Alkem Laboratories and Biosergen AB have inked 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. It was Dr C B Sanjeevi, Karolinska Institute assisted Biosergen in establishing the partnership with Alkem.
The company said that it is among the five largest pharmaceutical companies in India, and has more than 17,000 employees, with affiliates in the USA, Australia, UK, Germany and many other emerging countries. 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.
It 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.
Alkem will invest in the clinical development of BSG005 and will be granted an exclusive license to market it in India. According to 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, 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.”
Dr Akhilesh Sharma, president and chief medical officer, Alkem, said that “BSG005 should strengthen treatment of challenging systemic fungal infections such as black fungus.”
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