Patrys Limited (ASX: PAB) will trade higher after receiving confirmation of Orphan Medicinal Product Designation for its lead anti-cancer product PAT-SM6, from the US Food and Drugs Administration.
Under orphan drug status, PAT-SM6 qualifies for scientific and protocol assistance, grant funding during development as well as a period of 7 years of marketing exclusivity in the USA.
In the U.S., there are 78,000 people currently living with multiple myeloma, with 22,000 new cases and around 11,000 deaths each year.
No cure currently exists for multiple myeloma patients and limitations of available therapies are particularly evident in patients that have relapsed or become resistant to chemotherapy.
Patrys has now screened PAT-SM6 against more than 200 tumours from individual patients with various cancers, and the product binds to over 90% of the tumours screened regardless of cancer type, patient age, gender or disease stage.
Approval of the orphan designation in the USA adds to the existing orphan status granted in Europe and significantly expands the potential commercial market for PAT-SM6.
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