ALK announced that it has finalised its strategy for entering the US market for epinephrine (adrenaline) auto-injectors (EAIs) and that this will focus on a next-generation EAI in partnership with US-based Windgap Medical (“Windgap”).
EAIs are used for the emergency treatment of acute allergic reactions – also known as anaphylaxis – which can be triggered by exposure to certain foods, or by exposure to venom from bee or wasp stings.
There are more than 200,000 cases of anaphylaxis each year in the USA, and a study by the Asthma and Allergy Foundation of America estimated that up to 16 million Americans will experience it during their lifetime. ALK estimates that the EAI market in the USA exceeds USD 1 billion annually.
Carsten Hellmann, President and CEO, at ALK, said
“ALK has been targeting an entry into this important US market segment for a number of years. This product will meet the patients’, markets‘ and payers’ needs for a small, easy-to-use pen, which is heat-stable and has a long shelf life. We believe that, once ALK and Windgap complete development and successfully gain approval for the product, it has the potential to become highly competitive and very profitable for ALK within a few years, despite the current backdrop of genericisation.”
“ALK’s lengthy experience with auto-injector pens and our commercial expertise in allergy will be essential to market success. Allergists are key influencers of which epinephrine auto-injectors are prescribed to patients and we estimate that 25% of US EAI prescriptions are issued by doctors with whom ALK already has a relationship.”
Under its agreement with Windgap, ALK has exclusive, worldwide sales and distribution rights for the Windgap EAI in exchange for selected milestone payments and tiered royalties on net sales in the USA, along with a split of net profit for products sold outside of the USA.
The Windgap product has not been reviewed by the US FDA yet but the companies intend to submit a registration application and seek approval within the next few years once the development work is complete. ALK has been and will continue to leverage its own expertise to support Windgap during the development and registration processes.
In addition to these US-focused activities, ALK and Windgap will also work together to make the new EAI available in markets outside the USA in the longer term. Meanwhile, ALK’s existing EAI, Jext®, will remain an important product for the company in Europe.
This announcement does not impact ALK’s financial guidance for 2019.