January 17, 2014

European Commission Grants Marketing Authorization for Gilead’s Sovaldi® (Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection

Gilead

– Sovaldi Approved For Use in Genotypes 1-6 –

– High Cure Rates and Shortened, 12-Week Course of Therapy for Treatment-Na├»ve Patients –

– First All-Oral Treatment Option for Patients Who Cannot Take Interferon –

– First Regimen for Patients Awaiting Liver Transplantation to Prevent HCV Recurrence –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 17, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Sovaldi® (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection in adults, in combination with other antiviral agents (ribavirin (RBV) and pegylated interferon alpha (peg-IFN)). Today’s marketing authorization follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest, and allows for the marketing of Sovaldi in all 28 countries of the European Union (EU).

Sovaldi has been studied in hepatitis C virus (HCV) genotypes 1-6. The efficacy of Sovaldi has been established in patients with genotypes 1-4, in those awaiting liver transplantation and those with HCV/HIV-1 co-infection. The clinical data supporting the use of Sovaldi in patients with genotypes 5 and 6 is limited. Recommended regimens and treatment duration for Sovaldi combination therapy in HCV mono-infected or HCV/HIV-1 co-infected patients follow:

         
Patient population   Treatment   Duration
Genotype 1, 4, 5 or 6 CHC  

Sovaldi + RBV + peg-IFN

  12 weeks
  Sovaldi + RBV

 

Only for use in patients ineligible
or intolerant to peg-IFN

  24 weeks
Genotype 2 CHC   Sovaldi + RBV   12 weeks
Genotype 3 CHC   Sovaldi + RBV + peg-IFN

Sovaldi + RBV

  12 weeks

24 weeks

Patients with CHC

awaiting liver transplantation

  Sovaldi + RBV   Until liver transplantation

Monotherapy is not recommended. The Summary of Product Characteristics is available at www.ema.europa.eu.

“Unlike many chronic diseases, hepatitis C can be cured. However, for a number of reasons, many HCV patients have not currently achieved a cure and often progress to end-stage liver disease or liver cancer,” said Graham Foster, MD, Professor of Hepatology, Queen Mary University of London. “With high cure rates across a broad range of patients and a short duration of therapy, Sovaldi is a very welcome therapeutic advance that will increase the number of patients who can be treated and ultimately cured.”

Approximately nine million people in Europe are infected with HCV, a major cause of liver cancer and liver transplantation. The societal, clinical and economic burden of untreated HCV is substantial, with HCV-related healthcare costs directly related to disease severity. The current standard of care for HCV involves up to 48 weeks of therapy with a peg-IFN/RBV-containing regimen, which may not be suitable for certain types of patients.

“The marketing authorization of Sovaldi is an important step forward in the management of hepatitis C in Europe, enabling many more patients the opportunity of cure,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “We are committed to working with local governments and health systems to make Sovaldi available in Europe as quickly as possible.”

The European Commission marketing authorization for Sovaldi is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION in which 12 or 16 weeks of Sovaldi-based therapy was found to be superior or non-inferior compared with the currently available treatment options RBV/peg-IFN or historical controls, based on the proportion of patients who had a sustained virologic response (where HCV becomes undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. Trial participants taking Sovaldi-based therapy achieved SVR12 rates of 50-90 percent. For full study details, see the Summary of Product Characteristics at www.ema.europa.eu.

During the regulatory review, data from two additional Phase 3 studies, VALENCE and PHOTON-1 were added to the marketing authorization application. In the VALENCE study, patients with genotype 3 HCV infection were treated with Sovaldi and RBV for 24 weeks. The PHOTON-1 study evaluated Sovaldi and RBV for 12 weeks in patients with genotype 2 or 3 HCV infection co-infected with HIV-1 and for 24 weeks in patients with genotype 1 HCV co-infected with HIV-1. In all Phase 3 studies of Sovaldi, no viral resistance to the drug was detected among patients who relapsed following completion of therapy.

To date, nearly 3,000 patients have received at least one dose of Sovaldi in Phase 2 or 3 studies. Sovaldi was well tolerated in clinical studies. Adverse events were generally mild and there were few treatment discontinuations due to adverse events. The most common adverse events occurring in at least 10 percent of patients were consistent with the safety profiles of peg-IFN and RBV and included fatigue, headache, nausea, insomnia, dizziness, pruritis (severe itching) and anemia.

Sovaldi was approved in the United States on December 6, 2013 and in Canada on December 13, 2013. Applications are pending in Australia and New Zealand, Switzerland and Turkey.

Important Safety Information

Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use: The summary of product characteristics of co-prescribed medicinal products should be consulted before starting therapy with Sovaldi. When Sovaldi is used in combination with RBV or peg-IFN/RBV, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment as recommended in the Summary of Product Characteristics for ribavirin. Refer to the Summary of Product Characteristics for ribavirin for additional information.

Use with potent P gp inducers: Medicinal products that are potent P glycoprotein (P gp) inducers in the intestine (e.g. rifampicin, St. John’s wort [Hypericum perforatum], carbamazepine and phenytoin) may significantly decrease Sovaldi plasma concentration leading to reduced therapeutic effect of Sovaldi. Such medicinal products should not be used with Sovaldi.

For the Summary of Product Characteristics please visit www.ema.europa.eu.

