The UN-backed Medicines Patent Pool (MPP) announced on 7 July new generic manufacturing licensing, for antiretrovirals (ARVs) and direct acting anti-viral (DAA) for treating hepatitis C, with seven pharmaceutical companies, six of which are Indian.
MPP signed licences with the Hyderabad-based Aurobindo Pharma and Hetero Labs, Delhi-based Emcure, Vishakapatnam-based Laurus labs, Mumbai-based Lupin Limited and Ahmedabad-based Zydus Cadila. The organisation also signed an agreement with the Chinese pharmaceutical company, Desano.
Though China is making strides in the generic-drugs market — currently, about 95 percent of Chinese Food and Drug Administration (CFDA) drug licenses are for generics and non-comparable biologics products — and is keen to capture African markets, its overall global acceptability is much lower than Indian generic drugs. According to the World Health Organization’s (WHO) 2009 year book, India had 194 drugs in the global procurement list while only six Chinese generic drugs made its way to that list.
In an attempt to bolster their overseas sales, CFDA published a draft guidance document late 2015 asking approved generic-drugs manufacturers to perform conformity assessments of their product portfolios.
Geneva-based MPP is a public health organisation —fully funded by UNITAID—that works to increase access to treatments for HIV, viral hepatitis C and tuberculosis in low- and middle-income countries. Its unique business model involves partnering with pharma companies, civil society, patient groups and others to “prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations”.
These nine new sub-licensing agreements of MPP will produce generic versions of key WHO-priority HIV treatments and hepatitis C DAA daclatasvir.
The long-time partner of MPP, Aurobindo Pharma, signed two new agreements to produce lopinavir and ritonavir for Africa for treating HIV infections, and also to produce Bristol-Myers Squibb’s (BMS’) daclatasvir. Shanghai-based Desano and Emcure would produce lopinavir and ritonavir. Hetero signed sub-licences for atazanavir-- an important second-line ARV licensed to the MPP by BMS — and raltegravira — treatment MPP licensed in 2015 from Merck & Co. in the US and Canada—which has been recently recommended by the WHO as part of second-line treatment for children with HIV of less than 10 years of age.
Laurus Labs, one of the world's leading suppliers of anti-retroviral active pharmaceutical ingredients (APIs) and intermediates, will produce MPP-licensed drug daclatasvir for treating hepatitis C virus (HCV) while Lupin, the 10th largest generic drug maker by revenue, will produce raltegravira. The Zydus group — a specialist in developing hepatitis B and C drugs — newly joined the MPP network to produce daclatasvir.
Daclatasvir is the first hepatitis C medicine in MPP’s portfolio.
HCV treatment is prohibitively high in some parts of the world — in some rich countries, the cost to treat a single patient can exceed $100,000. This is such even though approximately 130 to 150 million people are estimated to be infected with HCV every year with about 7,00,000 people dying from HCV-related complications including fatty liver (cirrhosis), cancer (hepatocellular carcinoma) and liver failure annually. The situation is particularly bad in low-and middle-income countries where people can’t access such expensive treatments even as these countries are home to the majority of HCV patients in the world.
In 2014, WHO issued its first-ever recommendations on the treatment of HCV. Since then, several new medicines have been introduced and marketed. “These (new) medicines, called direct-acting antivirals (DAAs), are more effective and easier to use than established treatment regimens,” says the WHO. After the introduction of generic versions of DAAs, the price in countries, such as in India, is less than $500 to treat a single patient.
“These new sub-licences will secure greater volumes of low-cost medicines for people living with HIV and hepatitis C in low- and middle-income countries,” said Greg Perry, MPP’s executive director.
However, the time it will take for a manufacturer to develop, register and make available a drug it has licensed from MPP will depend on the drug and the company and the stage at which the drug is at during the time of the licensing. If the generic company starts from the beginning, then it could take between two to three years for API and formulation development. On the other hand, some companies that start work ahead anticipating the licensing take much lesser time in supplying the drugs. There are still other pharmaceutical companies that have already developed a drug and the licensing helps them supply the drugs to countries where they were previously not allowed to supply.
MPP currently has 13 generic manufacturing partners working on more than 60 projects to develop crucial treatments for patients in the developing world. Its generic partners have distributed more than three billion doses of low-cost medicines to 121 countries.
The UN adopted a resolution on “Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” on 1 July, encouraging countries to make use of the flexibilities in WTO’s implementation of the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Despite objections by some developed countries, the resolution was adopted by consensus for the first time at the UN Human Rights Council.