Fighting Multi-Drug Resistant Tuberculosis

More than 480,000 new cases of multi-drug resistant tuberculosis (MDR-TB) were reported worldwide in 2013, and only 20 percent of MDR-TB patients were enrolled in treatment. Through public-private partnerships in research & development, differentiated pricing and collaborations around responsible use and distribution, we are working to ensure that treatment is accessible for vulnerable populations in countries where it is approved.

In 2009, Janssen entered into an agreement with the Global Alliance for TB Drug Development (TB Alliance), a not-for-profit product development partnership, to collaborate in sharing expertise and resources. We continue to collaborate with the TB Alliance, and have granted a royalty-free license for worldwide development and access. Through continued collaboration with partners such as the TB Alliance, and through mechanisms including a royalty-free license, we are working to ensure appropriate access to medicines.

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Janssen cultivates and helps implement innovative pricing and results-based financing models that improve access to our medicines for patients in resource-limited and emerging markets. We are also creating sustainable, long-term solutions based on country ownership and accountability for both services and outcomes.

We’re working to assure sustainable access through five key elements:

1. Registration efforts prioritized by high disease burden to assure timely availability for patients in need;
2. Differentiated pricing, which balances value and innovation, as well as affordability;
3. Innovative research collaborations and access partnerships to advance new drug regimens and ensure responsible access to new healthcare solutions;
4. Post-approval commitments in R&D for continued treatment innovation including a Phase 3 program, pediatric formulation and patient registry; and
5. Support of appropriate use through responsible distribution in collaboration with international and national TB stakeholders.

In April 2014, we initiated a novel collaboration with the Stichting International Dispensary Association (IDA Foundation), a procurement agent for the Stop TB Partnership’s Global Drug Facility (GDF). Together, we are working to ensure the appropriate, responsible and rational introduction of health solutions in up to 130 low- and middle-income countries.

Our agreements and partnerships aim to improve access and advance new treatment regimens. These landmark collaborations include work with leading global health stakeholders, such as the TB Alliance and Harvard Medical School. A recent grant to Harvard aims to support a two-year research, policy and advocacy program to address significant unmet needs in drug-resistant TB. We will continue to establish additional collaborations with key stakeholders, such as the International Union Against Tuberculosis and Lung Disease, to advance public health goals.

In December 2014, we announced a Memorandum of Understanding with the United States Agency for International Development (USAID), which includes a commitment by Janssen to contribute an estimated US$30 million worth of our treatment for multi-drug resistant TB, translating into approximately 30,000 treatment courses. Collaborating with USAID to make this donation will offer Janssen the opportunity to partner around ensuring responsible and appropriate use based on USAID’s experience and best practices. In addition to bringing a much-needed treatment to people facing MDR-TB, Janssen and USAID are collaborating on this program to step up the broader fight against the health threat of antibiotic-resistant bacteria. Antimicrobial resistance – and specifically that seen in MDR-TB – is one of the world’s most serious public health threats.

In January 2013, Janssen signed an exclusive licensing agreement with Pharmstandard OJSC covering Russia, the Commonwealth of Independent States (CIS), Ukraine and Georgia. Under the agreement, Pharmstandard is responsible for the production and commercialization in these countries, including product registration with regulatory authorities and coordination with national authorities to ensure responsible and appropriate use.