Over 30% of therapies approved or launched globally represent drugs utilised for new indications, reformulations or new combinations of existing drugs.
These therapies commonly have demonstrated safety in their approved indication/s, potentially lowering the cost and risk associated with further clinical and commercial development.
Nonetheless, to date there are very few companies dedicated to transforming approved molecules and the space remains relatively unexplored - despite the opportunity it presents; both in providing new hope for patients and strong returns for investors.
Established in 2014, Paradigm is becoming a leader in the emerging industry.
Innovation from a different angle
As scientists, we look for evidence to support our hypotheses. We target specific molecules and we pursue the new. But in the process, it is possible to overlook alternate, equally valuable avenues of inquiry.
Without doubt, some of medicine’s greatest opportunities have never come to light because a drug or molecule was consigned to the darkened corners of history before we had the time, technology, or techniques to fully investigate it.
Paradigm is dedicated to identifying and liberating the true potential of underutilised drugs and molecules.
This novel approach addresses the growing need for effective, safe treatments for our targeted clinical indications – where there are currently limited options available to patients.
Challenging conventional wisdom and common practice, Paradigm is approaching unmet needs from a completely different angle.
Phase 1 clinical
Bringing a molecule’s unrealised
potential to life
New drugs approved by the FDA and other regulatory bodies have a long path to approval. An already-approved active pharmaceutical ingredient (API) that used in a novel way to treat another disease may have a considerably truncated route to FDA approval.
The Path to Regulatory Approval chart below compares de novo and transformed drug development. The complexity, cost, and timeline are often simplified and truncated for a transformed drug.
After proving effectiveness in phase 2 trials, a single positive pivotal trial may be sufficient for regulatory clearance and marketing approval for most transformed drugs in the US, using the FDA’s 505(b)(2) regulatory pathway. At Paradigm our seasoned team of scientists and regulatory professionals explores available regulatory pathways for drugs in its development pipeline.
Existing clinical, toxicology, manufacturing information and published material could potentially support regulatory submissions.