Proteon Therapeutics and Lonza Extend Manufacturing Agreement for Commercial Supply
- Partners extend existing contract for manufacture of vonapanitase to 2029 as ongoing Phase 3 trial nears completion
- Lonza Pharma & Biotech successfully scaled up a lab process at their Microbial facility in Visp, Switzerland, providing flexible solutions as Proteon moves toward possible commercialization
- Lonza’s experience in products with Breakthrough Therapy Designation provides expert support for these fast paced, challenging projects
BASEL, Switzerland and WALTHAM, Mass.,
“Proteon and Lonza have had a strong relationship for nearly a decade, and this amendment extends that relationship,” said Timothy Noyes, President and Chief Executive Officer of Proteon. “The amendment provides Proteon with access to a top-tier manufacturing site for the long-term commercial supply of investigational vonapanitase after potential FDA approval.”
“Lonza’s microbial expertise and versatile assets will enable us to anticipate and deliver API for Proteon at this critical phase in the lifecycle of their therapy,” said Marc Funk, COO Lonza Pharma & Biotech.
Karen Fallen, VP, Head of
Lonza has manufactured API for Proteon at its microbial manufacturing facility in Visp (CH) since 2009. Initially, a small-scale process was transferred into Lonza’s development labs for process optimization and consistency studies. The process was then scaled up to 1,000L scale cGMP manufacture to support Proteon’s early clinical studies and potential commercial requirements.
As Proteon worked to complete enrollment in its ongoing Phase 3 clinical trial, PATENCY-2, Lonza supported Proteon with three process validation batches at 1,000L commercial scale, each of which met the intended release criteria. If PATENCY-2 is successful, Proteon expects to include results from these validation runs in a potential Biologics License Application (BLA) filing in the second half of 2019, which Lonza will support.
Vonapanitase is an investigational drug intended to improve hemodialysis vascular access outcomes. Vonapanitase is currently being studied in a Phase 3 clinical trial in patients with chronic kidney disease (CKD). It has received Breakthrough Therapy, Fast Track and Orphan Drug designations from the FDA, and Orphan Medicinal Product designation from the
About Proteon Therapeutics
Proteon Therapeutics is committed to improving the health of patients with kidney and vascular diseases through the development of novel, first-in-class therapeutics. Proteon's lead product candidate, vonapanitase, is an investigational drug intended to improve hemodialysis vascular access outcomes. Proteon is evaluating vonapanitase in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula. Proteon is also evaluating vonapanitase in a Phase 1 clinical trial in patients with PAD. For more information, please visit www.proteontx.com.
About Microbial Manufacturing at Lonza Pharma & Biotech
Recent developments in next generation biotherapeutics including antibody mimetics and novel scaffolds have spurred a renewed interest in microbial protein expression and manufacture technologies. Lonza’s proven XS® Microbial Expression Platform combined with more than 30 years of process development and cGMP manufacture expertise make us an ideal partner to successfully support clinical and commercial programs. .More information can be found at: pharma.lonza.com/microbial.
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. As an integrated solutions provider, Lonza is boosting its value creation along and beyond the healthcare continuum with a strong focus on patient healthcare, consumer preventive healthcare and consumer's healthy environment.
Lonza harnesses science and technology to create products that support safer and healthier living and that enhance the overall quality of life. With the recent Capsugel acquisition, Lonza now offers products and services from the custom development and manufacturing of active pharmaceutical ingredients to innovative dosage forms for the pharma and consumer health and nutrition industries.
Benefiting from its regulatory expertise, Lonza is able to transfer its know-how from pharma to hygiene and fast-moving consumer goods all the way to coatings and composites and the preservation and protection of agricultural goods and other natural resources.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 14,500 full-time employees worldwide. The company generated sales of
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding Proteon’s product candidate, vonapanitase, and plans for its commercial manufacture. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks relating to: whether data from early nonclinical or clinical studies will be indicative of the data that will be obtained from future clinical trials; whether vonapanitase will advance through the clinical trial process on the anticipated timeline and warrant submission for regulatory approval; whether such a submission would receive approval from the
Additional Information and Disclaimer
Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of
Lonza Contact Details
Constance Ward, Head External Communications
Lonza Group Ltd
Tel +41 61 316 8840
Sanna Fowler, Assistant Director Public Relations
Lonza Pharma & Biotech
Tel +41 79 539 0615
Proteon Contact Details
George Eldridge, Proteon Therapeutics, Senior Vice President and Chief Financial Officer
Source: Proteon Therapeutics, Inc.