Sol-Gel Technologies and Galderma Announce Exclusive Licenses for the Commercialization of EPSOLAY® and TWYNEO® in the United States
- Upfront and approval payments of up to
- Tiered royalties ranging from mid- to high-teen percentage of net sales
Under these agreements, Galderma has an exclusive license to commercialize Sol-Gel’s most advanced investigational drug products using Sol-Gel’s proprietary micro-encapsulation technology, in each case provided the product is approved by the FDA:
- EPSOLAY (benzoyl peroxide, 5%, cream) is under investigation for the treatment of inflammatory lesions of rosacea in adults, with a Prescription Drug User Fee Act (PDUFA) goal date originally set for
April 26, 2021. Action on the NDA for EPSOLAY has not yet been taken due to the inability of the FDA to conduct a pre-approval inspection of the production site of EPSOLAY due to COVID-19 travel restrictions.
- TWYNEO (benzoyl peroxide, 3%, and tretinoin, 0.1%, cream) is under investigation for the treatment of acne vulgaris with a PDUFA goal date set for
August 1, 2021.
“Galderma already owns the current market leading brands for rosacea and acne, and I am therefore delighted that Galderma views EPSOLAY and TWYNEO as innovative and with the potential to become key market brands,” stated Dr.
“Innovation is at the heart of our commitment to advancing dermatology,” said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma. “The potential to deliver two innovative products featuring Sol-Gel’s proprietary micro-encapsulation technology represents an important milestone for acne and rosacea patients and underscores Galderma’s position as the partner of choice in dermatology.”
EPSOLAY is an investigational topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea, also known as papulopustular rosacea, in adults. EPSOLAY utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to release benzoyl peroxide slowly over time to provide a favorable efficacy and safety profile. If approved, EPSOLAY has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product. EPSOLAY is not approved by the FDA and the safety and efficacy have not been established.
About Papulopustular Rosacea
Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. Rosacea condition is common, especially in fair-skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin, or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness becomes more persistent, blood vessels become visible and inflammatory lesions (papules and pustules) often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.
TWYNEO is an investigational, fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris. If approved, TWYNEO will be the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin, which are separately encapsulated in silica using Sol-Gel’s proprietary micro-encapsulation technology. Tretinoin and benzoyl peroxide are widely prescribed separately as a combination treatment for acne; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The silica-based microcapsule is designed to protect tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability of the active drug ingredients. The silica-based shell is also designed to release the ingredients slowly over time to provide a favorable efficacy and safety profile. TWYNEO is not approved by the FDA and the safety and efficacy have not been established.
About Acne Vulgaris
Acne vulgaris is a common multifactorial skin disease that according to the
Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information: www.galderma.com
Forward-Looking Statements –
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding FDA approval of EPSOLAY AND TWYNEO and statements regarding the timing and potential commercialization of EPSOLAY and TWYNEO. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions, including statements regarding the financial benefits of the agreements with Galderma, the benefits of EPSOLAY and TWYNEO to patients, and the timing of the commercial availability of EPSOLAY and TWYNEO. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, the risk of a delay in receipt of approval, if any, of the NDA for TWNYEO, the risk of a further delay in receipt of approval, if any, of the NDA for EPSOLAY, the risk that
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