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Lilly to Enter Gene Therapy with Precision BioSciences

27.11.2020 - Eli Lilly is wading into gene therapy, inking a deal with Precision BioSciences to develop in vivo gene therapies for three gene targets. The first target will be Duchenne muscular dystrophy, a disease caused by mutations in the dystrophin gene that prevent it from producing a protein of the same name. The other two have not been revealed.

The US drugmaker will pay the Durham, North Carolina-based biotech $100 million upfront and also invest $35 million in the cell and gene specialist, This is on top of the $420 million in development and commercialization milestones it has agreed.

As part of the division of labor, Precision will lead preclinical research and IND-enabling studies, while Lilly will handle clinical development and commercialization.

For Indianapolis, Indiana-based Lilly, the move represents a change in direction. One analyst recalled that CEO David Ricks said last year that gene therapy was not on the company’s radar because it did not reach that many patients.

Commenting on the deal with Precision, Andrew Adams, Lilly’s vice president of new therapeutic modalities, said it “represents another milestone in the realization of our vision to create medicines with transformational potential, using new therapeutic modalities such as gene editing to tackle targets and indications which were previously undruggable.”

The companies plan to leverage the biotech’s ARCUS genome editing platform to develop new gene therapies. This technology is based on a homing endonuclease that can insert or delete a piece of DNA before shutting itself off using a built-in safety switch to prevent unwanted, off-target edits elsewhere in the genome.

FDA awards EUA for Lilly’s baricitinib

In other Lilly news, the US Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the company’s baricitinib (brand name Olumiant) to be used in combination with Gilead’s anti-viral remdesivir drug (Veklury) in hospitalized patients with suspected or confirmed Covid-19 who require oxygen or invasive mechanical ventilation.  Up to now, baricitinib is authorized for treatment of rheumatoid arthritis in adults whose disease was not well controlled using tumor necrosis factor (TNF) antagonists.

The EUA for the Lilly product joins the already controversial FDA nod for full authorization of remdesivir to treat Covid, previously administered under an EUA. The FDA’s move raised eyebrows in the pharmaceutical world, due in part to the fact that US president Donald Trump has pushed for it but also to doubts over its efficacy in the coronavirus application.

The World Health Organization (WHO) said last week that – based on the results of several studies, including one it backed – remdesivir should not be used as treatment for hospitalized Covid patients, as it neither reduced deaths nor helped those with severe forms of the disease get out of the hospital more quickly.

Author: Dede Williams, Freelance Journalist