Crescita Therapeutics gets USFDA nod for Enhanced Formulation of Pliaglis

New Delhi: Crescita Therapeutics Inc. ("Crescita"), a commercial dermatology company with manufacturing capabilities and a portfolio of non-prescription skincare products and prescription drug products for the treatment and care of skin conditions, diseases and their symptoms, recently announced that the U.S. Food and Drug Administration ("FDA") approved the enhanced formulation of Pliaglis (the "Enhanced Formulation") following its statutory six-month review process and in line with the target action date under the Prescription Drug User Fee Act ("PDUFA").

While the U.S. patent covering the original formulation of Pliaglis expired on September 28. 2019, the U.S. patent covering the Enhanced Formulation with extended protection to 2031, is in the process of being added to the Orange Book.

In its recent press release, Crescita said that its licensing partner for the U.S. market, Taro Pharmaceuticals Inc. ("Taro") filed a CBE-30 supplement seeking approval for an enhanced formulation of Pliaglis which has improved application and removal properties as well as extended patent protection until 2031 in the U.S. and several other jurisdictions. The approval of the Enhanced Formulation triggers a US$0.75 million milestone under the terms of the out-licensing agreement in place with Taro.

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"We are delighted with the FDA's approval of the Enhanced Formulation of Pliaglis," said Serge Verreault, President and CEO of Crescita. "With an improved formulation and extended patent protection, we are very optimistic about extending the commercial life of Pliaglis for many years to come."

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Pliaglis, a lidocaine and tetracaine (7%/7%) formulation, is a prescription topical local anesthetic cream approved in over 25 countries that provides safe and effective local dermal anesthesia on intact skin prior to superficial dermatological procedures, such as dermal filler injections, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal. This product utilizes the proprietary phase-changing topical cream Peel technology. The Peel technology consists of a drug containing cream which, once applied to a patient's skin, dries to form a pliable layer that releases drug into the skin. Following the application period, Pliaglis forms a pliable layer that is removed from the skin allowing the dermatological procedure to be performed with minimal to no pain.

The Company developed an enhanced formulation of Pliaglis, that also contains 7% lidocaine and 7% tetracaine but possesses improved application and removal properties compared to Pliaglis, with extended patent protection to 2031 in multiple jurisdictions. Like Pliaglis, the formulation dries to form a pliable layer which can be easily peeled from the skin once the active ingredients have been delivered to the site on the body, providing a long-lasting anaesthetic effect. The Company also developed alternate enhanced versions of Pliaglis and filed additional patent applications that may provide supplemental protection for the enhanced formulations of Pliaglis. On July 16, 2019, the United States Patent and Trademark Office granted U.S. Patent No. 10,350,180 for the FDA-approved enhanced formulation of Pliaglis.