Switzerland's Basilea Pharmaceutica saw its share price jump 9% to 73 Swiss francs on February 19, after a negative European regulatory opinion earlier that day on its antibiotic ceftobiprole led US partner Johnson & Johnson subsidiary Cilag to return rights to the product they had been jointly developing over the past five years.
This fueled speculation that the small Swiss biotechnology firm - created as a spin out from Swiss drug major Roche in 2000 - would be open to takeover, with analysts saying it was unlikely that it could support continued development of the antibiotic on its own. Ceftobiprole had been touted as potentially achieving annual sales of $500 million.
The European Committee for Medicinal Products for Human Use (CHMP) indicated on Friday that the study results of the clinical Phase III program of ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI) ' including methicillin-resistant staphylococcus aureus (MRSA) - suggested that the drug was beneficial to patients. The Committee, however, adopted a negative opinion on the Market Authorization Application due to concerns about the reliability of the results of the Phase III studies supporting the MAA, stating that they had not been conducted in compliance with "good clinical practice" (GCP) in some sites.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze