Basilea Pharmaceutica AG

Plus, news about Basilea, TME Pharma and Perceive Biotherapeutics: Septerna stops work on Phase 1: The newly public biotech ended a healthy volunteer trial for SEP-786, its hypoparathyroidism candidate, after “unanticipated events of elevated unconjugated bilirubin levels.” The company had been targeting a readout in the middle of this year, CEO Jeffrey Finer told Endpoints News at last month’s JP Morgan Healthcare Conference. The biotech now expects to select a follow-up candidate “to accelerate toward the clinic later this year to quickly regain momentum with our PTH1R program,” Finer said Tuesday. Multiple drugmakers are doing work in the rare endocrine disorder field, and Ascendis’ hypoparathyroidism drug was recently approved. Septerna’s stock $SEPN was down about 63% on Tuesday morning. — Kyle LaHucik FDA approves Sanofi’s Merilog: It’s the first FDA-approved, fast-acting insulin biosimilar to Novo Nordisk’s NovoLog, and is now the third insulin biosimilar approved by the agency to treat diabetes. — Alexis Kramer Basilea abandons MRSA drug ahead of clinic entry: The Swiss biotech decided not to exercise its option for its endolysin candidate, dubbed tonabacase, because it didn’t meet “stringent risk-return criteria.” Basilea licensed the option for tonabacase from iNtRON Biotechnology back in 2023 and did a preclinical assessment of the candidate last year. — Ayisha Sharma German cancer biotech has new eye focus: TME Pharma is planning to establish a “new entity” focused on the “rapid advancement” of NOX-E36 for ophthalmic indications, with support from private investors. The company said it has enough supply of the drug for initial preclinical and clinical studies. TME is also looking for a strategic partner for its lead asset, dubbed NOX-A12, for glioblastoma. — Ayisha Sharma Ophthalmology biotech reveals $15M Series A: Johnson & Johnson’s corporate venture arm, Deerfield Management and other investors are backing Perceive Biotherapeutics. The small molecule startup, a spinout of Perceive Pharma, is working on “neuroprotective therapeutics” for glaucoma and other eye conditions. — Kyle LaHucik

“This decision demonstrates that we are focused on stringent risk-return criteria when making portfolio decisions,” Basilea Pharmaceutica said.\n Basilea Pharmaceutica has cited its “stringent risk-return criteria” as a reason for not taking up its option to bring a MRSA antibiotic into clinical development.Basilea secured the license option for the endolysin antibiotic, called tonabacase, from Korea’s iNtRON Biotechnology in 2023. Basilea had been conducting a preclinical evaluation of the asset throughout 2024 ahead of a decision on whether to secure the exclusive rights to take tonabacase into human trials.When it signed the agreement with iNtRON, Basilea pointed to preclinical evidence of tonabacase’s activity against methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA and MSSA) as well as coagulase-negative staphylococci.“There continues to be a high medical need for new treatment options for patients with persistent infections caused by Gram-positive bacteria and tonabacase is an exciting and innovative asset for us to evaluate over the coming months,” Basilea Chief Medical Officer Marc Engelhardt, M.D., said back in 2023. “If the outcome of our evaluation is positive and we enter into a full license agreement, we may be able to start directly a phase 2 clinical study in 2025.” That trial is now off the menu, as Basilea has completed its own preclinical profiling of the medicine and “taken the decision not to pursue further development,” the Swiss company said in its full-year earnings report.“This decision demonstrates that we are focused on stringent risk-return criteria when making portfolio decisions,” the company added.Basilea currently markets Cresemba for invasive fungal infections and Zevtera for bacterial infections. The low return on investment means many of the biggest biopharmas have given up working on new antifungals or antibiotics in recent years—although GSK in particular has continued to sign deals and post encouraging clinical results against infections like gonorrhea.Meanwhile, Basilea has swum against the tide, pivoting away from cancer toward anti-infectives last year. The company’s clinical pipeline is headed up by fosmanogepix, an antifungal licensed from Amplyx Pharmaceuticals that Basilea is planning to enter into its second phase 3 study against mold infections.Basilea’s work developing new antifungals received a significant boost last September from the U.S. Department of Health and Human Services, which signed off on up to $268 million of funding to the biopharma over more than a decade.

Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today that the sales of the antifungal Cresemba® (isavuconazole) in Japan exceeded the threshold triggering the first sales milestone payment from its partner Asahi Kasei Pharma (AKP), amounting to approximately CHF 1.2 million. David Veitch, Chief Executive Officer of Basilea, said: “Japan is a key market with significant growth potential for Cresemba. The achievement of the first sales milestone already in the second year of commercialization is a testament of the commercial capability of our partner AKP in this important market. The strong sales ramp-up in the early stage of its life cycle in Japan underscores that Cresemba is meeting critical medical needs of patients with life-threatening fungal infections.” By year-end 2024, Cresemba was marketed in more than 70 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. In Japan, the oral and intravenous formulations are approved for the treatment of adult patients with aspergillosis, mucormycosis, and cryptococcosis.2 Isavuconazole is also approved in the United States (US),3 China, the EU4 and several additional countries in Europe and beyond.5 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. References IQVIA Analytics Link, September 2024. In-market sales reported as moving annual total (MAT) in US dollar. PMDA List of Approved Drugs April 2022 to March 2023: https://www.pmda.go.jp/files/000267877.pdf [Accessed: February 04, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: February 04, 2025] European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: February 04, 2025] The content above comes from the network. if any infringement, please contact us to modify.