BEERSE, BELGIUM – April 27, 2016 – Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), today announced it has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application for a 500mg chewable tablet formulation of mebendazole. If approved, mebendazole chewable tablets will provide a treatment alternative for adults and children aged one year or older with single or mixed soil-transmitted helminthiasis (STH), and address an unmet need for children too young to swallow a solid tablet.
This submission responds to recommendations by the World Health Organization (WHO) calling for a more child-friendly formulation of mebendazole to effectively treat young children, their families and communities. Specifically, the WHO recommends only chewable deworming tablets be given to children under five years, and that chewable tablets be mixed with water in children under three years.1
“At Janssen, we are committed to developing innovative treatments which address unmet public health needs,” said Wim Parys, M.D., Global Head of R&D, Global Public Health, Janssen. “This filing brings us closer to a chewable mebendazole tablet as a potential option for young children and adults in the treatment of intestinal worms. The tablet can be chewed by children over five years without a need for potable water. When mixed with water, it forms a soft mass, allowing the treatment to be extended to children as young as one year of age who cannot be given a solid tablet.”
If approved, Johnson & Johnson aims to replace its current mebendazole solid tablet with the 500mg chewable tablet in the VERMOXTM(mebendazole) donation program, providing free access to this treatment for people in high burden countries.
The FDA submission is supported by data from 712 patients across four clinical trials2 in children and adults with single or mixed intestinal worm infestations. The results of these trials are consistent with the safety and efficacy of all currently registered mebendazole dosage forms which have been used for more than 45 years.
About soil-transmitted helminthiasis
Soil-transmitted helminthiasis (STH) is among the most common infections worldwide, affecting the most deprived communities. STH is transmitted by eggs present in human faeces which can contaminate soil in areas where sanitation is poor.3
Approximately two billion people are infested with STH worldwide. STH can infect both children and adults, however children are more at risk. Over 270 million preschool-age children and more than 600 million school-age children live in endemic areas and are in need of treatment and preventive interventions. The most common species that infect people are the roundworm, whipworm and hookworm.3
STH is considered a Neglected Tropical Disease by the WHO and FDA.4 To help lower the disease burden, the WHO recommends mass drug administration (MDA) programs are carried out on a routine basis (for example twice a year) for at-risk people, particularly children, living in endemic areas.3
STH impairs the nutritional health of those infested, sometimes causing death by negatively affecting nutritional status (causing intestinal bleeding, loss of appetite, diarrhea or dysentery, and reducing absorption of micro and macronutrients), worsening school performance and/or causing complications that require surgical intervention (i.e. intestinal obstruction and rectal prolapse).5
About mebendazole 500mg chewable tablet
The mebendazole 500mg chewable tablet is an oral, rapidly disintegrating tablet that is in development for the treatment of STH in adults and children aged over one year.
Mebendazole interferes with cellular tubulin formation in intestinal worms which leads to the death of the worm.
The tablet can be chewed by children over five years without the need for potable water. With a small amount of water, the tablet can form a soft mass which can be swallowed by children as young as one year who cannot be given a solid tablet.
Janssen’s current 500mg single-dose VERMOX™ (mebendazole) tablet is indicated for the treatment of single or mixed intestinal infestations byTrichuris trichiura (whipworm), Ascaris lumbricoides (large roundworm) and Ancylostoma duodenale and Necator americanus (hookworm).
IMPORTANT VERMOX™ SAFETY INFORMATION
VERMOX™ is contraindicated in children below the age of one year. Convulsions in children, including infants below the age of one year have been reported very rarely. Adverse drug reactions with VERMOX™ include abdominal discomfort, diarrhea, flatulence, and rash. No adverse reactions occurred in ≥1% of mebendazole-treated patients.
About Johnson & Johnson’s VERMOXTM (mebendazole) donation program
In 2006, Johnson & Johnson founded the Children Without Worms partnership, a collaboration with the Task Force for Global Health, dedicated to the treatment of children with STH. In this partnership, Johnson & Johnson collaborated with the WHO to coordinate a global supply of medicines for intestinal worms and to facilitate distribution of the medicines via MDA programs in schools.
In 2012, Johnson & Johnson endorsed the London Declaration on Neglected Tropical Diseases and continued to expand the VERMOXTM(mebendazole) donation program.
Johnson & Johnson is committed to donating 200 million doses of VERMOXTM (mebendazole) tablets each year through 2020. If approved, the chewable tablet will replace the current solid tablet in donation programs.
For more information about the Children Without Worms program visit: http://www.childrenwithoutworms.org/
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at@JanssenGlobal or @JNJNews.
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Cautions Concerning Forward-Looking Statement
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and donation commitments. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including the uncertainty of clinical success and of obtaining regulatory approvals; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 World Health Organization. Preventive chemotherapy in human helminthiasis. Coordinated use of anthelminthic drugs in control interventions: a manual for health professionals and programme managers. Available at http://apps.who.int/iris/bitstream/10665/43545/1/9241547103_eng.pdf. Last accessed April 2016.
2 Janssen data on file.
3 World Health Organization. Media centre. Soil-transmitted helminth infections. Available at http://www.who.int/mediacentre/factsheets/fs366/en/. Last accessed April 2016.
4 Department of Health and Human Services, Food and Drug Administration. Report to Congress: Improving the Prevention, Diagnosis and Treatment of Rare and Neglected Diseases. March 2011. Available athttp://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/UCM265525.pdf. Last accessed April 2016.
5 World Health Organization, Intestinal worms. Available at http://www.who.int/intestinal_worms/more/en/. Last accessed April 2016.