A clear policy framework must: Edgard A Olaizola

Last Updated: Sun, Jul 20, 2014 00:47 hrs

Eli Lilly and Company, in the insulin segment, says there is a need for clarity in the policy framework as the pharmaceutical business is risky and requires huge investments. This comes against the backdrop of new price caps imposed on several diabetes and cardiovascular medicines. While the company is planning to launch more anti-cancer drugs in India, its investments in the country would depend on the government's "dialogue and intention to work in partnership," India Managing Director Edgard A Olaizola told Sushmi Dey. Excerpts:

Since diabetes is growing in India, is Eli Lilly planning new products?

The strategy around diabetes is very important. We have certain partnerships. We are talking about new products. We introduced a device earlier in the year. Recently, in partnership with Boehringer Ingelheim (BI), we introduced Trajenta Duo (used for type two diabetes). We have just made another product. It is on the review worldwide and we expect the approval by the next year.

How many products are you selling in India and what are the expansion plans?

We are selling 16 to 17 products. We have conventional human insulin as Huminsulin, analog as Humalog, Trajenta, which is a DPP4, and Humatrope. In oncology, we have Alimta for lung cancer and Gemcite for cancers in breast, urinary, etc. We have products in branded therapeutics, two drugs in cardiovascular. But most products are in the diabetes segment.

How is the company growing, mainly in the diabetes segment, your focus area?

We have been growing in high double digits for three years, both overall as well as in the diabetes segment. We cannot give you specific numbers.

The National Pharmaceutical Pricing Authority (NPPA) has fixed prices of various cardiac and diabetes drugs. Oncology is likely to follow soon. Lilly is present in all of these segments. What is your take?

It is important to have clarity and market-based approach on pricing. We are surprised and disappointed by this unexpected action. We are working on the recent announcements by the NPPA and will comply with those. The impact would not be good on the sector, access to medication is very important. It is important to have a framework for us as a company and for the sector because otherwise eventually it becomes very difficult to do business. It is a very risky business. It costs a lot of money to develop these medicines and we want patients to have access to those products.

Are you going to relook at your plans if such price cuts continue?

I don't know. We will have to first see what happens and take a decision. I do not want to speculate.

How important is India as a market for Eli Lilly? What is the current revenue contribution from India business to Eli Lilly's consolidated sales?

I can't share those numbers but I can tell you in Asia, India is a very important market for Eli Lilly and particularly in diabetes because 60 million people here are suffering from diabetes and it is growing by 20 per cent plus.

So, it is a very important market for us from that point of view. We have partnerships like the Lilly NCD (non-communicable disease) partnership, a five-year commitment involving $30 million. It is a global initiative in four countries: India, Brazil, Mexico and South Africa. The idea is to work in NCD particularly in diabetes and try to find solutions and approaches that can help the management of a disease like diabetes. We also have special projects such as Uday in India, with an initial focus on improving outcomes for people with diabetes and high blood pressure. In India, the project is being implemented by Public Health Foundation of India, Population Services International and Project Hope. In the first phase, the project is being implemented in Vizag (Andhra Pradesh) and Sonepat (Haryana).

What are your expansion plans in India?

We have just filed a product and expect approval in the near future. We have a partnership model for insulins with Gland; they make some insulin we commercialise in India. We have a partnership with Lupin, for human insulin. We have a partnership with BI for Humalog and Trajenta. From an education point of view, we are doing initiatives like Uday.

We have 13 products in Phase-III, globally. We just introduced Trajenta and as I mentioned to you there is expected to be one in the near term depending on approval. In the longer term, we have two insulins that we expect to launch in five years in India. We expect all diabetes products out of the total 13 will be launched in India depending on approvals in five years.

Are you planning to focus on any other area in India?

Oncology would be the other area in the near future. We have two products. We introduced branded generics in oncology earlier this year and we also have two more products by now in Phase-III in the oncology segment.

Are regulations in India conducive to innovation?

We are seeing progress which is encouraging but we would like to see more progress in that area. It is important to have dialogue and transparency because these are long-term investments as it may take 10 years to see a product come through. So, in matters like clinical trials, it is important to have clarity.

We want to do research in diabetes in India. We want to make sure that products get tested in India on Indian patients and, therefore, clinical trials are important.

Are there challenges in that space?

It is true but we are seeing progress. We will be pleased if we see dialogue. I think it was good intention to try and see and find a way to protect the safety and security of patients but at the same time we cannot stop to research. Regulations are going on through a lot of changes. A couple of years back almost no approvals were coming through but there is progress and it is now moving in the right direction, with new guidelines being circulated to companies for their feedback. But the process has been slightly slow.

What about the patenting scenario? Novartis lost the case on Glivec in the Supreme Court, and the government has been considering compulsory licences for a number of drugs. What is your take?

I cannot comment on the Novartis case. What I can say is it is important to have a framework that rewards innovation and makes sure patients get access to newer medications. Through dialogue and transparency, we believe we can make that happen. If we see that dialogue and intention to work in partnership, we will continue to invest in India.

Lilly's presence in India has largely been through partnership with companies. Now, many are opting for a similar model. Is this because multinationals have failed to penetrate the market on their own?

In the sector, there are partnerships all over the world because it is a very risky business, so one cannot diversify. In the case of BI, it is a global partnership and not just for India. In the case of Lupin, we complement each other and that is why there is a partnership.

Would you continue with the partnership model in India or do you plan investment in manufacturing here?

We are always open to new opportunities, specially in a market like India. We are pleased with our partners.

Do you have any plans for acquisition in the generic space or any other segment?

No. We believe in innovation. We think there are still a lot of unmet needs.

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