Ecallantide - Biologic Drug Details

Summary for ecallantide

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for ecallantide

Recent Clinical Trials for ecallantide

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Mark Davis-Lorton, MD	Phase 2
Shire	Phase 2
Bernstein, Jonathan A., M.D.	Phase 2

See all ecallantide clinical trials

Pharmacology for ecallantide

Mechanism of Action	Kallikrein Inhibitors
Established Pharmacologic Class	Plasma Kallikrein Inhibitor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ecallantide Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ecallantide Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ecallantide Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Ecallantide

Introduction

Ecallantide, a recombinant plasma kallikrein inhibitor, is a crucial biologic drug used in the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially life-threatening genetic disorder. Here, we delve into the market dynamics and financial trajectory of ecallantide, highlighting its development, market performance, and future prospects.

Development and Mechanism of Action

Ecallantide, developed by Dyax (now part of Takeda Pharmaceutical Co. Ltd.), is designed to inhibit plasma kallikrein, a key enzyme involved in the pathogenesis of HAE. This mechanism of action makes it an effective treatment for acute HAE attacks, reducing the severity and duration of symptoms[4][5].

Market Launch and Initial Performance

Ecallantide, marketed under the brand name KALBITOR, was approved by the FDA in 2009 for the treatment of acute attacks of HAE. Since its launch, KALBITOR has shown significant growth. In 2012, for instance, U.S. sales of KALBITOR reached $40 million, marking a pivotal year for Dyax's strategy focused on expanding its plasma kallikrein-mediated angioedema portfolio[2].

Global Expansion and Partnerships

To expand its reach, Dyax established partnerships for regulatory approval and commercialization of KALBITOR in various markets outside the United States. For example, partnerships were signed for China and Latin America, and a clinical study was initiated in Japan, paving the way for potential launches in these regions[2].

Clinical Efficacy and Patient Outcomes

Clinical trials have demonstrated the efficacy of ecallantide in treating acute HAE attacks. A double-blind, placebo-controlled trial showed that patients treated with ecallantide had significantly better treatment outcome scores and symptom complex severity scores compared to those receiving a placebo. This efficacy has been a key driver of its market success[5].

Market Segmentation and Competition

The global HAE therapeutics market is segmented by drug class, with C1 esterase inhibitors, bradykinin B2 receptor antagonists, and kallikrein inhibitors being the main categories. Ecallantide falls under the kallikrein inhibitors segment, which is anticipated to become the largest segment by the end of the forecast period due to its strong clinical profile and recent market entries like Takhzyro (lanadelumab) and Orladeyo (berotralstat)[1].

Financial Performance and Revenue Growth

The success of KALBITOR has contributed significantly to the financial performance of its developers. Dyax's focused strategy on HAE treatments, including KALBITOR, has generated substantial value for shareholders. The drug's annual sales have been on an upward trajectory, supported by its strong clinical profile and expanding market reach[2].

Future Prospects and Market Trends

The global HAE therapeutics market is projected to reach $6.8 billion by 2031, growing at a CAGR of 11.4%. This growth is driven by the launch of target-specific drugs, patient switches to prophylactic treatments, and a robust pipeline of potential candidates. The kallikrein inhibitors segment, where ecallantide is positioned, is expected to expand at the fastest double-digit growth rate during this period[1].

Competitive Landscape

The market for HAE therapeutics is highly competitive, with major players including CSL Limited, BioCryst Pharmaceuticals, Inc., Takeda Pharmaceutical Co. Ltd., and others. Ecallantide competes with other kallikrein inhibitors like Takhzyro and Orladeyo, as well as C1 esterase inhibitors like Haegarda. However, its unique mechanism of action and established market presence continue to make it a significant player in the HAE treatment landscape[1].

Regulatory and Licensing Dynamics

Ecallantide has been granted orphan drug status for HAE, which encourages the development of drugs for rare diseases. The drug's regulatory approvals and licensing agreements have been crucial in its global expansion. For instance, Takeda's acquisition of Shire, which included Dyax, has further strengthened the drug's market position[4].

Patient Support and Service Programs

Dyax's KALBITOR Care program is designed to provide individualized care and support to patients and caregivers, enhancing patient adherence and satisfaction. Such programs are vital in maintaining market share and driving patient growth[2].

Conclusion

Ecallantide, under the brand name KALBITOR, has established itself as a critical treatment for acute HAE attacks. Its strong clinical efficacy, global expansion through strategic partnerships, and favorable market trends position it for continued growth. As the HAE therapeutics market evolves, ecallantide is expected to remain a key player, driven by its unique mechanism of action and the increasing demand for effective HAE treatments.

Key Takeaways

• Ecallantide is a recombinant plasma kallikrein inhibitor used to treat acute HAE attacks.
• It was approved by the FDA in 2009 and has shown significant sales growth since its launch.
• The drug has been successful in clinical trials, demonstrating better patient outcomes compared to placebo.
• The global HAE therapeutics market is projected to grow significantly, with the kallikrein inhibitors segment expected to expand rapidly.
• Ecallantide competes in a highly competitive market but maintains a strong position due to its unique mechanism and established market presence.
• Regulatory approvals and licensing agreements have been crucial in its global expansion.

FAQs

What is ecallantide used for?

Ecallantide is used for the treatment of acute attacks of hereditary angioedema (HAE), a rare genetic disorder characterized by painful and potentially life-threatening swelling.

Who developed ecallantide?

Ecallantide was developed by Dyax, which is now part of Takeda Pharmaceutical Co. Ltd.

What is the mechanism of action of ecallantide?

Ecallantide works by inhibiting plasma kallikrein, an enzyme involved in the pathogenesis of HAE.

How has ecallantide performed in clinical trials?

Clinical trials have shown that ecallantide significantly improves patient-reported treatment outcome scores and symptom complex severity scores compared to placebo.

What is the current market trend for HAE therapeutics?

The global HAE therapeutics market is projected to reach $6.8 billion by 2031, growing at a CAGR of 11.4%, driven by the launch of target-specific drugs and a shift to prophylactic treatments.

Sources

1. Global Hereditary Angioedema Therapeutics Market: iHealthcareAnalyst, June 2024.
2. Annual Reports: Dyax, 2012.
3. Biologics Market Dynamics: FTC, March 2020.
4. Ecallantide - Takeda: AdisInsight - Springer.
5. Ecallantide for the treatment of acute attacks in hereditary angioedema: PubMed, August 2010.

Last updated: 2024-12-19