Paradigm Biopharmaceuticals Ltd (ASX:PAR) has extended its exclusive licence and supply agreement with bene pharmaChem, which remains the only FDA approved manufacturer and supplier of Pentosan Polysulphate Sodium (PPS).
This revised agreement extends the term to 25 years as well as extending the indications and territories, providing positive and material commercial outcomes for Paradigm.
PPS’s anti-inflammatory, antiviral and anti-carcinogenic effects, as well as its use for prion diseases, osteoarthritis, nephropathy, sickle cell anaemia, mucopolysaccharidoses and HTLV associated myelopathies, were qualified in numerous scientific articles.
This major upgrade in arrangements for the long-term supply of bene PPS is important for Paradigm’s commercial plans and represents a further significant de-risking for the company’s investors.
“25-year exclusive supply”
Paradigm managing director and CEO Paul Rennie said: “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 focused 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.”
Under the amended exclusive licence and supply agreement, Paradigm receives the following:
- Expansion of the territories to include all major pharmaceutical markets, excluding Japan which is covered under a separate arrangement;
- Expansion of the clinical indications under this agreement;
- Extension of the term for the exclusive supply of PPS to 25 years from the date of marketing approval.
Bene product exclusivity, along with regulatory exclusivity and patents combine to provide Paradigm with a multitiered ‘protective moat’ around the business.
“Solid commercial partnership”
Bene pharmaChem co-managing director Dr Harald Benend said: “Bene and Paradigm have developed a very solid commercial partnership over the past seven years.
“Bene is impressed with the speed and professionalism of Paradigm as they move pentosan polysulfate sodium through clinical trials and regulatory submissions.
“We are excited to see Paradigm commencing its Phase 3 clinical trials in Europe, the USA and Australia in the near future.
“Bene has great confidence in Paradigm to execute on its Phase 3 clinical trials and we are pleased to be able to extend our exclusive supply of PPS to Paradigm for a period of 25 years post-marketing approval.
“The bene PPS continues to be the only FDA approved PPS available worldwide and we are happy to support Paradigm with the long-term supply of our drug.”