Paradigm Biopharmaceuticals Ltd (ASX:PAR) (OTCMKTS:PBIGF) has received first revenue through physician prescription of Zilosul® to patients via the Therapeutic Goods Administration (TGA) pay-for-use Special Access Scheme (SAS).
Under the SAS, Zilosul® has been made available to physicians with SAS approval to treat patients experiencing chronic arthralgia from Ross River Virus (RRV) infection, previous SAS participants seeking re-treatment and other subjects that would not qualify for recruitment into the Para_OA_008 or Para_OA_002 clinical trials.
The company has already received five prescriptions for Zilosul® from physicians and the five patients will commence Zilosul® treatment in the coming week.
“Transforming to a revenue-generating company”
Modest revenues are expected, as only a limited supply of Zilosul® has been made available for SAS due to stock prioritisation for the pivotal clinical trial program.
Paradigm chief executive officer and chairman Paul Rennie said: “To achieve Paradigm’s first revenue through the first patient treated with Zilosul® by a physician under the pay-for[1]use SAS program is very pleasing and an exciting time for Paradigm shareholders.
“The recommencement of this program gives (i) patients suffering arthralgia as a result of RRV infection and previous patients who have received Zilosul® the ability to be re-treated, and (ii) Paradigm to transition from a pre-revenue to revenue-generating company, further increasing Paradigm’s institutional investment potential.
“Paradigm remains focused on our current OA [osteoarthritis] clinical program as we prepare for anticipated questions from the FDA, to ensure we minimize any further delays.”
Paradigm is working on paths to revenue, including the SAS provisional approval registration, and at the same time executing on the global registration of Zilosul®.
Notably, the company has not yet received any additional questions from the US Federal Drug Administration (FDA) regarding its investigational new drug (IND) submission.
Modest revenue expected
The pay-for-use SAS program Zilosul® will only be provided to practitioners with SAS approval and who are willing to perform the recommended monitoring of patients who have received Zilosul®.
With the impending commencement of the pivotal clinical trial program in OA, Paradigm has concentrated efforts and resources, including available stock of Zilosul®, on the execution and completion of the pivotal clinical trial program and achieving global marketing approval as soon as possible.
The cost to patients under the pay-for-use program will be at a premium to previously disclosed price estimates for Zilosul® due to significant setup costs, including the platform for safety monitoring and reporting requirements.
Revenue generated by the patient pay-for-use SAS program will be used to recoup the expenses incurred by Paradigm to support the provision of Zilosul® via this program.
Clinical trial and global marketing opportunities
Almost half of the required subjects in the PARA_OA_008 Synovial Fluid Biomarker study (or Disease Modifying Osteoarthritis Drug (DMOAD) study) have commenced screening and many moving to randomisation and treatment.
The Phase 2b study will measure the change in synovial fluid biomarkers associated with pain, inflammation and osteoarthritis disease progression following treatment with subcutaneous injections of PPS compared with subcutaneous injections of placebo in 60 participants (n=60) with OA.
The company hopes to provide further evidence that certain biomarkers are more prevalent in the synovial fluid of symptomatic OA patients with radiographic evidence of joint damage, determine if biomarker concentrations change in the synovial fluid with injectable Pentosan Polysulfate Sodium (iPPS) treatment, and to assess possible disease-modifying effects of iPPS on patients with knee OA pain.
Rennie said: “Shareholders please note, the revenue from the sale of iPPS under the pay-for-use SAS program will generate modest sales initially but the Paradigm executive management team achieved this milestone as we continue to work on the commencement of the Phase 3 clinical trial.
“In addition, Paradigm is working on characterising the disease modifying effects of Zilosul® in the PARA_008 clinical trial.
“This data will assist Paradigm with the continuation of its provisional approval submission to the TGA.
“Should the provisional approval submission be successful, this has the potential to generate significantly more revenue (from the Australian market) well before the product is registered in the USA or Europe.
“Paradigm is working to find paths to revenue and at the same time execute on the global registration of Zilosul”
Data from this study will also further inform the mechanism of action and potential disease-modifying effects of iPPS, assisting with the future pricing and reimbursement plans.