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MSF response to Gilead announcement on inclusion of hepatitis C drug GS-5816 in voluntary licence

GS-5816 is an important anti-hepatitis C compound that, in combination with sofosbuvir, will greatly simplify treatment for developing countries. However, it appears that none of the terms and conditions of the original licence agreement has been changed, meaning that the concerns that MSF has with the licence agreement remain, including the limited geographic scope of the agreement, restrictions on the production and export of active pharmaceutical ingredient, and the inclusion of an ethically and medically controversial and problematic anti-diversion clause.

Published
27 January 2015
From
Médecins Sans Frontières press release
Gilead Expands Hepatitis C Generic Licensing Agreements to Include Investigational Pan-Genotypic Agent

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. The expanded agreements will allow Gilead’s India-based partners to manufacture GS-5816 and the single tablet regimen of sofosbuvir/GS-5816, once approved, for distribution in 91 developing countries, which together account for 54 percent of the total worldwide population of individuals infected with the hepatitis C virus (HCV).

Published
27 January 2015
From
Gilead press release
German insurers win discounts on Gilead's Sovaldi

The head of Gilead's German operations told the magazine that discounts from the list price of 60,000 euros (44,867 pounds) per treatment had been negotiated with four of Germany's statutory health insurers but declined to give the size of the discounts.

Published
26 January 2015
From
Yahoo News
Merck discontinues Victrelis (boceprevir) voluntarily in the United States

Merck has decided to voluntarily discontinue the manufacture and distribution of Victrelis in the United States by December 2015.

Published
21 January 2015
From
EATG
Vertical transmission of HCV: The next big treatment frontier

Novel antiviral therapies with overwhelmingly positive sustained virologic response rates have dominated headlines in hepatitis C virus for the past few years, but many experts said eradication efforts may never completely succeed until the clinical community deals with mother-to-baby transmission of the disease.

Published
20 January 2015
From
EATG
UNITAID publishes comprehensive review of detection and monitoring technologies for hepatitis C

Diagnosis and screening currently too complex and expensive, but new options emerging.

Published
20 January 2015
From
UNITAID press release
Gilead and AbbVie take hepatitis C battle to Europe

Europe is to become the next battleground between Gilead Sciences and AbbVie in their scramble to win share of the fast-growing market for hepatitis C drugs. The companies have been fighting a high-profile price war in the US over a new generation of blockbuster medicines that can cure most people with the virus within weeks. The pair are preparing to open a new front across the Atlantic after European regulators gave AbbVie’s hepatitis C treatment the green light on Friday.

Published
20 January 2015
From
Financial Times (free registration required)
How India's Patent Office Destroyed Gilead's Global Game Plan

Sovaldi is a breakthrough drug. Shouldn't that be worth something? "It's important to recognize that what the patent office deals with is whether something is new in science," lawyer Tahir Amin said. "The decision says there are a number of earlier compound structures that are very close to what Gilead is trying to get a patent for. It's a scientific decision and has nothing to do with the utility of the drug."

Published
19 January 2015
From
Bloomberg Businessweek
The Cynical Connectedness of Gilead's Hepatitis C Pricing and Anti-Diversion Policies

Gilead has announced both the highest recorded prices ever for its direct acting hepatitis C antiviral, ledipasvir/sofosbuvir (Harvoni), and one of the most stringent anti-diversion programs ever devised. The price, highest in the U.S., comes in at a whopping US$94,000 for a 12-week course of treatment, with slightly lower prices in Europe.

Published
19 January 2015
From
The Body Pro
Hepatitis C drug delayed by NHS due to high cost

The NHS is to delay the introduction of a highly expensive drug that can save the lives of people infected with the hepatitis C virus. The move by NHS England is unprecedented, because the NHS rationing body, Nice (the National Institute for Health and Care Excellence) has approved the drug. Nice says sofosbuvir is cost-effective, because it is a cure for people who would otherwise run up huge NHS bills.

Published
16 January 2015
From
The Guardian
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