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CLINICAL TRIALS PROFILE FOR VEREGEN

All Clinical Trials for VEREGEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01082302 ↗	Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage	Completed	Charité Research Organisation GmbH	Phase 4	2010-01-01	This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
NCT01082302 ↗	Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage	Completed	Charité Research Organization GmbH	Phase 4	2010-01-01	This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
NCT01082302 ↗	Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage	Completed	MediGene	Phase 4	2010-01-01	This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in comparison to catechin plasma concentrations after oral intake of a defined dose of green tea beverage. The study is intended to demonstrate that topical administration of Veregen 15% induces catechin plasma concentrations lower or equivalent to those that can be reached with normal consumption of green tea.
NCT01222000 ↗	Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous	Unknown status	Centre Hospitalier Universitaire de Nice	Phase 3	2010-10-01	Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of keratinization of the skin which results in a severe generalized cutaneous xerosis with dark brown big scales, an ectropion, an eclabion, an alopecia and a palmo-plantar keratodermia. They are due to mutations of the gene TGM1 coding for the transglutaminase keratinocyte 1 (TG1) in 1/3 of the cases. Other genes were recently identified, ABCA12 coding for the triphosphate-binding adenosine cassette A12 and FLJ39501 which codes for a protein of the cytochrome p450 ( CYP4F2). No etiological treatment is available. Symptomatic treatment consists on twice application of emollients and keratolytic ointments which decrease the dryness of the skin and reduce scales. Oral isotretinoin is usually partially effective but is only suspensive and has numerous side effects. Recent studies showed that the epigallocatechin-3-gallate (POLYPHENON E®), extracted from green tea increases the differentiation of the normal human keratinocytes, as showedb by the increase of the involucrine, TG1 and caspase-14 genes expression. The main objective of this pilot study is to estimate the action and the tolerance of a daily application of topical Polyphénon E 10% ® to improve the desquamation and the cutaneous roughness of patients with lamellar ichthyosis, after 4 weeks of treatment. The secondary objectives - To estimate the duration of remission obtained after the treatment - To estimate the action of cutaneous Veregen® to improve the palmar and plantar involvement. - To estimate the action of cutaneous Veregen on the pruritus - And to estimate the global level of acceptability by the patient of the Veregen 10 %

Clinical Trial Conditions for VEREGEN

Condition Name

Condition Name for VEREGEN
Intervention	Trials
Carcinoma, Basal Cell	1
Sexual Pain Disorders	1
Dyspareunia	1
Verruca, Warts	1

Condition MeSH

Condition MeSH for VEREGEN
Intervention	Trials
Warts	4
Condylomata Acuminata	3
Carcinoma, Basal Cell	1
Somatoform Disorders	1

Clinical Trial Locations for VEREGEN

Trials by Country

Trials by Country for VEREGEN
Location	Trials
United States	27
Germany	2
France	1
Guam	1
Netherlands	1

Trials by US State

Trials by US State for VEREGEN
Location	Trials
Texas	2
New York	2
New Hampshire	1
Nebraska	1
Missouri	1

Clinical Trial Progress for VEREGEN

Clinical Trial Phase

Clinical Trial Phase for VEREGEN
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for VEREGEN
Clinical Trial Phase	Trials
Completed	5
Recruiting	1
Terminated	1

Clinical Trial Sponsors for VEREGEN

Sponsor Name

Sponsor Name for VEREGEN
Sponsor	Trials
MediGene	2
National Cancer Institute (NCI)	1
Charité Research Organization GmbH	1

Sponsor Type

Sponsor Type for VEREGEN
Sponsor	Trials
Other	8
Industry	5
NIH	1

VEREGEN Market Analysis and Financial Projection

Veregen: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Veregen, a topical ointment containing sinecatechins, is a treatment for external genital and perianal warts (condylomata acuminata) in immunocompetent patients 18 years and older. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Trial Design and Outcomes

Veregen's efficacy and safety were evaluated in two randomized, double-blind, vehicle-controlled studies. In these studies, patients applied the ointment three times daily for up to 16 weeks or until complete clearance of warts was achieved. The primary efficacy outcome measure was the proportion of patients who had complete clinical clearance of all warts by week 16.

