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Most Innovative Companies 2015: A Conversation With Gilead Sciences
Join Fast Company senior associate editor J.J. McCorvey for a live Q&A with Gilead Sciences EVP of corporate and medical affairs Gregg Alton. The event will begin at 1 p.m. ET Thursday, March 12, but you can get your questions in now.
Gregg Alton
Photo by: Photo: Mary Mark Ockerbloom
Gilead Sciences was recently named #16 on Fast Company's Most Innovative Companies list for "developing lifesaving drugs at the speed of need." The biotech powerhouse brought to market a Hepatitis C cure which became the most successful new drug in history.
Join Fast Company senior associate editor J.J. McCorvey as he chats live with Gilead Sciences EVP of corporate and medical affairs Gregg Alton. The event will begin Thursday, March 12 at 1 p.m. ET, but you can get your questions in now using the "make a comment" box below.
And be sure to check out Gilead Sciences' place on this year's Most Innovative Companies list, and read J.J. McCorvey's full feature "How Drug Company Gilead Outpaces Its Competitors--And Common Diseases."
Illustration: Nicolas Berger
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We're going to get started in about 5 minutes... Check out J.J.'s post on Gilead Sciences in the meantime:
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Hi everyone, thanks for joining our live chat today with Gregg Alton, executive vice president of corporate and medical affairs at company Gilead Sciences. Gregg can you start by telling us a little about your role at Gilead?
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I've been at Gilead for over 15 years. My current responsibilities include Medical Affairs, Public Affairs, Gov Affairs, Legal and our Emerging Markets and Access operations. Broadly speaking, I cover most policy initiatives at Gilead, both domestically and internationally.
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Specifically, this includes initiatives such as diagnosis and linkage to care efforts in the U.S. for HIV and hepatitis C, which is a program we call FOCUS.
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Another example is approaches to removing barriers to access to therapy in high disease burden areas such as sub-Saharan Africa.
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Great, thanks Gregg. Gilead has had a very successful year with the blockbuster drug Sovaldi, which has been extremely effective in curing hepatitis C in patients. What have been some of the key learnings from Sovaldi's success and how are you applying that to current/future drug development?
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We're very pleased with the success of Sovaldi. We estimate that we treated over 140,000 patients in the U.S. in 2014 and more than 30,000 in the European Union. And what is unprecedented is reaching nearly 40,000 patients in the developing world in the first year of launch.
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In terms of lessons learned, a key area would be how we communicate the value of medical therapies such as Sovaldi.
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I'm glad you mentioned Sovaldi's value -- one of the reasons Sovaldi has been making waves in the press, aside from its outstanding cure rates, is its cost: $1,000 per pill. How do you justify the cost to patients, insurance companies, etc.?
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The first thing to point out is that the costs that get quoted are public list prices that are a starting point for discussions with payers. For example, in 2014 the VA received a 41% discount and state Medicaids received a minimum discount of 23%. We give greater discounts when payers provide broader access. In 2015, these discounts have significantly increased with competition in the marketplace.
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In terms of the value, the biggest point is get people to understand the difference between the price of a product that can cure most patients with three bottles vs. the price of a product that is taken for life or that does not result in elimination of disease.
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We priced Sovaldi and Harvoni the same as the previously available treatments, however, due to the improved cure rates (95%) and lower cost of managing toxicities, Sovaldi significantly reduced the cost of curing hepatitis C.
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It's estimated that 130 million people globally suffer from hepatitis C -- can you talk about the prevalence and severity of the disease? Why was it important for you to focus on this particular area?
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As you said, there's a large number of patients suffering from HCV. Prior to Sovaldi, most of these patients couldn't or wouldn't use the available treatment options. So there was a significant unmet medical need. Without Sovaldi, many of these patients would have no opportunity to be cured and would develop advanced liver disease, cirrhosis or liver cancer.
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You mentioned removing barriers to therapy access in places like sub-Saharan Africa. How do you take an extremely expensive drug like Sovaldi and make that available in places where most people can't afford it and don't have the insurance coverage to help?
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We have experience with this from our work in HIV where our Access program is treating nearly 7 million HIV patients in the developing world every day. With HCV, based on these lessons, we start by broadly seeking regulatory approval in all countries throughout the world. In the poorest countries of the world, we price Sovaldi closer to the manufacturing cost at $300/bottle. In addition, we have licensed the rights to manufacture our HCV products to 11 Indian generic companies who have the rights to sell the product in 91 poor countries representing 54% of the global burden for HCV. We also advocate for government funding of hepatitis C at the local level as well as through donor programs.
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I should add that our $300/bottle price sets a ceiling for these countries. The Indian generic companies are free to set their own price. So we expect the price to go down as competition between the 11 generic companies increases.
