Unitaid welcomes sub-licenses to make hepatitis C drug widely available

UNITAID welcomes agreements to manufacture a key Hepatitis C medicine and make it available in many low- and middle-income countries.

The Medicines Patent Pool (MPP), which is fully funded by UNITAID, signed licenses for the generic production of Bristol-Myers Squibb’s daclatasvir with four generic companies – Cipla, Emcure, Hetero and Natco.

Between 80 and 156 million people worldwide are estimated to have Hepatitis C. This includes many people in Africa, Central and East Asia. “Making daclatasvir widely available in Africa and Asia is important to simplify diagnosis and treatments, as combinations with daclatasvir are effective against all genotypes of the Hepatitis C virus,” said Lelio Marmora, Executive Director of UNITAID. “These licenses will help countries that have limited resources, and I am delighted that UNITAID has helped to make this possible.”

These agreements follow an earlier license signed on 23 November 2015 between Medicines Patent Pool and Bristol-Myers Squibb. The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries.

For more information, view the press release here.

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The Medicines Patent Pool signs license with Bristol-Myers Squibb to increase access to hepatitis C medicine Daclatasvir

The royalty-free agreement allows manufacturers to develop daclatasvir for 112 low- and middle-income countries.

The Medicines Patent Pool (MPP) today announced its first licence for a hepatitis C medicine, signing an agreement with Bristol-Myers Squibb for daclatasvir, a novel direct-acting antiviral that is proven to help cure multiple genotypes of the HCV virus. The royalty-free licence will enable generic manufacture of daclatasvir for sale in 112 low- and middle-income countries (LMICs), 76 of which are World Bank classified middle-income nations. Nearly two-thirds of all patients living with hepatitis C in the LMICs reside in the territory covered by this agreement.

Hepatitis C is a major public health threat affecting up to 150 million people globally, with the vast majority living in low- and middle-income countries. Earlier this year the World Health Organization added several new hepatitis C treatments, including daclatasvir, to its Essential Medicines List, underscoring the urgent need to promote equitable access to innovative medicines.

“This agreement could change the lives of millions of people with hepatitis C,” said Dr. Margaret Chan, WHO Director-General. “It’s a vital step towards ensuring essential treatments are available to all who need them, both rich and poor.”

“The licence comes shortly after the MPP announced its mandate expansion into the area of hepatitis C and on the heels of a six-month dialogue with patient groups, civil society and other stakeholders on best approaches to improving access to new curative HCV solutions,” said Greg Perry, Executive Director of the MPP. “Thus, we believe the licence takes into consideration the concerns of patient advocates who have been campaigning for some time for new life-saving innovations such as daclatasvir to reach more people quickly.”

“We are very pleased to see that the recent decision of the UNITAID board to support the work of MPP in the HCV space has made possible the conclusion of an agreement opening the way to wider access to effective medicines against HCV among those in need,” said UNITAID’s Deputy Executive Director, Philippe Duneton.

MPP and Bristol-Myers Squibb have joined together previously, having negotiated an agreement in December 2013 for the Bristol-Myers Squibb HIV medication atazanavir. The daclatasvir agreement allows for manufacturers to be based anywhere in the world; generic daclatasvir can be made in any country as long as it is for sale in the 112 countries covered by the agreement. Importantly, the licence allows generic manufacturers to develop fixed-dose combinations with other direct-acting antivirals to create powerful pan-genotypic regimens that offer the potential to treat all of the six major genotypes of HCV. Pan-genotypic regimens are crucial in resource-limited countries where access to genotype testing is limited. Bristol-Myers Squibb will provide a technology transfer package and information needed for the manufacture and registration of the product.

“This agreement with the MPP is an important component of Bristol-Myers Squibb’s overall global efforts to make daclatasvir broadly available to patients around the world to help eliminate HCV,” said Amadou Diarra, Head of Global Policy, Advocacy & Government Affairs, Bristol-Myers Squibb. “We are pleased to work with the MPP in this collaborative effort.”

