Irinotecan Hydrochloride Lioposome

New Delhi: Executing the much-awaited overhaul of the Goods and Services Tax (GST) regime, the GST Council has brought a major relief for patients by reducing the indirect tax on medicines to 5 per cent, along with exempting as many as 36 life-saving medicines and other critical drugs. The GST council—a statutory body highest decision making body on indirect taxes led by the Union Finance Ministry at its 56th meeting in the national capital has recommended to reduce the GST on all drugs and medicines (finished formulations) from 12 per cent to 5 per cent under the new two-tier tax structure of 5 and 18 per cent slabs to be effective from September 22. Additionally the body has also recommended to exempt GST on 33 lifesaving drugs and on 3 other medicines used for treatment of cancer, rare diseases and other severe chronic diseases. Speaking at a press briefing after the council 10.5-hour long marathon meet, Finance Minister Nirmala Sitharaman said, “all recommendations have been cleared with zero reservations and have corrected various inverted duty structure problems, classification related issues and that this rationalization exercise will bring predictability and stability of GST.” “These reforms have been carried out with a focus on the common man, and after a rigorous evaluation process in most sectors including healthcare, the rates have come down drastically, she added. Previously, medicines in India were taxed at 5 per cent for life-saving and essential drugs, and at 12 per cent for others but following the announcement all medicines will attract a standard duty of 5 per cent with extensions for several medicines specified at the end of this article. Welcoming the move, Sudarshan Jain, Secretary General, IPA said, “the decision to exempt life-saving and cancer medicines from GST, is a step that will bring direct relief to patients and their families. and, the reduction in GST on a wide range of medicines from 12 per cent to 5 per cent will further help to ease the overall treatment burden and make essential therapies more affordable.” Meanwhile, for companies, the clarity on a 5 per cent slab and exemptions removes long-standing ambiguity, enabling transparent pricing and better market planning. The move will expand access in semi-urban and rural markets, ease litigation, and free up resources for innovation, said Manoj Mishra, Partner and Tax Controversy Management Leader, Grant Thornton Bharat LLP. Notably, on the issue of inverted duty involving APIs and key starting materials—which are currently taxed at 18 per cent against 12 or 5 per cent for finished formulations—further clarity is awaited from the industry. ETPharma earlier reported that, in a letter to the Finance Minister, the national chemist body, the All India Organisation of Chemists and Druggists (AIOCD) had urged, “to bring all medicines including vitamins, probiotics, nutritional, food supplements under the 5 per cent GST slab. The rate rationalization comes days after Prime Minister Narendra Modi had pitched for introducing next-gen reforms across sectors to “increase ease of living for the common man and strengthen the economy.” However, this rationalization brings a revenue shortfall challenge for governments with states likely to bear a greater share of the burden, as they receive over 40 percent of the inter-state inflows in addition to their own SGST collections. Responding to a media query at the media briefing Arvind Shrivastava, Revenue Secretary said that, based on the consumption of FY23-24 the ministry has estimated that the net revenue implication of this proposal will be around Rs 48,000 crore. “However the exercise will trigger buoyancy effects and will have a positive impact on consumer and compliance. And therefore we believe this proposal will be fiscally sustainable both for centers and the states,” Shrivastava noted. ' S.no. Drug Indication Brand name and (Company) 1 Onasemnogene abeparvovec SMA (One-time gene therapy) Zolgensma (Novartis) 2 Asciminib Blood Cancer Scemblix (Novartis) 3 Mepolizumab Asthma Nucala (GSK) 4 Pegylated Liposomal Irinotecan Pancreatic Cancer Onivyde (Ipsen) 5 Daratumumab Cancer Darzalex (J&J subsidiary) 6 Daratumumab subcutaneous Cancer Darzalex Faspro (J&J