ALK Teams Up with ARS Pharma to Launch Neffy® for Anaphylaxis

ALK Partners with ARS Pharma to Improve Anaphylaxis Treatment

ALK has announced a significant strategic licensing agreement with ARS Pharmaceuticals, Inc. This collaboration grants ALK exclusive global rights to neffy (the adrenaline nasal spray), except in the USA, Australia, New Zealand, Japan, and China. This move aligns perfectly with ALK's new strategy, Allergy+, and will bolster the company's long-term financial ambitions.

Innovative Approach to Anaphylaxis Management

The needle-free and nasal delivery of adrenaline presents a transformative option for treating anaphylaxis. Importantly, neffy represents the first and only approved nasal spray designed for emergency treatment, targeting patients facing potentially life-threatening allergic reactions. Its market authorization in Europe has set the stage for future growth possibilities.

Future Indications

In addition to current applications, ALK will gain rights to forthcoming indications, including those aimed at treating acute urticaria flares. With clinical trials for this indication anticipated to commence in the near future, ALK is strategically positioned to broaden its therapeutic offerings.

Market Opportunities and Expansion

In the immediate term, ALK is focusing on introducing neffy to European and Canadian markets, which rank as the second and third largest markets for adrenaline autoinjectors globally. Leveraging existing infrastructure and sales channels will facilitate a smoother market entry and capitalize on the demand for effective anaphylaxis treatments.

Addressing the Anaphylaxis Crisis

The urgent need for self-administration of adrenaline in anaphylaxis cases cannot be overstated. Currently, most adrenaline is delivered intramuscularly, primarily through autoinjectors. Unfortunately, many patients hesitate or even neglect to use their devices during emergencies due to the complexities involved. Approximately 20 million people in Europe face anaphylaxis risk; however, only around 2 million reliably obtain rescue medications.

Commitment to Patient-Centric Solutions

ALK is dedicated to developing solutions that cater to patients' needs across various segments. With the addition of neffy, they aim to establish a versatile portfolio of innovative treatment options, including the ongoing development of the next-generation adrenaline autoinjector.

Leadership Insights

Peter Halling, ALK’s CEO, expressed excitement regarding the partnership with ARS Pharma, emphasizing its crucial role in enhancing ALK's footprint in allergy treatments. He noted, "Nasal delivery of adrenaline is poised to become a substantial aspect of anaphylaxis management over the coming years, and we intend to offer robust solutions for patients and healthcare providers alike."

Financial Implications of the Agreement

This licensing agreement is expected to augment ALK’s financial growth, potentially leading to annual peak sales reaching DKK 3 billion in licensed territories. The contract outlines an upfront payment of USD 145 million, alongside prospects for additional payments linked to regulatory achievements and sales milestones.

Future Projections

ALK's financial strategies will evolve in tandem with this partnership, maintaining a net debt to EBITDA ratio favorable for future endeavors. The initial market launches for neffy are forecasted for 2025, following successful negotiations for market access.

Looking Ahead

While the future of anaphylaxis management trends towards advanced solutions like neffy, ALK will continue to uphold its existing products, such as the Jext® autoinjector. The company's commitment ensures diverse therapeutic options are available, catering to the varied needs of patients.

For more information or inquiries, please contact:

Investor Relations: Per Plotnikof, tel. +45 4574 7527
Media: Maiken Riise Andersen, tel. +45 5054 1434

Frequently Asked Questions

What is neffy?

neffy is an adrenaline nasal spray, the first approved needle-free emergency treatment for anaphylaxis.

What impact does the ALK and ARS partnership have?

The partnership allows ALK to market neffy globally, expanding treatment options for anaphylaxis.

When will neffy be available on the market?

The initial launches are expected in Europe in 2025, following successful market access negotiations.

How does neffy compare to traditional autoinjectors?

neffy offers a simpler, needle-free delivery method, enhancing user convenience and compliance for patients.

What are ALK's future financial expectations?

ALK anticipates significant revenue growth and a long-term sales potential of up to DKK 3 billion from neffy in the licensed regions.

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