REG - Poolbeg Pharma PLC - Market Opportunity for POLB 001 for CRS

Poolbeg PharmaAnnouncement

12/02/2024 07:00

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RNS Number : 7309C  Poolbeg Pharma PLC  12 February 2024

Poolbeg Pharma plc

 

Independent Research Confirms >$10bn Market Opportunity for POLB 001 as a
Preventative Therapy for Cancer Immunotherapy-Induced Cytokine Release
Syndrome (CRS)

 

Former Amryt team's arrival supports increasing focus upon Rare and Orphan
Diseases

 

12 February 2024 - Poolbeg Pharma (http://www.poolbegpharma.com/)  (AIM:
POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a biopharmaceutical company
focused on the development and commercialisation of innovative medicines
targeting diseases with a high unmet medical need, today announces that
independent research i  (#_edn1)  ii  (#_edn2) conducted on behalf of Poolbeg
confirms a >$10 billion market opportunity for POLB 001 in Cancer
Immunotherapy-Induced CRS as an orally delivered preventative therapy. Cancer
immunotherapies have been approved in rare and orphan blood cancers and so the
Company can see potential for POLB 001 in one or more of these cancer types.
POLB 001 in cancer immunotherapy-induced CRS will be developed alongside
Poolbeg's existing portfolio of assets including its influenza programme; its
AI drug discovery programmes; and oral delivery of GLP-1 for obesity and other
metabolic diseases.

 

Rare and orphan diseases represent a significant value creation opportunity
for the Company and its shareholders as they are underserved and there remains
a substantial opportunity for innovative medicines to treat these severe and
often chronic conditions. It is anticipated that acquiring and commercialising
rare and orphan drugs could potentially lead to attractive revenue generation
opportunities. Poolbeg will draw on the expertise of the wider team, including
the individuals of the former Amryt team, who have a proven track record of
successfully building and commercialising orphan drugs. Regulatory authorities
offer incentives to companies developing orphan drugs, such as reduced filing
fees, tax breaks and market exclusivity post approval and the Company
Directors believe that Poolbeg is well positioned to benefit from these
opportunities.

 

The Company also announced further detail on the significant market
opportunity for POLB 001 CRS induced by CAR-T and bispecific antibody
treatments (BsAb), where CRS can affect the majority of patients and can lead
to extended hospital stays, discontinuation of treatment and mortality risk.
There are currently few approved therapies for the management of acute CRS and
no preventative therapies indicated for CRS.

 

The size and attractiveness of this market has encouraged the Company, as the
field of cancer immunotherapies, including CAR-T and BsAb, is burgeoning and
is expected to grow to US$100bn - US$140bn iii  (#_edn3) by 2030. CRS occurs
in the majority of CAR-T and BsAb treatments frequently impacting >70% iv 
(#_edn4) of patients and cannot be predicted. All grades of CRS can lead to
extended hospital stays, causing an estimated US$5.5bn v  (#_edn5) of
hospitalisation costs to healthcare systems, and further indirect costs
through patient treatment and follow up.

 

An effective oral preventative therapy for cancer immunotherapy-induced CRS
has the potential to significantly reduce direct costs in the healthcare
system and improve patient access to these therapeutics, potentially including
access to these therapies outside of specialist centres, while further
augmenting wider market uptake.

 

Poolbeg recently announced promising in vivo results for POLB 001 in
addressing cancer immunotherapy-induced CRS, where CRS clinical symptoms were
significantly improved by administration of POLB 001. Dose dependent
reductions were seen in all serum proinflammatory cytokines measured.

 

Jeremy Skillington, Chief Executive Officer, Poolbeg Pharma plc said: "Rare
and Orphan disease medicines fit Poolbeg's efficient capital model
particularly well. Clinical development is typically more cost efficient and
the market opportunity remains high because of the high unmet medical need.
 There is also a very active M&A market in this sector which Amryt took
advantage of. We see this strategic approach as highly complementary to our
existing programmes. The former Amryt team that have joined Poolbeg have an
exceptional track record, have hit the ground running and are aligned with our
vision of rapidly generating revenues and creating value for shareholders."

