AstraZeneca’s Ajay Gautam On Innovation From Emerging Markets: An Interview With PharmAsia News (Part 1 of 2)

AstraZeneca Head of Emerging Market Collaborations Ajay Gautam talks to PharmAsia News about the company’s R&D strategy and deals with local partners.

SHANGHAI – Under the leadership of CEO Pascal Soriot, AstraZeneca PLC has transformed itself to a pure-play pharmaceutical innovator with a focus on three core therapeutic areas – cardiovascular/metabolic disease, oncology and respiratory/inflammatory disease – and a force in emerging market drug discovery efforts.

As part of that effort, the company announced on Dec. 19 (after this interview was conducted) that it would buy out Bristol-Myers Squibb Co.’s interest in their diabetes alliance, including the drug assets, employees and infrastructure. AstraZeneca will pay $2.7 billion upfront, as well as $1.4 billion in regulatory and commercial milestones, and royalties up to 2025 (Also see "AZ Doubles Down On Diabetes, Buys Out Bristol’s Share in Alliance" - Pink Sheet, 19 Dec, 2013.).

To drive innovation, the company restructured its R&D operation to consolidate all research and development across small molecules and biologics in three strategic regional centers: Cambridge (UK), Gaithersburg, Md. (U.S.) and Mölndal (Sweden). AstraZeneca’s new R&D structure includes the Innovative Medicines & Early Development (IMED) Program, which focuses on small molecules research from discovery through Phase II clinical studies. The goal of the new structure is to bring more autonomy and an entrepreneurial spirit to allow IMED to progress projects more quickly and efficiently (Also see "Revamping AstraZeneca, Soriot Calls For Focus And Speedier Innovation" - Pink Sheet, 25 Mar, 2013.).

As future pharmaceutical market growth is expected to be driven by emerging markets, the company’s strategy focus has also moved to countries such as China, including a 2011 in-license deal with local innovator Hutchison MediPharma Ltd.’s HMPL-504 (volitinib), an inhibitor of the c-Met receptor tyrosine kinase for the treatment of cancer (Also see "AstraZeneca Licenses Global Rights To Oncology Compound From China’s Hutchison" - Scrip, 21 Dec, 2011.).

AstraZeneca and WuXi AppTec Inc. formed MedImmune-WuXi Joint Venture in 2012 to develop and commercialize MedImmune LLC monoclonal antibody MEDI5117 for rheumatoid arthritis (Also see "B-Harmony: WuXi And MedImmune Establish JV To Seize Biologics Growth In China" - Scrip, 11 Sep, 2012.).

The company then signed a deal with Chinese clinical research organization Pharmaron Beijing Ltd. Co. to outsource its research work in chemistry, drug metabolism and pharmacokinetics and efficacy screening (Also see "Going Deeper Into China: AstraZeneca Strikes Drug Discovery Partnership With CRO Pharmaron" - Scrip, 16 Oct, 2012.).

AstraZeneca moved its Innovation Center China (ICC) in September to its new campus in Zhangjiang Hi-tech Park, next to its APAC commercial headquarters (Also see "Growth Strategy: AstraZeneca Launches APAC Headquarters In Shanghai" - Scrip, 28 Jun, 2012.).

As the first media organization to visit the new R&D site, PharmAsia News’ China Bureau sat down with AstraZeneca Head of Asia And Emerging Markets Collaborations Ajay Gautam to talk about the R&D strategy in emerging markets.

Prior to joining AstraZeneca in November 2011, Gautam was the co-founder and managing director of Bio-nAbler, a health care investment firm focused on India, the Middle East and North Africa region. Before that, he was corporate and business development vice president at U.S. specialty pharma moksha8 Pharmaceuticals Inc. Gautam also worked with Pfizer Inc.‘s worldwide business development group.

Ajay Gautam

AstraZeneca

PharmAsia News: Please tell us about your responsibilities within AstraZeneca’s R&D operation.

Ajay Gautam: I joined AstraZeneca about two years back in a newly created role, which was to lead emerging market external collaborations. The idea was to start thinking about establishing more collaborations with academia, with research institutions, with biotechs in countries like China, Korea, Russia, Brazil, Israel and so on, outside the traditional markets in U.S. and Europe.

My background is actually a mix of engineering, science and business. My undergrad is in biotechnology and biochemical engineering from India. And then, I did my PhD in biomedical sciences and business school in finance from the U.S.

“What my team does, is to look at what our strategy should be in building partnerships in the emerging markets, and then go scouting to find the labs and biotechs that are doing the leading science.”

I spent about four years or so with Pfizer on the licensing and acquisition side in New York. After leaving Pfizer, I was part of a startup called moksha8, which was formed out of private equity firm TPG, in Brazil and Mexico for about three years, where I led corporate and business development. And then I was co-founder and started another company in the Middle East, in Egypt and Dubai, for another three years or so, before moving to Shanghai about two years ago to join AstraZeneca.

So, I always joke that I'm trying to cover living and working across the globe in the shortest possible time. But it’s also linked to my passion for health care in these emerging economies.

