Medicines Patent Pool Expands From HIV To Hepatitis C & TB, With 100 Projects On The Go
Executive Summary
Drugs for hepatitis C and tuberculosis are now being licensed for generic production under the aegis of the Medicines Patent Pool, which says it now has 15 generic manufacturing partners working on more than 100 projects across the hepatitis C, TB and HIV areas.
The Medicines Patent Pool, which helps negotiate voluntary licenses for the manufacture of generic versions of patented drugs for use in low- and middle-income countries, has expanded its reach beyond HIV medications to include hepatitis C and tuberculosis, and says it is “confident that we can play a role in international efforts to meet treatment goals in coming years.”
As of December 2016, the MPP’s 15 generic manufacturing partners were working on more than 100 projects to develop active pharmaceutical ingredients for more than 14 formulations and seven compounds. The 15 licensees distributed 4.7 billion doses of low-cost HIV drugs during the year, and several MPP-licensed products were registered.
The MPP, founded by the UN humanitarian agency Unitaid in 2010, “serves as an important implementer of Unitaid’s objectives through its engagement with a range of stakeholders to license key medicines for generic manufacture,” according to the pool’s annual report for 2016.
“Since 2010, Unitaid’s investments in the MPP have yielded 10.9 times the value of its initial funding through expansion of generic access in countries and subsequent price reductions of licensed products,” the report says, adding that savings from these activities are projected to reach $2.3 billion by 2028 for HIV medicines alone.
There have also been suggestions that the MPP could serve as a model for tackling health crises like antimicrobial resistance and for promoting access to essential medicines for other diseases like cancer.
The Pool Deepens
The MPP’s expansion into the field of drugs for hepatitis C and TB took off last year after receiving approval for the move from Unitaid in November 2015.
Its activities in hepatitis C began with the signing of a license and technology transfer deal with Bristol-Myers Squibb for the antiviral daclatasvir at the end of 2015, and these activities were widened in 2016 with the addition of three new licensees – Beximco (Bangladesh), Sandoz International GMBH (Germany) and Zydus Cadila (India) – bringing to 10 the number of generics companies licensed to produce the drug.
Negotiations also began with Egypt’s Pharco Pharmaceuticals for the investigational hepatitis C product, ravidasvir, which is being developed in combination with Gilead Sciences Inc.’s Sovaldi (sofosbuvir) under a collaboration with the Drugs for Neglected Diseases initiative (DNDi) and Presidio Pharmaceuticals Inc. (Also see "DNDi Adds Affordable Ravidasvir Combo To Asian HCV Trials" - Scrip, 15 Apr, 2016.)
“Licensing deals should be made public and ideally negotiated through the MPP to ensure transparency” – WHO
The MPP noted that in its first global report on access to hepatitis C treatments in October 2016, the World Health Organization confirmed that “to allow a competitive market, license agreements need to cover a broad territory, be non-exclusive, and include a number of generics-producing companies.” These agreements “should be made public and ideally be negotiated through the Medicines Patent Pool to ensure transparency, and include pro-competitive, public health-friendly terms and conditions,” the WHO report said.
Tuberculosis
In April 2016, the pool signed a memorandum of understanding with the TB Alliance to promote the development of new, faster acting treatment regimens for tuberculosis, including properly formulated products for children.
“With its strong track record in negotiating voluntary licences for HIV treatments, we believe the MPP can contribute significantly toward improving the international response to combatting TB in low- and middle-income countries,” said Mel Spigelman, CEO of the TB Alliance.
TB Alliance and the MPP will also share patent status, sales data, epidemiological and other information as well as work in consultation with other public health organizations to develop TB drug market forecasts and intelligence, according to the MPP report.
Also in 2016, the MPP conducted a study to look at how MPP licenses could help to address challenges of sustainable access to new TB drugs, especially multi-resistant disease. The study acknowledged that the “proper stewardship of new drugs must meet the twin public health goals of ensuring broad availability of new therapies while promoting their proper use to counter further resistance.”
