Latest news with #Poolbeg
RTÉ News
27-05-2025
- Business
- RTÉ News
Poolbeg Pharma gets FDA support for POLB 001 drug
Biopharmaceutical company Poolbeg Pharma said the US Food and Drug Administration has granted Orphan Drug Designation (ODD) to its POLB 001 product as an oral preventative therapy for Cytokine Release Syndrome (CRS). Cancer immunotherapy-induced CRS is a severe side-effect that occurs in more than 70% of patients and which may lead to multi-organ failure and death. There are currently no approved preventative therapies for CRS. Poolbeg focusses on the development of innovative medicines to address unmet medical needs and its programmes target large addressable markets including, cancer immunotherapy-induced Cytokine Release Syndrome (CRS) and metabolic conditions such as obesity. The company said the FDA grants orphan status to support the development of medicines for rare disorders affecting less than 200,000 people in the US. It provides Poolbeg with clinical development and commercialisation benefits including the potential for a seven-year period of US market exclusivity after regulatory approval of POLB 001, potential waiver exemption of Prescription Drug User Fee Act application fees and the potential for tax credits for qualifying clinical trials. Poolbeg expects the first patient to be dosed in its proposed Phase 2a in the second half of this year, with interim analysis expected in the first half of 2026 and Phase 2a topline data in the second half of 2026. Jeremy Skillington, the chief executive of Poolbeg Pharma, said that POLB 001 is potentially a breakthrough, orally delivered, preventative therapy for cancer immunotherapy-induced CRS which could significantly impact patients' lives. "We were delighted to receive Orphan Drug Designation from the FDA, which is a significant development for Poolbeg and for POLB 001, one that we believe will enhance the commercial appeal for prospective partners and help bring POLB 001 to the market faster," he said. "If approved, we believe POLB 001 has the potential to improve quality of life for patients, reduce pressure on healthcare systems, and expand access to cancer immunotherapies," the CEO added.
Irish Times
27-05-2025
- Business
- Irish Times
Poolbeg Pharma treatment gets FDA backing
The US Food and Drug Administration (FDA) has granted orphan drug designation to Poolbeg's preventative therapy for cancer immunotherapy-induced Cytokine Release Syndrome (CRS). The treatment, named POLB 001, is an oral preventative therapy to treat inflammation in blood and tissues. CRS is a severe side-effect that occurs in more than 70 per cent of patients, leading to severe side-effects or death. Cytokines can sweep throughout the body and cause tissue damage and shut down circulation and other essential organs. Orphan status is granted by the FDA for to support the development of treatments for rare disorders that affect under 200,000 people in the US, and makes the development of the drug less risky for Poolbeg, with the potential for seven-year period of US market exclusivity following approval of the treatment, waiver exemption of some fees and tax credits for qualified clinical trials. READ MORE 'POLB 001 is potentially a breakthrough, orally delivered, preventative therapy for cancer immunotherapy-induced CRS which could significantly impact patients' lives,' said Poolbeg chief executive Jeremy Skillington. 'We were delighted to receive Orphan Drug Designation from the FDA, which is a significant development for Poolbeg and for POLB 001, one that we believe will enhance the commercial appeal for prospective partners and help bring POLB 001 to the market faster. If approved, we believe POLB 001 has the potential to improve quality of life for patients, reduce pressure on healthcare systems, and expand access to cancer immunotherapies.' There are currently no approved preventative therapies for CRS. The first patients are expected to get the drug in the second half of the year, as part of Poolbeg's Phase 2a trial. 'Orphan Drug Designation from the FDA underscores the urgency and importance of developing innovative therapies for this critical unmet medical need,' said Professor Brendan Buckley, Poolbeg non-executive director and a member of the scientific advisory board. 'We look forward to progressing POLB 001 in our upcoming Phase 2a clinical trial and working closely with prospective partners and regulatory agencies to bring this potential therapy to patients as quickly as possible.'
Irish Examiner
10-05-2025
- Business
- Irish Examiner
Books are my business: Poolbeg Press publisher Paula Campbell
Paula Campbell is publisher at Poolbeg Press, one of Ireland's leading book publishers. The company, founded in 1976, is based in Baldoyle, Co Dublin. How did you get into publishing? When I did my leaving cert, I had no idea what I wanted to do. That summer, my brother was working in the local bookshop, which was Books Unlimited in Donaghmede Shopping Centre. They were stuck for staff and he rang me to come down. I was working in the schoolbooks section and I would look across at the wall of fiction books, thinking that behind every cover was a story. I loved the idea of that. I did English in UCD, but not because I wanted to get into publishing, I was already in the door of bookselling and the English was just complementing that. During college I worked in the bookshop and when I graduated, I became the manager. I did that for a few years and then I moved into Hughes and Hughes in Stephen's Green. I have the best memories of my time there. We had so many celebrities in for events, from David Attenborough to Lauren Bacall. I moved into the wholesaling side of the business, doing the buying and the marketing attached to that. Then I moved to Poolbeg in a sales and marketing role. We were also agents for some of the big English publishers, so I learned a lot. Then, Philip McDermott, the founder of Poolbeg retired and told me I was going to be publisher. I have been doing this job for about 25 years now. What does your role involve? We are a small company so I am the first port of call for manuscripts. I read the first three chapters, and if I like what I see, I ask the author for the full manuscript. I read that and I will send it on to the editor to look at and we decide whether to publish it. I oversee the editing schedules, I work with the designer on the cover, and I do the sell-in to the key accounts. I mind the book as it goes through the system. I have been through every aspect of the business, from the literal bookselling to wholesaling to publishing. I know the booksellers, how they buy, and what you need to do to push a book out there. What do you like most about what you do? If I love a story, I'm driven to get it out there. I'm always determined, with every book, to tell people 'this is a great story, you will love this'. I also like working with authors when they are starting out and seeing their confidence grow. I enjoy the interaction with people, every day you are talking to someone different. What do you like least? It is relentless, you can never stop and say 'OK, we've done everything for that book' because you keep thinking you could do more. You are also fighting all the time for space. I understand booksellers are under pressure and they will always try to do their best for Poolbeg. The smaller companies are trying to compete against the bigger ones, but we are Irish, working with Irish authors, and we try to get that message out there. Three desert island books The first one would be Great Expectations by Charles Dickens. It is a timeless and unforgettable book, every time you read it, you come away with something else to think about. The second is The Pillars of the Earth by Ken Follett, about the building of a cathedral in 12th century England and I have a proof copy signed by the author. It is an amazing book — the characters, the setting, the history, architecture, the romance, it has everything. The third one would be The House of the Spirits by Isabel Allende. I couldn't put it down, you could read it five times and you would discover something new. It is such a colourful and passionate book, it really is magic. Read More Books are my business: Gill Books commissioning editor Sarah Liddy
