Paradigm Biopharmaceuticals Ltd(ASX:PAR) has executed a new collaboration agreement with bene pharmaChem which allows for the further development of injectable Pentosan Polysulfate Sodium (iPPS) and other formulations containing PPS to address unmet needs in new clinical indications.
Under the new agreement, both parties have agreed to jointly fund the R&D and work collaboratively on new Intellectual Property (IP) creation, which Paradigm will commercialise.
It is a new agreement to the recently updated exclusive license and supply agreement.
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Strengthen data package for global marketing approval
Paradigm chief executive officer and acting chair Paul Rennie said: “Paradigm is delighted to enter into this collaboration with bene pharmaChem; it facilitates the development of new potential formulations and indications for PPS, research will provide a deeper understanding of PPS and its potential to address unmet needs in new clinical indications and will help to strengthen the data package required for global marketing approval for all potential indications.
“We are eagerly awaiting the commencement of the pivotal phase 3 program for osteoarthritis; the market is eager for a safe and effective non-opioid therapy to relieve the burden of pain in osteoarthritis, PPS is showing great promise to meet this need.”
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Repurpose PPS for other indications
bene pharmaChem co-managing director Dr Harald Benend said: “With this collaboration, we further strengthen the already solid relationship between Bene and Paradigm and reflect the confidence Bene has in Paradigm to successfully execute the current development programs for OA and MPS and implement future programs to repurpose PPS for other indications.
“Bene is excited by the imminent commencement of the Phase 3 program for osteoarthritis and will be assisting Paradigm in any way possible to achieve the goal of successful registration and commercialisation of Zilosul for OA.”
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Details of collaboration
Paradigm has a longstanding relationship with bene pharmaChem, the only Food and Drug Administration (FDA) approved manufacturer/supplier of PPS.
In September 2020, the exclusive license and supply agreement between the companies was amended to include an expansion of territories and clinical indications covered under the agreement.
Paradigm also extended the term of exclusive supply of PPS from bene to 25 years from the date of marketing approval.
The scope of the new collaboration agreement includes, but is not limited to, furthering the understanding of chemical, scientific, and clinical attributes of PPS formulations in development.
A joint steering committee has been established to identify new projects, intended outcomes and attribute IP ownership.
The parties under this agreement will jointly fund activities identified by the joint steering committee and Paradigm will retain exclusive commercial rights to all information and developments resulting from this collaboration.
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bene pharmaChem
In 1947, Dr W Benend developed a standardised process for manufacturing a type of sulphated polysaccharides, PPS, which has an anticoagulant, fibrinolytic and thrombolytic quality with comparatively limited side effects.
As a medicinal product, PPS was first authorised and marketed in Germany in 1949, and later in other European countries, primarily for thromboembolism.
Subsequently, PPS was investigated on a global scale by research groups and its anti-inflammatory, antiviral and anticarcinogenic 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.
Contemporary research, longstanding medical and pharmaceutical experience as well as a network of excellent partners characterise bene pharmaChem.
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