What my team does, is to look at what our strategy should be in building partnerships in the emerging markets, and then go scouting to find the labs and biotechs that are doing the leading science within the core therapy areas we have in AstraZeneca, and help build partnerships with these institutions.

PharmAsia News: How does AstraZeneca define emerging markets?

Gautam: For us, the emerging markets cover a wide range of countries. What they have in common is that their economies are dynamic and growing. Expanding populations, people with higher incomes, but also increasing health challenges because of the rise in chronic disease. From a research collaboration perspective, some of the countries we are focusing on are China, Brazil, Russia, Israel, the Gulf countries, primarily Saudi Arabia, Turkey, and South Korea.

PharmAsia News: What has AstraZeneca’s R&D restructuring meant for operations in emerging markets?

Gautam: What we wanted to achieve as part of that restructuring was a simplified structure, an entrepreneurial culture but also a sharper focus on therapy areas, all built around the two core themes in our R&D philosophy - achieving scientific leadership and focusing on patients.

“A real strategy around building that momentum and accelerating our partnerships is establishing more collaborations in China, in Korea, in Russia, in Israel.”

So, to reorganize our research to align with those priorities, what we have done is to create three autonomous science units, one of which is the IMED, the Innovative Medicines and Early Development operating unit, which focuses on small molecules research from discovery through Phase II clinical studies. This structure brings in more autonomy, entrepreneurial spirit to our science and allows the IMED to progress projects more quickly and efficiently.

Our Asia and Emerging Markets IMED is part of that IMED science unit, focusing on Asia and emerging markets. We’re looking at how we can progress our science in these markets, think about our strategies for certain diseases which are more specific, for example, in China, and how we can further build our strengths in translational science. And also how we can build on the momentum and accelerate our partnering strategy in these markets.

We have really good science and scientists in-house, but we also realize there's a lot of great science that's happening outside of our labs. A real strategy around building that momentum and accelerating our partnerships is establishing more collaborations in China, in Korea, in Russia, in Israel, et cetera, while staying true to our philosophy of following the science and focusing on patients.

PharmAsia News: What kind of projects are you seeking in China?

Gautam: I can give you a few examples in China from a disease perspective, but then we can also talk about other emerging markets like Russia and Israel. In China, I think you know about our partnership with Hutchison MediPharma (Also see "Hutchison MediPharma CEO Christian Hogg On World-Class Innovation In China: An Interview With PharmAsia News" - Scrip, 12 Nov, 2013.).

“We are progressing a molecule first in China, and then possibly taking it globally.”

So, that's an example of the kind of collaborations we are building to both look for innovation that's happening in these countries, and also to progress that innovation – not just within China, but globally. With Hutchison, we in-licensed a molecule at the end of 2011, started clinical studies in Australia in 2012 and in mid 2013 in China. There’s a high unmet medical need in China from a lung cancer perspective. At the same time, this compound, a c-Met inhibitor, also fits very well within our core area of oncology.

Another example in China is the WuXi AppTec joint venture, established by our biologics arm, MedImmune. Through this partnership, MedImmune became one of the first multinational companies to bring a novel biologic, MEDI5117, to China. Our aim is to develop a medication for Chinese patients who are suffering from rheumatoid arthritis, an autoimmune disease with high unmet need in China.

In both of those examples, we are progressing a molecule first in China, and then possibly taking it globally.

I’d like to also share with you a couple of examples outside China. In Russia we have a collaboration with the Petrov Institute, which is the largest and oldest oncology institute in Russia.

Working together, we are looking at gene mutations in Russian patients, as certain mutations are more drug sensitizing, against a portfolio of compounds that we have. This includes launched compounds as well as some from our research portfolio.

The key is to understand the genetic profile of these Russian cancer patients, across different cancers, and how we can use the data to develop drugs tailored not just for Russian patients but hopefully globally as well.

Another example is our collaboration with Almazov Center in Russia. Here, we are working to understand the disease dynamics in cardiovascular and endocrinology. This is a very high unmet need in Russia, where there are an estimated 45 million patients with dyslipidemia.

PharmAsia News: As you mentioned that you have two deals with Hutchison MediPharma and WuXi AppTec here in China. Can you update us on the status of those deals, those compounds?

Gautam: I'm very excited about both those collaborations. They're progressing extremely well. With Hutchison, as I mentioned, we initiated Phase I trials in Australia in 2012, but more importantly, in June 2013 we initiated Phase I trials in China.

We are hoping to have some good data coming out in 2014, and if all goes well, we'll progress the compound to the next clinical stage. But right now, it's in Phase I studies in China and Australia.

I think the collaboration is moving really well. We are progressing most of these studies quite fast. From the day we signed the collaboration at the end of 2011, to where we are today, I think it's progressed extremely well. The two teams have very complementary skills that they are bringing to the table.

The WuXi AppTec joint venture collaboration is also progressing well.

[Editor’s Note: Part 2 of this interview will appear in an upcoming issue of PharmAsia News.]