Mankind Pharma Ltd.

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.”

The latest around the BIOSECURE Act, Takeda's plan to shut down a gene therapy facility, and an early death issue in Carvykti's clinical trial made our news this week. WuXi AppTec left the Biotechnology Industry Organization amid increasing pressure on the trade group stemming from a draft U.S. bill targeting certain Chinese biotechs. Takeda will shut down a facility in Austria as the Japanese pharma pivots away from research in adeno-associated virus gene therapies. The FDA questioned whether Carvykti should be approved in earlier multiple myeloma after noticing an early detriment to patients' survival in a clinical trial. And more. 1. Biotech trade group pledges support for BIOSECURE Act, plans to boot member WuXi AppTec The Biotechnology Industry Organization (BIO) is severing ties with WuXi AppTec as one of the “important steps” that the trade group is taking to support U.S. national security. In a revised statement, BIO said WuXi “proactively ended its membership.” BIO said it supports the BIOSECURE Act, which looks to block “adversary biotech companies,” including WuXi, from getting U.S. government contracts. BIO’s move came after its lobbying activity against the draft bill drew the ire of a lawmaker. 2. Takeda winds down manufacturing and R&D operations in Austria after gene therapy pivot, plots 190 layoffs Takeda is shutting down operations at its adeno-associated virus gene therapy plant in Orth, Austria, and nearly 200 employees will lose their jobs. Takeda said it would divest the site about a year ago as part of its decision to end early R&D activities around AAV gene therapies. But after a “thorough and lengthy effort,” the company couldn’t find a buyer, a Takeda spokesperson said. 3. FDA flags early deaths in CAR-T myeloma trials for J&J and Legend’s Carvykti, Bristol Myers’ Abecma The FDA has raised concerns about an increased risk of death for Johnson & Johnson and Legend Biotech’s Carvykti compared with standard combinations in the first few months of its phase 3 trial in earlier lines of treatment for multiple myeloma. More patients in the Carvykti arm died than those in the control arm in the first 10 months of the CARTITUDE-4 trial. That overall survival data set is up for discussion during an FDA advisory committee meeting. 4. Astellas puts the cork back in $350M Xork deal after Cartesian-Selecta merger Astellas has decided to end a licensing deal with Cartesian Therapeutics about a year after signing it originally with Selecta Biosciences. Under the deal, Astellas paid $10 million upfront to use Cartesian’s Xork, an immunoglobulin protease, with its gene therapy candidate AT845. The hope was that the asset would help more patients become eligible for adeno-associated virus-based gene therapies. 5. Insilico 'pulls back the curtain' on AI drug discovery process in hope of convincing skeptics In a Nature Biotechnology paper, Insilico Medicine described how it used artificial intelligence to discover, develop and test its lead candidate, INS018_055, a TNIK inhibitor that’s in phase 2 development for the lung disease idiopathic pulmonary fibrosis. The company’s AI platform, PandaOmics, was used to both identify a therapeutic target and to design a drug candidate. 6. Biocon continues to divest with $150M sale of insulin and other brands to Eris Biocon has agreed to sell its Indian branded formulations business to Eris for about $150 million. The deal includes a portfolio of metabolic, oncology and critical care products, including Insugen, which was the first recombinant human insulin product developed domestically in India. The divested franchise accounted for 3.7% of Biocon’s revenue in its fiscal year 2023. 7. Innovent shutters ADC-focused Maryland R&D site, moves lab to California (BioSpace, Yicai) Innovent Biologics will shut down its Rockville, Maryland, site, which serves as the Chinese firm’s U.S. headquarters and is conducting research in antibody-drug conjugates. A BioSpace article, citing former employees, reported that the R&D work will move to Chin and that the company has axed the entire research team at the Maryland location. But Innovent told Yicai that the lab will be relocated to California. Other News of Note: 8. Chinese authorities rumored to be working on policies to support innovative drugs (Bloomberg) 9. Aurobindo unit begins shipping drugs from India plant after FDA inspection triggered production halt 10. BeiGene bumps AbbVie, J&J from top lymphoma event sponsor spot 11. Sun Pharma issues recall of gout drug due to microbial contamination 12. AstraZeneca taps Mankind to distribute Symbicort in India (The Economic Times)