UNTAPPED POTENTIAL
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.
Potential advantages
Reduced R&D
cost
Reduced
development
timeline
Phase 1 clinical
trials not
required
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 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.
UNTAPPED POTENTIAL
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.
Potential advantages
Reduced R&D
cost
Reduced
development
timeline
Phase 1 clinical
trials not
required
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 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.
The Path to Regulatory Approval
discovery & development
market
In vitro function
In vivo validation e.g. knockouts
Bioinformatics
Novel insights
Specialised screening platforms
Serendipity
Discovery
Traditional
Combinatorial chemistry
Rational based drug design
Screening
Ex vivo and in vivo
High throughput
Licensing
Novel IP
Both licensing & novel IP
Internal sources
Traditional medicinal chemistry
Rational drug design
Can start at Phase I or Phase II
Ability to leverage existing data packages
Manufacturing complete
Bioavailability and systemic exposure
(absorption clearance and distribution)
United States (FDA)
Europe (EMA or country by country)
Japan (MHLW)
Rest of World
Must start clinical testing as Phase I
(Phase VI for cancer)
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 transforming medicines, Paradigm specialises in developing underutilised molecules for commercialisation.
Clear Selection Criteria
Paradigm is always looking for molecules to develop 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 transforming underutilised molecules to meet the growing need for new, safe and effective treatments, click below.