Mankind Pharma Ltd.

Under the agreement, Mankind Pharma will have the exclusive rights to register, import, market, sell, and distribute Sintilimab in India. Credit: Piotr Swat/Shutterstock. Mankind Pharma has entered into a partnership with Innovent Biologics for exclusively licensing and commercialising Sintilimab, an immunotherapy for cancer treatment in India. This strategic move is aimed at addressing significant challenges in cancer care and enhance patient access to new therapeutic options. Sintilimab, known as TYVYT (sintilimab injectable) in China, was developed through a collaboration between Eli Lilly and Innovent. Currently, the asset is not approved in India, IIFL Capital reported. Earlier next year, Mankind Pharma plans to seek regulatory approval in India and complete all regulatory processes, including the conduct of a Phase III study in the country. The study will commence once the company receives regulatory approval to conduct such studies. Under the agreement, Mankind Pharma will have the exclusive rights to register, import, market, sell, and distribute Sintilimab in India. Innovent will oversee the manufacturing and supply of the product to ensure steady availability and adherence to quality standards. Innovent Biologics chief business officer Samuel Zhang said: “The company is committed to advancing patient care in India by making cutting-edge treatments more accessible and affordable.” In July 2024, Mankind Pharma entered into a definitive agreement to acquire 100% of Bharat Serums and Vaccines (BSV) from private equity investor Advent International for an enterprise value of approximately Rs136.3bn ($1.59bn). Bharat Serums, a biopharmaceutical company founded in 1971, has a research and development centre in the Indian city of Mumbai with over 100 scientists. It operates in more than 70 countries, with subsidiaries in Germany, the Philippines, and the US.

Eisai and Biogen’s Leqembi received accelerated approval from the US Food and Drug Administration (FDA) in January, which was converted into full approval earlier this month. Image Credit: Alessandro Zappalorto / Shutterstock The European Medicines Agency (EMA) has halted Eisai and Biogen ’s expansion plan to launch its Alzheimer’s disease therapy Leqembi (lecanemab) in Europe after its drug review committee recommended against the therapy’s approval. The Committee for Medicinal Products for Human Use (CHMP) stated that Leqembi’s positive effect on delaying cognitive decline was “not large enough” to counterbalance the associated risk of serious adverse events. Eisai was quick to add that the company plans to re-examine the CHMP opinion. The committee was particularly concerned with the risk of developing amyloid-related imaging abnormalities (ARIA). These are observed exclusively on MRI and can signify oedema, effusion and /or haemorrhage. CHMP noted that “although most cases of ARIA in the main study were not serious and did not involve symptoms, some patients had serious events, including large bleeds in the brain which required hospitalisation.” The risk of ARIA was increased in patients with ApoE4 gene, the presence of one or more copies of the gene predisposes an individual to develop Alzheimer’s disease. The committee also pointed out that the difference in the improvement of cognitive decline , measured using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score, between the Leqembi and placebo arms was “small”. Adding that “the seriousness of this side effect should be considered in the context of the small effect seen with [Leqembi].” See Also: Mankind Pharma acquires Bharat Serums and Vaccines for $1.6bn AC Immune wins FDA fast track for Alzheimer’s vaccine Leqembi works by targeting the buildup of amyloid plaques in the brain, a hallmark of Alzheimer’s disease and a suggested cause of memory and cognition impairment. It received accelerated approval from the US Food and Drug Administration (FDA) in January, which was converted into full approval earlier this month. Leqembi is an important  drug for Biogen, which is codeveloping the drug with Eisai, especially after the former discontinued its other controversial Alzheimer’s treatment Aduhelm (aducanumab-avwa), in January. A GlobalData analysis forecasts Leqembi to generate over $6.1bn in sales by 2030. GlobalData is the parent company of Pharmaceutical Technology . Eisai and Biogen have also filled a supplemental biologics application (sBLA) with the US FDA for monthly Leqembi IV maintenance dosing for the treatment of patients with Alzheimer’s disease, with the Prescription Drug User Fee Act (PDUFA) action date being set for 25 January 2025.

The acquisition is anticipated to bolster Mankind Pharma’s position in the Indian women’s health and fertility drug market. Credit: fizkes / Shutterstock. Mankind Pharma has announced a definitive agreement for the acquisition of a 100% stake in Bharat Serums and Vaccines (BSV) from private equity investor Advent International in a Rs136.3bn ($1.6bn) deal. The move bolsters Mankind Pharma’s position in the Indian women’s health and fertility drug market. The deal will also aid Mankind Pharma in providing access to high-barrier products in critical care leveraging complex research and development (R&D) tech platforms. BSV, with more than five decades of expertise in biopharmaceuticals, has an established presence with its in-house developed recombinant and niche biologic products. The company’s branded product portfolio spans women’s health, fertility and critical care, with several leading brands in their respective therapy areas. See Also: FDA committee proposes overhaul of perioperative lung cancer trials Mankind Pharma vice-chairman and managing director Rajeev Juneja stated: “BSV’s acquisition represents a pivotal milestone in Mankind’s journey, establishing us as a market leader in the Indian women’s health and fertility segment. We believe the women’s health and fertility segment has massive opportunity along with strong growth visibility globally, led by structural tailwinds. “BSV’s established speciality R&D tech platforms with a complex portfolio across women’s health, fertility, critical care and [the] immunoglobulin segment perfectly aligns Mankind Pharma’s strategic vision to expand its footprint in high entry barrier portfolio. We are also delighted to welcome BSV’s 2,500+ members to our Mankind family.” The acquisition includes BSV’s comprehensive portfolio in women’s health, covering the reproductive lifecycle from fertility to post-pregnancy. Its significant portfolio in the fertility segment will aid in scaling in both Indian and international markets, especially with the increasing penetration of in vitro fertilisation (IVF) treatments. Mankind Pharma CEO and whole-time director Sheetal Arora stated: “Mankind’s strategic acquisition of BSV with branded speciality pharma portfolio across India and emerging markets presents immense growth potential and will add to the existing growth velocity of Mankind.”