Novartis’ COVID-19 deal; Shattered hopes for Remdesivir; Lilly’s R&D pact with Precision; Innovent’s Humira Biosimilar

Posted on Nov 24, 2020 by Delveinsight

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Novartis bags Mesoblast’s cell therapy, Remestemcel-L for COVID-19 ARDS

The COVID-19 pandemic has put tremendous pressure on scientists to develop a safe and effective vaccine as early as possible. According to the WHO, there are currently more than 100 COVID-19 vaccine candidates under development, with several in the human trial phase. While earlier news came of the efficacy of the potential vaccines from Pfizer and Moderna, this time, it is about a new licensing deal between Novartis and Australia-based Mesoblast. 

Novartis has bagged an exclusive worldwide license to develop, commercialize, and manufacture remestemcel-L, Mesoblast’s candidate for acute respiratory distress syndrome (ARDS). The company is paying Mesoblast USD 25 million upfront and USD 25 million investment in Mesoblast equity along with additional pre-commercialization milestone payments that could total USD 505 million and post-commercialization milestones up to USD 750 million. 

Remestemcel-L’s immunomodulatory properties have the potential to counteract the overactive immune reaction known as a cytokine storm that is linked to COVID-19 and other inflammatory conditions. Thus, it is under the Phase III trial in COVID-19-related ARDS. The company plans to launch a Phase III trial in non-COVID-19-related ARDS shortly after closing the deal. 

WHO recommends against the use of remdesivir to treat COVID-19, refutes early hopes

While therapeutic agents and vaccines are lining up in ques, the fate of therapies remains unpredictable. A once-promising treatment against COVID-19, Remdesivir, is out of the race now. The World Health Organization issued a conditional recommendation voicing against the use of remdesivir in hospitalized COVID-19 patients.

Gilead’s drug came into the news after a clinical trial demonstrated that the drug speeds up the recovery in people with severe COVID-19. This led to rampant production and purchasing deals for remdesvir worldwide. However, the advice against its use coming from the WHO has put the drugmaker in a whirlwind. 

The decision is based on a large-scale Solidarity Trial as well as 3 other randomized controlled trials led by WHO, which demonstrated no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes.

Lilly forms a USD 555M R&D alliance with Precision BioSciences for DMD breakthrough therapies

Owning a broad portfolio ranging from cancer and immuno-oncology to diabetes, psoriasis, and Crohn’s disease, it’s time for genome editing. Eli Lilly has announced a research collaboration and exclusive license agreement with Durham-based Precision BioSciences for leveraging Precision’s ARCUS genome editing platform to research and develop potential in vivo therapies for a series of genetic disorders. 

The doublet will be exclusively focusing on Duchenne muscular dystrophy (DMD), along with two other undisclosed gene targets. The deal will give a cash payment of USD 100 million to Precision along with an equity investment by Lilly of $35 million. The company will also be eligible for potential development and commercialization milestone payments per product of up to USD 420 million.  

Lilly has earlier bolstered similar research collaboration and licensing agreements with Sitryx earlier in March. The collaboration with Precision BioSciences, according to the company, is another step towards the realization of Lilly’s vision to develop transformational, novel therapies with the help of genome editing technology.

Innovent receives China’s NMPA approval for its Humira Biosimilar for of Polyarticular Juvenile Idiopathic Arthritis

Suzhou, China-based Innovent Biologics, announced the commercialization approval from China’s National Medical Products Administration (NMPA) for Sulinno, an adalimumab biosimilar.

The copycat of Humira (adalimumab), Sulinno is a recombinant human anti-tumor necrosis factor-alpha monoclonal antibody injection and is approved for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in China. The injection is already approved in the Chinese market for rheumatoid arthritis, ankylosing spondylitis, and psoriasis.

While adherence of Humira is wide in the American and European market, its cost keeps on defying gravity. The cost of Humira deters patients and therefore, biosimilars offer high-quality and affordable alternatives. 

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