Latest news with #Actemra
Daily Mail
02-06-2025
- Business
- Daily Mail
SMALL CAP IDEA: Poolbeg Pharma raises £4.1m to finance cancer drugs
Raising fresh capital is a familiar rhythm for early-stage biotech companies. For Poolbeg Pharma, the question is not simply whether it can fund its ambitions, but whether its pipeline can justify them. Expert opinion is broadly optimistic on this point - bolstered by a major tick in the box from the US regulator. The company recently announced a £4.1million equity raise, priced at 2.5p per share, a 12 per cent discount to the market price, to finance the next stage of development for its two lead assets. They are POLB 001, targeting cancer immunotherapy induced cytokine release syndrome (CRS), and an oral glucagon like peptide 1 (GLP-1) receptor agonist designed for obesity treatment. The latter is a next-generation, easier-to-administer upgrade to jabs such as Ozempic and Mounjaro. Tackling a major cancer therapy bottleneck POLB 001 is seen as a potential game-changer. It is being developed to tackle cytokine release syndrome, a serious complication arising in patients undergoing CAR-T or bispecific antibody therapies, where an overactive immune response can lead to high fevers, low blood pressure and organ failure. According to analysts at Shore Capital, CRS affects over 70 per cent of patients receiving such therapies and has been a major limiting factor in their wider deployment. POLB 001 is designed as an oral preventative treatment, a notable shift from existing drugs like Roche's injectable Actemra, which is approved for treating CRS after symptoms appear. Broker Cavendish notes that Poolbeg's preclinical and human challenge data already show clear suppression of key inflammatory cytokines. If Phase 2a data confirm this, the company could be first to market with an oral CRS prophylactic, a development that Cavendish estimates could unlock a market opportunity exceeding $10billion, initially in blood cancers and potentially in solid tumours too. The Phase 2a trial is expected to begin in the second half of this year. Big Pharma is reportedly providing the bispecific antibody therapy used in the trial at no cost, a move analysts at both Shore and Cavendish interpret as early validation of POLB 001's commercial promise. Crucially, the putative treatment recently received orphan drug designation from the America's Food & Drug Administration, which significantly enhances POLB 001's commercial appeal, especially when engaging prospective partners. This regulatory tick in the box can't be overstated. Seeking a slice of the weight loss boom Poolbeg's second programme enters another multibillion-dollar market: obesity. With injectable GLP-1 agonists such as Ozempic and Wegovy driving record revenues for Novo Nordisk and Eli Lilly, the race is now on to develop effective oral formulations that improve patient convenience and compliance. Poolbeg's answer is a proprietary microencapsulation technology licensed from AnaBio. A proof-of-concept study will begin this year at the University of Ulster, with topline data due in the first half of 2026. ShoreCap argues that the approach could provide a differentiated product in a market forecast to reach $150billion by the early 2030s. Cash, catalysts and credibility Cavendish notes Poolbeg ended the first quarter of 2025 with £6.2million in cash. The current raise, assuming shareholder approval, will extend the company's runway into 2027. That should be enough to reach multiple clinical milestones and, ideally, deliver the data needed to secure commercial partners. Importantly, the raise also comes with insider backing. Executive chair Cathal Friel has committed to invest £100,000, providing a measure of confidence in the company's direction. Execution Still, investors should keep their eyes on execution. While both POLB 001 and the GLP-1 asset are tackling real clinical problems with significant market potential, they remain pre-revenue and subject to trial risk. Poolbeg's ability to translate promise into partnerships will be the key driver of any future valuation shift. Cavendish maintains a 19p target on the shares, implying significant upside from the current 2.9p. But for that to materialise, the next 12 to 18 months will need to deliver more than just well-funded plans. They will need hard data. For all the latest small- and mid-cap news go to
Yahoo
02-04-2025
- Business
- Yahoo
Organon acquires Actemra biosimilar's US rights from Biogen
