Biosergen AB and Alkem Laboratories Ltd. on Monday 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.
According to a company statement, 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, it added.
India is one of the countries with the highest incidence of difficult-to-treat life-threatening fungal infections.
“Alkem is a leader in the anti-infective market, with clinical development expertise and an established commercial infrastructure. Moreover, Alkem has 144 ANDAs, two manufacturing sites and two R&D sites in the US market. Alkem, with its established clinical development engine and access to a broad clinical network, will prove to be a strong corporate partner for Biosergen,” the company said in a statement.
Alkem will manage the first clinical patient trial, which is expected to start immediately after the regulatory approval. The trial will enroll 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.
“Alkem will invest in the clinical development of BSG005 and will be granted an exclusive license to market it in India. Dr. Peder M Andersen, CEO of Biosergen, said, “Alkem has capabilities and a strong track record in drug development. They have been very responsive and fast in their evaluation and decision making.”
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.
“This is a strategic fit for Alkem’s portfolio given our presence in acute care segment, especially in hospital-based treatment,” Sandeep Singh, Alkem’s Managing Director, said in a statement.