 

Enquiries

 

 Poolbeg Pharma Plc                                                      +44 (0) 207 183 1499

 Jeremy Skillington, CEO

 Ian O'Connell, CFO

 Cavendish Capital Markets Ltd (Nominated Adviser & Joint Broker)        +44 (0) 207 220 0500

 Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)

 Singer Capital Markets (Joint Broker)                                    +44 (0) 207 496 3000

 Phil Davies, Sam Butcher

 J&E Davy (Joint Broker)                                                 +353 (0) 1 679 6363

 Anthony Farrell, Niall Gilchrist

 Optimum Strategic Communications                                        +44 (0) 208 078 4357

 Nick Bastin, Vici Rabbetts, Elena Bates                                 poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)

 

About Poolbeg Pharma

Poolbeg Pharma plc is committed to the development and commercialisation of
innovative medicines targeting diseases with a high unmet medical need. Its
model focusses upon developing its exciting clinical assets and
commercialising approved and marketed drugs to fund the development of its
robust pipeline of innovative products, thereby driving significant value
creation.

 

Poolbeg is led by an experienced leadership team with a history of delivering
significant shareholder value. The team has been strengthened by the
appointment of three former members of the Amryt Pharma plc leadership team,
with the intention of repeating Amryt's success and generating near term
revenues.

 

Poolbeg's clinical programmes target large addressable markets including
cancer immunotherapy-induced CRS, infectious disease, and metabolic conditions
such as obesity with the development of an oral GLP-1R agonist. It uses a
cost-effective development philosophy to generate high quality human data to
support partnering and further development. Its AI-led infectious disease
programmes analyse unique data from human challenge trials to identify
clinically relevant drug targets and treatments, leading to faster development
and greater commercial appeal.

 

Forward-Looking Statements

This announcement may contain forward-looking statements and the words
"expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast",
"project" and similar expressions (or their negative) identify certain of
these forward-looking statements. The forward-looking statements in this
announcement are based on numerous assumptions and Poolbeg's present and
future business strategies and the environment in which Poolbeg expects to
operate in the future. Forward-looking statements involve inherent known and
unknown risks, uncertainties and contingencies because they relate to events
and depend on circumstances that may or may not occur in the future and may
cause the actual results, performance or achievements to be materially
different from those expressed or implied by such forward-looking statements.
These statements are not guarantees of future performance or the ability to
identify and consummate investments. Many of these risks and uncertainties
relate to factors that are beyond Poolbeg's ability to control or estimate
precisely, such as future market conditions, currency fluctuations, the
behaviour of other market participants, the outcome of clinical trials, the
actions of regulators and other factors such as Poolbeg's ability to obtain
financing, changes in the political, social and regulatory framework in which
Poolbeg operates or in economic, technological or consumer trends or
conditions. Past performance should not be taken as an indication or guarantee
of future results, and no representation or warranty, express or implied, is
made regarding future performance. No person is under any obligation to update
or keep current the information contained in this announcement or to provide
the recipient of it with access to any additional relevant information.

 

 

 i  (#_ednref1) Grand View Research. CAR T-Cell Therapy Market Analysis
2023-2030; Bispecific Antibodies Market Size, Share & Trends Analysis
Report.

 ii  (#_ednref2) Datamonitor Healthcare. Forecast: Diffuse Large B-Cell
Lymphoma and Multiple Myeloma, 2023.

 iii  (#_ednref3) Grand View Research. CAR T-Cell Therapy Market Analysis
2023-2030; Bispecific Antibodies Market Size, Share & Trends Analysis
Report.

 iv  (#_ednref4) Average rate from Summary of Product Characteristics (SmPCs)
for Yescarta, Tecartus, Abecma, Kymriah, Carvykti, Breyanzi, Elrexfio,
Columvi, Epkinly, Tecvayli and Talvey

 v  (#_ednref5) Adapted from 1. Datamonitor Healthcare. Forecast: Diffuse
Large B-Cell Lymphoma and Multiple Myeloma, 2023 2. Abramson JS et al.
Cytokine release syndrome and neurological event costs in lisocabtagene
maraleucel-treated patients in the TRANSCEND NHL 001 trial. Blood Adv. 2021
Mar 23;5(6):1695-1705.

 

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