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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
22 hours ago
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
22 hours ago
From
Gilead press release
Merck (MRK) Receives Positive CHMP Opinion for Dutrebis as HIV 1 Treatment

On 22 January 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Dutrebis, 150 mg lamivudine/300 mg raltegravir, film-coated tablet intended for the treatment of human immunodeficiency virus (HIV 1) infection in adults, adolescents, and children.

Published
26 January 2015
From
Street Insider
Ahead of Obama visit, MSF warns US pressure on India could impact access to medicines for millions

New intellectual property ‘think tank’ draft policy already showing alarming trend.

Published
23 January 2015
From
Medecins Sans Frontieres press release
Peru: Patients Demand End to Monopoly on HIV Medication

Julio Cesar Cruz is an HIV patient and organizer with the Peruvian Network of Patients and Consumers . He participated in the demonstration and explained that, “The people who live with HIV in the country, are complaining that the Peruvian state is ...

Published
21 January 2015
From
TeleSUR
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
How Much Could AbbVie Inc. Make Selling Its Hepatitis C Drug This Year?

AbbVie has issued its guidance for 2015, and that guidance suggests that its newly launched hepatitis C drug cocktail, Viekira Pak, could be a big driver of earnings growth this year. In December, Viekira Pak received FDA approval as a treatment for hepatitis C genotype 1 after delivering compelling functional cure rates in the mid-90% range during clinical trials. That approval was highly anticipated by health care payers desperate for competition in this market, because hepatitis C market share leader Gilead Sciences' two hepatitis C drugs, Sovaldi and Harvoni, carry eye-popping price tags that are translating into billions of additional dollars in health care spending.

Published
15 January 2015
From
The Motley Fool
India rejects Gilead's Hepatitis C drug patent request

India's patent office has rejected an application from U.S.-based Gilead Sciences Inc for its hepatitis C drug Sovaldi, paving the way for local drugmakers to launch cheaper generic versions of the $1,000-a-pill medicine.

Published
14 January 2015
From
Reuters
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