Gilead Sciences Korea, which started business in 2011, celebrated its 10th anniversary on Wednesday. Over the past decade, the company has accomplished rapid growth and innovation to emerge as a strong player in the Korean market.
Notably, it has left a unique footstep in the field of antiviral treatments, such as human immunodeficiency virus (HIV), hepatitis B and C infections.
Continuous development of new therapies has changed the paradigm of treatment of HIV from an incurable to a chronic disease, and improved the quality of life of patients with hepatitis B treatment, which has proved its efficacy and safety through numerous clinical trials.
Also, the company released the first curable treatment in the field of hepatitis C infection.
Most of all, the company is drawing a lot of attention for conducting the clinical trials of remdesivir, an investigational antiviral drug to treat the new coronavirus.
Last Thursday, local regulators expanded the opportunity to test Gilead Sciences' remdesivir against the infection of COVID-19. The Ministry of Food and Drug Safety approved the investigator-initiated phase 2 clinical trial of remdesivir on 100 hospitalized patients.
The green light came after the ministry initially gave the nod to two phase-3 studies on 195 COVID-19 patients, on March 2.
Against this backdrop, Korea Biomedical Review met with Paul Lee, CEO of Gilead Sciences Korea, to learn more about the company's short- and long-term plans, including the company's vision for the next decade.
|Gilead Sciences Korea CEO Paul Lee talks about his company’s current efforts and future goals, during a recent interview with Korea Biomedical Review at his office in central Seoul.|
Question: It has been 10 years since Gilead Sciences Korea was founded. As you have seen all the processes since Day 1, how do you feel on the company’s 10th birthday?
Answer: When Gilead Sciences first started business in Korea, all of its employees were excited to have various good possibilities that the company can contribute to the local market. At the same time, we were somewhat anxious as the company's main pipeline belonged to relatively new fields.
In retrospect, however, Gilead Sciences Korea has grown significantly over the last decade, and it is very rewarding as the company was able to deliver excellent treatments and achieve substantial progress in all areas of the company's business platform.
Q: What are some of your significant achievements in the last decade? Also, did the company experience any difficulties over the years?
A: Gilead develops therapies that cure life-threatening diseases. It is good to see Gilead's treatments quickly become leading drugs in treating HIV, hepatitis B and C, and fungal diseases.
Through excellent treatments, the company was able to increase the accessibility of such drugs to Korean patients, which eventually has led to the treatment of such diseases. This process has been enriching for the company.
Notably, after the company received the regulator’s nod for Truvada as the first officially approved drug of the company in Korea in 2010, the drug has become the backbone therapy for treating HIV. The drug became the first HIV PrEP treatment in Korea in 2018, helping to open a new era for HIV prevention here.
Gilead is now working to prevent, treat HIV, helping people fully recover from it eventually.
There are still some obstacles the company faces in providing treatments in Korea. One such obstacle is social prejudice against HIV patients. Gilead is trying hard to improve the prejudicial environment against HIV in Korea.
Such efforts include company-wide public awareness campaigns, donations to various HIV-related organizations, screening of HIV patients, and supporting the economically vulnerable patients.
Q: Gilead has been strengthening its pipeline in Korea, particularly in antiviral therapies. The company attracted particular attention by introducing HIV drugs, which aim at its prevention and treatment. How has the company changed the area of HIV treatment?
A: In the early days, HIV was considered a deadly disease. Now, however, HIV patients have almost the same life expectancy as the average person. Such a development has made safety a critical issue, as important as virus suppression.
In this regard, our company has launched Descovy and Biktarvy, which have improved safety profiles and long-term tolerability, as part of our efforts to offer a variety of new treatment options.
Q: Let’s talk about Biktarvy, then. What is the outlook for Biktarvy in the Korean market, and how is the actual clinical response?
A: Biktarvy is recognized as an excellent remedy, both here and abroad. Globally, Biktarvy is the fast-growing product for the company. In Korea, too, the product has garnered 17 percent market share after just five months of its launch.
In the clinical setting, Biktarvy improves medication compliance through various benefits, such as antiviral effect, high growth barriers and safety, and medicines regardless of food effect, which can significantly help both the medical providers and the patients.
Q: The HIV drug market is expected to see the launch of new competitive products, including compound agents and prolonged administration period. What is Gilead's strategy in the new competitive environment?
A: Biktarvy is the newest HIV drug in the market. In practice, Biktarvy is expected to lead the market for a long time, as physicians recognize its clinical efficacy.
