Blog Exposure - Proteon Extended Long-term Contract with Lonza for Commercial Supply of Vonapanitase's Active Pharmaceutical Ingredient
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LONDON, UK / ACCESSWIRE / May 10, 2018 / If you want access to our free research report on Proteon Therapeutics, Inc. (NASDAQ: PRTO), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=PRTO as the Company's latest news hit the wire. On May 8, 2018, the Company announced that it has extended its long-term contract with Lonza Pharma & Biotech for the commercial supply of investigational vonapanitase's active pharmaceutical ingredient (API). Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Amendment Provides Proteon with Access to a Top-Tier Manufacturing Site for Long-Term Commercial Supply of Vonapanitase
Timothy Noyes, President and Chief Executive Officer of Proteon, mentioned that the Company and Lonza have had a strong relationship for nearly a decade, and this amendment extends that relationship.
Timothy added that 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 Supported Proteon with Three Process Validation Batches for PATENCY-2 Trial
As Proteon worked to complete enrollment in its ongoing, multicenter, randomized, double-blind, placebo-controlled Phase-3 clinical trial in patients with chronic kidney disease (CKD), 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. Lonza's experience in products with Breakthrough Therapy Designation will provide expert support for the fast-paced, challenging project.
Proteon Vonapanitase Manufacturing Deal with Lonza
Since September 2009, Lonza has clinically manufactured API for Proteon at its microbial manufacturing facility in Visp, Switzerland. Initially, a small-scale process was transferred into Lonza's development labs for process optimization and consistency studies. In July 2015, both companies extended the term to seven years (that could be further extended). The process was then scaled up to 1,000L scale cGMP manufacture to support Proteon's early clinical studies and potential commercial requirements.
About Vonapanitase
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 European Commission, for hemodialysis vascular access indications. Proteon Therapeutics is also currently conducting a Phase-1 clinical trial of vonapanitase in patients with peripheral artery disease (PAD).
About Lonza Pharma & Biotech
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.
About Proteon Therapeutics, Inc.
Founded in 2001 and based in Waltham, Massachusetts, Proteon Therapeutics is a late-stage biopharmaceutical company committed to improving the health of patients with kidney and vascular diseases through the development of novel, first-in-class therapeutics.
Stock Performance Snapshot
May 09, 2018 - At Wednesday's closing bell, Proteon Therapeutics' stock dropped 2.33%, ending the trading session at $2.10.
Volume traded for the day: 6.58 thousand shares.
Stock performance in the previous six-month period – up 5.00%; past twelve-month period – up 61.54%; and year-to-date - up 10.53%
After yesterday's close, Proteon Therapeutics' market cap was at $37.55 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.7% at the end of the session.
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