Exclusive: Costs to public of $84,000 hep C drug ‘outrageous' - Kaiser

By Deena Beasley
LOS ANGELES  Wed Apr 2, 2014 3:41pm EDT

(Reuters) - Kaiser Permanente, the biggest U.S. health maintenance organization, said it is using Gilead Sciences' new hepatitis C drug, Sovaldi, even though its $84,000 treatment price is "outrageous."

The medication is widely viewed as a breakthrough that can cure a majority of hepatitis C patients, often within 12 weeks. Analysts project 2017 sales of $9.1 billion, according to Thomson Reuters Pharma.

But Gilead has come under fire, from insurers and Congress, for Sovaldi's $1,000-a-pill price at a time when U.S. healthcare spending is under scrutiny and President Barack Obama's Affordable Care Act aims to make health coverage accessible to everyone.

The company says Sovaldi should create huge savings for the healthcare system over time by preventing complications from liver disease and transplants, but declined requests for evidence to back up those claims. A Gilead executive told Reuters last week that it had an agreement to discount the drug for the Kaiser network, based on their recognition of the long-term benefits.

In an interview, Kaiser officials disputed that view. Kaiser is using Sovaldi "not because we see this as a high-value, cost-effective approach," said Dr. Sharon Levine, associate director of the Permanente Medical Group. "It's because this is a therapy that represents a substantial improvement over existing therapies ... It's an outrageous price for a therapy that has huge public health implications."

She called Kaiser's discount on Sovaldi "modest" and said state Medicaid programs and private health insurers "are going to have to make very serious tradeoffs just based on a single manufacturer's decision on pricing a drug because they can."

Gilead officials declined to comment.

Hepatitis C, estimated to infect about 3.2 million Americans, is a blood-borne virus that can cause severe liver damage.

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Democratic lawmakers in the House of Representatives, led by California's Henry Waxman, have asked Gilead to explain Sovaldi's pricing. The company said it met with committee staff on Monday.

The public call to Gilead from Congress has sent shock waves through the biotech investment community, raising concerns that other leading drugmakers could face pressure on pricing new medicines. Over the past month the Nasdaq Biotechnology Index has fallen more than 8 percent.

Insurers and state officials running the Medicaid health program for the poor fear a multibillion-dollar tab from Sovaldi alone.

Investment bank Leerink Partners estimates the drug's cost could trim as much as 10 percent from the earnings of publicly traded health insurers.

Kaiser, a nonprofit, said Sovaldi will be a material portion of its drug budget - a cost ultimately born by members and employers who pay insurance premiums.

"It comes back to the question of who benefits at a time when there is enormous pressure to ensure that the cost of healthcare, the cost of providing access to cures doesn't bankrupt all of the rest of the investments that the country needs to make," Levine said.

(Reporting by Deena Beasley; Editing by Michele Gershberg and Prudence Crowther)

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Gilead Announces Results From Phase 3 Study of Sofosbuvir Among Hepatitis C Patients in Japan

– Results Confirm Efficacy and Safety of All-Oral Sofosbuvir-Based Regimen for Genotype 2 HCV Patients –

– Japanese Regulatory Filing Planned for Mid-Year –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 2, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced topline results from a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection. The study met its primary efficacy endpoint of superiority compared to a predefined historical control sustained virologic response (SVR) rate. In the study, 97 percent (n=148/153) of genotype 2 HCV-infected patients receiving 12 weeks of an all-oral regimen of sofosbuvir plus RBV achieved a sustained virologic response 12 weeks after completing therapy (SVR12). SVR12 rates among treatment-naïve and treatment-experienced patients were 98 percent (n=88/90) and 95 percent (n=60/63), respectively. Of the 153 patients who received treatment, 11 percent (n=17) had documented cirrhosis.

Japan has one of the highest rates of liver cancer of any industrialized country, and the majority of cases are due to chronic HCV infection. An estimated two million people in Japan are living with HCV infection, and approximately 20-30 percent have the genotype 2 strain of the virus. Current treatment options for genotype 2 HCV infection in Japan involve up to 48 weeks of therapy with pegylated interferon injections, which may not be suitable for certain patients.

In Study GS-US-334-0118, 153 patients (100%) became HCV undetectable by treatment Week 4 and remained undetectable through the remainder of the 12-week treatment period. Post-treatment relapse accounted for five virologic failures. There were no treatment discontinuations due to adverse events and all patients completed the 12 week post-treatment follow-up visit. The most common side effects observed in the study, consistent with the population and safety profile of RBV, included nasopharyngitis, anemia, headache, malaise and pruritis. Full study results will be presented at a future scientific meeting.

“This study confirms the high efficacy of all-oral therapy with sofosbuvir among genotype 2 hepatitis C patients in Japan, regardless of whether they are treatment experienced or new to treatment,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences. “Based on these trial results, Gilead anticipates submitting a New Drug Application for sofosbuvir to the Japanese Pharmaceutical and Medical Devices Agency (PMDA) by mid-2014.”

