Clinical stage biopharmaceutical company Paradigm Biopharmaceuticals Ltd (ASX: PAR) has received official acceptance of the Australian patent application “Treatment of bone marrow pathologies with polysulfated polysaccharides (Australian application number (2021201198).
The expiry date of the Australian patent (2021201198) is August 6, 2038. The first claim of the accepted patent (2021201198) refers to “a method of improving knee function where the subject has a bone marrow lesion and osteoarthritis in a knee by administering pentosan polysulfate sodium”.
It is very exciting for the company’s strategic plans to have a patent which claims the treatment of people with osteoarthritis and bone marrow lesions with pentosan polysulphate sodium (PPS) and we expect further acceptance and grants in other territories in the coming months,” Paradigm Chairman, Paul Rennie, said.
“We continue to work in partnership with our patent attorneys to proactively prosecute new patents to extend our protection on the use of PPS in disease indications with unmet medical needs.”
Summary of IP
Paradigm’s PPS has a multi-faceted protection consistent with composition of matter encompassing manufacturing, patents, and exclusive in-licensing and supply for new indications with unmet clinical needs.
There is only one FDA approved manufacturer of Pentosan Polysulfate Sodium (PPS), bene pharmaChem GmbH (bene), with whom Paradigm has an exclusive, sublicensable, global supply agreement for the manufacture and commercial use of PPS for multiple indications extending for 25 years post first marketing approval.
In addition, Paradigm has an ongoing collaboration agreement with bene for product related development support for meeting regulatory milestones and development of PPS for new indications and second-generation molecules.
PPS is a highly complex molecular platform technology; a highly sulphated semisynthetic xylan-based polysaccharide that structurally resembles glycosaminoglycans, which is derived from beechwood hemicellulose.
The manufacture and composition of PPS is a trade secret tightly held by bene for over 60 years. A generic manufacturer would be required to develop an identical molecular fingerprint of the bene PPS.
The complex molecular structure of PPS means generic manufacturers face a task of similar difficulty to that of developing a copy of a biosimilar.
Potential generic entrants must provide GPC (gas permeable chromatography) data demonstrating identical structure and purity for each of the multiple moieties. A generic copy is highly unlikely to be identical as described above.
Therefore, a full clinical development program to demonstrate equivalent pharmacokinetic, pharmacodynamic, clinical safety and efficacy profiles will be required. Paradigm has a broad patent portfolio covering multiple indications in all key jurisdictions.
Paradigm’s primary and foundational patents (US10,610,542, US9,861,657 and US9,101,650) which have been granted in the US and several other jurisdictions are for the use of PPS to treat bone marrow edema (BME).
Since BME is associated with painful knee OA our patent protection blocks any generic use to treat knee OA in the absence of BME.
Paradigm is proactively prosecuting new patents to extend its protection on the use of PPS in disease indications with unmet medical needs where the actions of PPS have been scientifically (in preclinical proof-of concept models) and/or clinically (population of patients) been ascertained to be therapeutically effective. For example, a patent related to the action of PPS in pain mediated by NGF is currently being prosecuted in key jurisdictions. Currently registered oral formulations of PPS are not suitable for conditions requiring systemic distribution for treatment effect. The bioavailability of oral formulations of PPS is 3.3 -3.5%.
