Danish allergy group ALK has long planned a strategy to become a major player in the US adrenalin market.

The company's adrenalin auto-injection pen Jext is mainly sold in Europe, but the new strategy is to help ALK capture the US market.

"We are very eager to enter the US market with a strong and competitive product, but we will do it in a new way as the entry of generic adrenalin products is changing the market," says Carsten Hellmann, CEO in ALK.

To enter the lucrative US market, the Danish company has joined forces with Boston-based company Windgap Medical that has developed a next-generation auto-injection pen.

Adrenalin pens, also known as epinephrine pens, are used for emergency treatment of allergic reactions, anaphylaxis, usually caused by foods or insect bites.

The partnership with Windgap ensures ALK exclusive global sales and distribution rights for Windgap's auto-injector pen in exchange for milestones, royalties from US net sales and a split of net profit for products sold outside the US.

"The new auto-injector fits well with ALK's strategy to develop a strong, broadly based business in North America with allergy solutions suitable for everyone's needs. It's a perfect supplement to our existing products in the US market," says Hellmann, referring to the house dust mite tablet Odactra.

An ideal position

In 2017, ALK announced its plans to invest DKK 1 billion (approximately USD 150 million) in establishing a US organization and kick off sales over a three-year period.

The aim is to increase the sales growth to over 10 percent in total. An expanded volume is to increase income and yield profits comparable to those of other specialized drug groups, says the CEO.

"Actually, we are in a quite ideal position because allergy specialists are key actors in the prescription of adrenalin auto-injectors. An informed guess is that approximately 25 percent of auto-injectors in the US are prescribed by doctors in contact with ALK," he adds.

Every year, there are more than 200,000 cases of anaphylaxis in the US alone. According to a study by The Asthma and Allergy Foundation of America, up to 16 million Americans will experience anaphylactic shock at least once in their life. ALK estimates the US market for adrenalin pens to be worth more than USD 1 billion annually.

Windgap uses a wet/dry drug delivery platform to keep the epinephrine dose dry until it is mixed with fluids the moment it is used. It keeps the temperature stable and extends the storage temperature range, which is one of the main advantages of the product, says Hellmann.

"The US market is still driven by Mylan and its EpiPen product, but other products, such as Auvi-Q and Adrenaclick, have stolen significant market shares. I see a great potential in the next-generation technology we introduce here," says the CEO without concealing the fact that he expects a very competitive product.

Yet to be approved

Windgap's auto-injector has not yet been reviewed by The US Food and Drug Agency (FDA). However, ALK and Windgap expect to file for regulatory approval with FDA during the coming years, when the development is completed.

"We have yet to finish the last development work, for instance collection of stability data, which ALK assists in," says Hellmann, adding:

"The finishing date is not confirmed but the aim is to prepare an application to the FDA within the next couple of years followed by a product launch if the pen is approved."

ALK and Windgap also have long-term plans to collaborate on launching the auto-injector pen in markets outside the US. Meanwhile, ALK's existing product, Jext, will remain an important product for the company in Europe, says Hellmann.

English Edit: Ida Løjmand

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