Latest news with #Alofisel
Yahoo
5 days ago
- Business
- Yahoo
Develop Robust In-Licensing Strategies in the Face of GI CGT Market Changes
Explore the evolving landscape of cell and gene therapies (CGTs) in gastroenterology. Key therapies include Anterogen's Cupistem and Takeda's Alofisel, the latter recently withdrawn by EMA. Understand market trends, develop licensing strategies, and identify opportunities in the CGT segment for GI diseases. Dublin, May 30, 2025 (GLOBE NEWSWIRE) -- The "Cell & Gene Therapies in Dermatology Disorders: Therapeutic Analysis" report has been added to there are only two cell and gene therapies (CGTs) on the market across all gastroenterology (GI) indications. Anterogen's Cupistem, indicated for the treatment of anal fistula in adult patients, was the first adipose tissue-derived mesenchymal stem cell (ASC) asset to receive approval in the GI market in Japan, 2012. This was followed by Takeda Pharmaceutical's Alofisel (darvadstrocel), which received approval from the European Medicines Agency (EMA) in 2018 and from Japan's Pharmaceuticals and Medical Devices Agency (PDMA) in 2021. However, on December 13th, 2024, the EMA announced the withdrawal of Alofisel (darvadstrocel) from the EU market citing lack of data that demonstrated the benefit of this therapy in Crohn's marketed therapies are prescribed when a patient has shown an inadequate response to at least one conventional or biologic to Buy Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Develop business strategies by understanding the trends shaping and driving the CGT in Gastrointestinal market. Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact Gastrointestinal disease targeting CGT therapeutics market in the future. Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors. Identify emerging players with potentially strong product portfolios and create effective counterstrategies to gain a competitive advantage. Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships. Company Coverage: Krystal Biotech Inc RHEACELL GmbH Tego Science Inc Japan Tissue Engineering Bio Solution International Co Ltd Organogenesis Holdings Inc EHL Bio Co Ltd Castle Creek Biosciences Inc Abeona Therapeutics Inc Kangstem Biotech Co Ltd Key Topics Covered: 1. Preface2. Executive Summary3. Introduction and Scope4. Current Treatment Options4.1. What is Cell & Gene Therapy?4.2. History of the Development of CGT in Dermatology Disorders4.3. Marketed Product Profiles - Cell and Gene Therapy4.4. Challenges and Opportunities in CGT in Dermatology Disorders5. Pricing and Reimbursement Assessment5.1. High Cost of CGTs Requires Adaptation of Payment Models to Ensure Affordability and Patient Access5.2. Price of Cell Therapy6. Regulations6.1. Regulation of CGTs in the 8MM7. Future Market Assessment7.1. Top 20 Dermatology Disorders with CGT Development7.2. Top Five Dermatology Disorders with the Most CGT Pipeline Assets7.3. Top Five Dermatology Disorders Stratified by Molecule Type7.4. CGT in Dermatology Disorders - Pre-reg and Phase II/III7.5. Additional Players Expected to Join the Competition Within Five Years7.6. Industry Trends in the Application of CGTs in Dermatology Disorders7.7. Most of CGT Market Catalyst is Concentrated in 20258. Likelihood of Approval and Phase - Transition Success Rate Analysis8.1. CGT Candidates Have Higher LoA and PTSR vs. Indication Benchmarks9. Sales Forecast9.1. Sales are forecast to reach $1.5 billion by 2030For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Irish Independent
25-04-2025
- Business
- Irish Independent
Japanese pharmaceutical firm Takeda's profits hit by €37m impairment charge
New accounts show that Takeda Ireland Ltd sustained the €37.2m impairment charge on its tangible assets after a group decision not to manufacture a new medicine, Alofisel, at Grange Castle to treat complex anal fistulas in adults who have Crohn's disease. The note states that in February last year, Takeda made a decision not to pursue marketing authorisations for Alofisel in the United States or Canada based on the findings of a clinical study announced in October 2023. However, it states that the Alofisel decision 'had a direct impact on the manufacturing facility P3 in Grange Castle, Ireland, which was built to enable the business to meet future demand in the US and Canada'. The note adds that as a result of this 'a decision was made to discontinue operation of the P3 Alofisel manufacturing facility in Grange Castle'. It further states that the impairment did not impact the entity's going concern due to limited size of Alofisel business. In accounts signed off on February 25, the note states that the 'P3 manufacturing facility remains unused' and that 'the Takeda group has not disclosed any plans regarding the future use of this facility'. The accounts show that despite the €37.2m impairment, pre-tax profits at Takeda Ireland more than doubled from €13.8m to €28.1m in the 12 months to the end of March 2024. This followed revenues increasing marginally from €383.9m to €388.29m. The company recorded a post-tax profit of €16.69m after incurring a corporation tax charge of €11.4m. The Japanese-headquartered Takeda has commercial operations, corporate services and manufacturing facilities across four locations in Ireland: Baggot Street in Dublin city, Bray, Citywest and Grange Castle. Profits increased sharply last year after cost of sales reduced from €351m to €308.8m, and the directors state that the decrease 'is mainly related to reduction in intercompany royalty expenses'. In 2004 Takeda chose Grange Castle as its first active pharmaceutical ingredient (API) facility outside Japan.
Irish Times
24-04-2025
- Business
- Irish Times
Takeda takes €37m hit manufacturing row back
The Irish arm of pharma firm, Takeda last year took a €37.2 million hit to profits after mothballing fresh manufacturing capacity at its Grange Castle site in south county Dublin. New accounts show that Takeda Ireland Ltd sustained the €37.2 million impairment charge on its tangible assets after a group decision not to manufacture a new medicine, Alofisel at Grange Castle to treat complex anal fistulas in adults who have Crohn's disease. The note states that in February 2024, Takeda made a decision not to pursue marketing authorisations for Alofisel in the United States or Canada based on the findings of a clinical study announced in October 2023. In 2020, Takeda Ireland secured planning permission for an expansion of its P3 manufacturing capacity that would result in 117 additional jobs at the site. READ MORE However, the note states that the Alofisel decision 'had a direct impact on the manufacturing facility P3 in Grange Castle, Ireland, which was built to enable the business to meet future demand in the US and Canada'. The note adds that as a result of this 'a decision was made to discontinue operation of the P3 Alofisel manufacturing facility in Grange Castle'. The impairment did not impact the entity's going concern due to limited size of Alofisel business, it adds. In accounts signed off on February 25th, the note states that the 'P3 manufacturing facility remains unused' and that 'the Takeda group has not disclosed any plans regarding the future use of this facility'. The accounts show that despite the €37.2 million impairment, pretax profits at Takeda Ireland more than doubled from €13.8 million to €28.1 million in the 12 months to the end of March 2024. This followed revenues increasing marginally from €383.9 million to €388.29 million. The company recorded a profit after tax of €16.69 million. The Japanese headquartered Takeda today has commercial operations, corporate services and manufacturing facilities across four locations in Ireland: Baggot Street in Dublin, Bray, Citywest and Grange Castle. The directors state that 'are satisfied with the company's progress and will continue to seek additional opportunities' Profits last year increased sharply after cost of sales reduced from €351 million to €308.8 million and the directors state that the decrease 'is mainly related to reduction in intercompany royalty expenses'. Today, the Irish unit has grown to employ over 1,000 people and staff costs last year increased from €64 million to €71.7 million.
