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Regulatory News | 09 March 2015 | By Michael Mezher
A generic drug maker has launched its copy of Gilead Sciences' hepatitis C drug Sovaldi—which costs $84,000 in the US—which it will sell in Bangladesh for just $900 under the brand name Hopetavir, Bloomberg reports.
Incepta Pharmaceuticals, a Bangladeshi company, is selling a 12-week course of a generic version of Gilead Sciences' Sovaldi for $900—almost 99% less than Gilead’s US price for the drugs—and has its eye on other markets where Sovaldi is not patented.
Sovaldi made headlines in 2014 for both its significant improvement over previous treatments for hepatitis C (HCV) as well as its price tag. At its launch, Sovaldi was priced at $84,000 in the US, a figure that drew the attention of US lawmakers and payer groups. Prices for Sovaldi vary by market; in Germany and the UK the drug launched at the equivalent of $66,000 and $57,000, respectively.
In September 2014, Gilead said it would license Sovaldi to multiple generic manufacturers in India. The licensing agreement would allow the generic manufacturers to market Sovaldi in India and 90 other low- and middle-income countries. Gilead has said it will price Sovaldi at $900 in India, though licensed generics could sell for less.
Some have criticized Gilead’s licensing practices, which leave out a number of countries where HCV is prevalent, including Brazil and Thailand.
Bloomberg is reporting that the World Health Organization (WHO) is considering reviewing Hopetavir under its prequalification program, which could make the drug available in countries where Sovaldi lacks patent protection, and to humanitarian groups such as Médecins Sans Frontières (MSF).
Abdul Muktadir, managing director at Incepta, told Bloomberg his company “should be able to launch [Hopetavir] wherever it is required … in Africa, and some of the Southeast Asian countries.” He also said that the drug will probably not be a big profit source for the company, and expects prices to come down over time.
Bangladesh is a member of the World Trade Organization (WTO), where it is classified as a least-developed country (LDC).
WTO members are required to abide by the requirements in the agreement on Trade-Related Aspects of Intellectual Property (TRIPS), which include recognition of patents for pharmaceutical products. However, LDCs were given longer to comply with the pharmaceutical provisions in TRIPS. Presently, the TRIPS Council is giving LDCs until 1 July 2021 to meet their obligations to provide intellectual property protection for pharmaceuticals, though LCD members are looking to extend the transition period for more time.
Tags: Gilead, Sovaldi, Sofosbuvir, Bangladesh, Hopetavir