We are the

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.

We are the

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.

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.

The Path to Regulatory Approval

De novo drug
discovery & development
Time to
market
Drug repositioning
2-3
Target Discovery
Expression analysis
In vitro function
In vivo validation e.g. knockouts
Bioinformatics
2-3
Compound Identification
Targeted searches
Novel insights
Specialised screening platforms
Serendipity
0.5-1
Discovery & Screening

Discovery
Traditional
Combinatorial chemistry
Rational based drug design

Screening
Ex vivo and in vivo
High throughput

0-2
Compound Acquisition

Licensing
Novel IP
Both licensing & novel IP
Internal sources

1-3
Lead Optimisation

Traditional medicinal chemistry
Rational drug design

2-3
Development

Can start at Phase I or Phase II
Ability to leverage existing data packages
Manufacturing complete

1-2
ADMET

Bioavailability and systemic exposure
(absorption clearance and distribution)

2-3
Registration

United States (FDA)
Europe (EMA or country by country)
Japan (MHLW)
Rest of World

5-7
Development

Must start clinical testing as Phase I
(Phase VI for cancer)

2-4
Registration

United States (FDA)
Europe (EMA or country by country)
Japan (MHLW)
Rest of World

3-10 year process

Reduced safety &
pharmacokinetic uncertainty

11-18 year process

<10% overall probability of success

What makes us the experts?

As a global late-stage drug development company dedicated to repurposing, Paradigm specialises in developing underutilised molecules for commercialisation.

Clear Selection Criteria

Paradigm is always looking for molecules to repurpose to address global unmet needs. Molecule feasibility is based upon four clear criteria:
• Clear potential to develop a new treatment for a new indication
• Address an unmet medical need or provide an alternative where current treatments are not suitable
• Clear potential to develop a distinct product for the new indication
• Clear path to market

Proven Processes

Paradigm’s business model is centred around Australia as an incubator for research and early-stage development.
Paradigm’s team boasts a leading level of expertise in the fields of science, medical research, pre-clinical / clinical management and commercial development.

Commercial Modelling

Paradigm undertakes commercial modelling to shed a light on the potential value of a molecule or other early-stage assets. Access to capital is also prioritised and facilitated to ensure product development remains well funded through to commercialisation and/or partnering.

Partnership & Co-development

Paradigm adopts a co-development approach for commercialising assets between a subsidiary entity, where the IP owner grants access to its IP via an intra group licensing agreement. The contribution, plus the risks and rewards for each of the entities are determined and arm’s length pricing mechanisms are established to recognise the entity’s contributions to development.

Exclusive Supply Agreements

Paradigm has experience entering into long-term, exclusive, supply agreements with the internationally approved manufacturers. We ensure manufacturing and scale-up issues are avoided and ensure clinical trials are conducted using drugs/molecules with the same pharmaceutical properties as the proposed commercial product.

Optimising & Protecting IP

Paradigm has a proven track record of developing strong intellectual property and commercialisation exclusivity agreements for the direct treatment of multiple conditions. Paradigm’s exclusive supply and licence agreement with Bene PharmaChem for PPS extends for 25 years post registration.

To learn more about how and why Paradigm is repurposing underutilised molecules to meet the growing need for new, safe and effective treatments, click below.