Poolbeg Pharma Regulatory News (POLB)

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Poolbeg Pharma plc

POLB 001 US Patent update

7 September 2021 - Poolbeg Pharma (AIM: POLB), 'Poolbeg' or the 'Company', a clinical stage infectious disease pharmaceutical company with a capital light clinical model, provides an update on the strengthening of its intellectual property (IP) position around lead product, POLB 001, a small molecule immunomodulator for the treatment of severe influenza.

As detailed in the Admission Document, Poolbeg has a worldwide license for POLB 001 and is developing a strong IP portfolio with patent protections in place covering the use of the class of p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment or prevention of severe influenza and hypercytokinaemia (or "cytokine storm"). The Company continues to also evaluate POLB 001's therapeutic uses beyond severe influenza.

The US Patent and Trademarks Office examiner reviewing the patent application around POLB 001 has indicated to the Company that the majority of the claims, including the main claim are allowable. The main claim relates to the use of p38 MAP kinase inhibitors as a class of compounds, including POLB 001, for the treatment of severe influenza through modulation of the immune response. Poolbeg anticipates receiving a formal patent grant in due course.

The European patent was granted prior to the IPO with claims to the treatment of severe influenza, which is characterised by symptoms that persist or recur for more than two days without signs of resolution, with a p38 MAP kinase inhibitor inhibiting the release of pro-inflammatory mediators from endothelial cells and pro-inflammatory cytokines from immune cells. This granted patent offers protection until 2037.

Assessment of the applications filed in other territories is ongoing.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:

"Our US patent assessment is going to plan and we look forward to updating our shareholders when we receive confirmation of its grant. With the fast-growing infectious disease market expected to exceed $250bn by 2025 and the current market for influenza already c. $800m, the protection of our intellectual property is very important. As stated in our AIM Admission Document upon listing, our intention is to continue to aggressively file patent applications to protect Poolbeg's assets."

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About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a "one-stop shop" for Big Pharma seeking mid-stage products to licence or acquire.

The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.

With its initial assets from Open Orphan plc, an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. It already has a Phase II ready repositioned small molecule immunomodulator for severe influenza and a portfolio of other exciting assets. The Company plans to broaden this portfolio further going forward and is in active discussions with AI data analysis platforms to help accelerate the power of its human challenge model data and biobank.

For more information, please go to www.poolbegpharma.com