Palvella Therapeutics Receives Sixth U.S. Patent for Rapamycin Compositions

Palvella Therapeutics, Inc., a biopharmaceutical company engaged in the development of innovative therapies for rare genetic skin conditions, has announced a significant advancement in its intellectual property portfolio. The United States Patent and Trademark Office (USPTO) has granted a new patent, numbered 12,329,748, which covers the company's primary product candidate, QTORIN™ 3.9% rapamycin anhydrous gel. This patent provides extensive protection for the unique anhydrous topical formulation and its application methods.

This newly issued patent is a critical component of Palvella's strategy to secure a competitive edge and extend the market exclusivity of QTORIN™ rapamycin. Wes Kaupinen, the company's Founder and CEO, emphasized the importance of this patent in reinforcing their multi-faceted approach to safeguarding QTORIN™ rapamycin. This approach includes strong intellectual property rights, proprietary formulation methods, manufacturing trade secrets, and regulatory exclusivities.

The patent not only covers the formulation and use of QTORIN™ rapamycin but also extends to a variety of mTOR inhibitors, such as temsirolimus and everolimus, in anhydrous compositions. This broad coverage is crucial for treating an array of dermatologic conditions, particularly those that are rare and challenging, like microcystic lymphatic malformations and venous malformations.

QTORIN™ rapamycin has already received several designations from the FDA, including Breakthrough Therapy, Orphan Drug, and Fast Track for the treatment of microcystic lymphatic malformations. Should it gain approval, it is anticipated to benefit from seven years of market exclusivity under the orphan drug status in the U.S. Additionally, Palvella has been granted an FDA Orphan Products Grant, which could provide up to $2.6 million over its duration to support ongoing research, particularly the SELVA Phase 3 trial for QTORIN™ rapamycin.

Palvella Therapeutics is led by a team of veterans in rare disease drug development. The company is dedicated to advancing treatments for severe, uncommon genetic skin disorders for which there are no FDA-approved therapies. Utilizing its patented QTORIN™ platform, Palvella is building a diverse pipeline with an initial focus on persistent and rare genetic skin diseases.

Presently, the lead product, QTORIN™ rapamycin, is undergoing evaluation in the Phase 3 SELVA clinical trial targeting microcystic lymphatic malformations and the Phase 2 TOIVA trial for cutaneous venous malformations. Although still in the investigational stage, and not yet approved by the FDA, QTORIN™ rapamycin represents a potentially groundbreaking treatment for patients with these rare conditions.

This development underscores Palvella’s commitment to leveraging its robust intellectual property strategy to deliver new therapeutic options for underserved patient populations. Through continued innovation and clinical research, the company aims to address significant unmet medical needs and pave the way for novel treatments in the field of dermatology.