Basilea Submits Groundbreaking NDA for Innovative Antibiotic Ceftobiprole to FDA

We seek approval for three bacterial infections: Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP). These conditions are significant causes of illness and medical attention is necessary to help prevent and treat them.

NDA applications may be eligible for Priority Review, which can be a beneficial process that takes advantage of expedited review timelines in order to get products to market in a timely manner. This provides the potential for increased access to life-saving treatments and increased competition in the marketplace to benefit consumers.

Ad hoc announcement pursuant to Art. 53 LR

It’s a glorious day in Allschwil, Switzerland, on this fourth of August in 2023. The sun is shining, the sky is a brilliant blue, and nature is alive with sweetness and life. The city itself is a sight to behold: buildings casting shadows along the rolling hills, birds soaring overhead, and the soft murmur of locals on the streets all make for a truly wonderful experience. Come, explore this beautiful town on this delightful day!

Basilea Pharmaceutica Ltd, the commercial-stage biopharmaceutical company based in Allschwil, Switzerland has taken a significant step in its mission to meet the needs of patients with severe bacterial and fungal infections by submitting their New Drug Application to the US Food and Drug Administration.

If approved, their antibiotic ceftobiprole could prove to be a major breakthrough in the treatment of Staphylococcus aureus bacteremia (including right-sided infective endocarditis), acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.

Dr. Marc Engelhardt, Chief Medical Officer, commented on the recent completion of Merck’s phase 3 ceftobiprole program for the treatment of staphylococcus aureus bacteremia, an infection that affects an estimated 120,000 people in the US each year and carries a high mortality rate.

Through this program, the efficacy of ceftobiprole has been firmly established and the additional successfully completed phase 3 studies in ABSSSI and CABP only further support its broad clinical utility. With its potent ability to fight bacteria, ceftobiprole could become a powerful new solution in the US for those suffering from severe bacterial infection, especially when MRSA is of concern.

Our recently submitted NDA draws upon extensive clinical evidence to support the efficacy and safety of our new antibiotic therapy for SAB, ABSSSI and CABP. Most notably, the ERADICATE study represents the largest double-blind randomized registrational study of a new antibiotic ever conducted for SAB. Its results, together with those of the TARGET and CABP studies, further reinforce its potential in delivering successful outcomes.

Basilea is pushing for a Priority Review for the NDA submission of ceftobiprole under the US Generate Antibiotics Incentives Now (GAIN) Act – a Qualified Infectious Disease Product. With acceptance of the NDA, a decision from the FDA is expected in the second quarter of 2024. In preparation for the potential approval, Basilea is looking for a commercial partner in the US for the product launch.

Basilea’s advanced ceftobiprole phase 3 program has been backed by the US Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), and Biomedical Advanced Research and Development Authority (BARDA). By offering approximately USD 112 million to the studies, regulatory activities and non-clinical work related to the SAB and ABSSSI, the US Government has invested 75% of the total cost of the program.

About ceftobiprole

Ceftobiprole medocaril, the active moiety of a cephalosporin antibiotic, is an innovative treatment option for patients suffering from hospital-acquired bacterial pneumonia (HABP) and community-acquired bacterial pneumonia (CABP). With its fast bactericidal activity against a broad range of Gram-positive bacteria, such as Staphylococcus aureus and methicillin-resistant strains (MRSA), and Gram-negative bacteria, Zevtera® and Mabelio® – its brand names – are now approved and marketed in around 80 countries across Europe and beyond. Unfortunately, ceftobiprole is not yet approved and partnered in the US.

About Basilea

Basilea is a biopharmaceutical powerhouse determined to revolutionize the way we fight bacterial and fungal infections. Founded over two decades ago in Switzerland, the company has already made tremendous strides in its mission to provide effective treatments and cure serious infections.

With its two hospital brands, Cresemba and Zevtera, Basilea has helped countless individuals find relief from their infections. Moreover, the company is exploring new, preclinical anti-infective assets – a testament to its commitment to improving public health. It’s no wonder Basilea’s stock is listed on the esteemed SIX Swiss Exchange.


At Basilea Pharmaceutica Ltd, Allschwil, we are deeply committed to our research, development and clinical studies for product candidates. However, this progress could be subject to any number of known and unknown risks, uncertainties and other factors. As such, we need to keep a watchful eye on these changes, and we are dedicated to staying up-to-date in our efforts.

We can only forecast future results, performance, and achievements expressed or implied by such prospects with caution. We are supplying this communication to keep everyone informed as of today, and we will continue to update on our forward-looking statements as more information is revealed.

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