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REPURPOSING EXPERTS

Over 30% of new drugs or biologics approved or launched globally represent drugs repurposed for new indications, reformulations or new combinations of existing drugs.

These drugs 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 solely to repurposing and the space remains relatively unexplored - despite the opportunity it presents; both in providing new hope for patients and strong returns for investors.

Repurposing is becoming an increasingly attractive proposition in the face of soaring drug prices and the slow pace of drug discovery and development. 1

Established in 2014, Paradigm has become a leader in the emerging industry.

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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 under-utilised 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.

Potential advantages

Reduced R&D
cost1

Reduced
development
timeline2

Phase 1 clinical
trials not
required2

Established
manufacturing

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 drug that is repurposed (used to treat another disease) may have a considerably truncated route to FDA approval.

The Path to Regulatory Approval chart below compares de novo and repurposed drug development. The complexity, cost and timeline are often simplified and truncated for a repurposed drug.

After proving effectiveness in phase 2 trials, a single positive pivotal trial may be sufficient for regulatory clearance and marketing approval for most repurposed 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.

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