Latest news with #Utreglutide
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Business Standard
03-08-2025
- Business
- Business Standard
Pharma Inc gears up for Day 1 launch of obesity drug in March 2026
As the global demand for next-generation diabetes and weight-loss therapies surge, Indian pharmaceutical companies are stepping up preparations to roll out generic versions of semaglutide—a blockbuster GLP-1 receptor agonist—once patent expires around March 2026. The generic launches will be significant, as the prices for the Indian consumer are expected to come down significantly from the current ₹17,000-26000 (monthly), thereby expanding the patient coverage. Dr. Reddy's Laboratories (DRL), Cipla, Sun Pharma, and Mankind Pharma, and others are ramping up peptide manufacturing, forming device partnerships, and aligning regulatory strategies to capture a share of the global GLP-1 market, estimated to cross $150 billion by decade's end. Hyderabad-based DRL is planning Day 1 launches in India and Brazil, part of a 2026 global rollout across 87 countries. 'The semaglutide launch is very important to us,' said CEO Erez Israeli. The company aims to price its product below Novo Nordisk's current ₹17,000 monthly offering. DRL is also working on 26 GLP-1 therapies, backed by a ₹2,700 crore FY26 capex plan to scale peptide and biosimilar production. Cipla is targeting first-wave launches through a mix of in-house and partner filings. 'We see GLP-1 as one of the biggest therapy opportunities in the last five years,' said Umang Vohra, MD and global CEO at the post earnings call. The company is building parts of its GLP-1 supply chain internally while leveraging partnerships to ensure scalability. Cipla is also crafting an affordable strategy for India's price-sensitive market, betting that post-patent price erosion will be offset by volume growth. Mankind Pharma aims to launch both oral and injectable semaglutide generics and is advancing MKP10241, a novel oral obesity drug in Phase 2 trials in Australia. Sun Pharma, meanwhile, is progressing its investigational GLP-1 molecule Utreglutide, targeted for launch in four to five years. It has secured Phase III approval for semaglutide trials in India, even as it reports negligible impact of GLP-1 drugs on its existing diabetes portfolio. The race for a piece of India's ₹628 crore anti-obesity market, however, comes at a time when the Indian courts and drug regulator body are looking to monitor the unregulated use of weight loss drugs. According to sources, the Central Drug Standards Control Organisation (CDSCO) has initiated work to form a panel after the Delhi High Court in July 2025 asked it to consult experts and relevant stakeholders to look into concerns arising out of approval for drug combinations being sold in the market for weight loss. The directive came in response to a public interest litigation filed by fitness entrepreneur Jitendra Chouksey, who had raised concerns about the marketing approval of drugs such as semaglutide, tirzepatide and liraglutide for weight management, despite limited safety data and the absence of India-specific clinical trials. While disposing of the petition, the court asked the drug regulator to respond to the petitioner within three months. At present, India has two officially available semaglutide brands: Rybelsus (oral) and Wegovy (injectable), both from Danish major Novo Nordisk. Rybelsus is approved for treating Type 2 diabetes, while Wegovy was launched in June 2025 for weight management. US-based Eli Lilly's tirzepatide drug, Mounjaro, is also available in India for obesity management. Analysts say the semaglutide opportunity is also fuelling India's peptide manufacturing ecosystem. 'Formulation is no longer enough—companies need full-stack execution,' said Nirali Shah, Pharma Analyst at Ashika Group, pointing to DRL, Cipla, and Sun Pharma's early moves to secure pen delivery partnerships. Contract development and manufacturing organisations (CDMOs) like Anthem Biosciences and Syngene are positioning themselves to capture a larger share of the growing peptide segment. Device manufacturers, too, are scaling up to meet rising demand for injection pens. India's peptide CDMO market, currently valued at $80 million, is growing at a CAGR of 14 per cent and could become a global supplier base for GLP-1 drugs, said Nilaya Varma, CEO of Primus Partners.
