Processa is an emerging pharmaceutical company focused on the clinical development of drug products that are intended to improve the survival and/or quality of life for patients who have a high unmet medical need. Within this group of pharmaceutical products, we currently are developing one product for multiple indications (i.e., the use of a drug to treat a particular disease) and searching for additional products for our portfolio.
(i) to identify drugs that have potential efficacy in patients with an unmet medical need, as demonstrated by some clinical evidence, including published case studies or clinical experience, such that the patient's survival and/or quality of life might improve, (ii) to identify drug products that have been developed or approved for other indications but can be repurposed to treat those patients who have an unmet medical need, and (iii) to identify drugs that can be quickly developed within 2-4 years to completion of a pivotal study for the submission of a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) or to license the drug to a potential strategic partner just prior to a more expensive and time-consuming pivotal study.
While time to develop a drug from finding/designing a molecule (i.e., the discovery stage) to FDA approval typically takes between 10-15 years, our business model is to identify drugs that are in the clinical stage of drug development where (i) a pivotal study can be completed in 2 to 4 years or (ii) enough clinical data can be obtained to demonstrate the value of the asset to a future licensing partner. The FDA approval of the drug would then occur after the preparation of the NDA documents and the FDA review process.