• Global Results: Treatment with Veregen resulted in a complete clearance rate of 53.6%, compared to 35.3% for the vehicle group[2][5].
• US Results: For patients in the US alone, the response rates were 23.8% for Veregen and 0% for the vehicle group[5].

These studies demonstrated the efficacy of Veregen in treating external genital warts, making it a viable treatment option.

Market Analysis

Market Size and Demand

The market for treatments of external genital warts (EGW) is substantial, with estimates suggesting it is worth around $200 million annually. More than a million new cases of EGW are reported each year, indicating a consistent demand for effective treatments[5].

Competitive Landscape

Veregen competes with other topical treatments such as Aldara (imiquimod) from Graceway Pharmaceuticals. The marketing strategy for Veregen involves promoting it to dermatologists and OB-GYNs, who are the primary healthcare providers for patients with EGW. The sales force from Nycomed, which acquired Bradley Pharmaceuticals, plays a significant role in this effort[5].

Global Availability

Veregen is not only available in the US but also in Canada, 15 European countries, and Taiwan. Its inclusion in the 2012 European Guideline for the Management of Anogenital Warts and the US Centers for Disease Control and Prevention's 2010 Sexually Transmitted Diseases Treatment Guidelines further solidifies its market position[2].

Marketing and Promotion

Promotional Strategies

The marketing of Veregen is handled by the Doak Dermatologics and Kenwood Therapeutics divisions of Bradley Pharmaceuticals, with additional support from Nycomed's dermatology sales force. The promotional efforts include comparing the efficacy of Veregen to other marketed topical therapies like Aldara. Journal buys and in-house advertising and PR are also part of the strategy, with potential outsourcing once the acquisition by Nycomed is finalized[5].

Regulatory Approvals and Guidelines

FDA and International Approvals

Veregen has obtained market approval in several countries, including the US, Canada, and multiple European nations. It is included in the US Centers for Disease Control and Prevention's treatment guidelines for external genital warts, which enhances its credibility and market acceptance[2].

Future Projections

Market Growth

Given the consistent demand for treatments of external genital warts and the efficacy of Veregen, the market for this drug is expected to remain robust. The expansion of promotional efforts and the inclusion in international treatment guidelines are likely to contribute to its continued market presence.

Competitive Advantage

Veregen's unique active ingredient, sinecatechins derived from green tea, sets it apart from other treatments. Its safety profile and efficacy rates make it a preferred option for many healthcare providers, which should help in maintaining its market share.

Key Takeaways

• Efficacy: Veregen has demonstrated significant efficacy in treating external genital warts, with a complete clearance rate of 53.6% in global trials.
• Market Size: The EGW treatment market is valued at around $200 million annually, with over a million new cases reported each year.
• Marketing Strategy: Promotional efforts are focused on dermatologists and OB-GYNs, with support from Nycomed's sales force.
• Regulatory Approvals: Veregen is approved in multiple countries and included in international treatment guidelines.
• Future Projections: The market for Veregen is expected to remain strong due to its efficacy, safety profile, and ongoing promotional efforts.

FAQs

What is Veregen used for?

Veregen is a topical ointment used for the treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients 18 years and older.

What are the active ingredients in Veregen?

The active ingredient in Veregen is sinecatechins, a partially purified fraction of the water extract of green tea leaves.

How effective is Veregen in treating external genital warts?

Veregen has shown a complete clearance rate of 53.6% in global trials, compared to 35.3% for the vehicle group.

Where is Veregen available?

Veregen is available in the US, Canada, 15 European countries, and Taiwan.

What are the key marketing strategies for Veregen?

The marketing strategies include promoting Veregen to dermatologists and OB-GYNs, comparing its efficacy to other treatments like Aldara, and utilizing Nycomed's dermatology sales force.

Sources

1. Medigene AG: "Medigene's Licensee enters promotion agreement to expand Veregen® product sales in the United States"[2].
2. MM+M: "Veregen - MM+M - Medical Marketing and Media"[5].
3. Medigene AG: "Annual Report 2018"[3].