subsidiary) 7 Teclistamab Blood Cancer Tecvayli (J&J subsidiary) 8 Amivantamab Lung Cancer Rybrevant (J&J subsidiary) 9 Alectinib Lung Cancer Alecensa (Roche) 10 Risdiplam SMA Evrysdi (Roche) 11 Obinutuzumab Blood Cancer Gazyva (Roche) 12 Polatuzumab vedotin Blood Cancer Polivy (Roche) 13 Entrectinib Cancer Rozlytrek (Roche) 14 Atezolizumab Cancer (PD-L1 immunotherapy) Tecentriq (Roche) 15 Spesolimab GPP flares Spevigo (Boehringer Ingelheim) 16 Velaglucerase Alpha Gaucher Vpriv (Takeda) 17 Agalsidase Alfa Fabry disease Replagal (Takeda) 18 Rurioctocog Alpha Pegol Hemophilia Adynovate (Takeda) 19 Idursulphatase Type II Mucopolysaccharidosis Elaprase (Takeda) 20 Alglucosidase Alfa Pompe Myozyme (Sanofi) 21 Laronidase Type I Mucopolysaccharidosis Aldurazyme (Sanofi) 22 Olipudase Alfa ASMD Xenpozyme (Sanofi) 23 Tepotinib Lung Cancer Tepmetko (Maerck KGaA) 24 Avelumab Cancer (PDL-1 immunotherapy) Bavencio (Pfizer) 25 Emicizumab Hemophilia Hemlibra (Roche subsidiary) 26 Belumosudil cGVHD - 27 Miglustat Gaucher Zavesca (J&J subsidiary) 28 Velmanase Alfa Alpha-mannosidosis - 29 Alirocumab Cholesterol lowering drug (LDL-C) Praluent (Sanofi) 30 Evolocumab Cholesterol lowering drug (LDL-C) Repatha (Amgen) 31 Cystamine Bitartrate Cystagon - 32 CI-Inhibitor injection Hereditary Angioedema - 33 Inclisiran Cholesterol lowering drug (LDL-C) Leqvio (Novartis) 34 Agalsidase Beta Fabry disease Fabrazyme (Sanofi) 35 Imiglucerase Gaucher Cerezyme (Sanofi) 36 Eptacog alfa activated recombinant coagulation factor VIIa Hemophilia NovoSeven Note: Above is the list of medicines exempted from GST tax recommended by the 56th GST Council Meet/ Source: PIB By Abhijeet Singh ,

H1 total sales growth of 11.4% at CER1, or 9.7% as reported, driven by the three therapeutic areas: 95.7% in Rare Disease, 9.7% in Neuroscience, and 6.4% in Oncology H1 core operating income of €656m, growing by 21.9% as reported, with a core operating margin of 36.0% of total sales, increasing by 3.6 points Upgraded FY 2025 financial guidance2: total-sales growth greater than 7.0% at CER (prior guidance: greater than 5.0% at CER); core operating margin greater than 32.0% of total sales (prior guidance: greater than 30%) Pipeline progression including regulatory filing of tovorafenib in Europe, and initiation of a Phase II trial of LANT3 (IPN10200) in cervical dystonia European Commission approval on 23 July 2025 of Cabometyx® in advanced neuroendocrine tumors (NETs), the sixth indication Key upcoming milestones with the pivotal FALKON trial results for fidrisertib in FOP4 and the Proof-of-Concept data readout for the LANT in aesthetics PARIS, FRANCE, 31 July 2025 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the first half of 2025. “Our half year results reflect continued strong momentum, with growth across all three therapeutic areas, particularly in our rare liver disease franchise, which is expanding rapidly and progressing well,” said David Loew, Chief Executive Officer, Ipsen. “Building on that performance, I am pleased to increase our full year guidance in terms of sales and profitability.” “I’m also delighted to report robust progression in our pipeline and portfolio, including the recent European Commission approval of Cabometyx® in advanced neuroendocrine tumors, an area where Ipsen has a strong legacy. In the second half of the year, we are anticipating the readout of our pivotal study of fidrisertib in fibrodysplasia ossificans progressiva and the proof-of-concept trial of our long-acting neurotoxin in aesthetics. Our focused strategy, our culture of excellence in execution and our commitment to science with purpose position us to provide a positive impact for patients and society.” Full-year 2025 guidance Based on the strong performance in the first half, Ipsen upgrades its financial guidance for 2025: Total-sales growth greater than 7.0%, at CER. Based on the average level of exchange rates in June 2025, an adverse impact on total sales of around 2% from currencies is expected Core operating margin greater than 32.