OREANDA-NEWS. Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today its financial results for the first half of financial year 2016 with a solid half-year cash position of CHF 310.9 million and a net loss of CHF 27.9 million.

Basilea's CEO Ronald Scott stated: "We are proud to have launched CRESEMBA, our antifungal for the treatment of invasive mold infections, in the first European markets. Product sales for CRESEMBA and Zevtera were in line with our guidance in the first-half of this year. We also entered into a new agreement with BARDA that allows us to proceed with the clinical development required for the potential registration of ceftobiprole in the commercially important US market in indications of high unmet medical need such as bacteremia. We intend to expand our oral clinical study for our most advanced cancer compound, the tumor checkpoint controller BAL101553, to include glioblastoma patients later this year."

Anti-infectives: CRESEMBA® and Zevtera®/Mabelio®
Basilea currently commercializes CRESEMBA® (isavuconazole) in Germany, Italy, the United Kingdom (UK) and Austria and receives royalties on product sales in the United States (US) where the drug is marketed by Basilea's license partner Astellas Pharma US.

Zevtera®/Mabelio® (ceftobiprole), Basilea's broad-spectrum antibiotic, is currently available in, Germany, Italy, the UK, France, Austria and Switzerland. In Europe, CRESEMBA® and Zevtera®/Mabelio® are marketed by a single dedicated sales force to leverage the commercial synergies due to the overlapping hospital prescriber base.

Basilea aims to bring ceftobiprole to the US market and in April 2016 signed a contract with the United States Biomedical Advanced Research and Development Authority (BARDA)1 for a clinical phase 3 program to potentially gain regulatory approval in the US. Under the terms of the contract, BARDA will provide initial funding of approximately USD 20 million. Upon successful completion of pre-defined milestones, the total value of the contract could reach USD 100 million over a period of 4.5 years.

As part of the ceftobiprole program agreed with BARDA, Basilea intends to initially conduct phase 3 studies in acute bacterial skin and skin structure infections (ABSSSI) and Staphylococcus aureus bacteremia (SAB). The company is in discussions with the United States Food and Drug Administration (FDA) on the studies with the goal to gain Special Protocol Assessments (SPAs) to support both indications.

After completing a full data review, Basilea decided not to further develop the pre-clinical, inhaled antibiotic BAL30072.

Oncology: BAL101553 and BAL3833
Overcoming tumor resistance is the second pillar on which Basilea is building its portfolio. Significant progress was made in the first half of 2016 in the development of our anti-cancer drug candidates, the oral/intravenous (i.v.) small-molecule tumor checkpoint controller BAL101553 and the oral panRAF/SRC kinase inhibitor BAL3833.

Data from the completed open-label phase 1/2a study with i.v. BAL101553 were presented at the American Society of Clinical Oncology (ASCO) annual meeting. Overall, the drug candidate was well tolerated at the recommended phase 2 dose for a 2-hour weekly i.v. administration. Signals of clinical activity were observed.

Basilea is currently exploring BAL101553 daily oral dosing in a phase 1/2a study in adult patients with advanced solid tumor cancers. In addition, based on the ability of BAL101553 to penetrate brain tissue and preclinical evidence of its activity in brain cancer, Basilea intends to extend the oral study to adult patients with glioblastoma by year-end. Glioblastoma is the most common and aggressive primary brain tumor, and is often associated with poor prognosis for patients.

Progress was also made in the dose-escalation phase 1 study with BAL3833, which is developed as a potential new treatment option for resistant melanoma and other cancers.

Second half 2016 focus
Basilea's CEO Ronald Scott commented: "In the second half of 2016, we will continue to increase market access and gain formulary adoption for CRESEMBA and Zevtera in key European countries. In addition, we plan to conclude further license and distribution agreements for both drugs to fully leverage their commercial potential in additional territories. We are in active discussion with the FDA regarding the ceftobiprole SPAs and aim in the first half of 2017 to initiate the ceftobiprole phase 3 studies necessary for a potential regulatory approval in the US. We are also focused on further advancing our oncology drug candidates in clinical development."