Patrys antibody awarded orphan drug status in US
Patrys (ASX:PAB) has now been awarded orphan drug status in the US for anticancer antibody PAT-SM6 in multiple myeloma.
The treatment candidate already has orphan drug designation in the EU and the FDA has now granted the same status for the US market.
As an orphan drug, PAT-SM6 will be eligible for scientific and protocol assistance, potential grant funding and a seven-year period of marketing exclusivity in multiple myeloma from the date of FDA approval.
There are currently around 78,000 cases of multiple myeloma in the US, with 22,000 new diagnoses per year.
Clinical trials and scientific studies suggest that PAT-SM6 can be effective even in multiple myeloma patients who have relapsed or grown resistant to currently available treatments.
Patrys CEO Marie Roskrow said the pair of orphan drug designations will provide the company an opportunity to fast-track development of PAT-SM6 in both markets.
“The FDA’s orphan drug designation for PAT-SM6 represents yet another confirmation of the quality of our product and supports and extends our efforts for a quicker development process in the USA as well as Europe,” she said.
Patrys (ASX:PAB) shares grew 16.67% on Tuesday and a further 8.57% on Wednesday, the day the company announced the FDA’s decision. The shares were treading 5.26% higher at $0.04 as of around 12.30 pm on Thursday.
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