Palvella Therapeutics has strengthened its executive leadership team with the appointment of Ashley Kline as Chief Commercial Officer, effective immediately. The appointment comes as the clinical-stage biopharmaceutical company prepares for the potential standalone U.S. launch of QTORIN™ 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations, a serious, rare, and lifelong genetic disease affecting an estimated more than 30,000 patients in the U.S.
Proven Track Record in Rare Disease Commercialization
Kline brings extensive experience in commercializing novel therapies for serious, rare diseases. Prior to joining Palvella, she served as Global Biotech Head and U.S. General Manager at Dompé Pharmaceuticals, where she led the successful launch of Oxervate®, a first-in-disease topical therapy approved in 2018 for neurotrophic keratitis (NK), a rare, serious, and progressive eye disease that previously had no FDA-approved therapies.
Under Kline's leadership, Oxervate surpassed $500 million in annual U.S. sales by 2023 and achieved early profitability through an innovative, capital-efficient, and high-touch launch strategy that emphasized high-impact physician outreach and education. This success established Oxervate as one of the top-performing non-oncology orphan drugs of the past decade.
"Ashley is a proven commercial executive in rare diseases and we are thrilled to welcome her to the Palvella team," said Wes Kaupinen, Founder and Chief Executive Officer. "Ashley brings a dynamic, results-driven approach and deep knowledge of the key factors for achieving success in launching the first FDA-approved therapy for a serious, rare disease."
Strategic Focus on Unmet Medical Need
Kline's appointment comes at a critical time for Palvella as the company develops therapies for serious, rare genetic skin diseases for which there are currently no FDA-approved treatments. The company is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare genetic skin diseases, many of which are lifelong in nature.
"This is an exciting time to join Palvella as the Company has the potential to market the first and only therapeutic option for patients suffering from microcystic lymphatic malformations and cutaneous venous malformations, both rare and debilitating genetic diseases that significantly impact quality of life," said Kline.
Current Clinical Development Programs
Palvella's lead product candidate, QTORIN 3.9% rapamycin anhydrous gel, is currently being evaluated in the Phase 3 SELVA clinical trial in microcystic lymphatic malformations and the Phase 2 TOIVA clinical trial in cutaneous venous malformations. The therapy remains investigational and has not been approved or cleared by the FDA or any other regulatory agency for any indication.
Executive Background and Qualifications
Earlier in her career, Kline was a member of the commercial team at Genentech and served as a consultant for Bain and Company. She also held commercial roles at Santen Pharmaceuticals and Adverum Biotech. Kline earned her M.B.A. from the Kellogg School of Management at Northwestern University with majors in Finance, Decision Science, and Analytical Consulting, and a B.A., with distinction, from the University of North Carolina at Chapel Hill.
Kaupinen emphasized that Kline's leadership was instrumental to Oxervate's success, which is widely regarded as one of the top rare disease launches over the last decade. "Ashley's strong patient-orientation, her ability to build and lead high performing teams, and her analytically driven approach will contribute to Palvella achieving our vision of building the leading rare disease biopharmaceutical company focused on serious, rare genetic skin diseases," he added.