Gilead established operations in Japan with the formation of Gilead K.K. in Tokyo in September 2013. If approved by the PMDA, sofosbuvir would be the first product to be launched and marketed by Gilead in Japan.

Gilead is also conducting a Phase 3 study in Japan evaluating the efficacy and safety of a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir 90 mg and sofosbuvir 400 mg with and without ribavirin for the treatment of patients with genotype 1 chronic HCV infection, the most common strain of HCV in Japan. SVR12 results are expected in the second half of 2014.

Sofosbuvir is an investigational product in Japan and its safety and efficacy has not yet been established. The compound has been approved by regulatory authorities in the United States, European Union and Canada and is commercialized under the tradename Sovaldi^®. The ledipasvir/sofosbuvir fixed-dose combination is an investigational product and its safety and efficacy has not yet been established.

About Gilead Sciences

Gilead Sciences 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 has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from additional clinical trials involving sofosbuvir or the ledipasvir/sofosbuvir fixed-dose combination in Japan, and the possibility we may not file for regulatory approval of sofosbuvir in Japan in the currently anticipated timelines. Further, the PMDA may not approve these products in Japan, and any marketing approvals, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2013, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Sovaldi is available at www.Gilead.com

Sovaldi is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O’Brien, Investors, 650-522-1936
Cara Miller, Media (U.S.), 650-522-1616

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Hepatitis C Drug Trials to Take Spotlight at Liver Congress

Miriam E. Tucker
April 02, 2014

New all-oral interferon-free treatment regimens for hepatitis C will take center stage at the European Association for the Study of the Liver (EASL) International Liver Congress 2014, with an unprecedented number of phase 3 trials demonstrating cure rates of up to 100%.

The congress will take place April 9 to 13 in London, United Kingdom.

"There are a lot of very important things being discussed, but I think what really stands out are the remarkable results achieved in several trials on the treatment of hepatitis C, particularly genotype 1, which is the most difficult to treat," explained Giorgina Mieli-Vergani, MD, who is honorary president of the EASL.

"Hepatitis C is a major killer in the world, and doctors have been trying for a long time to find the best way of treating it. Now we are very close to being able to treat it very effectively — this is a major, major thing coming out of this congress," Dr. Mieli-Vergani told Medscape Medical News.

In fact, "we've never had this many phase 3 studies in one conference before, said Markus Peck-Radosavljevic, MD, secretary-general of the EASL. "They will be changing clinical practice."

Dr. Markus Peck-Radosavljevic

The studies will show that "without interferon, by combining 2 or 3 drugs, you can cure hepatitis C in 95% and 99% of cases, which means essentially you can cure everybody with very little side effect," said Dr. Peck-Radosavljevic told Medscape Medical News.

Moving "Very, Very Fast"

Some of the most highly anticipated phase 3 results are from the SAPPHIRE trials, which evaluated 12-week regimens of ribavirin plus ABT-450/r, ABT-267, and ABT-333, under development by AbbVie, in patients with genotype 1 hepatitis C. SAPPHIRE I involves treatment-naïve patients and SAPPHIRE II involves treatment-experienced patients.

Also anticipated are results from the ION-2 study, which evaluated the fixed-dose combination of sofosbuvir plus ledipasvir (Gilead Sciences), with and without ribavirin, in treatment-naïve and treatment-experienced patients with genotype 1 hepatitis C.

Dr. Giorgina Mieli-Vergani

The once-daily sofosbuvir/ledipasvir pill appears to work in a short period of time in the most difficult-to-treat patients, and with far fewer adverse effects than regimens containing pegylated interferon. Dr. Mieli-Vergani called the results "amazing."

"I am a pediatrician, and this is exceedingly exciting for me," she told Medscape Medical News. "The current oral drug regimens require up to 12 pills a day, which is impossible for a child. There are no trials in children yet, but they will follow." Although hepatitis C is much less common in children than in adults, 6% to 7% of infected mothers pass along the infection to their infants, she explained.

New treatment guidelines for hepatitis C from the World Health Organization — primarily addressing the developing world — will be presented at the meeting.

Also presented will be EASL guidelines on hepatitis C. Although they were published online in December 2013, they are already outdated, Dr. Peck-Radosavljevic told Medscape Medical News (J Hepatol. 2014;60:392-420).

"Things are moving very, very fast. We will definitely need to update again within a year," he said. The organization will probably stop printing the guidelines on paper and only house them online so that they can be continually updated, he said.

Hallway Conversation

Not officially on the agenda but sure to be discussed is the high cost of new drugs for hepatitis C. "How all people who need it are going to be able to have it, I don't know," said Dr. Mieli-Vergani.

Dr. Peck-Radosavljevic pointed out that "companies have to recover their cost of development and satisfy their investors." But, he added, "you have a drug curing a deadly disease in 100% of patients. If you put that into perspective, the pricing is not outrageous."

Both he and Dr. Mieli-Vergani predict that the prices will eventually drop, as was the case with the HIV drugs.