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The controversy that has surrounded Gilead's pricing gets to a specific issue -- the ability of large pharmaceutical/biotech companies to capitalize on life-saving medicine. (However, you are a for-profit company.) How do you think the rules of innovation change for a company when you're saving people's lives?
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We do have to strike a balance between maximizing profits and pricing at a level that enables access to those who need our medicines. This is different from other industries that may have products that are nice to have, but not necessary for health. This also means that those who pay for the medicine, which varies from country to country, share that responsibility.
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One of the keys to Sovaldi's success was how fast you brought the drug to market availability -- drug development can take up to 10-15 years, but Sovaldi was available to hepatitis C patients within 2 years. Can you lay out your strategy for getting highly effective drugs to market quickly?
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When we acquired Pharmasset, which brought us Sovaldi, we realized very early that we needed to do everything possible to compress development timelines in order to get this important therapy to patients as quickly as possible. This involved our scientists working with regulators to develop comprehensive clinical trials that could provide definitive data in the shortest time. Once we had the data, this involved filing for regulatory approval in the markets with the greatest need. A key component of this is working with health ministries, leading physicians and patient groups. That's something I feel we do well.
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You also have another drug, Truvada, that has become a hot-button issue. It's been shown to be highly effective in preventing the transmission of HIV when taken as a prophylactic, but has also faced resistance by some activist groups. 1) Why do you think some people have protested Truvada PrEP? and 2) With the drug gaining more mainstream popularity, how do you think HIV/AIDS will be perceived 10-20 years from now?
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For the first question, the vast majority of HIV advocates support PrEP. The concern raised by some revolves around increasing risky behavior by those using PrEP and concerns that people won't take the medicine as needed.
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PrEP could play an important role in reducing the number of new HIV infections. Since the beginning of AIDS, significant progress has been made. The number of annual new infections today in most countries is significantly less than 25 years ago. However, we have seen a leveling of the number of new infections over the past 10 years. For example, in the U.S., there are an estimated 40,000 new infections each year. So we need to do more. In addition to PrEP, we also know that we can significantly reduce new infections by diagnosing and treating individuals who are currently not diagnosed. An estimated 90% of new infections are driven by people who are unaware they're infected.
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PrEP could indeed play an important role in reducing the rate of HIV infections, but during my reporting, some Truvada users wondered why Gilead has chosen not to fully market the drug and make people more aware of its availability. Can you elaborate on your strategy for getting Truvada in the hands of people who could use it most?
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We are working to provide awareness of the availability of Truvada for PrEP. We are doing this in collaboration with community groups and medical providers. We have chosen not to take a traditional marketing approach for several reasons. First, PrEP is only appropriate for those engaged in high risk behavior who are unwilling to change that behavior. It is not appropriate for all. So we want to have an approach that targets those who can benefit most. We certainly would not want to encourage those who are not engaging in at-risk behavior to see PrEP as an alternative.
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We have another great reader-submitted question, regarding the drug development process for Sovaldi:
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Does Gilead expect its approach to influence other companies? Will all drugs be developed this way someday?
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Looking at the experience of Sovaldi in terms of rapid regulatory approval and launch and the number of patients reached, it has been a tremendous success. I would expect others - both large and small companies -- to strive for that same level of success. It starts with having the best science but also a strong dedication to ensure that the science benefits patients and improves health outcomes.
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Another reader is curious about Gilead's ideas on humans living longer lives (or forever):
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What is your opinion of the quest to live forever championed by Ray Kurzweil and others in the scientific community? www.macleans.ca The question may not fit within the realm of this discussion, but Kurzweil and others think medicine may advance to the point of nanobots being used to heal and help people live longer lives. I'd be curious to know what someone in the biotech field thinks of these things.
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We are driven to develop medicine that lets people live longer and better lives. I'm not sure about "forever", but most people do see tremendous value in living longer and healthier lives. This is why we continue to push ourselves to out-innovate our own prior innovation. A good example of this is HIV, where we are driven to develop more potent, but also safer and more tolerable therapies. Another example is fatty liver disease. Now that we have a cure for HCV, fatty liver disease is expected to be the #1 cause of liver transplant by 2020. So we have a number of development programs focused on this disease.
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And I think that'll be our last question -- thanks for being with us today Gregg, and thanks everyone for your participation!
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Thanks very much, J.J. This has been a pleasure. And thanks to everyone who submitted questions.
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Thanks, everyone for coming! For more on Gilead please read J.J.'s excellent feature story:
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How Drug Company Gilead Outpaces Its Competitors—And Common Diseases
Fast CompanyIt can take up to 15 years to bring a lifesaving drug to market. Gilead operates at the speed of need.