WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) announced the issuance of U.S. patent No. 12,329,748 by the United States Patent and Trademark Office (USPTO), providing increased protection for its lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel. This milestone strengthens Palvella’s intellectual property position for its proprietary topical formulation and its application in treating rare and challenging dermatologic conditions.
The patent broadly covers composition and method-of-use claims for QTORIN™ rapamycin and related mTOR inhibitors, including temsirolimus and everolimus, in anhydrous formulations. It also provides protection for treating conditions such as microcystic lymphatic malformations and venous malformations.
Wes Kaupinen, Founder and CEO of Palvella, described the sixth patent issuance as a “meaningful milestone” in securing QTORIN™ rapamycin’s exclusivity, emphasizing the company’s multi-layered strategy encompassing intellectual property, trade secrets, and regulatory protections.
QTORIN™ rapamycin has already received Breakthrough Therapy, Orphan Drug, and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for the treatment of microcystic lymphatic malformations. If FDA approval is secured, the product will qualify for seven years of orphan drug market exclusivity. Additionally, Palvella has been awarded a grant of up to $2.6 million from the FDA’s Orphan Products Development program to support its ongoing SELVA Phase 3 trial.
With the new patent and its strategic designations, QTORIN™ rapamycin is positioned as a promising therapy for patients with rare and difficult-to-treat diseases.
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