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 risk that physicians and patients may not see advantages of Sovaldi over other therapies and may therefore be reluctant to prescribe the product and the risk that government reimbursement and pricing approval may take longer than anticipated. In addition, pending marketing applications for Sovaldi in other territories may not be approved in the currently anticipated timelines or at all, and marketing approval, 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.

Sovaldi is a registered trademark of Gilead Sciences, Inc., or its related companies

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 (650) 574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O’Brien (Investors, U.S.)
+1 650-522-1936
or
Cara Miller (Media, U.S.)
+1 650-522-1616
or
Arran Attridge (Media, Europe)
+44 208 587 2477

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The price and cost of hepatitis C treatment

Provided by Family Practice News

By: CHRISTOPHER MOORE, M.D., AND STEVEN FLAMM, M.D.

01/16/14

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Dr. Christopher Moore

Chronic hepatitis C virus (HCV) infection is a major cause of liver disease affecting 180 million people globally. HCV infection, both silent and slow in its revelation, and devastating in its complications, has been described as a "viral time bomb." In December 2013, the Food and Drug Administration approved sofosbuvir, a nucleotide NS5B polymerase inhibitor, given compelling evidence that when taken with pegylated interferon-alfa and ribavirin for genotype 1 or 4 (for 12 weeks) or with ribavirin for genotype 2 (for 12 weeks) or 3 (for 24 weeks), sustained virologic response (SVR) rates are excellent, with very limited side effects.

The excitement has been tempered by the knowledge that sofosbuvir alone is priced at approximately $80,000 for a 12-week course. This cost is beyond the means of many individuals in countries with affluent economies, even with insurance and/or patient assistance programs, and vastly beyond those of developing countries – where HCV infection is most burdensome. It should be noted that the cost of therapy with high SVR rates may greatly offset the price required to manage the long-term complications and indirect effects of chronic HCV infection. And further, since the treatment is shorter than in the past and since the regimen has far fewer side effects, the overall cost of therapy may be similar to that of first-generation protease inhibitor–based regimens that constituted the standard of care for genotype 1 previously. With that said, idealized studies have shown that generic sofosbuvir–based regimens could be priced substantially lower.

The query "why must it cost so much?" articulates traditional concerns of the public and its advocates who feel confusion, cynicism, and anger at corporate strategies. As physicians and fellow citizens, armed with both Hippocratic and democratic principles, we immediately identify with these positions. Yet, we would also urge restraint in attempting traditional actions, such as government fiat, that would seek to arbitrarily lower price.

The concepts "price" and "cost" are commonly conflated: The former is the amount a buyer, or third party, is willing to pay the seller; the latter is the amount it takes to bring that good or service to market. The pharmaceutical industry is straddled with high fixed costs of production (research and development) and aggressive FDA regulatory control over efficacy and safety. Prices attempt to recapture cost and justify the risk of initial investment. Generic drug replication does not embody these extreme costs that are partially reflected in lower prices.

Nevertheless, it is hoped that price reduction through traditional market measures will be achieved, i.e., to create "cooperation without coercion." Perhaps price reduction will be achieved when competitive products reach the market in the near future. Perhaps price reduction will be achieved by aggressive negotiation of cost with third-party payers. Sofosbuvir retains patent protection until 2029; thus, generics are not readily possible outside of "compulsory licensure" – the ability of governments to violate patent law in periods of national necessity. Such intervention, or the threat of it, has occurred in many countries, including the United States. We believe it is unlikely to occur in this case.

The HCV market, estimated at greater than $10 billion annually in sales, provides a strong incentive for drug development – producing the multitude of agents in various stages of development for FDA approval. The competition of multiple sellers for buyers will drive down price and facilitate quality. An extreme example of this can be seen in countries practicing socialized medicine, which effectively have a single buyer, so there is greater leverage for price reduction.

Compulsory licensure, while based upon sound moral intentions, would stifle future innovation by removing profit incentive and creating an unstable economic atmosphere. It is informative to review the vaccine market, in which economic instability has led to fewer sellers, either from attrition or conglomeration. The ultimate consequence is decreased innovation, competition, and drug availability.

Corporations are not moral agents. Similarly so, government has no agency, but rather should be considered an instrument through which a moral citizenry can achieve agreed upon objectives. Aggressive education and collaboration amongst physicians and their patients, purchasing groups, and public lobbying agencies to collectively negotiate reasonable price reduction are encouraged – to realize the potential we have as buyers en masse.

Pharmaceutical profits may be conspicuous, but nevertheless, it is that very incentive of profit that brings such powerful drugs so quickly to the market in the first place. Patients can neither benefit from nor feel the loss of drugs that never make it to market. A morality of intention, absolved of comprehensive economic parameters, while psychologically enticing and proximally politically advantageous, would lead to greater long-term harm for the very patients we have vowed to protect.

We hope that price and cost issues will not prohibit large numbers of HCV-afflicted patients from receiving the current therapies and other highly efficacious regimens that will soon be forthcoming.

Dr. Christopher Moore is a fellow in transplant hepatology, and Dr. Steven Flamm is chief of transplantation hepatology and professor of medicine and surgery, at Northwestern University Feinberg School of Medicine, Chicago. Dr. Moore reported having no conflicts of interest. Dr. Flamm is a speaker for Vertex and Gilead; does research and consults for Abbvie, Vertex, and other companies; and does research for Boehringer Ingelheim.

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