New Treatments for Patients Who Need Them
Processa Pharmaceuticals develops products that improve survival and quality of life for patients with unmet medical needs. Using our years of regulatory experience, we identify de-risked, underappreciated drugs and develop assets with an unmet medical need and leverage prior research toward high value clinical milestones and a lower risk of development failure. Our management and development teams have a track record of obtaining FDA approvals and creating significant shareholder value by successfully delivering much needed therapies to patients and caregivers.
Our portfolio of candidates is disease agnostic and all programs must meet strict evaluation criteria for further development including (but not limited to): representing an unmet medical need; have demonstrated (preferably in humans) clinical evidence of efficacy; that our Regulatory Science approach can make a difference in the time, cost and risk to obtaining marketing authorization and thus are highly capital efficient and contributes to substantial returns on equity. This includes studies of the drug itself, an analog of the drug, or a drug with similar pharmacological targets. We then work with the FDA to define a complete development program and out-license the drug after 2 to 5 years, either just before or after the pivotal study. We have a history and are known for working collaboratively with Regulators to identify an efficient path to commercialization and our intention is to out-license programs either just before or after pivotal studies.