General Information

Veregen (kunecatechins) 15 percent is a botanical drug product for topical use. It is comprised of kunecatechins, which is a partially purified fraction of the water extract of green tea leaves, and is a mixture of catechins and other green tea components. Catechins are bioflavonoids, polyphenols and powerful antioxidants and are linked to evidence of fighting tumors as well as enhancing immune system function.

Veregen is specifically indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years of age and older.

Mechanism of Action

Veregen is a botanical drug product for topical use. The drug substance in Veregen is Kunecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis O Kuntze, and is a mixture of catechins and other green tea components. While the exact mechanism of action of catechins is unknown, they are powerful antioxidants and are linked to evidence of fighting tumors as well as enhancing immune system function.

Side Effects

Adverse events associated with the use of Veregen may include, but are not limited to, the following:

• Erythema
• Pruritus
• Burning
• Pain/discomfort
• Erosion/Ulceration
• Edema
• Induration
• Rash vesicular

Dosing/Administration

Veregen is supplied as an ointment for topical administration. The recommended initial dose of the drug is a 0.5-cm strand applied in a thin layer over all external and perianal warts, three times a day. Treatment should not exceed 16 weeks.

Clinical Trial Results

FDA Approval
FDA approval of Veregen was based on the pooled results of two randomized, double-blind, vehicle-controlled phase 3 clinical trials. These trials enrolled a combined 1,000 immunocompetent subjects who received the ointment three times daily for up to 16 weeks or until complete clearance of all warts. The primary end point was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16. Of the subjects treated with Veregen, 53.6 percent reached complete clearance versus 35.3 percent on placebo. The median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two trials.

Ongoing Study Commitments

• Medigene has agreed to a phase 4 study comparing the pharmacokinetics of catechin following topical application of Veregen Ointment, 15 percent, with that obtained after oral administration of green tea solution. The two-arm study will be designed to enroll into one arm 20 evaluable patients (completer) with external genital and perianal warts who will be treated three times daily for seven days with Veregen Ointment, 15 percent, and into the second arm 20 evaluable healthy volunteers, who are to drink a green tea solution three times daily for seven days. Blood samples for the analysis of catechin levels will be obtained prior to and at several sampling time points (over 12 hours) after oral intake of a green teal solution or topical application of Veregen Ointment, 15 percent, respectively, at Days 1 and 7. The study will be carried out with material from the final commercial source for API to be established in Japan and fulfilling the FDA-defined specifications for the botanical drug substance and drug product.
  Protocol submission: July 2007
  Study start: January 2008
  Final report submission: January 2009