Patrys receives FDA Orphan Medicinal Product Designation for PAT-SM6

Nov 7 2013

Patrys Limited (ASX: PAB), a clinical stage biotechnology company, has received confirmation of Orphan Medicinal Product Designation for its lead anti-cancer product PAT-SM6, from the USA Food and Drugs Administration (FDA).

PAT-SM6 has previously been granted orphan drug designation for multiple myeloma in Europe.

Orphan product designation is intended to provide incentives to encourage companies to pursue cures and treatments for rare diseases with high unmet medical needs.

Under orphan drug status, PAT-SM6 qualifies for scientific and protocol assistance, potential grant funding during development as well as a period of 7 years of marketing exclusivity in the USA upon FDA approval.

In the USA, there are 78,000 people currently living with multiple myeloma, with 22,000 new cases and around 11,000 deaths each year. Approval of the orphan designation in the USA adds to the already existing orphan status granted in Europe and significantly expands the potential market for PAT-SM6. It also presents a unique opportunity for Patrys to fast track the development of the PAT-SM6 product in both the USA and Europe.

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 treatments.  Even though the appearance of some new agents in recent years have shown promise in treatment of multiple myeloma, a clear need for the development of additional novel therapeutics still exists.

Patrys' lead antibody drug PAT-SM6 is showing convincing evidence of potential therapeutic benefit in its ongoing Phase I/IIa clinical trial in patients with relapsed and refractory multiple myeloma and as such has a potential to improve and add to current treatments for myeloma.

Dr. Marie Roskrow, Patrys’ CEO said: “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."