Organon has announced the acquisition of the US regulatory and commercial rights for intravenous infusion of the Actemra biosimilar, Tofidence, from Biogen. The move is set to bolster and widen Organon's US biosimilars immunology portfolio with multi-indication arthritis treatment. Launched in May 2024, Tofidence is available in three vial sizes: 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL, for further dilution before intravenous infusion. It is the first tocilizumab biosimilar to enter the US market, and treats systemic juvenile idiopathic arthritis, moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and Covid-19. Organon will make an upfront payment to Biogen and is committed to making tiered royalty payments based on net sales and milestone payments to Bio-Thera Solutions. Bio-Thera Solutions, the developer of Tofidence, will continue to have the manufacturing rights for the biosimilar in the US market. Organon CEO Kevin Ali stated, 'Biosimilars continue to be a key growth driver for Organon, and this acquisition complements our existing business, enabling us to expand our immunology portfolio. 'We believe that by leveraging our commercial expertise and market access capabilities, there is considerable growth potential for this product.' In September 2023, Biogen announced the receipt of US Food and Drug Administration (FDA) approval for Tofidence. The biosimilar's commercialisation and licence agreement between Biogen and Bio-Thera was established in April 2021, granting Biogen exclusive regulatory, manufacturing and commercial rights to Tofidence in all nations except China, inclusive of Taiwan, Macau and Hong Kong. Organon's portfolio includes medicines and products in therapeutic areas such as women's health, and biosimilars. The company is headquartered in Jersey City, New Jersey, US. Organon previously completed the acquisition of the Roivant subsidiary, Dermavant Sciences, broadening its dermatology portfolio. "Organon acquires Actemra biosimilar's US rights from Biogen" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Korea Herald
13-03-2025
- Business
- Korea Herald
Celltrion launches autoimmune disease treatment in US
Celltrion Inc., a major South Korean biopharmaceutical firm, said Thursday it has launched its biosimilar product for Stelara, an autoimmune disease treatment, in the United States. Steqeyma, a treatment for plaque psoriasis, Crohn's disease, active psoriatic arthritis and ulcerative colitis, is Celltrion's seventh biosimilar product that has hit the US market, the company said in a press release. The US Food and Drug Administration approved the biosimilar drug in both intravenous and subcutaneous formulations in December, it said. Celltrion has been making efforts to expand its presence in the US biosimilar market. In recent months, it has obtained FDA approval for the US sale of several biosimilars, including Avtozma, an autoimmune disease biosimilar to Actemra, as well as Stoboclo and Osenvelt, biosimilar drugs to Prolia and Xgeva. The global market for Stelara is estimated at US$10.36 billion, with the US accounting for two-thirds of global sales. Celltrion aims to commercialize 22 biosimilar products in global markets by 2030. (Yonhap)
Korea Herald
24-02-2025
- Business
- Korea Herald
Celltrion's Avtozma receives European marketing approval
South Korean pharmaceutical firm Celltrion announced Monday that Avtozma, a biosimilar of Actemra, has received approval from the European Commission. The approval covers major indications of the original drug, including rheumatoid arthritis and giant cell arteritis. Avtozma, an interleukin inhibitor, reduces inflammation by targeting the IL-6 protein. With this approval, Celltrion expands its autoimmune disease treatment portfolio beyond tumor necrosis factor-alpha inhibitors, broadening the scope of treatable patients. The biosimilar is the last of four product approvals in Europe this month, following Eydenzelt (Eylea biosimilar), Osenbelt and Stovoclo (Prolia-Xgeva biosimilar). These additions complete Celltrion's 11-product portfolio in Europe, a milestone already achieved domestically in December 2024. Celltrion's total market value for the 11 products is approximately 150 trillion won ($105.2 billion), covering treatments for autoimmune diseases, cancer, allergies, ophthalmology and bone disorders. The company aims to strengthen its position in the fast-growing autoimmune market while expanding into other therapeutic areas. "With consecutive product approvals in Europe, one of our key markets, we have successfully achieved our 2025 goal of establishing an 11-product portfolio. This also reaffirms our capabilities in pharmaceutical development,' a Celltrion representative stated. 'We will now focus on commercialization to drive global expansion and accelerate growth.'
Korea Herald
24-02-2025
- Business
- Korea Herald
Celltrion's autoimmune disease treatment gets approval in Europe
Celltrion Inc., a major South Korean biopharmaceutical firm, said Monday its new biosimilar for an autoimmune disease treatment has obtained approval from the European Commission. The EC approved Celltrion's Avtozma, a biosimilar to Actemra, in both intravenous and subcutaneous formulations, for sales in the member countries of the European Union, the company said in a press release. Avtozma can be used as a treatment for multiple autoimmune diseases, including rheumatoid arthritis and giant cell arteritis. "The EC approval on Avtozma marks a critical step in Celltrion's mission to provide European healthcare systems with affordable, effective solutions for immunological disorders," Ha Tae-hun, senior vice president in charge of Celltrion's European operations, said in the release. Avtozma was also approved by the US Food and Drug Administration for local sales last month. The Korean drugmaker aims to commercialize 22 biosimilar products by 2030, up from the current 11. (Yonhap)
