The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price has been a very strong performer on Tuesday.
In morning trade the biopharmaceutical company’s shares are up a sizeable 12% to $2.70.
Why is the Paradigm share price surging higher?
Investors have been buying the company’s shares following the release of its second positive announcement in as many days.
On Monday Paradigm announced that it has received positive feedback from the European Medicines Agency after its recent scientific advice meeting.
Based on this feedback, applications to commence clinical trials in EU member countries can now begin for its Zilosul product. This product is targeting the knee osteoarthritis market.
What was today’s announcement?
Today’s announcement reveals that its exclusive license and supply agreement with bene pharmaChem has been amended with positive and material commercial outcomes for Paradigm.
The company notes that this is an important development as bene pharmaChem remains the only FDA approved manufacturer/supplier of Pentosan Polysulphate Sodium (PPS).
This is very important to Paradigm’s commercial plans, as the aforementioned Zilosul product is an injectable pentosan polysulfate.
According to the release, Paradigm now has a term of 25 years from the date of marketing approval. In respect to territories, its agreement now includes all major pharmaceutical markets. This excludes Japan, which is covered under a separate arrangement. It also has the option to expand the clinical indications.
Paradigm’s CEO and Managing Director, Paul Rennie, commented: “There are no generic versions of bene PPS on the market and this makes the exclusive supply of bene PPS so valuable to our commercial plans.”
“Paradigm is focussed on executing on our pivotal clinical trials in the USA and Europe and moving onto registration of Zilosul in the major pharmaceutical markets. We are very grateful for the support that Dr Harald Benend and his Bene colleagues have provided to Paradigm and we are very excited about the additional territories, clinical indications and the 25-year exclusive supply of bene PPS post registration,” Mr Rennie concluded.