Basilea reported positive top-line results for the Phase III TARGET trial testing broadspectrum MRSA antibiotic ceftobiprole in severe skin infections. This is one of two Phase III trials required for the filing of a new drug application ("NDA") with the US FDA, both conducted under Special Protocol Assessment ("SPA") agreements. The second study (ERADICATE) in blood poisoning is on track to read out in H2/2021E. Although ceftobiprole is already marketed for pneumonia (HAP and CAP) in many European and RoW countries, the US is the key market for MRSA antibiotics and accounts for 56% of our peak sales estimate for the drug. We forecast launch in 2022E and peak sales of $225m in 2029E. Since ceftobiprole was designated Qualified Infectious Disease Product ("QIDP") by the FDA, we anticipate up to 10 years of market exclusivity from the date of launch. The ceftobiprole US opportunity accounts for c.10% of our CHF108 target price ("TP") for Basilea. We maintain our OUTPERFORM recommendation.
06 Aug 2019
Ceftobiprole succeeds in first US Phase III trial
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Ceftobiprole succeeds in first US Phase III trial
Basilea Pharmaceutica AG (0QNA:LON) | 0 0 0.0% | Mkt Cap: 605.3m
- Published:
06 Aug 2019 -
Author:
GOETZPARTNERS CORPORATE RESEARCH Research Team -
Pages:
5
Basilea reported positive top-line results for the Phase III TARGET trial testing broadspectrum MRSA antibiotic ceftobiprole in severe skin infections. This is one of two Phase III trials required for the filing of a new drug application ("NDA") with the US FDA, both conducted under Special Protocol Assessment ("SPA") agreements. The second study (ERADICATE) in blood poisoning is on track to read out in H2/2021E. Although ceftobiprole is already marketed for pneumonia (HAP and CAP) in many European and RoW countries, the US is the key market for MRSA antibiotics and accounts for 56% of our peak sales estimate for the drug. We forecast launch in 2022E and peak sales of $225m in 2029E. Since ceftobiprole was designated Qualified Infectious Disease Product ("QIDP") by the FDA, we anticipate up to 10 years of market exclusivity from the date of launch. The ceftobiprole US opportunity accounts for c.10% of our CHF108 target price ("TP") for Basilea. We maintain our OUTPERFORM recommendation.