Padagis Israel Pharmaceuticals Submits First-to-File ANDA for Generic Version of Roflumilast

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An announcement by Sol-Gel Technologies, Ltd., was made that Padagis Israel Pharmaceuticals, Ltd., submitted its first-to-file Abbreviated New Drug Application (ANDA) to officials with the US Food and Drug Administration (FDA) for a generic version of Zoryve (roflumilast cream) 0.3% treatment of patients with plaque psoriasis.¹

The generic version would also treat patients with psoriasis aged 6 years and older, in the footsteps of the FDA’s October 2023 approval of roflumilast for the same patient population and the same age range. The drug’s application may also involve the intertriginous regions of patients’ bodies.²

The major takeaway from the announcement is that there is now pending FDA approval of this ANDA, with profit-sharing arrangements between Sol-Gel and Padagis, amid a patent infringement action that has been reportedly initiated by Arcutis Biotherapeutics, Inc.¹

The report noted that on March 26, 2024, Arcutis had begun a patent infringement action within the US District Court for the District of New Jersey that was related to the Padagis ANDA for the generic version of roflumilast cream.

In the April 1 announcement, it was noted that Sol-Gel Technologies, a major dermatology company with specialization in advanced treatments for severe skin diseases, is currently working on a phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome.

The announcement then went on to describe the development of its collaboration partner, Padagis submitting the first-to-file ANDA for the generic version of roflumilast cream, 0.3%.

It was noted that Arcutis reported net product revenues in the fourth quarter of 2023 for the original roflumilast cream of $13.5 million, and the announcement added that this was a 357% increase compared to the same quarter of 2022 and a 67% jump compared to 2023’s third quarter.

“Submissions such as Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic value of Sol-Gel’s partnership with Padagis,” Mori Arkin, executive chairman of the board at Sol-Gel, said in a statement. “Though Sol-Gel exited the majority of the partnership in the generic divestment deal announced on November 4, 2021, the Roflumilast Cream, 0.3% project was maintained because of the potential value to both companies.”

The Sol-Gel Technologies referred to the company as being dedicated to the identification, the development, and the commercializing or partnering of drug products for the treatment of several different skin conditions.

The pipeline Sol-Gel maintains includes the aforementioned phase 3 clinical trial of the drug known as SGT-610, a drug candidate which was formulated as a potentially new topical hedgehog inhibitor that may help to prevent new basal cell carcinoma lesions among those with Gorlin syndrome.

The announcement referred readers to the new Sol-Gel website for additional information.

References

1. ^{Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream. Sol-Gel Technologies Ltd. April 1, 2024. https://www.globenewswire.com/news-release/2024/04/01/2855070/0/en/Sol-Gel-s-Collaboration-Partner-First-to-File-ANDA-Drug-Product-Generic-to-Zoryve-Cream.html. Date accessed: April 1, 2024.}
2. ^{Smith T. FDA Grants Approval of Roflumilast Cream 0.3% for Psoriasis Patients Aged 6 to 11. HCPLive. October 6, 2023. https://www.hcplive.com/view/fda-grants-approval-roflumilast-cream-for-psoriasis-patients-aged-6-to-11. Date accessed: April 1, 2024.}