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities Guidance includes a negative impact on Somatuline sales due to a potential increased generic competition in the U.S. and Europe. It excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions. Pipeline update since Q1 2025 In May 2025, Ipsen presented data on Iqirvo® (elafibranor) from the Phase II ELMWOOD study at the European Association for the Study of the Liver congress. It showed a favorable safety profile and demonstrated dose-dependent efficacy over 12 weeks for people living with PSC5, a rare liver disease with no approved treatment options. In June 2025, Ipsen initiated a Phase II study of LANT (IPN10200), in cervical dystonia. This marked the fourth study in the global long-acting neurotoxin development plan in therapeutics and aesthetics indications. On 23 July 2025, Ipsen received European Commission approval for Cabometyx® (cabozantinib) in previously treated advanced neuroendocrine tumors. This approval was based on positive outcomes from the Phase III CABINET trial. Consolidated financial statements The Board of Directors approved the condensed consolidated financial statements on 30 July 2025. The Company’s auditors performed a limited review of the H1 2025 condensed consolidated financial statements. The interim financial report, with regards to the regulated information, will be available on ipsen.com in due course, under the Reports and Accounts tab in the Investor Relations section. Conference call A conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here. Calendar Ipsen intends to publish its year-to-date and third-quarter sales update on 22 October 2025. Notes All financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2025 (H1 2025) and the three-month period to 30 June 2025 (Q2 2025), compared to the six-month period to 30 June 2024 (H1 2024) and the three-month period to 30 June 2024 (H1 2024), respectively, unless stated otherwise. Commentary is based on the performance in H1 2025, unless stated otherwise. ABOUT IPSEN We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. IPSEN CONTACTS Investors Khalid Deojee khalid.deojee@ipsen.com +33 6 66 01 95 26 Media Sally Bain sally.bain@ipsen.com +1 857 32 00 517 Anne Liontas anne.liontas@ipsen.com +33 7 67 34 72 96 1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period. 2 Excluding any impact from potential late-stage (Phase III clinical development or later) external-innovation transactions. 3 Long-acting neurotoxin. 4 Fibrodysplasia ossificans progressiva. 5 Primary sclerosing cholangitis Attachment H1 total sales growth of 11.4% at CER1, or 9.7% as reported, driven by the three therapeutic areas: 95.7% in Rare Disease, 9.7% in Neuroscience, and 6.4% in Oncology H1 core operating income of €656m, growing by 21.9% as reported, with a core operating margin of 36.0% of total sales, increasing by 3.6 points Upgraded FY 2025 financial guidance2: total-sales growth greater than 7.0% at CER (prior guidance: greater than 5.0% at CER); core operating margin greater than 32.0% of total sales (prior guidance: greater than 30%) Pipeline progression including regulatory filing of tovorafenib in Europe, and initiation of a Phase II trial of LANT3 (IPN10200) in cervical dystonia European Commission approval on 23 July 2025 of Cabometyx® in advanced neuroendocrine tumors (NETs), the sixth indication Key upcoming milestones with the pivotal FALKON trial results for fidrisertib in FOP4 and the Proof-of-Concept data readout for the LANT in aesthetics PARIS, FRANCE, 31 July 2025 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the first half of 2025. “Our half year results reflect continued strong momentum, with growth across all three therapeutic areas, particularly in our rare liver disease franchise, which is expanding rapidly and progressing well,” said David Loew, Chief Executive Officer, Ipsen. “Building on that performance, I am pleased to increase our full year guidance in terms of sales and profitability.” “I’m also delighted to report robust progression in our pipeline and portfolio, including the recent European Commission approval of Cabometyx® in advanced neuroendocrine tumors, an area where Ipsen has a strong legacy. In the second half of the year, we are anticipating the readout of our pivotal study of fidrisertib in fibrodysplasia ossificans progressiva and the proof-of-concept trial of our long-acting neurotoxin in aesthetics. Our focused strategy, our culture of excellence in execution and our commitment to science with purpose position us to provide a positive impact for patients and society.” Full-year 2025 guidance Based on the strong performance in the first half, Ipsen upgrades its financial guidance for 2025: Total-sales growth greater than 7.0%, at CER. Based on the average level of exchange rates in June 2025, an adverse impact on total sales of around 2% from currencies is expected Core operating margin greater than 32.