Daclatasvir, a once-daily, all oral treatment, inhibits HCV by targeting a key protein, NS5A, involved in the replication of the virus. Daclatasvir, in combination with sofosbuvir, produces high cure rates after 12 weeks of treatment, even among HIV/HCV co-infected patients. Recent Phase III studies demonstrated that the daclatasvir regimen could cure up to 100% of HCV patients depending on genotype and stage of liver disease.

“BMS should be congratulated for their strong commitment to patient access and for sharing their IP and technology so widely. We will continue to work with the company to review access needs for daclatasvir,” concluded Perry.

The full MPP licensing agreement is available here.

About the Medicines Patent Pool

The Medicines Patent Pool is a United Nations-back public health organisation working to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with six patent holders for twelve HIV antiretrovirals and for one hepatitis C direct-acting antiviral. Its generic partners have distributed more than three billion doses of low-cost medicines to 117 countries. The MPP was founded and remains fully funded by UNITAID.

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Unitaid sees access to hepatitis C treatments and diagnostics as top priorities

World Hepatitis Day

As World Hepatitis day is marked this year we can celebrate that a cure is available for hepatitis C, a condition often leading to fatal liver disease if left untreated. The biggest challenge now is to find effective tests to diagnose those infected and to make curative medicines affordable and accessible to those in need.

UNITAID  is working with partners on both fronts to help find a solution, as the World Health Organization calls for stepped up diagnosis and treatment. Up to 180 million people worldwide are infected with hepatitis C.

This year UNITAID launched a project with Médecins sans Frontières to demonstrate that wide scale hepatitis C treatment is viable. It will help overcome market-based obstacles to gaining access to the medicines, such as the lack of in-country registration of the new medicines in low- and middle-income countries where three-quarters of those infected are found. Programmes to screen, diagnose and treat patients will also be encouraged.

The investment will catalyse wide scale demand for new highly-effective medicines and aims to reduce the cost of a treatment to US$ 500-1000, a fraction of what many have to pay today, by facilitating generic production and negotiating lower prices with manufacturers.

UNITAID also recently initiated a search for new diagnostic technologies that will target an estimated 5 million people globally with HIV co-infection – 16 percent of all people living with HIV — who are especially at risk of developing serious liver disease.  Existing diagnostics are unreliable with the result that millions of people who are infected with hepatitis C go undiagnosed.

New investments in this area are expected to be announced by UNITAID later this year.

UNITAID identifies new areas for investment through continuous dialogue with countries and other global health partners to understand real challenges on the ground in tackling the diseases, and by tracking emerging potential solutions.

UNITAID will shortly publish new reports assessing the patent landscape of some key medicines for hepatitis C that are in the pipeline.  UNITAID published the first ever comprehensive report on hepatitis C diagnostics in January this year, followed by a report on hepatitis C medicines in February.

Solutions identified to enable affordable medicines for hepatitis C, Unitaid new report highlights

UNITAID signs grant with MSF to spur action.

UNITAID’s newly published analysis on the rapidly changing medicines market for hepatitis C [PDF, 2 MB] indicates four routes by which recently developed but currently prohibitively expensive medicines can be made affordable and available for widespread use.  There are up to 150 million infected worldwide with this curable disease, and up to 700,000 deaths each year from related liver disease.  The new medicines could be game-changers for the fight against the disease if made widely available.  UNITAID has already started working with Médecins Sans Frontières (MSF) to demonstrate the feasibility of treating hepatitis C with these new medicines in resource limited settings, including through reducing prices.

The UNITAID report highlights interlinked ways this price reduction gridlock can start to be unblocked, and where global efforts for the disease should concentrate in 2015: the terms of voluntary licenses for generic production must be improved, and,  more middle income countries should be included;  the advocacy which began last year must continue, especially to call for more donor funding, further price reductions, and the rejection of “evergreening patents” on these medicines;  improved diagnostic capabilities are needed to identify many more of those in need and build reliable data to inform on the size of the need, through introducing and scaling up access to more effective and affordable diagnostic devices which can be used where patients are found;  and efforts to demonstrate the viability of testing and treating on a large scale must be pushed.

