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Indian pharma eyes US gains as $63.7 bn patent cliff nears: Analysts
Indian pharma eyes US gains as $63.7 bn patent cliff nears: Analysts

Business Standard

time4 days ago

  • Business
  • Business Standard

Indian pharma eyes US gains as $63.7 bn patent cliff nears: Analysts

The Indian pharmaceutical industry is poised to benefit from a major wave of patent expiries in the US, with small-molecule drugs worth $63.7 billion expected to go off-patent between 2025 and 2029—a 65 per cent increase over the previous five years. Combined with a broader Loss of Exclusivity (LoE) opportunity across the US and EU projected to reach $180 billion by 2035, this marks a significant opening for Indian drugmakers, according to a report by Antique Stock Broking Limited. This shift is expected to spur a rise in generic launches, particularly benefiting Indian players with emerging US operations and expertise in complex generics. Firms such as Alembic Pharmaceuticals and Shilpa Medicare, which have smaller US footprints, and larger players like Cipla and Lupin, which have invested early in differentiated products such as injectables and respiratory therapies, are seen as well positioned to gain market share. With global majors like Teva, Viatris and Sandoz having closed dozens of manufacturing sites since 2018, Indian companies are stepping in to fill the supply gap. However, the opportunity is unfolding amid growing strategic discipline. Filings of Abbreviated New Drug Applications (ANDAs) in the US declined 25 per cent year-on-year. FY25 filings are projected to close around 550—down from 740 in FY24 and 857 in FY22. This signals a pivot from volume to portfolio quality, regulatory compliance and margin protection. Commenting on this shift, Nilaya Varma, Group CEO and Co-founder of Primus Partners, said, 'India's pharma exports have grown from $15 billion in 2013–14 to nearly $28 billion in a decade. With 750+ USFDA-approved plants and rising strength in complex generics and biosimilars, India is primed to lead the next wave of affordable, high-quality medicines. Tapping the $180 billion LoE opportunity will require continued focus on compliance and quality systems.' Regulatory headwinds are also easing. The share of US FDA inspections resulting in Official Action Indicated (OAI) for Indian firms has fallen from 19 per cent in 2013 to 9 per cent in 2023. Companies like Cipla are further de-risking their US supply chains by adopting multi-site manufacturing and digital quality systems. Cipla, which holds a robust US portfolio of 284 ANDA and NDA filings—175 of which are approved and 73 under review—is focusing on commercialisation-ready products, including PEPFAR-approved generics. The company is betting on complex respiratory and injectable therapies to drive growth. Pharma major Lupin, which continues to benefit globally from its blockbuster autoimmune biologic Etanercept, plans to finalise its US commercialisation strategy closer to the drug's 2029 patent expiry. Meanwhile, Sun Pharma, despite offering a conservative FY26 outlook amid global macro uncertainties, is expanding its oncology pipeline. Its recently acquired UNLOXCYT (cosibelimab) is expected to significantly contribute to US revenues. The company noted that Keytruda's upcoming patent expiry was already factored into the acquisition. UNLOXCYT targets only one of Keytruda's multiple indications, and Sun remains confident in its potential to become a meaningful contributor to its US specialty business. In parallel, Sun is also strengthening its immunotherapy portfolio through a global licensing agreement with Philogen.

Advent to invest $175 million in Felix Pharma to acquire minority stake
Advent to invest $175 million in Felix Pharma to acquire minority stake

