Basilea Reveals Key Advancements in Its Biopharmaceutical Portfolio

Basilea Pharmaceutica Ltd Announces Exciting Developments

Basilea Pharmaceutica Ltd, a dynamic biopharmaceutical company known for its dedication to developing critical therapies for severe bacterial and fungal infections, has provided an insightful update on its Research & Development efforts. With a strong focus on innovation and patient needs, Basilea is making significant strides.

Milestones Achieved in 2024

As of late 2024, Basilea has successfully partnered with a dedicated company for the US commercialization of its anti-MRSA antibiotic, Zevtera, following its approval. Additionally, the European Commission has extended the approved uses of the leading antifungal, Cresemba, to include treatment for pediatric patients. This move not only allows young patients to access Cresemba but also extends its market exclusivity in the EU until late 2027.

Significant Funding Secured

In an impressive boost to its R&D efforts, Basilea has secured significant non-dilutive funding from BARDA and CARB-X. These funds will aid the development of first-in-class antifungal and antibacterial agents, thereby enhancing Basilea’s robust research pipeline. The company also commenced a phase 3 study focusing on invasive yeast infections using its promising antifungal product, fosmanogepix.

Commercial Performance and Market Presence

Cresemba’s commercial performance has been remarkable, leading to multiple milestone payments for Basilea throughout 2024. By the end of the year, Cresemba was successfully marketed in over 70 countries including the United States, selected EU member states, Japan, and China.

Impressive Sales Growth

Recent data indicates Cresemba achieved global in-market sales of USD 533 million between October 2023 and September 2024, reflecting a 20% year-on-year growth, solidifying its position as the leading branded antifungal for invasive fungal infections worldwide.

Key Highlights for 2024-2025

The approvals for pediatric use were also a highlight, with the European Commission granting usage in children with invasive aspergillosis and mucormycosis. This milestone came shortly after a similar decision by the U.S. FDA, cementing Cresemba's market presence with exclusivity extended until October 2027 in the EU.

With the U.S. FDA's approval of Zevtera for various severe infections, commercial progress has accelerated. Notably, in December, Basilea announced its partnership with Innoviva Specialty Therapeutics for the U.S. market’s anticipated launch in mid-2025. In China, Zevtera has been included in the National Reimbursement Drug List, significantly expanding its accessibility under the national medical insurance program starting in 2025.

Robust Clinical Pipeline

Substantial progress has been made in both clinical and preclinical pipelines, including notable funding agreements. Through a recent agreement with BARDA, Basilea aims to invest a significant amount into the development of innovative antifungals and antibacterials.

Promising Studies Underway

The company has initiated a phase 3 clinical trial for fosmanogepix, focusing on adults suffering from severe invasive fungal infections. Furthermore, preparations for another phase 3 study addressing mold infections are expected to start soon.

About Basilea Pharmaceutica Ltd

Founded in 2000, Basilea Pharmaceutica Ltd is headquartered in Switzerland and has built a concentrated portfolio focused on developing important therapies for severe bacterial and fungal infections. The company has successfully launched its leading products, Cresemba and Zevtera, aimed at tackling these critical health challenges. With a dedicated R&D focus, Basilea is poised for continued success in bringing innovative solutions to market.

Contact Information

For more details, please contact:

Peer Nils Schröder, PhD
Head of Corporate Communications & Investor Relations
Basilea Pharmaceutica International Ltd
Hegenheimermattweg 167b
4123 Allschwil
Switzerland

Phone: +41 61 606 1102

Email: media_relations@basilea.com
investor_relations@basilea.com

Frequently Asked Questions

What are the recent milestones achieved by Basilea?

Basilea has formed partnerships for Zevtera commercialization, expanded Cresemba’s indications, and secured substantial funding for R&D.

How has Cresemba performed commercially?

Cresemba's global sales reached USD 533 million in just one year, showing significant growth and market reach.

What is Zevtera’s current status in the market?

Zevtera has received FDA approval, is set for launch in mid-2025, and is now included in China’s reimbursement drug list.

What clinical studies are currently ongoing?

Basilea is conducting phase 3 studies for its antifungals, including fosmanogepix, targeting severe invasive infections.

Where can I find more information about Basilea?

Additional information about Basilea and its portfolio can be found on their official website.

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