ALT™ is a collection of unique lipophilic delivery systems capable of by-passing the food effect seen in most lipophilic drug products.
ALT™ has been proven to allow lower dosing levels to achieve efficacy.
ALT™ allows drug and nutrient absorption in the absence of healthy intestines, bile or normal gastric enzymes.
ALT™ is a drug delivery platform that uses proprietary formulation and manufacturing techniques to create products that permit better absorption.
Sancilio & Company submitted an application to the Federal Drug Administration requesting orphan drug designation for SC411 for the treatment of Sickle Cell Disease. The designation was granted in April 2015. This designation may provide seven years of market exclusivity in the United States, subject to certain limited exceptions. However, the orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.
Orphan drug designation is an important regulatory advancement and the designation is granted to drugs that demonstrate promise for the treatment of a rare disease, that affect fewer than 200,000 people in the U.S. Orphan designation is assigned based on FDA’s evaluation of scientific and clinical data for the drug. Upon FDA’s review of the data for SCI’s investigational product, FDA has identified the drug as a promising treatment for sickle cell disease. The designation of Orphan status is granted to further advance the scientific development of promising medicinal products for rare diseases.
Orphan designation qualifies SCI for various development incentives.