This morning, Prometic Life Sciences (TSX:PLI) announced that the FDA has cleared the company’s IV plasminogen to enter human testing for the treatment of hypoplasminogenemia.
With its Investigational New Drug (IND) application approved, Prometic isn’t wasting anytime, it plans to commence a 6 patient Phase I study this quarter. That study will lead into a Phase II/III study in early 2015, followed by a Biologic License Application (BLA) for commercial approval in Q4 2015. In today’s press release the company said the FDA has agreed to the company’s clinical development plan for plasminogen.
“We are very pleased with the FDA’s decision and welcome their support to bring an innovative and tangible medical solution for patients affected by this severe condition that has no adequate treatment,” said CEO Pierre Laurin. “Seeing our first PPPS plasma-derived therapeutic enter the clinical trial stages also represents an important milestone achievement for ProMetic as we get ready to proceed with additional plasma-derived products targeting other orphan indications”.
This remarkably quick path to a potential FDA approval decision on plasminogen is reflective of the small number of patients who have hypoplasminogenemia. Prometic received orphan drug designation for the use of plasminogen in this rare disease in 2013. Orphan drug designation is granted to drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S.
Prometic has quietly become one of Canada’s largest public life science companies. After years of lacklustre performance, the company found renewed investor interest starting in 2012 when it began focusing its development efforts on plasma-derived orphan drugs. Prometic closed today up 6.3%, giving it a market cap of approximately $900 million.
One word of caution to investors, especially those who don’t frequently invest in the life sciences. In the press release today, Prometic states that “When approved, this product will provide replacement therapy for patients with this condition…” Although the company is clearly very optimistic, and perhaps rightfully so, about the chances plasminogen has for FDA approval, there are no assurances that it will be successful and safe in clinical trials. Using the words “when” and “will” imply certainty, when perhaps terms like “if” and “could” are more appropriate given the development stage of the product.