Propella’s acute vision accurately locates off-patent drugs in need of renewed energy. Our enlightened approach to the design and development of improved therapies derived from these “waning stars” brings welcome light and hope to patients and healthcare professionals.
bright light thinking
We accomplish our mission by thoroughly investigating and then re-designing existing drugs to yield improved therapies. Once an existing drug is identified as a candidate program, we laser focus on all aspects of its profile, including clinical liabilities and commercial opportunity. We then canvass patients, doctors, payers and other experts for insight and validation.
All of our drug product candidates are proprietary and eligible for approval under the FDA’s 505 (b) (2) pathway, which provides a fast-tracked and risk-mitigated development path. Taking established drugs and making them more effective, tolerable and convenient is both smart science and great business. Brighter treatments lay ahead.
leveraging the FDA 505 (b) (2) path
Congress enacted Section 505 (b) (2) of the Federal Food, Drug, and Cosmetic Act in 1984 to streamline the development and approval of new pharmaceutical products that utilize an already approved active pharmaceutical ingredient (API). This regulatory pathway encourages innovation while reducing the need to duplicate prior studies of well-characterized APIs for the approval of new, improved versions. Utilizing publicly available data or results previously accepted by the FDA eliminates many unneeded studies leading to significant savings of both time and money.
In addition to any patent protection granted the new product, therapies approved via the 505 (b) (2) process may qualify for three, five or seven years of FDA granted market exclusivity in the US.