Piramal Pharma expands into paediatric critical care with UK approval for Neoatricon

Piramal Pharma Limited’s critical care division, Piramal Critical Care, has secured approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for Neoatricon, marking a major milestone in paediatric critical care. Developed in partnership with Ireland-based BrePco Biopharma, Neoatricon is the first paediatric-strength dopamine hydrochloride solution for infusion, specifically designed for neonates, infants, and children suffering from hypotension.

With this regulatory approval, Piramal Critical Care gains exclusive commercialisation rights for Neoatricon across the UK, the European Union, and Norway, further strengthening its footprint in the global critical care market. This move positions the company as a leader in paediatric cardiovascular support while addressing a longstanding gap in paediatric medicine, where off-label use of adult dopamine formulations has remained the norm.

Why Is Neoatricon a Game-Changer for Neonatal and Paediatric Intensive Care?

Dopamine hydrochloride is a widely used inotropic agent for managing hypotension in critical care settings, but existing formulations have primarily been developed for adult patients. In neonatal and paediatric intensive care units (NICU & PICU), healthcare providers have historically relied on diluted or modified versions of adult dopamine solutions, increasing the risk of inaccurate dosing.

Neoatricon addresses this challenge with two distinct paediatric-strength concentrations—1.5 mg/mL for neonates and children under 10 kg, and 4.5 mg/mL for older infants and adolescents. The drug’s ready-to-use formulation minimizes preparation time in emergency settings, facilitating faster intervention and reducing dosing errors. As a result, this approval represents a significant advancement in paediatric critical care by enhancing patient safety and improving treatment outcomes.

How Does the Neoatricon Approval Impact Piramal Pharma’s Business Strategy?

For Piramal Pharma, the approval of Neoatricon aligns with its broader strategy of expanding into high-need therapeutic areas. The company, which has a presence in over 100 countries, has historically been recognized for its expertise in anaesthesia, pain management, and intrathecal therapies. With this new approval, Piramal Critical Care enters the paediatric cardiovascular segment—a market that has seen limited innovation in recent years despite the critical need for age-appropriate formulations.

Peter DeYoung, CEO of Piramal Global Pharma, emphasized that Neoatricon represents not just a commercial milestone but a crucial step in improving outcomes for vulnerable paediatric patients. The collaboration with BrePco Biopharma, which specializes in developing paediatric medicines, has been instrumental in bringing this product to market. The project also benefited from funding under the European Commission’s 7th Framework Programme, highlighting the role of public-private partnerships in advancing paediatric drug development.

How Has the Market Reacted to Piramal Pharma’s Regulatory Milestone?

Investor sentiment surrounding Piramal Pharma Limited (PPL) has turned positive following the announcement of Neoatricon’s approval. On March 19, 2025, PPL’s stock closed at ₹218.50, reflecting a 2.65% increase from the previous trading session. Analysts have issued a bullish outlook, with the stock’s 12-month price target averaging ₹304.29—a potential 38% upside from current levels.

Jefferies & Co. has reaffirmed its ‘Buy’ rating on PPL, increasing its price target from ₹195 to ₹260, reflecting confidence in the company’s ability to drive revenue growth through its expanding critical care portfolio. However, while the stock has shown strong momentum, some analysts caution that PPL’s current valuation is significantly above industry norms. The company’s trailing twelve months (TTM) price-to-earnings (P/E) ratio stands at 1,120.77, compared to the sector’s average of 40.88. Additionally, its return on equity (ROE) over the last three years remains low at 1.06%, signaling that profitability may take time to catch up with growth initiatives.

Given these factors, investment advisors suggest a ‘Hold’ strategy for existing shareholders, recommending that new investors monitor the company’s financial performance in the coming quarters before taking a position.

What Does the Future Hold for Neoatricon and Paediatric Drug Innovation?

The approval of Neoatricon sets a precedent for the development of specialized paediatric medications, an area that has long been overlooked due to complex regulatory requirements and lower commercial incentives. The lack of age-appropriate formulations has historically led to widespread off-label prescribing, a practice that introduces variability in treatment efficacy and safety.

With the introduction of Neoatricon, regulatory agencies and pharmaceutical companies may increasingly prioritize paediatric drug development. The success of this product could pave the way for further innovations in neonatal and paediatric care, particularly in critical conditions where precision dosing is crucial.

As Piramal Pharma moves forward with the commercial launch of Neoatricon, healthcare providers, regulators, and investors will closely watch its market adoption and real-world impact. If the product gains widespread acceptance among paediatric specialists, it could serve as a blueprint for the future of paediatric pharmaceutical innovation.