Stallergenes & DBV Technologies Announce $198-Million Deal

Stallergenes S.A., and DBV Technologies recently announced they have entered into a research and development agreement for the treatment of birch allergy. This collaboration is the first agreement following their previously announced collaboration focused on developing innovative treatments for respiratory allergies. This partnership combines Stallergenes’ world-class respiratory allergy know-how with DBV’s novel Viaskin epicutaneous delivery technology that modulates the immune response to allergens.

Birch pollen-allergic patients commonly have seasonal allergic rhinitis and allergic asthma. The majority of Birch pollen-allergic patients also develop allergies to certain plant foods, also known as oral allergy syndrome (OAS), due to a cross reaction between birch pollen allergens and food proteins with similar structures. This syndrome can manifest itself in itching or swelling of the lips, tongue, and throat. Occasionally, the reaction is more severe. DBV’s Viaskin technology, which has shown excellent safety in clinical setting into dangerous and life-threatening allergies, may therefore be particularly well-suited to address the Birch-sensitized population.

Under the terms of this agreement, Stallergenes will fully fund DBV’s preclinical development. The goal of the preclinical program, which will last between 18 and 24 months, is for DBV to deliver to Stallergenes a clinical product candidate that uses Stallergenes’ Birch pollen allergen. Stallergenes will have full development and worldwide commercialization rights on the product candidate, and DBV is eligible to receive several preclinical, clinical, regulatory, and commercial milestone payments totaling up to EUR145 million, as well as royalties on the future product’s net sales.

In conjunction with this agreement, Stallergenes acquires a 2% equity position in DBV from existing shareholders.

“We are pleased to partner with Stallergenes on this exciting respiratory development program using a recombinant Birch allergen protein,” said Dr. Pierre-Henri Benhamou, Chairman and CEO of DBV Technologies. “This reflects the broader potential of the Viaskin technology beyond only food allergies. Given Stallergenes’ experience in immunotherapy and allergen development, coupled with DBV’s epicutaneous delivery technology, this collaboration could lead to a valuable medical treatment for patients with respiratory allergies.”

“This collaboration on birch allergy with DBV Technologies is the first concrete project combining our in-depth expertise in allergen immunotherapy with DBV’s promising epicutaneous route of administration,” added Dr. Roberto Gradnik, CEO of Stallergenes. “Illustrating our continuous focus on innovation and patients’ needs, it will provide a highly innovative solution for patients suffering from intense symptoms due to birch allergy.”

In 2003, Stallergenes licensed Biomay recombinant birch pollen protein technology. Very common in Northern Europe, and especially Germany, the Netherlands, Norway, Sweden, and Switzerland, the prevalence of allergic rhinitis caused by birch pollen affects between 10% and 20% of the northern and central European population and exceeds 20% in some large cities. Birch produces the most allergenic pollen among all trees in northern, central, and eastern Europe.

DBV Technologies is opening up a decisive new approach to the treatment of allergy – a major public health issue that is constantly increasing in prevalence. Food allergies represent a true handicap in everyday life for millions of people and thus constitute a major unmet medical need. DBV Technologies has developed a unique, proprietary, worldwide-patented technology for administering an allergen to intact skin and avoiding massive transfer to the blood. The Viaskin technology combines efficacy and safety as part of a treatment that seeks to improve the patient’s tolerability of peanut and thus considerably lower the risk of a systemic, allergic reaction in the event of accidental exposure to the allergen. For more information, visit www.dbv-technologies.com.

Stallergenes is an international biopharmaceutical company dedicated to the treatment of allergy-related respiratory diseases, such as severe rhinoconjunctivitis and rhinitis, as well as allergic asthma, using allergen immunotherapy. For more information, visit www.stallergenes.com.