Beyond Hepatitis C

Beyond hepatitis C, new information on numerous liver disease-related topics, including hepatitis B and D, nonalcoholic fatty liver disease, hepatocellular carcinogenesis, liver regeneration, and noninvasive assessment of liver disease, will be featured, and beginner and advanced sonography workshops will be offered.

Of note, phase 3 data will be presented on the use of obeticholic acid (Intercept Pharmaceuticals) for the treatment of primary biliary cirrhosis.

"This is a new type of drug. It's very interesting because it's the first time in many years we will have a new drug that works in primary biliary cirrhosis," said Dr. Peck-Radosavljevic.

The current treatment, ursodeoxycholic acid, has been on the market for about 40 years. "It helps, but doesn't work for all patients, so it is really quite important to have something new here," he said.

Primary biliary cirrhosis is an autoimmune liver disease of major interest to Dr. Mieli-Vergani. She is looking forward to meeting with 40 to 50 fellow members of an international ad hoc autoimmune hepatitis interest group that meets every year at the EASL and major liver meetings, she told Medscape Medical News.

"Autoimmune liver disease is a small part of the meeting, but a very intense and important part," she said.

Another "small but important" topic is children with liver disease. They are by and large surviving into adulthood now and transitioning to adult hepatology care, Dr. Mieli-Vergani explained.

"When I started doing pediatric hepatology 40 years ago, 60% of my patients died within 2 years of diagnosis. There were many conditions we didn't understand or know how to treat. Transplantation didn't exist. Nowadays, it's about 5%," she reported.

It is challenging for adult hepatologists, she said, because these patients are very different from those who develop liver disease in adulthood. In the United Kingdom, efforts have been made to ease the transition by having pediatric, adolescent, and adult specialists coordinate care for the patient during a transition period.

"Pediatrics is a very small part of the meeting, but the fact that they have me as the honorary president is a very nice sign," she told Medscape Medical News.

Dr. Mieli-Vergani reports receiving research funding from Roche, and being a consultant for Roche, Bristol Myers Squibb, and Novartis. Dr. Peck-Radosavljevic reports consulting for or receiving speaker honoraria from BMS, AbbVie, Gilead, Merck, Roche, Lilly, Bayer, Boehringer, and GlaxoSmithKline.

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Two phase III trials evaluating once-daily Simeprevir and Sofosbuvir in hepatitis C infected patients have been initiated

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that two phase III trials are recruiting patients to examine the efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in treatment-naïve and treatment-experienced patients with and without cirrhosis.

“Positive safety and efficacy results have previously been demonstrated in genotype 1 HCV infected patients with the interferon- and ribavirin free combination of simeprevir and sofosbuvir in the phase II COSMOS study. The OPTIMIST trials aim to further consolidate these data and to explore a shorter treatment duration of eight weeks to potentially further simplify this promising treatment option,” says Charlotte Edenius, EVP Development, Medivir AB

Study design
OPTIMIST-1
The first trial, called OPTIMIST-1 or TMC435HPC3017, is a phase III, open-label, randomized study investigating the efficacy and safety of simeprevir 150 mg in combination with sofosbuvir 400 mg.
The combination will be administered once daily for 8 or 12 weeks in chronic HCV genotype 1 infected patients without cirrhosis who are HCV treatment naïve or treatment experienced. This study will enroll approximately 300 patients in the U.S. and Canada.

OPTIMIST-2
The second trial, called OPTIMIST-2 or TMC435HPC3018, is a phase III, open-label, single-arm study investigating the efficacy and safety of simeprevir 150 mg in combination with sofosbuvir 400 mg.
The combination will be administered once daily for 12 weeks in HCV genotype 1 infected patients with cirrhosis who are HCV treatment naïve or treatment experienced. This study will enroll approximately 100 patients in the U.S. and Canada.

Ribavirin will not be administered in the OPTIMIST trials. The primary efficacy endpoint in each study is the proportion of patients achieving sustained virologic response 12 weeks after the end of treatment (SVR12).

For additional information, including inclusion and exclusion criteria for these trials, please visit www.clinicaltrials.gov

COSMOS study
The combination of simeprevir and sofosbuvir was previously evaluated in the phase II COSMOS trial.
The final cohort 1 study results (SVR12) in patients without fibrosis or cirrhosis (METAVIR score of F0-2) and the interim cohort 2 study results (SVR4) in patients with fibrosis or cirrhosis (METAVIR score of F3-4) from the COSMOS study were presented at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting 2013 in Washington, D.C.

Final cohort 2 results (SVR12) have been accepted for presentation at the European Association for the Study of the Liver (EASL) International Liver Congress 2014 on April 12.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 13.00 CET on 2 April 2014.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the U.S. and in March 2014 in Russia. The Committee for Medicinal Products for Human Use (CHMP) recently recommended Marketing Authorisation in the European Union for the use of Simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. An approval is expected during Q2-2014.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

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