Poolbeg Pharma plc

Immunomodulator I Patent Opposition to be Withdrawn

Important step in continued protection of Poolbeg's patent family

19 September 2023 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company targeting diseases with a high unmet medical need, announces that the opposition to one of its European patents (Immunomodulator I) that was previously filed by a third party is to be withdrawn.

In the pharmaceutical industry it is not unusual for patents to be challenged. The Immunomodulator I European patent was opposed by a third party in September 2021. Further to engaging with the opposing party, Poolbeg has reached an amicable conclusion in relation to the patent dispute without any financial compensation between the parties. This has resulted in the opposing party agreeing to withdraw its opposition to the Immunomodulator I European patent and agreeing not to challenge any of Poolbeg's Immunomodulator I or Immunomodulator II patents in the future.

The Company will be communicating with the European Patent Office ('EPO') regarding the necessity of continuing with the scheduled hearing in November. Based on specialist advice received, and the fact that the patent went through an extensive examination process prior to being granted by the EPO, Poolbeg continues to have full confidence in the validity and strength of the patent and will defend its intellectual property to the extent required.

Poolbeg has a worldwide licence for POLB 001 for all uses in humans and is developing a strong IP portfolio with patents in place, including Immunomodulator I and Immunomodulator II, covering the use of the class of p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment of severe influenza and hypercytokinaemia. The Company has also filed patent applications to expand its IP around POLB 001 and the use of p38 MAP kinase inhibitors in new disease areas, such as oncology. This enhances the value and attractiveness of POLB 001 to potential pharma partners.

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: "The favourable resolution of the opposition filed against our Immunomodulator I European patent is an important outcome for us. We have full confidence in the strength and validity of our patent portfolio and look forward to continuing to expand our intellectual property and protecting our pipeline of assets. We remain committed to addressing global unmet medical needs by driving innovation in healthcare."

Footnote:

Immunomodulator I: Use of p38 MAPK inhibitors for the treatment of severe influenza

Immunomodulator II: Use of p38 MAPK inhibitors in combination with antiviral compounds for treatment of severe influenza, and the use of p38 MAPK inhibitors, alone or in combination with an antiviral agent, for the treatment of hypercytokinaemia

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About Poolbeg Pharma

Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in infectious and other prevalent diseases. Poolbeg Pharma has a disciplined portfolio approach to mitigate risk, accelerate drug development, and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg Pharma also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, leading to faster development and greater commercial appeal.

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. Through opportunistic identification of assets which complement Poolbeg Pharma's existing pipeline, the Company is progressing programmes in oncology and metabolic syndromes; adding disease areas with significant addressable markets.

With its initial assets from hVIVO plc, an industry leading infectious disease and human challenge trials business, Poolbeg Pharma 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. Amongst its portfolio of exciting assets, Poolbeg Pharma has a small molecule immunomodulator for severe influenza and other acute inflammatory conditions (POLB 001) which produces a highly significant reduction in p38 MAP kinase driven cytokines in a clinical setting; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is progressing two Artificial Intelligence (AI) Programmes to add promising new assets to its pipeline as well as developing an Oral Vaccine Programme and an Oral Delivery Programme focussing on metabolic syndrome related diseases.  

For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.