FDA clearance of ProMetic Life Sciences’ IND a big positive, says Paradigm

This morning, ProMetic announced that The U.S. Food and Drug Administration had completed its review and has cleared the investigational new drug (IND) application for ProMetic Life Sciences Inc.’s IVIG for the treatment of primary immunodeficiency diseases.

“We are pleased to have received regulatory clearance for our IVIG IND and now anticipate enrolment of the first patients to rapidly follow,” said CEO Pierre Laurin. “The yield advantage provided by our PPPS technology for more mainstream plasma-derived products such as IVIG is of great importance to our commercial strategy. The significant financial contribution from products like IVIG will greatly facilitate the pursuit of our strategy, namely the development of much-needed and more affordable orphan products addressing rare diseases.”

Lam, noting that ProMetic will proceed directly to a pivotal Phase III clinical trial for IVIG says there is now a “reasonable assumption” that ProMetic will be able to compete in the market.

“This is positive news for ProMetic, as it marks the advancement of the second protein developed from PLI’s proprietary PPPS platform to enter clinical trials,” said the analyst. “This is critical as the leverage in the ProMetic platform is only exploited if multiple products are commercialized from the same litre of plasma. PLI’s other pipeline products (AAT and C1-INH) remain in advanced pre-clinical phases. We believe the IVIG protocol will serve as a template model that could inform and expedite future regulatory submissions for AAT and C1-INH. We expect steady newsflow to continue through to year-end.”

In a research update to clients today, Lam maintained his “Buy” recommendation and one-year target price of $3.75 on ProMetic Life Sciences, implying a return of 101% at the time of publication.