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Business Standard
03-08-2025
- Business
- Business Standard
Pharma Inc gear up for Day 1 launch of obesity drug in March 2026
As the global demand for next-generation diabetes and weight-loss therapies surge, Indian pharmaceutical companies are stepping up preparations to roll out generic versions of semaglutide—a blockbuster GLP-1 receptor agonist—once patent expires around March 2026. The generic launches will be significant, as the prices for the Indian consumer are expected to come down significantly from the current ₹17,000-26000 (monthly), thereby expanding the patient coverage. Dr. Reddy's Laboratories (DRL), Cipla, Sun Pharma, and Mankind Pharma, and others are ramping up peptide manufacturing, forming device partnerships, and aligning regulatory strategies to capture a share of the global GLP-1 market, estimated to cross $150 billion by decade's end. Hyderabad-based DRL is planning Day 1 launches in India and Brazil, part of a 2026 global rollout across 87 countries. 'The semaglutide launch is very important to us,' said CEO Erez Israeli. The company aims to price its product below Novo Nordisk's current ₹17,000 monthly offering. DRL is also working on 26 GLP-1 therapies, backed by a ₹2,700 crore FY26 capex plan to scale peptide and biosimilar production. Cipla is targeting first-wave launches through a mix of in-house and partner filings. 'We see GLP-1 as one of the biggest therapy opportunities in the last five years,' said Umang Vohra, MD and global CEO at the post earnings call. The company is building parts of its GLP-1 supply chain internally while leveraging partnerships to ensure scalability. Cipla is also crafting an affordable strategy for India's price-sensitive market, betting that post-patent price erosion will be offset by volume growth. Mankind Pharma aims to launch both oral and injectable semaglutide generics and is advancing MKP10241, a novel oral obesity drug in Phase 2 trials in Australia. Sun Pharma, meanwhile, is progressing its investigational GLP-1 molecule Utreglutide, targeted for launch in four to five years. It has secured Phase III approval for semaglutide trials in India, even as it reports negligible impact of GLP-1 drugs on its existing diabetes portfolio. The race for a piece of India's ₹628 crore anti-obesity market, however, comes at a time when the Indian courts and drug regulator body are looking to monitor the unregulated use of weight loss drugs. According to sources, the Central Drug Standards Control Organisation (CDSCO) has initiated work to form a panel after the Delhi High Court in July 2025 asked it to consult experts and relevant stakeholders to look into concerns arising out of approval for drug combinations being sold in the market for weight loss. The directive came in response to a public interest litigation filed by fitness entrepreneur Jitendra Chouksey, who had raised concerns about the marketing approval of drugs such as semaglutide, tirzepatide and liraglutide for weight management, despite limited safety data and the absence of India-specific clinical trials. While disposing of the petition, the court asked the drug regulator to respond to the petitioner within three months. At present, India has two officially available semaglutide brands: Rybelsus (oral) and Wegovy (injectable), both from Danish major Novo Nordisk. Rybelsus is approved for treating Type 2 diabetes, while Wegovy was launched in June 2025 for weight management. US-based Eli Lilly's tirzepatide drug, Mounjaro, is also available in India for obesity management. Analysts say the semaglutide opportunity is also fuelling India's peptide manufacturing ecosystem. 'Formulation is no longer enough—companies need full-stack execution,' said Nirali Shah, Pharma Analyst at Ashika Group, pointing to DRL, Cipla, and Sun Pharma's early moves to secure pen delivery partnerships. Contract development and manufacturing organisations (CDMOs) like Anthem Biosciences and Syngene are positioning themselves to capture a larger share of the growing peptide segment. Device manufacturers, too, are scaling up to meet rising demand for injection pens. India's peptide CDMO market, currently valued at $80 million, is growing at a CAGR of 14 per cent and could become a global supplier base for GLP-1 drugs, said Nilaya Varma, CEO of Primus Partners.
