New commitment will ensure 1 billion additional doses of Janssen’s VERMOX® CHEWABLE (mebendazole) are delivered to at-risk children in developing countries through 2025
RARITAN, N.J., 16 July 2019 – Johnson & Johnson today announced that it is extending through 2025 global product donations of an intestinal worms treatment made by its Janssen Pharmaceutical Companies. The new five-year expanded commitment will ensure that one billion doses of VERMOX® CHEWABLE (mebendazole chewable 500mg tablets) are provided in the 2021-2025 period to high-burden countries via donations to the World Health Organization (WHO), which manages and coordinates country requests for this valuable medicine. Also known as soil-transmitted helminths (STH), intestinal worms are considered the most widespread of neglected tropical diseases (NTDs) and have a particularly damaging impact on the health and development of children.[i],[ii]
“This is the latest example of Johnson & Johnson’s deep and enduring commitment to achieve a world free of NTDs,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “Intestinal worms are a particularly damaging condition for children¾they can lead to malnutrition, which can impair cognitive development and limit children’s ability to learn, grow, and prosper. We’re proud to continue this program so that children in the world’s poorest countries can achieve their full potential and thrive.”
The new pediatric VERMOX CHEWABLE formulation was approved by the U.S. Food and Drug Administration in 2016 and received prequalification from the WHO in April 2019. Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, developed the formulation, which can either be chewed, or mixed with a small amount of water to form a soft mass that is easier for very young children to safely ingest.
This year, VERMOX CHEWABLE is being integrated into the donation program operated by the WHO, and the first large-scale shipments are being delivered. In 2020, the program will fully transition from the existing solid tablet to the new pediatric formulation. The chewable tablet will only be available via the donation program and there are no plans to make it commercially available. To date, the program has delivered more than 1.4 billion doses of VERMOX to approximately 800 million children and forms a critical part of our Health for Humanity goals.
“This innovative pediatric formulation of mebendazole fills a major gap in global treatment efforts against intestinal worms, allowing for safer dosing in children as young as one year of age,” said Jaak Peeters, Global Head, Johnson & Johnson Global Public Health, Janssen-Cilag GMBH. “Extending our donation commitment for an additional five years means we ensure that our easier-to-swallow formulation of VERMOX that Janssen spent many years developing reaches the children most vulnerable to these debilitating infections.”
Johnson & Johnson has a long history of working to eliminate intestinal worms as a public health problem. In 2006, the company in collaboration with the Task Force for Global Health formed Children Without Worms (CWW), and donations of Janssen’s VERMOX solid tablets for school-aged children began. GSK subsequently joined the partnership. In 2012, Johnson & Johnson endorsed the London Declaration on NTDs, and committed to provide 200 million doses of mebendazole annually through 2020. This commitment is now extended through 2025.
In 2017, the latest year for which data are available, Johnson & Johnson’s donation of VERMOX in combination with GSK donations of albendazole played a key role in achieving nearly 70% treatment coverage for at-risk children.[iii]
“Although we still have a lot of work to do, the progress we are making on intestinal worms is undoubtedly a success story in the world’s fight against NTDs,” said Ellen Agler, Chief Executive Officer of The END Fund, a key partner organization dedicated to ending the most common NTDs. “Increased access to safe and effective medicines is critical to this effort and the extension of Johnson & Johnson’s donation program is warmly welcomed¾particularly as it will now provide an innovative pediatric formulation.”
Beyond drug donations, Johnson & Johnson is working with partners to identify sustainable solutions to combat intestinal worms longer term. These include improving diagnostics for STH and developing national monitoring and evaluation frameworks to allow for better data collection, more informed decision-making, and ultimately optimized therapeutic interventions that have the potential to eliminate intestinal worms in endemic countries.
About Intestinal Worms
Approximately 1.5 billion people¾nearly 20% of the world’s population¾are infected with intestinal worms, also called soil-transmitted helminths (STH).[iv] STH is transmitted by eggs present in human feces, which can contaminate the soil in areas where sanitation is poor. Nearly 270 million preschool-age children and nearly 570 million school-age children live in endemic areas and are in need of public health interventions such as preventive chemotherapy (such as VERMOX), sanitation, and safe water.[v] The most common species that affect people are roundworm, whipworm, and hookworm.