The new UNITAID work with MSF will start to address this gridlock. Through MSF, patients will be screened, diagnosed and treated in India, Iran, Kenya, Mozambique, Myanmar, Uganda and Ukraine to catalyse demand for newly-available medicines. MSF will document feasible, simplified models of care that can be built into global normative guidance and national policies; they will also work with researchers to understand the production costs to support negotiations for lower prices and stimulate entry of generic manufacturers.

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World Hepatitis Day: Why Unitaid is investing in hepatitis C

Today is World Hepatitis Day, an important occasion to raise awareness about viral hepatitis, which kills close to 1.4 million every year. This year, World Hepatitis Day is particularly important for UNITAID.

UNITAID has already committed almost $2 billion to fighting HIV/AIDS, malaria and tuberculosis, but in May 2014 it made its first investments in addressing the Hepatitis C virus (HCV). These interventions will result in significant price reductions for drugs and increase access to desperately needed diagnostics (see below) for millions of people.

What is Hepatitis C and why is UNITAID investing?

An estimated 150-180 million people worldwide are infected with HCV and up to 500,000 die every year. HCV is bloodborne virus that begins in an acute phase and leads to a chronic infection in the great majority of cases. For those with chronic infections, HCV evolves slowly, attacking the liver and often resulting in liver cirrhosis or liver cancer.

Those co-infected with HIV and HCV are particularly vulnerable. HIV speeds the progression of HCV and people with both infections are much more likely to develop life-threatening diseases. Approximately 16% of the HIV-infected population is co-infected with HCV. To tackle this global challenge of co-infection, UNITAID’s new Strategy 2013-2016 specifically identified HCV and other HIV co-infections as a target for market-shaping interventions.

Why is a market shaping approach needed?

Until recently, the only HCV cure involved a combination of injections and oral tablets; the treatment lasted nearly a year. In addition to having limited efficacy, this regimen caused serious side effects that deterred patients from finishing the full course of treatment. New HCV medicines are available or poised to enter the market: they work more quickly and effectively than current regimens. Approximately 10 of these drugs have reached an advanced stage in clinical trials.

In December 2013, the US Food and Drug Administration (FDA) approved the first pill that may not require weekly interferon injections. At the end of 2013, this medicine cost $84,000 for a 12-week course. While pharmaceutical companies are likely to offer the world’s poorest countries a discounted price, they will not do the same for the middle-income countries where an estimated 75% of those infected with HCV live.

What is UNITAID doing?

In early May, UNITAID agreed to fund two revolutionary grants, which constitute the first major global action toward making these new HCV treatments available in low- and middle-income countries. These investments should lead to substantially larger HCV cure rates for people living with HIV. Importantly, these grants will also provide the evidence needed to define the best treatment package for HCV.

Up to $15 million to Médecins Sans Frontières (MSF) has been committed to reduce barriers in product markets to enable improved treatment of HCV in low- and middle-income countries. Patients will be screened, diagnosed and treated in India, Iran, Kenya, Mozambique, Myanmar, and Ukraine to catalyse demand for newly-available medicines. MSF anticipates that this will help to reduce the price to $500-1000 per treatment course by the end of the intervention through negotiations and entry of new generic manufacturers. This grant will also provide a model of simple and low-cost HCV care for people living in low-resource settings.

Another grant of up to $5.2 million was committed to French NGO Coalition Internationale Sida to work with partners in Brazil, China, Ecuador, Egypt, Georgia, Indonesia, Malaysia, Morocco, South Africa, Thailand and Ukraine to advance access to new treatments for HCV for HIV co-infected patients.

UNITAID is committed to continue additional investments in market-shaping interventions for HCV.

What remains to be done for low-income populations affected by HCV?

The vast majority of people infected with HCV are unaware of their status because the initial stages of infection have no symptoms. Moreover, testing and monitoring for HCV is currently complicated and expensive, involving a set of initial and confirmatory tests that are difficult to perform in resource-limited settings. Patients then need to be monitored during and after their treatment using RNA tests.

Similar challenges exist with HIV viral load testing, the WHO-recommended approach to monitor treatment efficacy for those on HIV antiretrovirals. As with HIV viral load testing, new point-of-care diagnostic tests for HCV are emerging that could increase access in low-income communities. As HCV treatment becomes more effective and hopefully more affordable, testing and monitoring must follow with simpler device