The Hindu

time09-06-2025

  • Business
  • The Hindu

Advent to invest $175 million in Felix Pharma to acquire minority stake

Advent, a private equity investor, has announced that funds managed by it have signed a definitive agreement to invest $175 million via primary and secondary capital for a significant minority stake in Dublin, Ireland-based Felix Pharmaceuticals Pvt. Ltd. (Felix), a global Gx animal pharma player. Felix Pharma is one of the developers and manufacturer of off-patent medicines for companion animals. Felix develops, manufactures and supplies to distributors and other branded Gx players for private labelling, particularly in the U.S. Shweta Jalan, Managing Partner, Advent, said, 'Healthcare has been a long-standing focus for us, and strong parallels we see between success in human Gx globally and emerging opportunity in animal health Gx. Felix is well positioned to lead this space with its strong leadership, broad portfolio, and robust R&D and commercial capabilities.' 'Its rapid growth and high customer satisfaction make it a differentiated platform, and we are excited to support Neeraj and the Felix team in scaling it into a global franchise,' she added, Founded in 2015 by Neeraj Agrawal, a McKinsey alum, Sir Jonathan Symonds, Chair of GSK and with 30 years of experience in global pharmaceuticals, and Dr. Shumeet Banerji, ex-CEO of Booz-Allen, Felix said it has pursued strategic growth through a disciplined approach, While the company achieved its first U.S. FDA approval in 2020, it has quickly scaled to a 14 commercialised product portfolio and has several others in advanced stages of pipeline. It has a USFDA-approved oral solid facility dedicated to animal health products and an injectable facility that is expected to be ready by Q3 2025. Neeraj Agrawal, Co-Founder, Felix Pharma, said, 'As we scale in a fast-evolving market, we were looking for a partner who brings not just capital, but also deep operating expertise and the right mindset and networks to help us grow faster and stronger. Advent's strong track record in healthcare and pharma, and their close involvement in building strong businesses, gives us great confidence.'

Advent to invest $175 million in animal health drugmaker Felix Pharma
Advent to invest $175 million in animal health drugmaker Felix Pharma

Business Standard

time09-06-2025

  • Business
  • Business Standard

Advent to invest $175 million in animal health drugmaker Felix Pharma

The deal, which includes both primary and secondary transactions, positions Felix to accelerate its global ambitions as a differentiated player in the nascent but expanding companion animal generics Jaden Mathew Paul Alappuzha Private equity firm Advent International is set to invest $175 million in Felix Pharmaceuticals, securing a minority stake in the Dublin-based company that specialises in off-patent medicines for pets. The deal, which includes both primary and secondary transactions, positions Felix to accelerate its global ambitions as a differentiated player in the nascent but expanding companion animal generics space. The company expects to commission a new injectable facility by the third quarter of 2025, adding to its USFDA-approved oral solid manufacturing plant. 'Healthcare has been a long-standing focus for us, and strong parallels we see between success in human Gx globally and emerging opportunity in animal health Gx,' said Shweta Jalan, managing partner, Advent. 'Felix is well positioned to lead this space,' said Jalan, adding, 'Its rapid growth and high customer satisfaction make it a differentiated platform.' Less than 10 per cent of the companion animal market is currently held by generic players, said Pankaj Patwari, managing director, Advent. The company develops bio-equivalent generics across a wide range of therapeutic categories, including NSAIDs, antibacterials, and antiparasitics, for dogs, cats, and horses. 'We were looking for a partner who brings not just capital, but also deep operating expertise and the right mindset and networks to help us grow faster and stronger,' said Agrawal. Felix has offices in Kansas City and Gurugram, alongside its Dublin headquarters, and employs around 500 people globally.

Advent to acquire significant minority stake in animal drug maker Felix Pharmaceuticals for $175 million
Advent to acquire significant minority stake in animal drug maker Felix Pharmaceuticals for $175 million

Mint

time09-06-2025

  • Business
  • Mint

Advent to acquire significant minority stake in animal drug maker Felix Pharmaceuticals for $175 million

