New Pediatric Formulation of Janssen’s Treatment for Intestinal Worms Achieves World Health Organization Prequalification

WHO prequalification of VERMOX^TM CHEWABLE (mebendazole) will ensure broad deployment for children in high-burden countries

More than 1.4 billion doses of VERMOX^TM tablets donated to date, for approximately 800 million children

Raritan, N.J., April 9, 2019 – Janssen Pharmaceutica N.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced that the World Health Organization (WHO) has prequalified the company’s new pediatric formulation of a treatment for intestinal worms. With WHO prequalification, VERMOX^TM CHEWABLE (mebendazole 500mg tablets) will be made available to children as young as one year of age in high-burden countries. The chewable formulation will be donated by Johnson & Johnson to the WHO, which manages and coordinates country requests for this valuable medicine. Since 2006, the donation program for VERMOX^TM has delivered more than 1.4 billion doses to approximately 800 million children worldwide.

Globally, approximately 1.5 billion people – nearly 20% of the world’s population – are infected with intestinal worms, also called soil-transmitted helminths (STH), which is considered a neglected tropical disease (NTD).^[i] While both children and adults are affected, children are particularly vulnerable to these debilitating parasitic infections. Intestinal worms can lead to malnutrition and stunting, conditions that can have long-lasting effects and impair cognitive development, limiting children’s ability to learn, grow, and thrive.

“As part of Johnson & Johnson’s longstanding commitment to combat NTDs, Janssen developed VERMOX^TM CHEWABLE to reach younger children with a safe and effective treatment for intestinal worms,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “The WHO prequalification of this easier-to-swallow formulation is a critical step in our efforts to help young children suffering from these devastating infections.”

Solid oral tablets can be difficult for children to swallow, posing a barrier to pediatric treatment. In response to recommendations by the WHO calling for more child-appropriate formulations of deworming medicines used in donation programs, Janssen developed VERMOX^TM CHEWABLE. The new pediatric formulation 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 formulation is now 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 Necator americanus and Ancylostoma duodenale (two species of hookworm).

Johnson & Johnson has been donating VERMOX^TM solid tablets for school-aged children since 2006. Through Johnson & Johnson’s endorsement of the 2012 London Declaration on NTDs, the company committed to donate 200 million doses of the medicine annually, and to develop this pediatric formulation of VERMOX^TM. Following the WHO prequalification announced today, VERMOX^TM CHEWABLE will be integrated into the donation program operated by the WHO in limited quantities this year, and in 2020, the program will fully transition from the existing solid tablet to the new pediatric-appropriate formulation. The chewable tablet will not be commercialized and will be available only via the donation program, at no profit to Johnson & Johnson.

“Beyond drug donations, we are also actively collaborating with our partners to improve STH diagnostics, monitoring, and evaluation to allow for better data collection and decision-making,” said Jaak Peeters, Head of Johnson & Johnson Global Public Health, Janssen-Cilag GmbH. “We want to help the global health community identify sustainable, long-term solutions to reduce the prevalence of intestinal worms.”

STH is one of the most common infections worldwide. It 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, sanitation, and safe water.^[ii] The most common species that affect people are roundworm, whipworm, and hookworm.

In 2006, Johnson & Johnson in collaboration with the Task Force for Global Health formed Children Without Worms (CWW) to reduce the burden of parasitic infections in children. GSK subsequently joined the partnership. In 2017, Johnson & Johnson’s donation of VERMOX^TM, in combination with GSK donations of albendazole, played a key role in achieving 70% treatment coverage for at-risk children.^[iii]

“We need every tool at our disposal to combat the harmful effects of intestinal worms among children,” said Rubina Imtiaz, M.B.B.S., Director of CWW. “WHO prequalification of this new pediatric formulation supports the introduction of a welcome addition to treatment programs on the ground.”

About VERMOX^TM CHEWABLE (mebendazole 500mg tablet)

VERMOX^TM CHEWABLE (mebendazole 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 species 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^TM 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^TM CHEWABLE and metronidazole.

Drug Interactions: Concomitant use of VERMOX^TM 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^TM CHEWABLE to a breastfed infant; therefore, developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VERMOX^TM CHEWABLE and any potential adverse effects on the breastfed infant from VERMOX^TM CHEWABLE or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of VERMOX^TM CHEWABLE 500 mg chewable tablets have been established in pediatric patients 1 to 16 years of age. The safety and effectiveness of VERMOX^TM 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
Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash.

When available, the final WHO public assessment report will be 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 one 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. 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., Johnson & Johnson and/or their affiliates. 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 April 2019.
^[ii] Ibid.
^[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 April 2019.