David Veitch, CEO of Basilea Pharmaceutica (BSLN), gave a “whistle-stop” overview of the
company, including plans for the portfolio of two commercial stage assets and three oncology
products in the pipeline, as well as the financial position of the company going into 2019. With a
stronger than expected preliminary revenue in 2018, the company is in a good financial position
to focus on their goals of expanding the oncology and anti-infectives pipeline, including multiple
clinical oncology products and ceftobiprole – a fifth generation cephalosporin.
The company’s strong 2018 performance was mainly driven by the continued uptake of
Cresemba and Zevtera. Cresemba’s in-market sales amounted to $145m as of Q3 2018, and
Basilea intends on launching Cresemba in 40 additional markets over the next three years. With
clinical studies demonstrating non-inferiority of Cresemba to the standard of treatment,
voriconazole, while showing a superior safety profile and broader action spectrum, the company
hopes to increase the US market share of Cresemba in the upcoming years. The increase in
market share is expected to be further powered by the ECIL-6 guidance for the use of Cresemba
in first-line treatment of aspergillosis in leukemia and hematopoietic stem cell transplant patients
due to its safety profile. Zevtera, which is indicated for use in hospital- and community-acquired
pneumonia, is marketed in the major EU markets, Canada, and several other markets in South
America and Asia. In its anti-infective pipeline, the company plans to gain market approval for
ceftobiprole in 2022 for the treatment of acute bacterial skin and skin structure infections, as well
as Staphylococcus aureus bacteraemia, following the completion of two ongoing supportive
Phase III studies in the US.
In the presentation of the oncology portfolio, the CEO mentioned three main agents: BAL10153
for recurrent or progressive glioblastoma and platinum-resistant ovarian cancer, BAL3833 for
patients with solid tumors including metastatic melanoma, and an in-licensed pan-FGFR kinase
inhibitor, derazantinib, for intrahepatic cholangiocarcinoma. Derazantinib, which is Basilea’s lead
oncology compound, is currently in a registrational Phase II study with interim results expected in
H1 2019. The CEO disclosed that the interim analysis of the Phase II study shows encouraging
results, which mirrors the achievements seen from a Phase I study, including an increased
objective response rate and improved disease control rate.
Veitch briefly mentioned BAL10153 and BAL3833. He highlighted that BAL10153, with its ability
to penetrate the blood brain barrier, is being investigated in three ongoing studies in patients
with newly diagnosed and recurrent glioblastoma. Data from two of the studies is expected in
2019. BAL3833 has completed one Phase I study to date, but with the maximum tolerated dose
not identified during the trial, the company will further explore the use of the drug in solid tumor
treatment.
company, including plans for the portfolio of two commercial stage assets and three oncology
products in the pipeline, as well as the financial position of the company going into 2019. With a
stronger than expected preliminary revenue in 2018, the company is in a good financial position
to focus on their goals of expanding the oncology and anti-infectives pipeline, including multiple
clinical oncology products and ceftobiprole – a fifth generation cephalosporin.
The company’s strong 2018 performance was mainly driven by the continued uptake of
Cresemba and Zevtera. Cresemba’s in-market sales amounted to $145m as of Q3 2018, and
Basilea intends on launching Cresemba in 40 additional markets over the next three years. With
clinical studies demonstrating non-inferiority of Cresemba to the standard of treatment,
voriconazole, while showing a superior safety profile and broader action spectrum, the company
hopes to increase the US market share of Cresemba in the upcoming years. The increase in
market share is expected to be further powered by the ECIL-6 guidance for the use of Cresemba
in first-line treatment of aspergillosis in leukemia and hematopoietic stem cell transplant patients
due to its safety profile. Zevtera, which is indicated for use in hospital- and community-acquired
pneumonia, is marketed in the major EU markets, Canada, and several other markets in South
America and Asia. In its anti-infective pipeline, the company plans to gain market approval for
ceftobiprole in 2022 for the treatment of acute bacterial skin and skin structure infections, as well
as Staphylococcus aureus bacteraemia, following the completion of two ongoing supportive
Phase III studies in the US.
In the presentation of the oncology portfolio, the CEO mentioned three main agents: BAL10153
for recurrent or progressive glioblastoma and platinum-resistant ovarian cancer, BAL3833 for
patients with solid tumors including metastatic melanoma, and an in-licensed pan-FGFR kinase
inhibitor, derazantinib, for intrahepatic cholangiocarcinoma. Derazantinib, which is Basilea’s lead
oncology compound, is currently in a registrational Phase II study with interim results expected in
H1 2019. The CEO disclosed that the interim analysis of the Phase II study shows encouraging
results, which mirrors the achievements seen from a Phase I study, including an increased
objective response rate and improved disease control rate.
Veitch briefly mentioned BAL10153 and BAL3833. He highlighted that BAL10153, with its ability
to penetrate the blood brain barrier, is being investigated in three ongoing studies in patients
with newly diagnosed and recurrent glioblastoma. Data from two of the studies is expected in
2019. BAL3833 has completed one Phase I study to date, but with the maximum tolerated dose
not identified during the trial, the company will further explore the use of the drug in solid tumor
treatment.
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