Enteris BioPharma is enhancing the value of its Peptelligence® oral drug delivery platform by developing an innovative internal pipeline of orally delivered therapeutics that have been previously marketed as injectable-only formulations. Enteris has developed a strong regulatory strategy involving the use of the 505(b)(2) regulatory pathway, allowing the company to take advantage of existing safety data.
Ovarest® (oral leuprolide tablet) is our most advanced candidate and is being evaluated for its potential to treat endometriosis, a painful and chronic disease that six million women in the United States. For women suffering with this disease, a daily oral treatment of leuprolide will offer an attractive alternative to monthly depot injections.
Enteris has also advanced Tobrate™ (oral tobramycin tablet) into clinical development for the potential treatment of uncomplicated urinary tract infections (uUTI). An oral formulation of tobramycin offers an attractive alternative to available first-line treatments that are now less effective due to antibiotic resistance.
External market analyses demonstrate projected annual U.S. revenue potential for these two products in excess of $1 billion in the aggregate.