Where the science is settled, the opportunity is in the product
ReForma works with established active ingredients: substances whose safety and efficacy are already characterized and approved for use, and whose remaining limitation lies in the product built around them. Where a new formulation, route or delivery system can address a defined treatment limitation, our development effort builds on what is already known and concentrates new evidence on what has changed.
That is a particular approach, and there is a regulatory pathway designed for it.
A regulatory pathway designed for it
Section 505(b)(2) of the U.S. Federal Food, Drug, and Cosmetic Act allows a marketing application to rely in part on data the applicant did not generate: use published literature, or rely on the FDA's previous findings of safety and efficacy for an approved product. The applicant still generates the evidence needed to support its own product and the ways in which that product differs from the original reference product. What changes is where the evidence effort goes.
For a company improving an established medicine, that means development concentrates on the formulation, the delivery system and the studies that bridge the new product to the established one. The European Union provides an equivalent route through the hybrid application process, and comparable routes exist in most major markets.
We look for a documented limitation in an existing treatment such as an established safety concern, variability in drug exposure, or practical challenges with dosing or administration that may affect treatment in everyday use. The limitation must be supported by evidence and meaningful enough to justify developing a differentiated product; convenience alone is not enough.
Start from a real limitation.
We evaluate potential delivery formats and dosing intervals against what the medicine requires, including how much drug must be delivered, how quickly and over what period. Approaches that cannot meet those requirements are ruled out early, allowing us to focus development on those that can.
Match the delivery approach to the treatment requirements.
We pursue programs where the product has the potential to create a meaningful difference for patients and healthcare professionals, supported by an appropriate clinical and regulatory evidence strategy. We also evaluate whether that differentiation can be protected and sustained through new intellectual property and other sources of competitive differentiation.
Require meaningful and defensible differentiation.
Each program advances against predefined technical, regulatory and commercial criteria, with clear development milestones and go/no-go decision points established before significant capital is committed. This disciplined approach allows us to identify risk early, focus resources on the most promising opportunities and make evidence-based decisions about continued investment.