In morning trading on March 28, Biocon’s shares experienced a notable uptick of over 2% as the company received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom for its diabetes drug. The approval comes after Biocon filed for regulatory clearance for its complex formulation Liraglutide, a 6mg/ml solution for injection in a pre-filled pen. This medication is primarily utilized in the treatment of Type 2 diabetes mellitus, a condition characterized by inadequate insulin production or abnormal responsiveness to insulin, resulting in elevated blood sugar levels.
The regulatory green light from MHRA signifies a significant milestone for Biocon and its European partner Zentiva, paving the way for the commercialization of this crucial diabetes treatment in the UK market.
As a result of this positive development, Biocon’s shares were trading at Rs 260.40 on the National Stock Exchange (NSE) at 9:20 am, marking a 1.6% increase from the previous close. Year-to-date, the company’s stock has rallied over 2%, slightly outperforming the benchmark Nifty index, which has surged approximately 12% during the same period. This uptrend underscores investor confidence in Biocon’s growth prospects, fueled by its successful regulatory endeavors and innovative healthcare solutions.
CEO Siddharth Mittal hailed the approval of Liraglutide, describing it as a pivotal achievement for Biocon. “This marks a significant milestone for us as the first generic Liraglutide approved in a major regulated/ICH market,” Mittal remarked. He emphasized how this approval further solidifies Biocon’s leadership position in introducing pioneering solutions in the realm of complex drug products. Mittal highlighted Biocon’s track record of innovation, citing achievements such as the approval of bTrastuzumab, bPegfilgrastim, and the first interchangeable biosimilar Insulin Glargine by the US FDA.
In a regulatory filing, Biocon disclosed that, according to IQVIA MAT Q4 2023 data, the total addressable market opportunity for GLP-1 in the domains of diabetes and weight loss in the UK amounted to $425 million. This insight underscores the considerable market potential for Biocon’s recently approved Liraglutide, positioning the company to capture a significant share of this lucrative market segment.
Earlier this month, Biocon’s subsidiary, Biocon Biologics, entered a significant long-term commercial collaboration with Eris Lifesciences. The partnership aims to broaden patient access to Biocon Biologics’ extensive portfolio of metabolics, oncology, and critical care products across India.
In an exchange filing, Biocon revealed that the total transaction value for this collaboration amounted to Rs 1,242 crore. This value reflects an accretive multiple equivalent to 3.4 times of revenue and 18 times of EBITDA, underscoring the strategic and financial significance of the collaboration for both companies.
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