Case Study

Revolutionizing Allergy Therapy

Source: Catalent
allergens

Executive Summary
ALK-Abelló is a global research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. Before ALK-Abelló partnered with Catalent, all marketed allergen immunotherapies were delivered by injection, resulting in a limited patient population and reduced patient adherence. Catalent worked with the client to apply Zydis® Fast Dissolve Technology to their therapy, bringing a vastly superior product to market. The overall result was a marked improvement in patient tolerability, preference and compliance. This new technology has allowed ALKAbelló to deliver on their promise to improve the quality of life for allergy patients.

The Challenges
ALK-Abelló approached Catalent with challenges similar to others in the industry. Allergy injection-based therapy had been essentially unchanged for the past 100 years. These therapies required lengthy patient-specific dose-titration phases and required patients to go to specialist clinics for monthly subcutaneous injections, which contributed significantly to patient time spent as well as out-of-pocket medical cost. Additionally, patients needed to undergo successful completion of therapy for 3 years (3 seasons, for seasonal allergies) if they were to expect long-term protection. Potential patients were subject to stringent criteria for specialist therapies, which limited treatment to only the most severe cases. Finally, potentially dangerous systemic adverse events had occurred with this class of therapeutics, requiring risk / benefit assessments and availability of rescue facilities.

The Catalent Solution
Catalent’s team partnered with ALK-Abelló to quickly develop a superior alternative drug delivery solution using Zydis® Bio technology. This unique technology not only enables administration by sublingual dose, but also offers a number of unique benefits that differentiate it from other orally-disintegrating tablet technologies on the market (fig 1).

Fig. 1 features of the Zydis® fast dissolve technology

As a result of their partnership with Catalent, ALK-Abelló was able to launch Grazax®, the first patient friendly allergen immunotherapy using Zydis® Bio technology.

  • Patients can administer a daily sublingual dose themselves at home, which has led to increased patient adherence.
  • The reduction in clinical visits and elimination of complex dose titrations has further improved the patient experience.
  • ALK-Abelló was also able to improve their company’s market position by increasing the patient reach of this remarkable immunotherapy to pediatrics and primary care patients.

FDA approved Grastek® (Timothy Grass Pollen Allergen Extract) for the US market in April 2014. Many additional allergens for allergic rhinitis and asthma are in development using Zydis® Bio technology.

Conclusion
The collaboration between Catalent, with our history of innovative drug delivery systems, and the customer, with its ability to realize a strong synergistic partnership, enabled this therapy to come to market. Ultimately this allowed ALK-Abelló to realize the first patient-friendly allergen immunotherapy and deliver on their promise of improving the quality of life for allergy patients.