Australian Government numbs capital expenditure pain for Paradigm Biopharmaceuticals
Paradigm Biopharma’s Phase 2b OA/BMEL trial remains on track to read out top-line results mid/late December 2018.
Biotechnology company Paradigm Biopharmaceuticals (ASX: PAR) has received a further boost in its mission to bring a potentially industry-leading chronic pain medication to the Australian and US markets after Aussie authorities granted the company with a A$2.3 million Research & Development (R&D) tax incentive refund for the past financial year.
The Australian Government’s R&D tax incentive is designed to assist up-and-coming pharmaceutical developers by easing the strain on their operational budgets and incentivising investment into their R&D programs that benefit Australians.
To achieve this, Australian legislators have introduced a refundable tax offset of up to 43.5% for eligible R&D activities.
Paradigm has made a successful application to receive rebate given its ongoing development of its injectable Pentosan Polysulfate Sodium (iPPS) drug to treat osteoarthritis – the most common type of arthritis that causes severe pain in stiff joints.
Injectable PPS is not currently registered in Australia but has been given the green light in four of the seven major global pharmaceutical markets.
In Europe, iPPS is registered as an antithrombotic agent, while In Australia, the drug is not currently available for sale but has been provided as part of the TGA’s SAS Category B scheme that allows its use under strict guidelines and the supervision of a qualified physician.
The treatment has received widespread plaudits amongst the more than 100 patients using it, including several professional AFL players.
Additionally, iPPS is on course to make its debut in the US next year.
Pain reductive capital boost
Additional funding at this stage of its development means Paradigm is able to further strengthen its capital reserves and enables the company to fund its imminent regulatory filings with the US FDA and the Australian TGA – immediately following the publication of its Phase 2b trial results, expected within the coming weeks.
“Receipt of this R&D rebate is well timed with the upcoming release of the primary endpoint for the 110 patient Phase 2b osteoarthritis randomised double-blind, placebo-controlled, multi-centre clinical trial,” said Mr Paul Rennie, CEO of Paradigm Biopharmaceuticals.
Mr Rennie added that “data QC, analysis and preparation of documents for regulatory submissions in 2019 are currently underway for the Phase 2b OA clinical trial,” and confirmed that the clinical trial remains on its original timeline and within the financial budget with the readout of results expected in “mid to late December 2018” – potentially a “major value inflexion point” for the company.
In a possible hint that Paradigm has plans to maximise both its financial and R&D position, Mr Rennie revealed that Paradigm’s strong cash position means that the company will not only accelerate its osteoarthritis programs and regulatory filings, but also, “bring forward other value-add initiatives” with market updates expected “in due course”.
Today’s news helped push Paradigm shares up to $0.935 per share, up around 4.5% in morning trade.