Galderma receives FDA Complete Response Letter with comments isolated to Chemistry, Manufacturing, and Controls items

International Chamber of Commerce (ICC) arbitration is complete and the regulatory applications are under review

Regulatory filings in other territories are ongoing and remain on track

ZUG, Switzerland--(BUSINESS WIRE)--Galderma, the emerging pure-play dermatology category leader, announced today updates related to the regulatory progress of its pending Biologics License Application (“BLA”) for RelabotulinumtoxinA (QM-1114) to the U.S. Food and Drug Administration (“FDA”).

The FDA has issued a Complete Response Letter (“CRL”) to Galderma related to its BLA for RelabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines (frown lines) associated with corrugator and/or procerus muscle activity in adult patients as well as moderate-to-severe lateral canthal lines (crow’s feet) associated with orbicularis oculi muscle activity in adult patients.

The CRL points out certain deficiencies isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. All other aspects of the BLA, including safety and efficacy related parts, did not solicit deficiencies to be addressed. Galderma has already identified changes to the manufacturing process to address feedback. It will also be seeking further guidance through continued open dialogue with the FDA toward resolution of the relevant issues.

Further update on the regulatory filing strategy of RelabotulinumtoxinA and broader neuromodulator R&D partnership

On September 28, 2023, the International Chamber of Commerce (ICC) issued its award on the arbitration commenced by Galderma in 2021 regarding the regulatory filing strategy for RelabotulinumtoxinA, and as a result, the arbitration is complete. While the award is confidential, the result is that the applications submitted for regulatory review are proceeding according to the initial strategy and Galderma and Ipsen await further feedback from regulators.

Galderma remains responsible for development, regulatory filing and strategy, manufacturing, and commercialization. Interactions with regulatory authorities remain the responsibility of Galderma. Regulatory approval submissions and issued certificates will ultimately be in the name of Ipsen.

The ICC award has no impact on the ongoing European decentralized procedure for the filing of RelabotulinumtoxinA nor on the commercialization of Galderma’s neuromodulator portfolio. Regulatory submissions in other territories are ongoing and remain on track.

Furthermore, in a press release dated July 27, 2023, Ipsen made statements about the purported termination of the Galderma-Ipsen Research and Development (R&D) partnership. Galderma contests those statements and remains committed to resolution with Ipsen.

Galderma remains committed to bringing scientific innovation to its healthcare professionals, consumers and patients globally by expanding its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market.

About Galderma

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. Galderma’s portfolio of flagship brands includes Restylane®, Dysport®, Azzalure®, Alluzience® and Sculptra® in Injectable Aesthetics; Soolantra®, Epiduo®, Differin®, Aklief®, Epsolay®, Twyneo®, Oracea®, Metvix®, Benzac® and Loceryl® in Therapeutic Dermatology; and Cetaphil® and Alastin Skincare® in Dermatological Skincare. For more information: www.galderma.com.