Amgen has filed a lawsuit in the USA against Sanofi and Regeneron Pharmaceuticals claiming that their investigational cholesterol drug, the PCSK9 inhibitor alirocumab, infringes its patents.
Amgen, which submitted its own PCSK9 inhibitor evolocumab across the Atlantic at the end of August, is claiming Sanofi and Regeneron have infringed three Amgen patents. As such, the biotech major is seeking an injunction “to prevent the infringing manufacture, use and sale” of alirocumab, which has completed Phase III trials.
Sanofi and Regeneron have not filed their offering yet but paid $67.5 million in August to buy a US priority review voucher from BioMarin. This will allow them to fast-track alirocumab as the Food and Drug Administration’s review will take six months not ten.
A submission is likely before the end of the year, meaning that the two competitors could get approvals around the same time next summer. There is much excitement around inhibitors of PCSK9, a protein that reduces the liver’s ability to remove bad cholesterol from the blood.
Eylea beats Acastin. Lucentis for DME
Better news for Regeneron came from a head-to-head study in patients with diabetic macular edema which showed that its flagship drug Eylea (aflibercept) demonstrated significantly greater improvement in visual acuity compared with Roche’s Avastin (bevacizumab) and Lucentis (ranibizumab).
The top-line results showed that the median number of injections was one fewer in patients treated with Eylea compared to bevacizumab and ranibizumab and fewer people in the Regeneron drug group received macular laser treatments.
