Tetra Bio-Pharma Receives EMA Orphan Drug Designation For A Novel Topical Therapeutic Containing CBD

The European Medicines Agency (EMA) has classified Tetra Bio-Pharma Inc.’s TBPMF TBP JAM PPP004 as an orphan medicinal product for the treatment for epidermolysis bullosa (EB). The designation represents PPP004's third orphan drug designation (ODD) as a treatment for EB.

"This important designation is a milestone in the development of PPP004 as Tetra continues to execute its regulatory strategy in Europe. It also highlights the critical need for effective treatment options for people living with EB", stated Dr. Guy Chamberland, CEO and chief regulatory officer of Tetra Bio-Pharma.

About PPP004

PPP004 is a topical preparation containing either a standardized amount of CBD or a defined ratio of THC and CBD. The base product is a proprietary pharmaceutical-grade formulation composed of active pharmaceutical ingredients (APIs) that are manufactured as per good manufacturing practices requirements, and excipients classified as GRAS (generally regarded as safe). The cream will be packaged in a metered-dose, airless pump system, designed to deliver a measured dose of API consistently per actuation and to protect the APIs from known sources of degradation, namely light and oxygen. PPP004 was developed to help manage pain and itch in patients with EB and promote wound healing.

• PPP004 containing CBD only has been granted ODD by both the U.S. FDA and the EMA for treatment of EB.

• PPP004 containing a combination of THC and CBD has been granted ODD from the U.S. FDA for treatment of EB.

EMA Orphan Drug Designation is granted to investigational therapies intended to treat, prevent, or diagnose life-threatening or chronic debilitating conditions or conditions that affect fewer than 5 in 10,000 people in European Union. An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time effective and allows the company to easily gain market shares in a competitive free environment.

About epidermolysis bullosa

Epidermolysis bullosa is a group of rare medical conditions that result in blistering of the skin and mucous membranes. Blisters occur with minor trauma or friction and are painful. Its severity can range from mild to fatal. Epidermolysis bullosa has no cure, though mild forms may improve with age. Treatment focuses on caring for blisters and preventing new ones.

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