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Business Standard
22-05-2025
- Business
- Business Standard
Sun Pharma results: Profit down 19% at Rs 2,149.8 cr, revenue up 8%
India's largest drug maker Sun Pharmaceutical on Thursday posted a decline of 19 per cent year-on-year (Y-o-Y) for its consolidated net profit for the fourth quarter of the financial year 2025 (Q4FY25) at ₹2,149.8 crore. Meanwhile, its revenue from operations rose by 8 per cent at ₹12,958.8 crore. Barring an exceptional item, the company's net profit for the quarter will come to ₹2,889.1 crore, rising 4.8 per cent. Sun Pharma attributed the lower growth in the quarter partly to softer sales in January and February in the US, which is a typical trend. However, the company clarified that there is no specific product driving this and that overall prescription and inventory trends for key brands remains strong. The fall in the net profit can also be attributed to the rise in input costs compared to last year. For FY25, Sun's net profit surged by 14 per cent Y-o-Y, reaching ₹10,929 crore. While revenue from operations also grew by 8 per cent, reaching ₹52,578 crore. Both net profit and revenue missed Bloomberg estimates, falling short by 23 per cent and 2.23 per cent, respectively. On Thursday, Sun Pharma's share fell by 0.74 per cent ending the day's trade at ₹1718.70. The results came after market hours. On the legal front, Sun Pharma reported an exceptional item of ₹677.8 crore for the full year, related to a legal settlement in the US. In a key development, the company — previously awaiting the outcome of the Leqselvi (a hair loss treatment inhibitor) litigation — announced that the United States Court of Appeals has reversed its earlier ruling and vacated the preliminary injunction, now allowing for the commercial launch of Leqselvi. Sun Pharma will now launch Leqselvi in Q2FY26. Dilip Shanghvi, chairman and managing director of Sun Pharmaceuticals, said, 'The nearterm pipeline in global specialty is promising, with products such as Leqselvi and Unloxcyt — the latter through our recently announced Checkpoint acquisition — offering significant improvements in patient care.' Sun Pharma announced updates to its global specialty pipeline, stating that it is now seeking a partner for the development and commercialisation of MM-II (used for treatment of knee osteoarthritis pain) in select geographies, following a strategic reassessment. The company reaffirmed its confidence in the product's potential. Additionally, it plans to initiate clinical trials of GL0034 (Utreglutide), a peptide-1 receptor with type 2 diabetes as the first target indication. The company expects a mid to high single-digit consolidated top-line growth for FY26. Sun Pharma also plans to invest around $100 million this year to support the commercialisation of a new specialty product. This investment is aimed at significantly strengthening its specialty business in the long term. The company views this as a strategic investment to deepen its presence and growth in the specialty segment. The domestic formulations sales for FY25 India sales rose by 13.7 per cent which stood at ₹16,923 crore, up 13.7 per cent Y-o-Y. For the quarter, sales were up by 13.6 per cent reaching ₹4,213 crore, contributing 33 per cent to total quarterly revenue. The company launched 10 new products in the quarter. US formulations sales which accounts for 31.4 per cent of total revenue for the quarter fell by 2.5 per cent to $464 million. For FY25, the sales rose by 3.6 per cent Y-o-Y at $1,921 million. The global specialty revenue rose by 17 per cent Y-o-Y to $1,216 million for the full year, while for the quarter the sales grew by 8.6 per cent to $295 million contributing 19.9 per cent to total revenue. The emerging markets sales rose by 7 per cent Y-o-Y to $1,114 million in FY25. For the quarter the sales rose by 6.3 per cent forming 17 per cent of the revenue. The rest of world (RoW) region accounting for 13 per cent of revenue saw a growth of 2 per cent for the quarter at $200 million. For the year the sales increased by 4.5 per cent at $847 million. The active pharmaceutical ingredient (API) business grew by 11 per cent Y-o-Y at ₹2,129 crore in FY25, in Q4 sales were up by 28 per cent at ₹533 crore. Sun's consolidated research and development (R&D) investment for the year was ₹3,248 crore or 6.2 per cent of sales. In Q4 it stood at ₹817 crore or 6.4 per cent of sales. The specialty pipeline includes 8 novel clinical-stage entities.
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Business Standard
22-05-2025
- Business
- Business Standard
Sun Pharma Q4 results: Profit down 19% at Rs 2,149.8 cr, revenue up 8%
India's largest drug maker Sun Pharmaceutical on Thursday posted a decline of 19 per cent year-on-year (Y-o-Y) for its consolidated net profit for the fourth quarter of the financial year 2025 (Q4FY25) at ₹2,149.8 crore. Meanwhile, its revenue from operations rose by 8 per cent at ₹12,958.8 crore. Barring an exceptional item, the company's net profit for the quarter will come to ₹2,889.1 crore, rising 4.8 per cent. Sun Pharma attributed the lower growth in the quarter partly to softer sales in January and February in the US, which is a typical trend. However, the company clarified that there is no specific product driving this and that overall prescription and inventory trends for key brands remains strong. The fall in the net profit can also be attributed to the rise in input costs compared to last year. For FY25, Sun's net profit surged by 14 per cent Y-o-Y, reaching ₹10,929 crore. While revenue from operations also grew by 8 per cent, reaching ₹52,578 crore. Both net profit and revenue missed Bloomberg estimates, falling short by 23 per cent and 2.23 per cent, respectively. On Thursday, Sun Pharma's share fell by 0.74 per cent ending the day's trade at ₹1718.70. The results came after market hours. On the legal front, Sun Pharma reported an exceptional item of ₹677.8 crore for the full year, related to a legal settlement in the US. In a key development, the company — previously awaiting the outcome of the Leqselvi (a hair loss treatment inhibitor) litigation — announced that the United States Court of Appeals has reversed its earlier ruling and vacated the preliminary injunction, now allowing for the commercial launch of Leqselvi. Sun Pharma will now launch Leqselvi in Q2FY26. Dilip Shanghvi, chairman and managing director of Sun Pharmaceuticals, said, 'The nearterm pipeline in global specialty is promising, with products such as Leqselvi and Unloxcyt — the latter through our recently announced Checkpoint acquisition — offering significant improvements in patient care.' Sun Pharma announced updates to its global specialty pipeline, stating that it is now seeking a partner for the development and commercialisation of MM-II (used for treatment of knee osteoarthritis pain) in select geographies, following a strategic reassessment. The company reaffirmed its confidence in the product's potential. Additionally, it plans to initiate clinical trials of GL0034 (Utreglutide), a peptide-1 receptor with type 2 diabetes as the first target indication. The company expects a mid to high single-digit consolidated top-line growth for FY26. Sun Pharma also plans to invest around $100 million this year to support the commercialisation of a new specialty product. This investment is aimed at significantly strengthening its specialty business in the long term. The company views this as a strategic investment to deepen its presence and growth in the specialty segment. The domestic formulations sales for FY25 India sales rose by 13.7 per cent which stood at ₹16,923 crore, up 13.7 per cent Y-o-Y. For the quarter, sales were up by 13.6 per cent reaching ₹4,213 crore, contributing 33 per cent to total quarterly revenue. The company launched 10 new products in the quarter. US formulations sales which accounts for 31.4 per cent of total revenue for the quarter fell by 2.5 per cent to $464 million. For FY25, the sales rose by 3.6 per cent Y-o-Y at $1,921 million. The global specialty revenue rose by 17 per cent Y-o-Y to $1,216 million for the full year, while for the quarter the sales grew by 8.6 per cent to $295 million contributing 19.9 per cent to total revenue. The emerging markets sales rose by 7 per cent Y-o-Y to $1,114 million in FY25. For the quarter the sales rose by 6.3 per cent forming 17 per cent of the revenue. The rest of world (RoW) region accounting for 13 per cent of revenue saw a growth of 2 per cent for the quarter at $200 million. For the year the sales increased by 4.5 per cent at $847 million. The active pharmaceutical ingredient (API) business grew by 11 per cent Y-o-Y at ₹2,129 crore in FY25, in Q4 sales were up by 28 per cent at ₹533 crore. Sun's consolidated research and development (R&D) investment for the year was ₹3,248 crore or 6.2 per cent of sales. In Q4 it stood at ₹817 crore or 6.4 per cent of sales. The specialty pipeline includes 8 novel clinical-stage entities. The company has 542 approved abbreviated new drug applications (ANDA) and 117 pending with the US Food and Drug Administration, including 33 tentative.
Reuters
28-02-2025
- Business
- Reuters
India's Sun Pharma aims to launch its obesity drug in five years, managing director says
MUMBAI, March 1 (Reuters) - India's largest drugmaker by revenue Sun Pharmaceutical ( opens new tab is aiming to launch its experimental anti-obesity and type 2 diabetes drug in the next four to five years, Managing Director Dilip Shanghvi said on Friday. The company is among many Indian drugmakers looking to grab a slice of the growing weight-loss drug market, which is expected to reach $150 billion globally by the end of the decade. Sun Pharma's push into this category comes after companies such as Novo Nordisk ( opens new tab and Eli Lilly (LLY.N), opens new tab saw skyrocketing demand for their weight-loss drugs Wegovy and Zepbound, which boosted the drugmakers' valuations. Sun Pharma's novel investigational drug, also known as Utreglutide (GL0034), belongs to a drug class called GLP-1 receptor agonists, which suppress appetite by mimicking gut hormones and have also been found to have medical benefits for conditions beyond type 2 diabetes and weight loss. The active ingredients in Wegovy and Zepbound also belong to the same class of drugs. Sun Pharma, which expects to conduct mid-stage trials for the drug this year, earlier said it demonstrated clinically meaningful weight loss and significant metabolic improvements in the first phase of trials. "The findings highlight GL0034's potential as a therapeutic option for individuals with obesity, providing not only weight loss but also improvements in key cardiometabolic biomarkers," it said last year. The company will focus on launching it in India as well as global markets, a source with knowledge of the matter said on Friday. Sun Pharma said in August it would consider a partnership or licensing the product in large markets such as the U.S. and Europe for commercialization. Generic drugmakers such as Dr Reddy's ( opens new tab, Cipla ( opens new tab and Lupin ( opens new tab are also developing their own generic versions of these drugs, the launch of which is subject to patent expiry of active ingredients in original drugs.
