loreaux is a pharmacist by training and has a degree from Temple University School of Pharmacy in Philadelphia. As a mother of twin boys who were diagnosed with life-threatening food allergies as infants, Ms. Loreaux brings a personal passion and commitment to bringing epinephrine delivery alternatives to market.

About Bryn Pharma

Bryn Pharma, established in 2017, is a privately held pharmaceutical company founded by patients for patients. Bryn is focused on positively disrupting the existing market for epinephrine autoinjectors by delivering an accessible, easy-to-use alternative that better meets the needs of patients. Bryn Pharma seeks to provide this growing population at risk for anaphylaxis with A Better Way to be prepared for a life-threatening allergic reaction. For more information visit www.brynpharma.com.

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Sandy’s extensive pharmaceutical commercialization and leadership experience will be instrumental to Bryn as we advance UTULY.