JETREA Drug Profile

Summary for Tradename: JETREA

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for JETREA

Recent Clinical Trials for JETREA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Universitaire Ziekenhuizen Leuven	Phase 1
KU Leuven	Phase 1
Katholieke Universiteit Leuven	Phase 1

See all JETREA clinical trials

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 JETREA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	7,445,775	2020-12-21	Company disclosures
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	7,547,435	2022-12-06	Company disclosures
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	7,914,783	2022-12-06	Company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	10,821,075	2037-07-12	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	11,110,176	2036-11-25	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	9,421,129	2032-04-02	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	9,474,688	2031-10-25	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	9,504,603	2032-04-02	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	9,603,739	2032-04-02	Patent claims search

International Patents for JETREA

Country	Patent Number	Estimated Expiration
Japan	2010222369
Japan	5996026
Norway	343759
Belgium	2013C055
Denmark	1343903
Israel	202851

Supplementary Protection Certificates for JETREA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2013C/055	Belgium		PRODUCT NAME: MICROPLASMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/819/001 20130315
300603	Netherlands		PRODUCT NAME: OCRIPLASMINE; REGISTRATION NO/DATE: EU/1/13/819/001 20130313
1390041-0	Sweden		MARKNADSGODKAENNANDE NR.: EU/1/13/819/001, 2013-03-15, MIKROPLASMIN
CA 2013 00047	Denmark		PRODUCT NAME: MIKROPLASMIN HERUNDER OCRIPLASMIN; REG. NO/DATE: EU/1/13/819/001 20130313
PA2013020	Lithuania		PRODUCT NAME: OCRIPLASMINUM (MICROPLASMINUM); REGISTRATION NO/DATE: EU/1/13/819/001 20130313
2013/033	Ireland		PRODUCT NAME: OCRIPLASMIN; REGISTRATION NO/DATE: EU/1/13/819/001 20130313

Market Dynamics and Financial Trajectory for the Biologic Drug: JETREA

Introduction

JETREA, also known as ocriplasmin, is a biologic drug used for the treatment of vitreomacular traction (VMT) and symptomatic vitreomacular adhesion (sVMA), including cases associated with macular holes. Here, we will delve into the market dynamics and financial trajectory of this drug.

Indication and Mechanism of Action

JETREA is indicated for adults with VMT, a condition caused by the abnormal attachment of the vitreous humour to the central part of the retina. The active substance, ocriplasmin, is similar to human plasmin and works by breaking down the proteins responsible for this adhesion, thereby reducing retinal swelling and improving vision[4].

Clinical Efficacy

Clinical studies have shown that JETREA is effective in resolving the adhesion between the vitreous humour and the retina. In two main studies involving 652 adults with VMA and decreased vision, a single intravitreal injection of 0.125 mg JETREA demonstrated modest but significant benefits, including the resolution of VMA in a quarter of patients and a reduction in the need for surgery[4].

Market Position

Biologics Market Overview

Biologics, including JETREA, represent a growing share of the pharmaceutical market. As of 2019, biologics accounted for 42% of the total medicines market, up from 30% in 2014. This growth is driven by their efficacy in treating complex diseases and their increasing acceptance in various therapeutic areas[3].

Competition and Market Access

The biologics market is gradually becoming more accessible to biosimilar competition. By the end of 2019, 17% of the biologics market was accessible to biosimilars, with biosimilars achieving a 20% share of this accessible market. However, JETREA, being a relatively niche product, has not yet faced significant biosimilar competition[3].

Financial Performance

Revenue and Sales

ThromboGenics, the company behind JETREA, reported varied financial performances in the early years of the drug's commercialization. In the first half of 2014, JETREA sales in the US totaled €5.0 million, which was part of the company's total revenues of €7.1 million. This was a significant drop from the €102.7 million in revenues in the same period in 2013, largely due to the absence of milestone payments from Alcon in 2014[2].

By the end of 2014, JETREA sales in the US had totaled €8.8 million, a decrease from €20.2 million in 2013. This decline was attributed to several factors, including market dynamics and competition[5].