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities Guidance includes a negative impact on Somatuline sales due to a potential increased generic competition in the U.S. and Europe. It excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions. Pipeline update since Q1 2025 In May 2025, Ipsen presented data on Iqirvo® (elafibranor) from the Phase II ELMWOOD study at the European Association for the Study of the Liver congress. It showed a favorable safety profile and demonstrated dose-dependent efficacy over 12 weeks for people living with PSC5, a rare liver disease with no approved treatment options. In June 2025, Ipsen initiated a Phase II study of LANT (IPN10200), in cervical dystonia. This marked the fourth study in the global long-acting neurotoxin development plan in therapeutics and aesthetics indications. On 23 July 2025, Ipsen received European Commission approval for Cabometyx® (cabozantinib) in previously treated advanced neuroendocrine tumors. This approval was based on positive outcomes from the Phase III CABINET trial. Consolidated financial statements The Board of Directors approved the condensed consolidated financial statements on 30 July 2025. The Company’s auditors performed a limited review of the H1 2025 condensed consolidated financial statements. The interim financial report, with regards to the regulated information, will be available on ipsen.com in due course, under the Reports and Accounts tab in the Investor Relations section. Conference call A conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here. Calendar Ipsen intends to publish its year-to-date and third-quarter sales update on 22 October 2025. Notes All financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2025 (H1 2025) and the three-month period to 30 June 2025 (Q2 2025), compared to the six-month period to 30 June 2024 (H1 2024) and the three-month period to 30 June 2024 (H1 2024), respectively, unless stated otherwise. Commentary is based on the performance in H1 2025, unless stated otherwise. ABOUT IPSEN We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. IPSEN CONTACTS Investors Khalid Deojee khalid.deojee@ipsen.com +33 6 66 01 95 26 Media Sally Bain sally.bain@ipsen.com +1 857 32 00 517 Anne Liontas anne.liontas@ipsen.com +33 7 67 34 72 96 1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period. 2 Excluding any impact from potential late-stage (Phase III clinical development or later) external-innovation transactions. 3 Long-acting neurotoxin. 4 Fibrodysplasia ossificans progressiva. 5 Primary sclerosing cholangitis Attachment Cabometyx® approved in the EU for previously treated advanced neuroendocrine tumors Ipsen announces changes to its Executive Committee Ipsen receives positive CHMP opinion for Cabometyx® in previously treated advanced neuroendocrine tumors Late-breaking analysis demonstrates characteristics associated with long-term overall survival with Onivyde® regimen in metastatic pancreatic adenocarcinoma Late-breaking exploratory data highlights the impact of IQIRVO® (elafibranor) on fatigue and provides mechanistic insights into anti-inflammatory and symptom-related effects in patients with primary biliary... Ipsen appoints Laura Réveillon as EVP, Strategy & Transformation Late-breaking elafibranor primary sclerosing cholangitis (PSC) data demonstrates favorable safety profile and significant efficacy in second potential rare liver disease indication Ipsen delivers strong sales in the first quarter 2025 and confirms its full-year guidance Ipsen publishes its 2024 Universal Registration Document Ipsen announces issuance of €500 million inaugural Rated Public Bond You are now leaving the Ipsen group website. To continue, please click on Continue? These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. 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