VERMOX® Chewable (500mg mebendazole) Tablet for Donation

To address WHO’s recommendations on STH dosing needs in small children, Janssen developed a new 500mg mebendazole
tablet, VERMOX® Chewable, that can either be chewed or dispersed in water.

The new chewable tablet was approved by the FDA in Oct-16 and received WHO pre-qualification in April-19. With WHO
prequalification, donation is initiating in 2019 with limited quantities available (20M doses). In 2020, the full mebendazole
donation program will transition to the new chewable tablet.

Added Benefits of New VERMOX™ Chewable Tablet:

 Easier to administer
 Safer  less risk of choking
 More appealing to children  better tasking: sweet strawberry flavor

VERMOX™ Chewable Dosing and Administration

VERMOX Chewable is indicated for the mass treatment of subjects one year of age and older with gastrointestinal infections
caused by Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Necator americanus and Ancylostoma
duodenale (hookworms). In subjects living in heavily endemic areas, the recommended dosage in subjects one year of age
and older is one mebendazole 500 mg chewable tablet taken as a single dose. This dose may be repeated on an annual or
biannual basis, according to programmatic recommendations. Vermox Chewable can be taken without regard to food intake.

VERMOX Chewable tablets may be administered in 2 ways:

1) Chew VERMOX Chewable 500 mg tablet completely before swallowing, or
2) For subjects who have difficulty chewing the tablet, follow the instructions below:

Key Differences Between the Solid Tablet and the New Chewable Tablet
 At launch, the new Chewable tablet will only have a 2-year shelf life vs. 5 year for old solid tablet
 At launch, the new Chewable tablet will have an in-use period of one month, meaning that once the bottle is opened,
the tablets are only good for one month
 The new Chewable bottle label is bright yellow vs. white for solid, to clearly differentiate it

Any questions can be directed to Lynn Leonard, J&J STH Global Program Leader: LLeonar1@its.jnj.com