Background
Tuberculosis (TB) is the leading infectious cause of death worldwide. According to the World Health Organization (WHO) there were 10 million new cases and 1.5 million deaths from TB in 2018. Over one million children developed TB during the same timeframe (WHO 2019). Almost 500,000 of last year’s new TB cases are resistant to one or more first line drugs; with some estimates putting the total number of children infected with drug-resistant (DR) TB strains at 2 million (Dodd et al 2016) and more than 30,000 becoming sick with active DR-TB disease annually (Jenkins and Yuen 2018).
While there are a number of generic medicines available to treat drug susceptible TB, there are critical gaps in the availability of several second-line medicines, in particular for child-friendly formulations for the treatment of paediatric DR-TB. This results in suboptimal treatment options, putting children at risk for substantial preventable morbidity and mortality.
Stellenbosch University has organized a comprehensive network of partners to help address these availability gaps in key second line medicines for children under the BENEFIT Kids Project (Better Evidence and Formulations for Improved MDR-TB Treatment for Children), funded by Unitaid. Partners include the product development partnership TB Alliance, UCSF, JHU/BJMC Pune, Uppsala University, De La Salle University Medical Centre, and Chang Mai University. BENEFIT Kids proposes to enable and support generic manufacturers to develop and commercialize affordable, child-friendly formulations (generally as dispersible tablets, and effectively taste masked) of drugs indicated by WHO as preferred medicines for use in children with DR-TB (WHO 2019).
Request for Proposals
To achieve this initiative, BENEFIT Kids is issuing a request for proposals to develop and manufacture child friendly formulations of three “Group A” TB drugs: bedaquiline, linezolid and moxifloxacin.
Bedaquiline is a diarylquinoline class antibiotic, approved by the USFDA in December 2012 for the treatment of MDR-TB in adults and in 201u for children down to 6 years old with MDR-TB, for whom an effective treatment regimen is not otherwise available.
Linezolid is an oxazolidinone class antibiotic, used for the treatment of infections caused by multi-drug resistant bacteria, including TB. It was approved by the USFDA in 2000.
Moxifloxacin is a fluoroquinolone antibiotic used to treat different types of bacterial infections and approved by the USFDA in 1999.
BENEFIT Kids invites manufacturers to develop and make available these products at an affordable price in novel or optimized child-friendly formulations that are scored, in strengths suited for administering to children across weight bands, and effectively taste-masked.
Application Instructions
The objective of this RFP is to work with a manufacturer to develop new child-friendly formulations (or optimize existing formulations) of the above products and ensure that they are bioequivalent, stable, packaged appropriately, and meet quality standards for WHO Prequalification, Regulatory Authorities and approval by WHO PQ and regulatory authorities such as the Drug Controller General of India (DCGI) and the South Africa Health Products Regulatory Authority (SAHPRA).
Each applicant may apply for one or more products in the RFP. Evaluation for each product will be done separately and applying for fewer products will not affect an application in any way. Applicants are encouraged to provide as much detail as possible.
Among other criteria, willingness to comply with the draft contract, co-investment, and competitive pricing of products will be considered. A copy of the draft agreement is included with this RFP and applicants are requested to share a marked-up version along with the application form.
All commercial and/or technical information will be kept confidential and will not be disclosed or used for any purpose other than for the assessment of the RFP without your prior consent.
This process does not obligate either the applicant or BENEFIT Kids to negotiate or enter into any additional agreement or relationship.
Please note, the deadline for submission of the completed form and draft agreement is Monday, August 10, 2020.
All questions and RFP responses, including a marked-up version of the draft contract, should be directed to BENEFITKidsRFP@tballiance.org and addressed to Ms. Aastha Gupta.
For further information, please also visit the TB Alliance page at https://www.tballiance.org/benefit-kids-rfp
