Czechs' R&D role in bird flu, HIV

The Gilead portfolio also includes Tamiflu, the only commercially available treatment for the deadly avian influenza, or bird flu. Tamiflu is marketed and uniquely manufactured by Gilead’s partner Hoffman La Roche, a Swiss health care company.

Sales of Tamiflu exceeded € 1 billion in 2005, from which Gilead received some € 128.4 million in royalties. In the meantime, another pharmaceutical company, GlaxoSmithKline, has announced it has produced an effective bird flu vaccine for humans that produced a strong immune response against the H5N1 virus in 80 percent of the people who tested it.

Q: What does the cooperation with ÚOCHB mean for you?

A: It’s the first time that Gilead has signed an alliance of this sort, that we’re funding an organization. We have done so because Dr. Holý and his team have shown such productivity and such impressive scientific leadership over the years — and, of course, we benefited because we licensed many products 15 years ago that are now making it onto the market.

Another reason is to continue with the excellence of this institution and to thank Dr. Holý for what he contributed to science, to medicine and to Gilead. Also … we know that there will be future discoveries [coming from this Prague institute] that could be quite important. So, in addition to the funding for the faculty, for students we’ve also set up a patent arrangement. We’ll do a lot of patent work for the institute — we’ll help them file patents and in return will get to look at new discoveries first; we have the right of the first refusal. Our hope is that there will be future discoveries that will lead to new medicines for Gilead to develop.

Q: Where will you introduce the new patents?

A: The patents will be introduced on a global basis. [Apart from in the U.S. and European Union] we intend to file patents in many parts of the world, such as India, China, Japan, parts of South America.

Q: What are your expectations concerning the number of patents per year?

A: It depends on the productivity of the group, so we don’t know how many patents will come up. Some years there will be very few, some years more, but the experience with Dr. Holý taught us that it will probably be a large number.

Q: How many pills from your portfolio have a Czech contribution?

A: Gilead currently has nine marketed products. The Czech contribution includes Vistide [an antiviral medication], Hepsera [a Hepatitis B treatment] and Viread [HIV treatment]. In addition, Viread is a component of two other Gilead drugs for the treatment of HIV — Truvada and the recently approved Atripla. Therefore, five out of nine Gilead products include some sort of Czech contribution.

Q: In which phase of HIV infection do the pills intervene?

A: We tend to treat people who are very early on in their infection with tenofovir. That’s not the way it started [but] what we saw is that this medicine has a very good long-term profile. So, for example, we had patients under [this] medication for seven years. The reason why we’re using it early is that now we have the data sets that can help physicians and patients to know that you can come up with a medicine that will help [people] carry on for a very long time.

That’s important because there was an article that just came up this month in the Journal of Infectious Diseases and patients diagnosed with HIV in more developed countries can expect to live about 15 years [after infection] on average. I think it will go longer than that, but based on the current information, it’s 15 years. And that’s because the medicines are getting better and easier to take every day; that makes the difference.

Q: What about the price of these medicines; is it accessible for all patients infected with HIV?

A: It’s accessible. We have different prices in different parts of the world. In the EU and U.S., the price is very consistent, but … there is nearly universal coverage that governments or private insurers cover, so there aren’t many pockets of people who don’t have access to the medicines.

In other countries we have tiered pricing; the price in South America is far below the U.S. and EU level. It’s the price we find proper for the economic development of that country. We basically use rough United Nations guidelines to divide the world in four tiers and in every one of these tiers we have prices differing on the economic conditions.

For the lowest tier we have something called the Gilead Access Program, in which we’re currently selling Truvada and we’ll sell Atripla with a no-profit price, the no profit price equals the cost of manufacturing the product, and even that is quite high for some countries, but it’s the lowest we can go. Gilead continues to work to lower the cost of manufacturing and in doing so will continue to reduce the no-profit price.

The Gilead Access Program concerns 97 countries, it’s all of Africa, and a whole series of other countries that are considered the least developed countries [LDCs] by the UN and WHO [World Health Organization] guidelines. It also includes countries that have a very high prevalence of HIV; parts of Southeast Asia, parts of Southeast America and the Caribbean are typically included. Then, there is another group that we call a middle-income group that’s slightly higher than the price we have for the LDCs. It’s designed for countries like China, India.

The hard part is that in each of these countries we have to spend enormous time from our own resources to get regulatory approval. [There are also high costs for introducing the drug] in many countries that don’t have regulatory bodies.

We’re in the process of registering the drug in basically every country in the world. We have 56 approvals for tenofovir but we still have more than 100 to go, so it's a long, challenging process to do.

Q: How long does the newly approved pill Atripla prolong people's lives?

A: I believe it’ll be decades. I think that someone [HIV-positive] who takes this pill every day can live for decades.

Q: How would you comment on speculation that the H5N1 avian influenza is more a panic created to sell more Tamiflu, the only treatment available on the market now?

A: I think the specter of influenza is very real. We know that in the past there have been massive pandemics, as new strains of influenza came out of animals and were transferred to humans, which is [how the mutation] always happens.

In 1918–19 something like 20 million to 25 million people died from influenza — predominantly healthy adults. So, when you think of normal seasonal influenza, people who died are particularly the elderly, not the very young.

When a new [strain of] flu comes out, the people who are at most at risk are healthy adults. That’s because for a new flu, your body has no immunity, your body has never seen it before. The immune system reacts vigorously — and overreacts — and you have something called a massive side response which leads to rapid deterioration and death, very frequently.

We know that it happened; we know that it happened in response to flu, we know that there have been two minor influenza shifts with the Hong Kong flu [1956 and 1968]. So, we have history on our side to tell us that this can occur and we have a strain that’s circulating the globe. H5N1 has never been seen in humans before. We know that if it lives in humans, it will circulate very fast and will be very deadly.

I think what will happen is that when it will mutate, it will be very deadly to humans. It may be less deadly than some other viruses, but still the probability for many to die is very high. We have the opportunity to stop a pandemic and if we don't take this opportunity, and the pandemic occurs, then tens of millions of people will die unnecessarily.