Competitive Strengths

  • Diversified clinical stage innovative and generic product pipeline.  We have multiple drugs in clinical development, including VERED and TWIN.  We expect to commence pivotal Phase III clinical trials for VERED in rosacea in the first half of 2018. We have completed recruitment of subjects in a Phase II clinical trial for TWIN in acne. Our pipeline also includes a generic drug product, which we aim to be the first-to-file.  
  • Proprietary drug delivery system may improve therapeutics.  Our silica-based delivery system is designed to improve the tolerability of topical dermatological drug products by entrapping drug substances in porous silica microcapsules, thus creating a protective barrier between the drug substance and the skin and controlling the release rate of the entrapped substance.
    This delivery system is designed to substantially improve the stability of topical fixed-dose combinations of non-compatible drug substances, allowing us to produce stable fixed-dose combinations of active ingredients that have been well tolerated in the clinical trials we have conducted to date.
      
  • Efficient regulatory approval process.  Our innovative drugs are based upon our proprietary microencapsulation delivery system, consisting of microcapsules made of silica.  We expect the FDA approval process for these drug product candidates to be conducted according to 505(b)(2) regulatory pathway, which allows some of the information required for approval to come from studies and trials that we did not conduct, leading to a relatively less expensive and faster approval process.  Furthermore, silica is an inorganic inert excipient already approved by the FDA as a safe excipient for topical drug products, which could simplify and expedite the regulatory approval process for our drug products.
  • High barriers to entry of generics.  We have developed broad expertise and an in-depth understanding of the critical chemical and physical parameters affecting the release rate of active pharmaceutical ingredients from microcapsules made of silica.  This complex know-how is essential in order to obtain a desired, well-defined, controlled-release profile for each drug product and in order to maintain it to support commercial scale production.  As an added protection to our strong patent portfolio, the inclusion of a delivery system with a well-defined, controlled-release profile of the drug substance creates a barrier to entry for generic drugs that must demonstrate a comparable release profile in order to support pharmaceutical equivalence. 
  • Experienced management team.  Our executive management team has extensive experience in the development and commercialization of dermatology drug products.  Mr. Moshe (Mori) Arkin, who serves as the Chairman of our Board of Directors, has ties to innovative and generic drug companies.  Among other positions, Mr. Arkin headed Agis Industries Ltd., expanding it into becoming a leading dermatological company in the U.S. until its acquisition by Perrigo where he served as Vice Chairman.