Today, a brief rundown of news involving Teva Pharmaceutical and BioMarin Pharmaceutical, as well as updates from GSK, the Food and Drug Administration and BioNTech that you may have missed.
Teva Pharmaceutical said an experimental antibody drug it’s developing succeeded in a mid-stage trial in celiac disease. When compared to a placebo over the course of eight weeks, Teva’s drug, TEV ‘408, demonstrated a “statistically significant and clinically meaningful” ability to prevent gluten-induced intestinal damage, according to Teva. Coupled with data from an early-stage trial in the inflammatory skin condition vitiligo, the results suggest TEV ‘408 has “pipeline-in-a-product potential,” Teva said. Analyses from an ongoing Phase 2a study are underway. Teva will present additional results at a future scientific meeting. — Delilah Alvarado
BioMarin Pharmaceutical has settled a patent dispute with rival Ascendis Pharma over a drug Ascendis recently brought to market for achondroplasia, the most common form of dwarfism. BioMarin had alleged that Ascendis infringed on a patent in developing that treatment, known as Yuviwel and approved by U.S. regulators in March. The settlement announced Monday hands BioMarin a 20% royalty on net U.S. sales of Yuviwel and an 18% royalty on net sales in Europe, Brazil and South Korea until 2030. While investors expected a deal, the economic terms for BioMarin are “better than anticipated,” and a “hedge” against patients switching off the company’s drug Voxzogo, wrote Stifel analyst Paul Matteis. — Ben Fidler
A federal judge has delayed a closely watched lawsuit two attorneys general in Texas and Florida filed against the Food and Drug Administration over the abortion pill mifepristone. The FDA approved mifepristone in 2000 and testing, as well as years of use, have proven the drug safe and effective for terminating pregnancy. But the states have argued that the agency didn’t adequately evaluate mifepristone, and aim to convince the courts to curb access. Monday’s ruling, from a judge in Texas, granted a Department of Justice request to pause the suit until either Dec. 1 or when the FDA finishes an ongoing safety review of the drug, whichever comes first.— Delilah Alvarado
GSK said Tuesday it will move an experimental mRNA vaccine for seasonal influenza into late-stage testing following positive results in a Phase 2 study. According to GSK, the shot spurred stronger immune responses, against all strains, than standard- and high-dose flu vaccines in that mid-stage trial. The upcoming study beginning in September will be the first Phase 3 trial of an mRNA vaccine targeting two key surface antigens — hemagglutinin and neuraminidase — that help the flu virus spread. GSK acquired that vaccine in a deal with CureVac two years ago. — Delilah Alvarado
BioNTech on Friday announced plans to terminate a Phase 2 study testing an experimental mRNA vaccine called autogene cevumeran against colorectal cancer. BioNTech previously said that the trial was likely to fail, but still continued the study as trial investigators concluded there hadn’t been enough follow-up time to properly evaluate the treatment’s efficacy. Since then, though, those trial monitors detected a “numerical imbalance” in survival between the treatment and placebo groups and recommended ending the trial. BioNTech and Roche are co-developing the vaccine under a longstanding alliance. — Ben Fidler
