March 31, 2014

WHO to launch first-ever guidelines on hepatitis C treatment

07:30 - 08:30, Thursday, 10 April 2014

The International Liver Congress 2014, London ExceL, United Kingdom

The Global Hepatitis Programme is organizing a satellite session on the launch of the first-ever WHO guidelines for Hepatitis C treatment.

The satellite session will focus on evidence, recommendations and implications with a line-up of speakers from the Burnet Institute, Médecins Sans Frontières, the World Hepatitis Alliance and WHO.

The session will be held at the upcoming International Liver Congress 2014 in London on 10 April. The Congress will take place from 9-13 April 2014.

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Flyer of the event pdf, 50kb

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March 31, 2014 12:59 PM Eastern Daylight Time

MONTREAL--(BUSINESS WIRE)--New hepatitis C (HCV) treatment regimens have advanced rapidly in recent years, including the recent Health Canada approval of interferon-free therapy. To support patients to access these newest options, Pendopharm, a division of Pharmascience Inc., today announced that it has received a Priority Review designation from Health Canada for the first stand-alone ribavirin tablet for the Canadian market.

“New HCV treatment regimens, specifically in genotypes 2 and 3 where we can now eliminate interferon, have the potential to transform HCV treatment in Canada”

In Canada, ribavirin, a component of the current standard of care for the treatment of HCV, is only approved in a format that is co-packaged with pegylated interferon. As such, Pendopharm has sought Health Canada approval of the first stand-alone ribavirin to support the treatment of HCV. Health Canada has granted Pendopharm a Priority Review given the need for single-agent ribavirin in new and evolving HCV treatments.

Gilead Sciences Canada, Inc.’s Sovaldi® (sofosbuvir), the most recent HCV treatment to receive a Notice of Compliance from Health Canada, is the first treatment regimen that now allows some patients to eliminate interferon entirely. Sovaldi is a once-daily direct-acting antiviral agent for the treatment of genotypes 1 and 4 in combination with pegylated interferon and ribavirin, and in genotypes 2 and 3 in combination with ribavirin alone. Patients with genotypes 2 and 3 represent an estimated 30 per cent of HCV cases in Canada.

Responding to Patient Treatment Needs

Pendopharm and Gilead Sciences share a mandate to address medical areas of high unmet need and burden of illness, as well as to improve the quality of life of patients. “Pendopharm and Gilead Sciences are pleased to be part of the solution to bring the newest HCV interferon-free treatment regimens to physicians and patients,” commented Élise Vézina, Vice President and Division Head, Pendopharm, and Edward Gudaitis, General Manager, Gilead Sciences Canada, Inc. “Upon Health Canada approval of our ribavirin, we will work diligently with provinces to support timely access for patients,” added Ms. Vézina.

Hepatitis C is an emerging and costly public health issue, but many Canadians are not aware that HCV can be cured. It is estimated that more than 250,000 Canadians have chronic hepatitis C infection. Hepatitis C is the leading cause of liver cancer and liver transplantation in Canada. Combined with the indirect costs of HCV, the financial burden of the disease in Canada is estimated at $500 million annually.1

“New HCV treatment regimens, specifically in genotypes 2 and 3 where we can now eliminate interferon, have the potential to transform HCV treatment in Canada,” said Jordan Feld, MD, MPH, Staff Hepatologist, Toronto Western Hospital, Department of Medicine, Division of Gastroenterology. “Interferon has been the main stumbling block to treatment in the past. New regimens without interferon are a huge advance, giving us higher cure rates and shortened treatment duration with a lot fewer side effects. This gives us our best opportunity to successfully treat and cure Canadians with hepatitis C,” added Dr. Feld.

Company Information

Pendopharm is a division of Pharmascience Inc., a Canadian privately-owned company. Established in 1983, Pharmascience Inc. is the largest pharmaceutical company in Quebec, with a highly-skilled workforce of 1,300 people. It commercializes nearly 300 products, including branded prescription, OTC and BTC products as well as generic products in Canada and with its affiliates and distributors in Europe, Asia, Middle East, Africa and Oceania.

Strategically committed to growth, Pendopharm (www.pendopharm.com) is actively engaged in licensing, partnering, developing and marketing late-stage specialty prescription medicines as well as consumer brands.

Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead Sciences has operations in North and South America, Europe and Asia Pacific. Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario in 2005.

References:
1. Public Health Agency of Canada. The Evaluation of Hepatitis C http://www.phac-aspc.gc.ca/publicat/2008/er-re-hepc/er-re-hepc1-eng.php. October 17, 2013.

Contacts

Pendopharm
Élise Vézina, 514-340-9800 ext. 3482

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Gilead says has discounted hepatitis C drug for some health plans

By Deena Beasley
Sat Mar 29, 2014 12:13pm EDT

(Reuters) - Gilead Sciences Inc, under fire for pricing a new hepatitis C drug at $1,000 a pill, has discount agreements with a number of health insurers, a company executive said in an interview.

The medication, Sovaldi, has a list price of $84,000 for a 12-week course of therapy and is seen as a breakthrough in the treatment of the serious liver disease.

It has been shown to raise cure rates and cut treatment time with fewer side effects than older medicines, but critics maintain that a price of $1,000 each is too high for an easy-to-make pill needed by millions of Americans.

On March 20, Democratic lawmakers led by California Representative Henry Waxman asked Gilead to explain the price tag, and a meeting with the company is scheduled for next week.

Health insurers and state Medicaid programs for the poor are pushing for further discounts, fearing a multibillion-dollar pricetag from treating most hepatitis C sufferers with Sovaldi and similar new medicines likely to be approved in coming years.

Gilead shares have dropped 9 percent in the last week on concerns over the pushback on drug pricing. The news has also weighed on other biotechnology companies that are banking on their ability to command high prices for new treatments.

"It's the volume (of patients) payers are looking at here. It's not the price," said Gregg Alton, Gilead's executive vice president, corporate and medical affairs. "A lot of them are looking for a discount, but I think the real issue here is how many patients they now have in their plans that need hepatitis C treatment."

The Centers for Disease Control and Prevention estimates that about 3.2 million Americans are infected with hepatitis C, a liver-destroying virus transmitted through blood.

If each were treated with full-priced Sovaldi, the cost would be $269 billion. Gilead already provides a mandated discount off its list price to U.S. government health plans and insurers at about 23 percent.

Alton said the company has deals for "supplemental discounts" for government-funded agencies such the Veterans Administration and the Department of Defense, on top of the 23 percent. He would not provide details.

He said the VA, which accounts for about 10 to 15 percent of the hepatitis C population in the United States, has been "proactive" in recognizing the need to treat the disease, which can lead to liver failure and necessitate liver transplants.

He estimated that patients eligible for Medicaid, the government-funded health plan for the poor, account for another 10 to 15 percent of Americans with hepatitis C.

Alton singled out health maintenance organization Kaiser Permanente for taking action to secure Sovaldi, also at a discount, for its patients.

"We have an arrangement with Kaiser that works very well for both of us," the Gilead executive said. "They recognize that if they make the investment today, they get all the benefit."

He said that is because many Kaiser patients stay for many years with the organization known for quality, integrated care, even into retirement when they qualify for a managed Medicare plan. So Kaiser's upfront investment treating hepatitis C will pay off years later by averting future costs of liver disease. Kaiser officials were not immediately available for comment.

But many traditional insurers can't rely on the same kind of stability among their policyholders, who tend to switch health plans more frequently, meaning they cannot be sure of the same savings over time.

"One of the challenges we have with some insurers is that the benefits may not come to them," the Gilead executive said. "No matter how we price this product, the benefits and the savings are going to come later."

Alton also sees the concerns over a deluge of patients demanding immediate treatment as unlikely to materialize.

"Most of the patients are not diagnosed, and many aren't seeking care currently," he said. "This is going to take some time."

ISI Group analyst Mark Schoenebaum noted on Friday data showing that new prescriptions of Sovaldi had dropped 5 percent in the past week. He estimated that Gilead's 2014 U.S. sales of Sovaldi, which was approved by the Food and Drug Administration late last year, will total as much as $9 billion even if it sees no new prescription growth.

(Reporting By Deena Beasley; Editing by Michele Gershberg, Tom Brown and David Gregorio)

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