In morning trade the Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is sinking lower despite the release of its end of year update.
At the time of writing the biopharmaceutical company's shares are down 4% to $3.00.
What was in Paradigm's update?
In its update Paradigm revealed that it met with the Therapeutic Goods Administration (TGA) in November. This was to present its case for the provisional approval of its Zilosul drug for the treatment of knee osteoarthritis (OA) with subchondral Bone Marrow Lesions (BMLs).
Management advised that the TGA provided it with valuable guidance. As a result, the company is proceeding with the provisional determination assessment process.
Across the pond in the United States the company will be meeting with the U.S. FDA in February for a pre-IND meeting for its osteoarthritis program in OA knee pain with subchondral BMLs. This meeting will provide feedback on the phase 3 clinical program to support regulatory approval.
Paradigm also has its eye on the European market. It is preparing a scientific advice application for submission to the EMA to discuss the knee OA development program in the first quarter of calendar year 2020. This meeting will provide clarification on the clinical trial design to support regulatory approvals for the European market.
What is Zilosul?
Zilosul is an injectable version of Pentosan Polysulfate Sodium (PPS). PPS has been around for many decades and has been used to relieve the symptoms of the bladder condition called interstitial cystitis.
Paradigm is repurposing PPS to treat osteoarthritis, which is the most common joint disorder in the United States.
Furthermore, the company notes that the number of people affected with symptomatic osteoarthritis is likely to increase in the future. This is due to the ageing of the population and the obesity epidemic.
As a result, it estimates that Zilosul has a massive market opportunity if it is approved by regulators. This is demonstrated on the table below:
In light of this, I think Paradigm is one to watch very closely in the coming years and could even be worth a small investment today. Especially after the recent pull back in its share price.
Also on the move today have been fellow mid cap shares Nearmap Ltd (ASX: NEA) and Redbubble Ltd (ASX: RBL). This follows an acquisition update by Nearmap and a disappointing trading update from ecommerce company Redbubble.
