Statement 23 March 2018

IFPMA Statement: Biopharmaceutical industry marks World TB Day

By IFPMA
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Geneva, 23 March 2018 – IFPMA, the world body representing biopharmaceutical companies, confirms its commitment to the World Health Organization (WHO) drive to eradicate tuberculosis and its campaign “Wanted: Leaders for a TB-free world”, focusing on building commitment at all levels of the community.

The biopharmaceutical industry is dedicated to bringing effective therapies and solutions to improve access to treatment and accelerate progress to end TB for good. IFPMA endorses the World Health Organization’s End Tuberculosis Strategy[1], as well as broader efforts to end TB that are underpinned by the Sustainable Development Goals.

The biopharmaceutical industry is contributing to the TB challenge with R&D and measures to improve access to treatments. The industry’s R&D efforts focuses on finding more effective, safer, all-oral regimens to treat all forms of TB, and new vaccines for adolescents and adults. There are now over 60 R&D projects for TB medicines and vaccines in the pipeline, including seven products in phase III clinical trials. The recent breakthroughs made by Johnson & Johnson and Otsuka (bedaquiline and delamanid) for the treatment of MDR-TB are not only important innovations, they are also illustrative of new approaches being taken by biopharmaceutical companies to make broadening sustainable and responsible access a priority.

2018 is a critical year for the global TB community, including IFPMA, culminating with the first ever UN High-Level Meeting on TB on 26 September 2018. Progress is being made. Just last week, Prime Minister Narendra Modi announced at the Delhi End TB Summit a bold vision for a TB-free India by 2025. As India has the highest burden of TB in the world, IFPMA acknowledges the importance of the commitments made by India’s PM.

 

For further information: Morgane De Pol (m.depol@ifpma.org)

 

Background:

Today, tuberculosis is curable, but its long treatment regimen is demanding, often unfortunately proving challenging for patients to complete their full course. This accounts in part to today’s continued death toll, as does lack of diagnosis, weak health systems and lack of access to medicines. It also accounts for the rise of multidrug-resistant or extensively drug-resistant TB (MDR-TB and XDR-TB).

Today, the biopharmaceutical is searching for new treatments for TB. There currently 60 R&D projects for TB medicines and vaccines in the pipeline[2], including seven products in phase III clinical trials. These new products are reaching the final stages of the 10-15-year R&D process – one in which many other possible treatments or vaccines have fallen by the wayside. Innovation in the field of TB research is becoming increasingly collaborative. Today, biopharmaceutical companies are involved in more than 30 collaborators (universities, research institutes, product development partnerships, etc.) to develop innovative medicines and vaccines for TB and MDR-TB.

After a gap of 50 years, major breakthroughs by Johnson & Johnson and Otsuka have seen the light of the day: two new medicines (bedaquiline[3] and delamanid[4]) have been approved for the treatment of MDR-TB under programmatic conditions in numerous countries, with both added to the World Health Organization’s Essential Medicines List. A priority is getting these new treatments to patients by broadening sustainable and responsible access.

Both Johnson & Johnson and Otsuka collaborate with a number of local, national and global partners to expand access to treatment, diagnostics and care. Both companies have introduced responsible, innovative and clearly structured approaches to expand dissemination of their new treatments while ensuring safe and appropriate use. They include programs providing healthcare professionals training and appropriate pharmacovigilance and surveillance activities to monitor resistance. This is a crucial for the introduction of new TB regimens to ensure they remain effective for patients today as well as tomorrow.

In addition to R&D, bioharmaceutical companies are involved in over 30 partnerships to increase access to TB treatment, diagnosis and care. These programs include donations, but also manufacturing partnerships to increase local capacity. Companies are working with the Global Drug Facility[5], a unique TB-specific mechanism for pooling the procurement of medicines and diagnostics. Some initiatives also focus on reaching isolated groups with TB diagnostics through door-to-door screenings and training of health workers. Companies work with health providers to prevent medicine stock-outs in rural health centres and ensure the quality of tuberculosis medicines in pharmacies across the world with mobile labs[6].

 

[1] http://www.who.int/tb/strategy/end-tb/en/

[2] R&D Pipeline for Tuberculosis (IFPMA) (March 2017).

[3] Also known as SIRTURO®

[4] Also known as Deltyba™

[5] The Global Drug Facility is the largest procurer of quality-assured TB medicines and provides TB drug management technical assistance in an effort to promote equitable access to TB medicines and diagnostics.

[6] More information on IFPMA Health Partnerships Directory

About IFPMA

IFPMA represents the innovative pharmaceutical industry at the international level, engaging in official relations with the United Nations and multilateral organizations. Our vision is to ensure that scientific progress translates into the next generation of medicines and vaccines that deliver a healthier future for people everywhere.

To achieve this, we act as a trusted partner, bringing our members' expertise to champion pharmaceutical innovation, drive policy that supports the research, development, and delivery of health technologies, and create sustainable solutions that advance global health.

ifpma.org

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