About VERMOX CHEWABLE (mebendazole chewable 500mg tablet)
VERMOX CHEWABLE (mebendazole chewable 500mg tablet) is prequalified by the WHO for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), and Ancylostoma duodenale and Necator americanus (two types of hookworm)
Janssen markets a wide range of mebendazole formulations worldwide. Mebendazole interferes with cellular tubulin formation in intestinal worms which leads to the death of the worm.
IMPORTANT SAFETY INFORMATION (PROFESSIONAL)
CONTRAINDICATIONS: VERMOX CHEWABLE is contraindicated in children below the age of 1 year and in persons with a known hypersensitivity to the drug or its excipients.
WARNINGS AND PRECAUTIONS
Risk of Convulsions: Convulsions have been reported in infants below the age of 1 year during post-marketing experience with mebendazole.
Hematologic Effects: Agranulocytosis and neutropenia have been reported with use at higher doses and for more prolonged durations than is recommended for the treatment of soil-transmitted helminth infections. Monitor blood counts if used at higher doses or for prolonged duration.
Metronidazole Drug Interaction and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of VERMOX CHEWABLE and metronidazole.
Drug Interactions: Concomitant use of VERMOX CHEWABLE and metronidazole should be avoided.
USE IN SPECIFIC POPULATIONS
Pregnancy: The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages. There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy.
Lactation: Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. There are no reports of effects on the breastfed infant, and the limited reports on the effects on milk production are inconsistent. The limited clinical data during lactation precludes a clear determination of the risk of VERMOX CHEWABLE to a breastfed infant; therefore, developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VERMOX CHEWABLE and any potential adverse effects on the breastfed infant from VERMOX CHEWABLE or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of VERMOX CHEWABLE 500 mg chewable tablets have been established in pediatric patients 1 to 16 years of age. The safety and effectiveness of VERMOX CHEWABLE have not been established in pediatric patients less than one year of age. Convulsions have been reported with mebendazole use in this age group.
Overdosage: In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported: alopecia, reversible transaminase elevations, hepatitis, agranulocytosis, neutropenia, and glomerulonephritis. In the event of accidental overdose, gastrointestinal signs/symptoms may occur. There is no specific antidote.
Hepatic impairment liver disease: Impaired hepatic function, impaired metabolism, or impaired biliary elimination may lead to higher plasma levels of mebendazole.
Renal impairment: There is no need for dosing adjustment in renal insufficiency. Less than 2% of an orally administered dose of mebendazole is renally excreted.
Elderly patients: Clinical studies of mebendazole did not include sufficient numbers of subjects aged 65 or older to determine whether they respond differently from younger subjects.
Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash.
Please see full Prescribing Information
The final WHO public assessment report is accessible here.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @jnjglobalhealth.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Pharmaceutica N.V. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
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 Pharmaceutica N.V., any of the other Janssen Pharmaceutical Companies 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 December 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” in the company’s most recently filed Quarterly Report on Form 10-Q and in 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. The Janssen Pharmaceutical Companies, Johnson & Johnson and their affiliates do not undertake to update any forward-looking statement as a result of new information or future events or developments.
[i] World Health Organization. News. Soil-transmitted helminth infections. Available at https://www.who.int/en/news-room/fact-sheets/detail/soil-transmitted-helminth-infections. Last accessed June 2019.
[ii] Imperial College London, Schistosomiasis Control Initiative. Neglected Tropical Diseases. Available at: https://www.schistosomiasiscontrolinitiative.org/ntds?rq=prevalent. Last accessed June 2019; PLoS Neglected Tropical Diseases. Testing for soil-transmitted helminth transmission elimination: Analysing the impact of the sensitivity of different diagnostic tools. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5773090/. Last accessed June 2019.
[iii] World Health Organization. Neglected tropical diseases. WHO data show unprecedented treatment coverage for bilharzia and intestinal worms. Available at https://www.who.int/intestinal_worms/en/. Last accessed June 2019.
[iv] World Health Organization. News. Soil-transmitted helminth infections. Available at https://www.who.int/en/news-room/fact-sheets/detail/soil-transmitted-helminth-infections. Last accessed June 2019.