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XEOMIN Botulinum Toxin Type A

Xeomin

XEOMIN® is a purified Botulinum Toxin Type A without accessory protein.

Mechanism

XEOMIN® is a Botulinum Toxin Type A that blocks transmission of acetylcholine (ACh) from neuron to muscle

This inhibits muscle contraction and causes muscle paresis (weakness) or paralysis

Botulinum Toxin Type A only affects “cholinergic neurons” (neurons which use acetylcholine as a neurotransmitter)

Botulinum Toxin Type A effects dissipate after ~ 3 months because new SNAP-25 proteins take 3 months to be synthesized¹

Manufacturing Process

XEOMIN® is made through a unique precision manufacturing process that isolates the therapeutic component of the molecule and removes the accessory proteins that don’t play an active role in treatment. XEOMIN® is a highly purified neurotoxin.

Exacting Standards

XEOMIN® (incobotulinumtoxinA) is a highly purified neurotoxin, precision manufactured in a facility using advanced technology. The active ingredient of XEOMIN® is botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum serotype A. Merz takes the toxin complex and employs a proprietary manufacturing process that isolates the therapeutic component and removes the accessory proteins to produce XEOMIN®. Accessory proteins accompany the active neurotoxin but do not play an active role in treatment.

INDICATIONS AND USAGE

XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity in adult patients.

A prospective, multicenter, randomized, double blinded, parallel trial, XEOMIN® and BOTOX® subjects were randomized 1:1. The study enrolled 250 healthy female patients (≥18 years old) with glabellar lines of at least moderate severity at maximum frown. 122 subjects were treated with 20 Units of XEOMIN; 128 subjects were treated with 20 Units of BOTOX in a single treatment cycle. Patients were classified as responders only. If they had a ≥ 1 point improvement from the baseline on the Facial Wrinkle Scale (FWS) at maximum frown, as assessed by the independent review panel using subject photographs at one month post treatment.1-3

CLINICALLY PROVEN

In two randomized, double blinded, multicenter, clinical trials, Xeomin was clinically proven to temporarily improve the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.1-3

1. XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use. Prescribing Information. Merz Pharmaceuticals, LLC, 2015.

2. Carruthers A, Carruthers J, Heinz M, et al. Multicentre, randomized phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines. Dermatol Surg 2013;39:551–558.

3. Hanke CW, Narins RS, Brandt F, et al. A Randomized, Placebo-Controlled, Double-Blind Phase III Trial Investigating the Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines Using a Stringent Composite Endpoint. Dermatol Surg. 2013;39(6):891-899.