Private equity firm Advent International has signed a definitive agreement to invest $175 million (about ₹ 1,500 crore) for a significant minority stake in Felix Pharmaceuticals Pvt. Ltd, an Ireland-headquartered company focused on developing and manufacturing generic medicines for companion animals such as dogs, cats, and horses. This marks another bet by Advent in the growing healthcare space, this time tapping into the under-penetrated animal health generics segment, where branded drugs continue to dominate. Founded in 2015, Felix Pharma is among the fastest-growing companies in the animal health space, with 14 USFDA-approved products and several more in the pipeline. The company primarily supplies to distributors and other branded generics players, especially in the US, through private labelling. 'Felix has an opportunity to shape the companion animal health generics market. The industry is nascent, with less than 10% share held by generic players, providing a long-term growth opportunity,' said Pankaj Patwari, managing director at Advent, in a statement. 'As we scale in a fast-evolving market, we were looking for a partner who brings not just capital, but also deep operating expertise and the right mindset and networks to help us grow faster and stronger,' said Neeraj Agrawal, co-founder of Felix. 'Advent's strong track record in healthcare and pharma, and their close involvement in building strong businesses, gives us great confidence,' he added. Felix was co-founded by Neeraj Agrawal, a McKinsey alum, Sir Jonathan Symonds, chair of GSK, and Dr. Shumeet Banerji, former CEO of Booz Allen Hamilton. The company received its first USFDA approval in 2020, and now operates a dedicated R&D centre and a USFDA-approved manufacturing plant for animal health products. The facility includes dedicated oral solids and liquids capabilities tailored specifically for the veterinary generics market. 'Healthcare has been a long-standing focus for us, and strong parallels we see between success in human Gx [generics] globally and emerging opportunity in animal health Gx,' said Shweta Jalan, managing partner at Advent. 'Felix is well positioned to lead this space with its strong leadership, broad portfolio, and robust R&D and commercial capabilities,' she said. The deal comes amid a sharp rise in global demand for animal drugs, as pet ownership and spending on pet healthcare rise across geographies. Advent has been actively investing in Indian healthcare and financial services. In April 2024, it acquired a 12.1% stake in Apollo Healthco, a unit of Apollo Hospitals, for ₹ 2,475 crore. Last year, it invested $230 million in Svatantra Microfin along with Multiples PE, and exited Bharat Serums and Vaccines, selling it to Mankind Pharma for ₹ 13,630 crore.

Carlyle portfolio firms SeQuent Scientific and Viyash Life get stock exchange nod for merger
Carlyle portfolio firms SeQuent Scientific and Viyash Life get stock exchange nod for merger

Economic Times

time29-05-2025

  • Business
  • Economic Times

Carlyle portfolio firms SeQuent Scientific and Viyash Life get stock exchange nod for merger

SeQuent and Viyash move a step closer to merging, with Carlyle aiming to build a 2X scale business in animal health and pharma R&D. Carlyle-backed SeQuent Scientific and Viyash Life Sciences have secured stock exchange approvals for their merger. Next, they will approach NCLT. The merged entity aims to double in scale, with SeQuent's animal health focus complemented by Viyash's R&D and API strengths. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Carlyle portfolio firms SeQuent Scientific and Viyash Life Sciences have got stock exchange approvals for their planned merger. The former is listed while the latter is Scientific conveyed the development in a stock exchange filing on a next step, they will approach the national company law tribunal (NCLT) for holds a 53% stake in SeQuent and is the majority shareholder in privately held Viyash. SeQuent operates in the niche segment of Animal Health and markets its products in over 90 has built a strong presence in active pharmaceutical ingredients (API) and R&D space with strong business relations with leading companies around the globe.'We are pleased that our proposed merger with Viyash Life Sciences is progressing as planned. This merger will accelerate a compelling new journey for SeQuent as a leading player in animal health, and Viyash with its world-class R&D capabilities and USFDA-approved facilities,' said Rajaram Narayanan, managing director, SeQuent Scientific.'FY 2024–25 marks a pivotal year for us, with strong business results as we accelerate our growth and lay the foundation for the next phase of growth. With Viyash joining us, we are poised to become a significantly stronger business—2X in scale, capability, and opportunity.'Under the agreed merger terms, shareholders of Viyash will receive 56 SeQuent shares for every 100 Viyash shares Q4 FY25, the combined entity of SeQuent and Viyash delivered robust performance with consolidated revenues of Rs. 770 crore reflecting a 13.2% year-on-year growth. Adjusted earnings before interest, tax, depreciation and amortization stood at Rs. 122 crore, up 63.2%, with margins expanding by 485 basis points to 15.8%.

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