WHO estimates that approximately 10 million people worldwide require medical treatment against rabies each year after being exposed to an animal suspected of rabies infection. In the U.S. alone there are approximately 40,000 post-exposure prophylaxis treatments administrated each year, representing a more than $100 million annual market opportunity.

KamRAB is the brand name for Kamada's human rabies immune globulin currently marketed for this indication in 10 countries worldwide.

Kamada has a strategic agreement with Kedrion S.p.A for the clinical development and marketing of its IgG product, which will be branded as KedRAB in the U.S., subject to receiving marketing approval from the FDA.

The Phase 2/3 clinical trial was a prospective, randomized, double-blind, non-inferiority study of 118 healthy subjects.  The study evaluated pharmacokinetic (PK) parameters of anti-rabies IgG levels in serum at different time points and assessed whether Kamada’s IgG interferes with the development of self-active antibodies. In addition, safety and tolerability were assessed.  The trial’s primary end point measured the anti-rabies titer on day 14 as well as on additional time points for secondary end points, following drug infusion and infusion of an active vaccine as recommended by the standard-of-care.

top-line results showed that the primary endpoint of non-inferiority was met with a difference of -1.8% between the two therapies with variability between -8.2% and 3.1% (90% Confidence limit).  Results showed that Kamada’s IgG was safe and well tolerated with no drug-related Serious Adverse Events (SAEs) experienced.

 Kamada expects that an approved product in the U.S. will provide diversity of supply in a market with ample room for a new product entry while improving Kamada profitability with higher margins expected in the US compared to rest of the world countries. Kamada plans to leverage the U.S. trial and potential future marketing approval to expand global market leadership with this critical medical treatment.