In an exchange filing, the pharma company said, “Biosergen AB (Biosergen) and Alkem announced the signing of a co-development and license agreement for BSG005, an innovative polyene macrolide, through phase II and phase III trials for sale in the Indian market.”
Biosergen AB is developing BSG005 for the treatment of severe and difficult-to-treat invasive fungal diseases.
After the successful completion of two phase I studies, the first patient trial will be conducted in India on patients with severe fungus disease who are intolerant or resistant to treatment with Amphotericin B. India is one of the countries with the highest incidence of difficult-to-treat life threatening fungal infections.
The company said that it will manage the first clinical patient trial, which is expected to start immediately after the regulatory approval. The trial will enrol patients suffering from severe fungal infections such as mucormycosis (Black Fungus), aspergillosis, and candidiasis, who are intolerant or resistant to Amphotericin B.
Based on the safety and efficacy profile demonstrated in the preclinical studies and the phase I trials, BSG005 may provide a suitable treatment option for these patients. Once the clinical trials are successfully completed in India, Biosergen and Alkem aim to expand its use for similar patient groups in the US and EU via pivotal trials, it added.
Sandeep Singh, Alkem's managing director, said, “This is a strategic fit for Alkem's portfolio given our presence in acute care segment, especially in hospital-based treatment.”
Dr. Peder M Andersen, CEO of Biosergen, said, “Alkem will invest in the clinical development of BSG005 and will be granted an exclusive license to market it in India.”
Alkem Laboratories is engaged in pharmaceutical business with global operations. The company is engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products.
The pharmaceutical company's consolidated net profit surged 124.64% to Rs 286.73 crore on 15.19% rise in revenue from operations to Rs 2,902.6 crore in Q1 FY24 over Q1 FY23.
Shares of Alkem Laboratories rose 0.73% to Rs 3,570.75 on the BSE.
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