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Even though this was a holiday week for those in the US, we've still got Eyes on Pharma - some of the latest updates include CRISPR/Vertex Casgevy Gene Therapy approval in the EU, Novo's REDEFINE 4 Trial, Lilly's new Manufacturing plant, and Pfizer's Layoff plans. What caught your eye this week?
The UK’s MHRA was the first to approve Vertex and CRISPR Therapeutics’ Casgevy gene therapy last week. Casgevy (exagamglogene autotemcel) is the world’s first gene-editing therapy for the treatment of sickle cell disease and transfusion-dependent beta-thalassemia. This is a historic milestone for the treatment of genetic disorders of the blood. Casgevy’s conditional authorization was granted on the back of successful sickle cell and beta thalassemia clinical trials. Both studies proved Casgevy's- efficacy and safety profile with side effects similar to autologous stem cell transplants - nausea, fatigue, fever, and an increased risk of infections. Just 29 of the 45 sickle cell disease patients enrolled were included in the primary efficacy interim analysis, with 28 reporting elimination of severe pain at least 12 months post-treatment. The beta thalassemia data were collected from 42 patients, with 39 of them transfusion-free for at least 12 months. The MHRA’s endorsement of Casgevy’s safety and efficacy as a single-use gene therapy comes with an expectation of a price point close to US$2 million with a lingering question mark over NICE’s view of its cost-effectiveness. Casgevy’s potential side effects include cell toxicity and genomic instability that could increase the risk of tumor development The FDA’s decision date for the sickle-cell indication is December 8th, and the end of March 2024 for beta thalassemia. Click for more details here and here.
Pfizer to cut hundreds more jobs in the UK & US. The $3.5 billion cost-cutting campaign aimed at the end of 2024 hit Ireland earlier this month as one hundred Newbridge employees working on the oral COVID medicine Paxlovid lost their jobs. The Sandwich facility in the UK, currently employing nine hundred and forty people, is next on the list. Five hundred roles together with Pharmaceutical Sciences Small Molecule capabilities are being cut in support of Pfizer’s cost realignment as future sales of COVID vaccine Comirnaty and antiviral Paxlovid remain uncertain. A further 200 layoffs are planned to take place in Pfizer’s Kalamazoo site in Michigan due to a decrease in demand for COVID products. Early 2024 will see almost all 791 jobs in Peapack, New Jersey, reassigned to the company’s New York headquarters. For more details, click here and here.
Novo Nordisk CagriSema going head-to-head with Eli Lilly’s Mounjaro as the fixed-dose combination of Wegovy and cagrilintide (a long-acting amylin analog) enters new phase 3 trial study REDEFINE 4. 800 non-diabetes patients’ weight loss will be assessed based on 72 weeks treatment, monitoring triglycerides, waist circumference, cholesterol levels and systolic blood pressure. The once-weekly injection of a combination of 2.4mg semaglutide (Wegovy) with 2.4mg cagrilintide is set to take on Lilly’s Zepbound. The trial subject lost 15.6% of their body weight at week 32 of a Phase 2 trial in June; this is a significant improvement to the single molecule trial results of 5.1% for Wegovy’s or 8.1% for cagrilintide’s body weight reduction stats. For more details, click here and here.
Lilly plans a US$2.5 billion new manufacturing plant in Germany, starting construction in 2024 and operational by 2027. Zepbound and Mounjaro are suffering from supply shortages as they struggle to keep up with demand. Mounjaro captured US$1.4 billion in the third quarter, up from US$980 million the previous quarter. Novo’s sales and operating profit showed a significant increase, with third-quarter earnings revenue from Wegovy of US$1.38 billion, an increase of 730% over the same period in 2022. Goldman Sachs' US$100 billion forecast for the obesity drug market sees Novo Nordisk and Eli Lilly scooping up 80% between them by 2030. For more details, click here.
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