The Medicines Patent Pool
Founded in 2010 by the UN organization Unitaid, the Medicines Patent Pool works with governments, patent holders, civil society, international bodies, patient groups and other stakeholders to prioritize and license new and existing drugs for HIV, hepatitis C and tuberculosis that are particularly needed in developing countries, based on the concept of patent pooling.
MPP licenses are non-exclusive and non-restrictive, and there are provisions for generic firms to sell the licensed products outside the agreed territory if there is no patent infringement. Terms of licenses are “fully transparent” and company patent information is publicly disclosed. Licensees are free to combine different medicines and develop appropriate fixed-dose combinations.
All MPP licenses are publicly available in their entirety on the MPP website, something the MPP describes as “unprecedented in the pharmaceutical field.”
The MPP’s originator partners and patent holders are AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Roche, Gilead Sciences, Janssen, Merck Sharp & Dohme, the University of Liverpool, ViiV Healthcare, and the US National Institutes of Health.
Its generic manufacturing partners are Aurobindo, Beximco, Cipla, Desano, Emcure, Hetero, Huahai, Laurus Labs, Lupin, Micro Labs, Mylan, Natco, Sandoz, Strides Shasun, and Zydus Cadila.
HIV Therapies
In the HIV area, the MPP last year extended the license for ViiV Healthcare’s dolutegravir to all lower middle-income countries, so that 94% of all people with HIV in developing world have access (ViiV Healthcare is a partnership between GlaxoSmithKline PLC, Pfizer Inc. and Shionogi Inc.). Dolutegravir was also prequalified (assessed for quality, safety and efficacy) by the WHO last year, less than three years after it was approved in Europe. Forecasts published in the journal PLOS One in 2016 concluded that dolutegravir would “likely be a major player among antiretroviral treatment regimens through 2025,” the report notes.
The MPP says that tenofovir alafenamide, licensed to the MPP by Gilead, “will likely witness an increasing market share. Other currently used ARVs are expected to also play a crucial role, and their continued supply will be key to sustaining international scale-up targets.“
“With increased access to viral load testing, substantially more people living with HIV could be using protease inhibitor-containing regimens as second-line treatment by 2025, mainly lopinavir/ritonavir and atazanavir/ritonavir, the report says. “Both of these treatments are licensed to the MPP for generic manufacture and supply.”
The MPP is currently leading two Paediatric HIV Treatment Initiative (PHTI) projects to improve treatment options for children and their caregivers. In collaboration with its generic partners, the report says, the pool is spearheading the development of the WHO-recommended first-line treatment for children from three to 10 years of age, ABC/3TC/EFV, as well as the development of pediatric raltegravir for infants and young children.
Products that have been licensed to the MPP since 2010: abacavir (pediatric), atazanavir, cobicistat, daclatasvir, darunavir, dolutegravir, elvitegravir, emtricitabine, lopinavir, raltegravir (pediatric), ritonavir, solid drug nanoparticle technology, tenofovir alafenamide, tenofovir disoproxil fumarate.
More Collaboration
Across HIV, TB and hepatitis, the MPP has been strengthening its collaborations with experts, civil society, patient groups and industry, and last year expanded its Expert Advisory Group to 11 new members with hepatitis C and tuberculosis expertise.
In October last year it launched a new database, MedsPal, which contains patent and licensing data on HIV, hepatitis C and TB treatments covering more than 4,000 national patent applications in more than 100 low- and middle-income countries.
In addition, the Lancet Commission on Essential Medicines Policies recognized that the MPP model “could support the international public health commitment to access to essential medicines.” The commission, a group of 21 independent experts, noted that there was “great potential for expanding access to […] new essential medicines through licensing of patents through patent pooling.”
Other public health leaders have raised the possibility of an MPP-like approach in tackling health crises, such as antimicrobial resistance (AMR), or have proposed patent pooling for oncology compounds, the report adds.
From the editors of Scrip Regulatory Affairs.