Klaria Pharma regains rights to Epinephrine Alginate Film and initiates clinical development program to treat anaphylaxis (serious allergic reactions)
Klaria Pharma Holding AB (publ) announces today that it has regained the global rights for the Epinephrine Alginate Film from Purdue Canada and the Mundipharma network. Klaria also announces that it has decided to progress Epinephrine Alginate Film into clinical development, GMP production activities of the product have been initiated. The initiation of clinical studies allows Klaria to build on the successful development activities and new data that has been generated in the program over the previous 18 months. The total addressable market for Epinephrine Alginate Film is worth in excess of 2 billion USD in world-wide annual sales. With Epinephrine Alginate Film, Klaria now has the opportunity develop a novel product with important medical benefits compared to all incumbent products, including Mylan’s EpipenTM.
“There is a high need for innovative new products that address the significant unmet medical needs that exist today for patients who suffer from severe allergies and are at risk of anaphylaxis. Our Epinephrine Alginate Film holds the promise of being exactly such a new product and will, if approved, disrupt the 2 billion USD market for these products,” said Klaria’s CEO Jesper Wiklund. “In fact, in a testament to the significant interest in developing new and better products in this space, two potential new partners have expressed an interest in this program. These interested parties have approached us. We did not seek them out since this program was already partnered until today.”
After having secured total financing in 2020 of 38.5 million SEK, Klaria is in a position to expand the clinical pipeline with a third program. Klaria now has Sumatriptan Alginate Film, Naloxone Alginate Film and Epinephrine Alginate Film in clinical development. In addition, Klaria is pursuing the commercialization of the Cannabis Alginate Film in the daughter company Cannabis Delivery Sciences.
“Epinephrine Alginate Film is a very exciting program for Klaria. Firstly, it addresses a large market with a high unmet medical need. Secondly, it is a perfect strategic fit. We are aiming to replace the old product EpiPenTM with a new product, based on modern technology, that has the potential to be far superior to the aged incumbent. We are also planning to offer our product at a significantly lower price. Therefore, if we reach the market, we expect to claim a large portion of it with a product that is better for both patients and payors” continued Jesper Wiklund.
About Anaphylaxis
Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Typical symptoms include throat or tongue swelling, an itchy rash and shortness of breath. These symptoms typically come on over minutes to hours. Common causes include insect bites and stings, foods, and medications. Diagnosis is based on the presenting symptoms and signs after exposure to a potential allergen. The primary treatment today of anaphylaxis is epinephrineinjection into a muscle such as the thigh. Worldwide, up to 2% of the population is estimated to experience anaphylaxis at some point in life and rates appear to be increasing.
Specific Opportunity for Epinephrine Alginate Film in treatment of anaphylaxis
In addition to the benefits listed above, an Epinephrine Alginate Film could meet a specific medical need, namely the need for anaphylaxis prophylaxis. Treatment of allergen exposure with a compact and more economical film containing epinephrine also allows earlier intervention in the development of anaphylaxis. A recurring theme among allergy specialists and health authorities is that epinephrine should be given as a prophylactic measure prior to development of anaphylaxis, but seldom is. This is due to current injections being viewed exclusively as a ‘rescue’ medication, patients inherent fear of injections and the relatively high cost of each dose. Thus, a less expensive and easier to administer film formulation of epinephrine could allow patients to intervene in their allergic reaction sooner, producing better outcomes and reducing the anxiety and uncertainty following allergen exposure.
For more information, visit the Klaria Pharma Holding website klaria.com or contact:
Jesper Wiklund, CEO Klaria Pharma Holding AB (publ)
investor.relations@klaria.com
Tel: +46 (0) 8-446 42 99
This is Klaria Pharma Holding AB
Klaria (Klaria Pharma Holding AB) is a Swedish listed pharmaceutical company that develops innovative, rapid-acting products. By combining patented technology of a film that attaches to the oral mucosa and well proven pharmaceuticals, the company has developed a drug distribution concept with many benefits and potential uses. Klaria is listed on Nasdaq First North Growth Markets under the short name KLAR. FNCA Sweden is Certified Advisor (info@fnca.se, +46(0) 8-528 00 399) for Klaria Pharma Holding AB. For more information, see www.klaria.com.