We are a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Our current product candidate pipeline consists of late-stage branded product candidates that leverage our proprietary, silica-based microencapsulation technology platform, and several generic product candidates across multiple indications.
Our branded product candidates are TWIN, SIRS-T and Epsolay (formerly VERED). TWIN is a novel, once-daily, non-antibiotic topical cream containing a fixed-dose combination of encapsulated tretinoin and encapsulated benzoyl peroxide that we are developing for the treatment of acne vulgaris (acne). SIRS-T is a topical formulation containing encapsulated tretinoin for the potential treatment of acne; and Epsolay is a, once-daily, cream containing encapsulated benzoyl peroxide, 5% for the potential treatment of papulopustular (subtype II) rosacea. In June 2018, we commenced the pivotal Phase III clinical program for Epsolay and we expect to report top-line data from these trials in mid-2019. In December 2018, we commenced the pivotal Phase III clinical program for TWIN and we expect to report top-line data from these trials by the end of 2019. The pivotal Phase III clinical programs for both TWIN and Epsolay are being conducted in accordance with a Special Protocol Assessment agreement with the FDA regarding the design of the pivotal trials.
We are also currently developing a portfolio of seven generic topical dermatological products, six of which are in collaboration with Perrigo and one with Douglas Pharmaceuticals of New Zealand. In February 2019, Perrigo received approval from the FDA for acyclovir cream, 5%, developed in collaboration with Sol-Gel and indicated for herpes labialis. In January 2018, Perrigo received tentative approval from the FDA for a generic ivermectin cream, 1%, for the treatment of inflammatory lesions associated with rosacea, which is also being developed in collaboration with Sol-Gel. In 2019, the company plans to report bioequivalence study results for 5-fluorouracil cream, 5% for the treatment of actinic keratosis that is being developed in collaboration with Douglas Pharmaceuticals.
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|Apr 18, 2019|
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