Cost and Pricing

The cost of JETREA is substantial, with a single dose priced at $3,950. This high cost is a significant factor in the drug's cost-effectiveness analysis. Studies have shown that the incremental cost per quality-adjusted life year (QALY) for JETREA can range from $40,000 to over $100,000, depending on the assumptions made about long-term efficacy and the perspective of the analysis[1].

Strategic and Financial Outlook

ThromboGenics has maintained an independent business strategy aimed at delivering value through the commercialization of JETREA. The company has targeted achieving profitability in the US by 2016 and becoming overall cash flow positive by 2017. With a cash reserve of €148.8 million as of June 2014, ThromboGenics was well-positioned to sustain the US commercialization of JETREA, conduct further research, and expand its R&D pipeline[2].

Cost-Effectiveness Analysis

A cost-utility analysis (CUA) conducted by the manufacturer compared JETREA with "watchful waiting" (medical management), including the option of surgical vitrectomy. The analysis showed that the cost per QALY for JETREA could range from $63,264 to $124,621, depending on the assumptions about long-term spontaneous VMA resolution. The CUA suggested that JETREA is likely to have a cost per QALY of around $40,000 under certain assumptions, although this figure can increase significantly when considering uncertainty in long-term relative efficacy[1].

Safety and Side Effects

The safety profile of JETREA is generally favorable, with the most common side effects being short-lived and manageable. These side effects often occur as a response to the injection procedure or are linked to the resolution of the disease itself. Serious side effects, such as non-reversible decreased vision or changes to retinal function, are rare[4].

Market Strategy and Real-World Data

ThromboGenics has focused on strategic key accounts and a targeted marketing and sales approach to establish JETREA as a treatment for patients with symptomatic VMA. The company has also been conducting studies to generate additional real-world data, which is crucial for demonstrating the benefits and value of JETREA to the retina community[2].

Conclusion

JETREA, as a biologic drug for treating VMT and sVMA, operates within a complex market dynamic influenced by its clinical efficacy, cost, and competition from other treatments. Despite initial challenges in sales and revenue, ThromboGenics has maintained a strategic focus on commercialization and R&D to maximize the drug's potential.

Key Takeaways

• Clinical Efficacy: JETREA is effective in resolving vitreomacular adhesion and reducing the need for surgery.
• Market Position: JETREA is part of the growing biologics market, though it faces limited biosimilar competition.
• Financial Performance: Sales have been variable, with significant drops in revenue post-2013 due to the absence of milestone payments.
• Cost and Pricing: High cost per dose, with significant variations in cost-effectiveness analysis.
• Strategic Outlook: ThromboGenics aims for profitability and cash flow positivity through targeted marketing and R&D.
• Safety Profile: Generally favorable, with manageable side effects.

FAQs

Q: What is JETREA used for? A: JETREA is used for the treatment of vitreomacular traction (VMT) and symptomatic vitreomacular adhesion (sVMA), including cases associated with macular holes.

Q: How does JETREA work? A: JETREA works by breaking down the proteins responsible for the abnormal attachment of the vitreous humour to the retina, using the active substance ocriplasmin.

Q: What are the common side effects of JETREA? A: The most common side effects are short-lived and manageable, often related to the injection procedure or the resolution of the disease itself.

Q: How much does JETREA cost? A: A single dose of JETREA costs $3,950.

Q: What is the financial outlook for ThromboGenics regarding JETREA? A: ThromboGenics aims to achieve profitability in the US by 2016 and become overall cash flow positive by 2017, supported by a significant cash reserve.

Sources

1. Pharmacoeconomic Review Report – ocriplasmin (Jetrea)
   • Common Drug Review January 2014
2. ThromboGenics Business Update H1 2014
   • Regulated Information
3. Biologics Market Dynamics: Setting the Stage for Biosimilars
   • FTC Presentation
4. Jetrea | European Medicines Agency (EMA)
   • EMA Website
5. ThromboGenics reports net loss in 2014
   • Healio News