Thursday, February 6, 2014

Hepatitis C - Big Pharma pushes for U.S. action against India over patent worries

Big Pharma pushes for U.S. action against India over patent worries

February 6, 2014 4:49 AM ET

By Sumeet Chatterjee and Ben Hirschler
MUMBAI/LONDON (Reuters) - Global pharmaceutical firms are pressuring the United States to act against India to stop more local companies producing up to a dozen new varieties of cheap generic drugs still on-patent, sources with direct knowledge of the matter said.

An Indian government committee is reviewing patented drugs of foreign firms to see if so-called compulsory licenses, which in effect break exclusivity rights, can be issued for some of them to bring down costs, two senior government officials told Reuters.

The drugs that are part of the review process are used for treating cancer, diabetes, hepatitis and HIV, said the sources, declining to give details. No timeline has been given for completion of the review process.

Emerging markets, from South Africa to China and India, are battling to bring down healthcare costs and boost access to drugs to treat diseases such as cancer, HIV/AIDS and hepatitis.
Western drugmakers, including Pfizer Inc, Novartis AG, Roche Holding AG and Sanofi SA, covet a bigger share of the fast-growing drugs market in India.

But they have been frustrated by a series of decisions on patents and pricing, as part of New Delhi's push to increase access to life-saving treatments where only 15 percent of 1.2 billion people are covered by health insurance.
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Gilead In The News

Gilead to license hepatitis C drug to lower-cost manufacturers in India
Thu Feb 6, 2014 4:28am IST

(Reuters) - Gilead Sciences plans to license its breakthrough hepatitis C drug Sovaldi to a number of Indian generic pharmaceutical manufacturers, allowing for lower-priced sales of the medication in that developing nation, according to the company.

Although prices for the drug have not been set, company spokesman Nick Francis said in an emailed statement on Wednesday that Gilead aims to establish "tiered pricing."

For example, the price discussed for 24 weeks of Sovaldi therapy would run about $2,500 for certain patients at public hospitals, community clinics and non-governmental agencies in India, the Hindu Business Line reported earlier this week.

"Providing treatment in resource-limited settings presents complex challenges, and we will work with partners in multiple sectors around the world to ensure our access program reaches as many patients as possible," Francis said.
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Sovaldi sales help push revenue increases for Gilead Sciences
Boosted by a 15% increase in 2013 antiviral product sales over the previous year, Gilead Sciences announced fourth-quarter sales were up 21% from 2012 and full-year revenues improved by 15%, according to a company press release.

Gilead’s annual product sales climbed to $10.8 billion, up 15% from $9.4 billion in 2012, and the release said the company’s newest product, Sovaldi (sofosbuvir) 400 mg tablets, played a significant role in sales increases. Approved by the FDA in December, Sovaldi is indicated for use in combination with other agents for patients with chronic hepatitis C virus.

The company said Sovaldi sales were “driven by initial inventory stocking, patient demand and a clinical trial order.” Sovaldi is a once-daily oral nucleotide analog polymerase inhibitor for treating patients with HCV genotypes 1, 2, 3 or 4 infection; patients with hepatocellular carcinoma, awaiting liver transplantation; and patients coinfected with HCV/HIV-1.
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