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    BSLN   CH0011432447

BASILEA PHARMACEUTICA AG

(BSLN)
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Real-time Estimate Cboe Europe  -  03:22:36 2023-02-08 am EST
47.98 CHF   +0.05%
02/07Basilea to Get Milestone Payment from Pfizer After Antifungal Drug Sales Exceed Threshold
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02/07Continued strong Cresemba« (isavuconazole) sales performance in Asia Pacific and China triggers second sales milestone payment to Basilea from Pfizer
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02/07Continued strong Cresemba« (isavuconazole) sales performance in Asia Pacific and China triggers second sales milestone payment to Basilea from Pfizer
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Basilea Pharmaceutica AG 's ERADICATE Phase 3 Study Results Highlight the Potential Role of Ceftobiprole in the Treatment of Staphylococcus Aureus Bacteremia

10/24/2022 | 01:15am EST

Basilea Pharmaceutica AG reported that data from the successfully completed phase 3 ERADICATE study1, evaluating ceftobiprole in the treatment of adult patients with bacterial bloodstream infections caused by Staphylococcus aureus, (SAB), have been presented at the scientific conference, IDWeek 2022, which took take place in Washington, D.C. from 19 to 23 October. The randomized, double-blind, multicenter phase 3 study ERADICATE was a global study, performed in 60 study centers in 17 countries from August 2018 to March 2022. 390 patients were randomized to ceftobiprole or daptomycin, with or without intravenous aztreonam for coverage of Gram-negative pathogens, for up to 42 days of treatment.

Patient characteristics in the 387 patients included in the modified intent-to-treat (mITT) population were balanced between the ceftobiprole and daptomycin treatment groups. As presented at IDWeek, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. The overall success rate, assessed by a blinded independent Data Review Committee consisting of five experienced U.S. infectious disease specialists, was 69.8% with ceftobiprole, compared to 68.7% with daptomycin, in the mITT population at 70 days post randomization.

The statistically adjusted difference between ceftobiprole and daptomycin for overall success was 2.0% (95% confidence interval: -7.1% to 11.1%) and thus well within the pre-specified non-inferiority margin of 15%. Results for the primary efficacy outcomes were consistent in key subgroups including in patients with MSSA or MRSA bloodstream infections at baseline, and in various categories of underlying conditions such as skin and skin structure infections, abdominal abscesses, chronic dialysis, septic arthritis, osteomyelitis, definite right-sided infective endocarditis and in patients with persistent SAB.Secondary efficacy outcomes such as the overall success rate in the clinically evaluable population (77.9% in the ceftobiprole group, 77.8% in the daptomycin group), microbiological eradication (82.0% in the ceftobiprole group, 77.3% in the daptomycin group), all-cause mortality (9.0% in the ceftobiprole group, 9.1% in the daptomycin group) and the emergence of new SAB complications (5.8% in the ceftobiprole group, 5.6% in the daptomycin group) were also similar between the two treatment groups at 70 days post-randomization in the mITT population. The median time to Staphylococcus aureus bloodstream clearance for MSSA was 3 days with ceftobiprole and 4 days with daptomycin, and 5 days for MRSA for both ceftobiprole and daptomycin.Emergence of resistance under treatment was observed in three patients on daptomycin.

No emergence of resistance under treatment was observed with ceftobiproleBoth treatments were well tolerated. The overall rate of adverse events was similar between the ceftobiprole and daptomycin groups. In line with the known safety profile of ceftobiprole, gastrointestinal disorders were more frequent with ceftobiprole compared to daptomycin, mainly driven by mild to moderate nausea.

Basilea is planning to submit a New Drug Application (NDA) for ceftobiprole to the U.S. Food and Drug Administration (FDA) around year-end 2022. Ceftobiprole at IDWeek 2022LB2302 - Late Breaking Clinical Trials:Ceftobiprole Compared to Daptomycin With or Without Optional Aztreonam for the Treatment of Complicated Staphylococcus aureus Bacteremia (SAB): Results of a Phase 3, Randomized, Double-Blind Trial (ERADICATE) – Thomas L. Holland, Sara E. Cosgrove, Sarah B. Doernberg, Oleksandr Pavlov, Ivan Titov, Boiko Atanasov, Maziar Assadi Gehr, Marc Engelhardt, Kamal Hamed, Daniel Ionescu, Mark Jones, Mikael Saulay, Jennifer Smart, Harald Seifert, Timothy C. Jenkins, Nicholas A. Turner, Vance G. Fowler Jr.


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All news about BASILEA PHARMACEUTICA AG
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01/11Basilea Pharmaceutica : Updated January 11, 2023
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Financials
Sales 2022 120 M 130 M 130 M
Net income 2022 -15,1 M -16,4 M -16,4 M
Net Debt 2022 89,7 M 97,1 M 97,1 M
P/E ratio 2022 -34,5x
Yield 2022 -
Capitalization 572 M 620 M 620 M
EV / Sales 2022 5,53x
EV / Sales 2023 4,71x
Nbr of Employees 177
Free-Float 88,1%
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Number of Analysts 4
Last Close Price 47,95 CHF
Average target price 73,82 CHF
Spread / Average Target 53,9%
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Managers and Directors
David Veitch Chief Executive Officer
Adesh Kaul Head-Corporate Development
Domenico Scala Chairman
Laurenz Kellenberger Chief Scientific Officer
Marc Engelhardt Head-Clinical Research
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