FDA to Approve More Precision Than Non-precision Drugs By 2021 – Diaceutics

– Diaceutics announces a series of forecasts based on research published in its annual Pharma Precision Medicine Readiness Report

– Report highlights that the precision medicine testing ecosystem is fractured and many patients who would respond well to a specific treatment may never receive it

– Diaceutics anticipates that better diagnostic testing will be driven by pharmaceutical executives eager to demonstrate its benefits to the investor community

PARSIPPANY, N.J.–(BUSINESS WIRE)–#FDA–Diaceutics PLC (AIM: DXRX), the precision diagnostic commercialisation company, forecasts that the next 18 months will be the tipping point that will see the FDA approve more precision drugs – along with new indications of existing precision medicine therapies – than ‘one-size-fits-all’ drugs¹. Diaceutics’ prediction is based on research published in the 2019 Diaceutics Pharma Precision Medicine (“PM”) Readiness Report.

In the report, Diaceutics anticipates that the FDA will be a driving force behind the movement towards more personalised treatments across all disease areas. It asserts that the regulator will continue to legislate to further advance the movement towards more personalised medicines, while offering accelerated approvals and collaboration around innovation².

Diaceutics notes that approximately 30% of FDA approvals in 2017 were for therapies with a biomarker cited in the therapy label as essential or recommended for prescribing. This rose to 40% in the years 2018 and 2019.

The PM Readiness Report also looked at the 517 Phase III clinical trials of test-dependent therapies being carried out in 2019. Based on the likely timing of submissions emanating from these trials, Diaceutics’ research indicated that the number of approved precision medicine assets will exceed non-precision medicine assets in the next 18 months. In line with current trends, Diaceutics believes that most of the approved drugs will be cancer treatments.

Diaceutics’ confidence in the overall trajectory of the precision medicine marketplace is supported by its real-world diagnostic testing data, which tracks on-market and newly approved therapies with a high dependency on efficient diagnostic pathways for patients.

Diaceutics’ analysis also looks at the conduit testing that is typically carried out on patients with early-stage diseases and doesn’t always include testing for specific biomarkers, but helps to channel patients towards the right treatment or dose. Applying this holistic view of precision medicine addresses the fractured testing ecosystem at the very start of the patient journey. It therefore enables more patients to get access to the treatment that is right for them earlier in their illness. When these conduit tests are taken into account, Diaceutics’ research shows that 68% of drugs approved in 2019 could already be considered ‘precision medicine’ drugs.

Peter Keeling, CEO, Diaceutics, said: “Precision medicine is transforming healthcare. It is prolonging life expectancies and has become a major focus for Pharma. Our research, however, shows that within oncology, the average precision medicine drug comes to market a staggering 4.5 years before the accompanying diagnostic test is readily accessible by all patients. This lag means that many patients who would respond well to a specific treatment will never get it.

“It is widely accepted now that this is not good enough, especially when the FDA is accelerating its advocacy of test-dependent therapies. However, the tide is changing and central to this must be a broader, but equally intense, focus on the testing taking place at every stage of a disease. We must force ourselves to view precision medicine as more than the treatments prescribed in the later stages of a disease so that cutting-edge drugs can be used to intervene earlier on.

“We expect that the investor community will have a significant impact on this. In the immune-oncology space, Pharma is compelled to explain why drugs that act in the same way might be accompanied by very different testing strategies or, in some situations, none at all. As a result, CEOs across the industry are now making testing strategies a top priority at their investor briefings, explaining that all, or most, of their oncology therapies will be launched alongside better testing.

“At Diaceutics, we are using our expansive real-world data to help pharmaceutical companies identify and eliminate the testing hurdles and ensure precision treatments reach more patients worldwide.”

An analysis of FDA 2019 approvals is available here: https://www.diaceutics.com/pharma-precision-medicine-readiness-report-2019-supplemental-update-analysis-of-fda-2019-test-dependent-therapy-approvals/

– Ends –

Notes

¹Data extracted from Diaceutics’ historical Precision Medicine asset tracking database 2010-2019. Based on active Phase 3 clinical trials with completion dates scheduled from January 2019 to December 2020, there are a total of 517 trials with 267 finishing in 2019 and 250 finishing in 2020. Assuming 20% of these trials result in an FDA/NDA/BLA application, there will be 103 submissions over the next 2 years. The 3 months with the greatest amount of trials finishing are June 2019, December 2019, and December 2020. Based upon a 9-month submission timeline, Diaceutics is expecting to see large amounts of FDA applications in March 2020, October 2021, and October 2022.

The pipeline is still primarily made up of oncology assets, but there are increasing amounts of assets in cardiology; pulmonology; diabetes and associated conditions including obesity; genetic diseases; endocrinology; metabolic disorder; and infectious diseases.

² In 2018, the FDA produced finalised guidelines on the development of tissue-agnostic therapies and the use of information in FDA-recognised public genetic variant repositories, drafting legislation called the Diagnostic Accuracy and Innovations Act (DAIA) – intended to regulate the lab space beyond the Clinical Laboratory Improvement Amendments (CLIA) and recognising expert-classified variants from the Clinical Genome Resource consortium.

About Diaceutics

Diaceutics PLC is the precision diagnostic commercialisation company for global pharmaceutical companies. The Company, quoted on the Alternative Investment Market (AIM) of the London Stock Exchange, is enabling pharma to accelerate their market penetration and achieve a better return on precision medicine therapies by helping them to revolutionise patient testing. By generating insights from its data lake of clinical laboratory testing data and other data, Diaceutics helps pharma understand and leverage the diagnostic landscape through initiatives that improve patient testing, leading to better treatment outcomes. The Company works with more than 35 global pharmaceutical companies across hundreds of precision medicine projects. The Company employs a leading global group of experts from the laboratory, diagnostic and pharmaceutical industries. www.diaceutics.com

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