Also, the company is researching long-acting HIV treatment, where one injection can last longer than six months, as well as various studies for PrEP treatment other than Truvada.
Gilead is also in the process of developing treatments for patients who build resistance to drugs. While the number is small, it is a much-needed treatment in the field of HIV.
Q: The domestic hepatitis B treatment market is also a significant source of revenue for Gilead Sciences Korea. The complete replacement of Viread with Vemlidy seems to be the company's impending goal. What are your plans this year?
A: Hepatitis B, like HIV, has become more of chronic disease as the life expectancy of the patients has significantly increased. With the increase in life expectancy, its associated disorders have become a problem, and the paradigm for the field has shifted to safety.
In line with such a paradigm shift, the company has developed Vemlidy.
A recent study, published in Lancet, a globally renowned medical journal, proved the effectiveness and safety of switching from Viread, our previous generation of treatment, to Vemlidy. The company is also working to ensure that hepatitis B patients have access to new therapies without insurance restriction.
Q: Unlike the hepatitis B drug market, sales of the hepatitis C drug product line declined due to fierce competition. Is there a plan to make up for the loss of sales?
A: In 2018, Harvoni expanded its indications and reimbursement to treat hepatitis C patients with type 1 and type 2 genes.
Therefore, the company believes that many patients can be treated with Harvoni. The decline in sales is due to competitive products, but Harvoni has already treated many patients.
As many patients do not recognize that they are infected with hepatitis C, the company hopes to expand the screening to treat more patients in Korea.
The World Health Organization (WHO) has set the goal of eradicating hepatitis B and C and HIV by 2030. In accordance with the WHO's goal, Gilead is working to contribute in various ways, including diagnosis, screening and treatment.
Q: In Korea, there is a high interest in remdesivir due to the outbreak of COVID-19. The nation has recently been included in the COVID-19 clinical trials for remdesivir. We are curious about the size and progress of the trial.
A: Both Gilead headquarters and Gilead Korea regards COVID-19 as a global public health crisis, and every member of our staff has been working hard to begin clinical trials as quickly as possible.
Clinical trials for the application of remdesivir for COVID-19 began in China in February, and Asian clinical studies, including South Korea, will begin soon as the Ministry of Food and Drug Safety has approved our drug after a three-day review.
As the approval of a new drug generally takes more than 30 days, this shows how hard the company and the ministry worked together to conduct the trials of the treatment.
Clinical trials will begin in Korea at three institutions-- Kyungpook National University Hospital, National Medical Center, and the Seoul Medical Center. The clinical protocol consists of two groups of patients, one for severe patients and one for moderate ones.
It is hoped that as soon as the clinical trials are started, many patients will participate in the clinical trials, and the information on the efficacy and safety of the treatment will be available, allowing more patients to access the treatment.
Q: What are the company's plans and aspirations in the future?
A: Recently, Gilead headquarters has laid out a new vision for the development of 10 new and transformative therapies over the next decade.
To this end, Gilead is conducting a number of new drug researches in the field of antiviral such as a complete cure for hepatitis B and HIV as well as a treatment for non-alcoholic steatohepatitis (NASH).
Also, the company has acquired Kite Pharma, a CAR-T specialist, and has been conducting research in the field of cell therapy and anticancer drugs since 2017, and recently acquired Forty Seven, a cancer drug developer to help our progress.
New drug research is also going on in the field of inflammation, including rheumatoid arthritis drug Filgotinib, which we plan to register in the U.S. and Europe this year.
Gilead has competence in the fields of antiviral and immuno-oncology, inflammation, and immunomodulation. Based on this competence, we hope that the company will continue to contribute to saving the lives of many patients through more diverse research and development in the field of treatment with unmet needs.
Q: Are there any additional comments that you would like to make to Korean regulatory officials and patients?
A: Pharmaceutical companies have a mission to develop therapeutics and a vision of saving people's lives. Looking at various debates in society, however, it seems that such goals and visions are sometimes misunderstood due to the perception of pharmaceutical companies as organizations trying to profit by raising drug prices.
The existence of pharmaceutical companies is based solely on contributing to our society through the development of innovative new drugs. Therefore, I hope society will regard the development of a new drug by pharmaceutical companies not just from industrial aspects but from the viewpoint of developing a cure for diseases.
We hope that the public sees pharmaceutical companies as an essential stakeholder in society.
The same is for Gilead as we are working to promote public health, and not just for profit. For example, the company is trying its best to support the global community during the current COVID-19 outbreak. Such efforts include providing remdesivir free of charge to China and other countries as they conduct the clinical trials of the drug.
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