Sol-Gel Technologies announces the sale of its generic dermatology portfolio to its partner Padagis for $ 21 million

– Sol-Gel will receive $ 21 million over 24 months in exchange for the transfer of its rights to two commercialized generic drugs and eight unapproved generic programs

– Sol-Gel will retain two generic programs encompassing four high value-added generic drug candidates

– Sol-Gel’s treasury track should extend at least until the fourth quarter of 2023

– Sol-Gel remains focused on supporting Galderma for the launch of TWYNEO®, and EPSOLAY®, subject to FDA approval, while advancing its portfolio of innovative assets

NESS ZIONA, Israel, November 04, 2021 (GLOBE NEWSWIRE) – Sol-Gel Technologies, Ltd. (Nasdaq: SLGL), (“Sol-Gel”), a dermatology company focused on the identification, development and commercialization of branded and generic topical drugs for the treatment of skin diseases, today announced hui a new agreement with Padagis (formerly a division of Perrigo Company plc) (the “Agreement”), which will replace previous collaboration agreements for the development and commercialization of certain generic drugs for skin diseases.

After an in-depth strategic analysis and following the encouraging results of previously disclosed preclinical studies, Sol-Gel has decided to focus on accelerating the advancement of its innovative pipeline towards clinical stage development. Sol-Gel has therefore decided to assign to Padagis its rights relating to 10 generic collaboration agreements between the parties, including the agreements for acyclovir cream, ivermectin cream, halobetasol propionate lotion and lotion. halobetasol propionate and tazarotene. Under the new agreement, Sol-Gel retained the collaborative rights to two generic programs related to four generic drug candidates that it believes have the highest value creation potential.

Under the new agreement with Padagis, effective November 1, 2021, Sol-Gel will unconditionally receive $ 21 million over 24 months, instead of its share of future gross profits from acyclovir cream and cream. to ivermectin and its potential gross benefits. for eight unapproved generic programs. The new agreement also provides that as of November 1, 2021, Sol-Gel will stop paying all unpaid and future operational costs related to the collaboration agreements. Importantly, this deal is expected to extend Sol-Gel’s cash flow trail at least until the end of 2023.

Alon Seri-Levy, Co-Founder and CEO of Sol-Gel, said: “Today’s announcement underscores our commitment to accelerate the development of Sol-Gel’s innovative pipeline. Earlier this year, we licensed to Galderma the US commercialization rights for EPSOLAY® and TWYNEO® while retaining the possibility of recovering the marketing rights five years after the first commercial sale. We can now focus on advancing our pipeline of innovative actives in clinical studies, while supporting Galderma in the launch of TWYNEO, already approved by the FDA, and EPSOLAY, subject to FDA approval. “

About Sol-Gel Technologies

Sol-Gel is a dermatology company focused on the identification, development and commercialization of branded and generic topical drugs for the treatment of skin diseases. Sol-Gel takes advantage of its proprietary microencapsulation technology platform for TWYNEO, which is FDA approved for the treatment of acne vulgaris in adults and pediatric patients aged nine years and older; and EPSOLAY, under investigation for the treatment of inflammatory lesions of rosacea with an NDA filed with the FDA and a PDUFA deadline which has been set for April 26, 2021. No action on the NDA for EPSOLAY has yet was taken due to the FDA’s inability to conduct a pre-approval inspection of the EPSOLAY production site due to COVID-19 travel restrictions. Both product candidates are exclusively licensed for commercialization in the United States with Galderma.

The Company’s pipeline also includes early stage topical drug candidates SGT-210 (topical erlotinib) under investigation for the treatment of palmoplantar keratoderma, SGT-310 (tapinarof cream) and SGT-510 (topical roflumilast) at study for the treatment of plaque psoriasis and other dermatological indications.

For more information, please visit www.sol-gel.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 in this press release that do not relate to historical facts should be considered as forward-looking statements, including, but without limitation, statements regarding the receipt of future payments under the new agreements with Padagis and the advancement of our portfolio of innovative assets. These forward-looking statements include information about possible or expected future results of our business, our financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by using terms such as “believe”, “may”, “estimate”, “continue”, “anticipate”, “intend”, “should”, “plan” “,” “” Predict “,” potential “or the negative of these or other similar expressions. Forward-looking statements are based on information available to us at the time these statements are made or on the current expectations of our management and are subject to risks and uncertainties that could cause actual performance or results to differ materially. those expressed or suggested by forward-looking statements. Important factors that could cause such differences include, but are not limited to, the risk that we will not receive all future payments under the new agreements with Padagis, the risk that we may not be able to grow our portfolio of innovative assets as well. that the following factors: (i) the adequacy of our financial and other resources, in particular in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our comprehensive business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal action relating to our product candidates even if the approval regulatory is obtained; (v) our ability to market our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third party claims for intellectual property infringement; (xi) the timing and results of any clinical trials that we may conduct or that our competitors and others may conduct with respect to our products or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than us; (xiii) potential product liability claims; (xiv) potentially adverse federal, state and local regulations in the United States, Europe or Israel; and (xv) the loss or retirement of key executives and researchers. These and other important factors discussed in the Company’s annual report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 4, 2021, and our other reports filed with the SEC may cause actual results to differ materially from those indicated by the forward-looking statements contained in this press release. These forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we do not undertake to publicly update any forward-looking statements after the date of this press release to comply with such statements.

Contact:

Irina Koffler
Investor Relations, LifeSci Advisors
[email protected]
+ 1-917-734-7387

Sol-Gel Technologies
Gilad mamlok
Financial director
[email protected]

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