'We are open to collaborative research in India'

Q&A: Sandeep Sahney, Managing Director, Genzyme

US-based Genzyme, the world's third largest biotechnology company, is going through a crisis. The key manufacturing facility of the $4.6-billion company was shut due to contamination issues, affecting the supply of its drugs to the world market, and India. This setback for the company, which specialises in costly drugs for rare genetic diseases, has not impacted its expansion plans for India, where it entered two years earlier, Sandeep Sahney, managing director (India & South Asia), tells Joe C Mathew and Vandana Gombar in an interview. Edited excerpts:

Genzyme has announced that it has dropped clinical trials on one of its potential new drug candidates. It is yet to resume normal production from its key manufacturing facilities. It is a spate of bad news for the company.
It is true that we decided not to proceed with the clinical trials of our advanced phosphate binder, as results did not show any significant improvement over our existing product, Renvela. These are routine developments in drug research. Innovation is risky business.

While you knew about the clinical trial development, you missed the good news that was also announced the same day. Data from the Phase-III clinical trial on mipomersen said our lipid-lowering therapy was very positive.

How close are you to resolving the medicine supply crisis? What has been its impact on Indian supplies?
The supplies are expected to be back to normal in the next three to four months. The shortage in supply led us to ration supplies, but none of our patients were denied the medicine in India.

What are Genzyme priorities for India — marketing, research or manufacturing?
Genzyme focuses on illnesses that are rare and have few available treatments, like Gaucher’s disease, which affects one in 50,000 to 100,000 humans. In most cases, our treatments are expensive — treatment of Gaucher could cost anywhere between $50,000-75,000 a year (Rs 23-35 lakh), with the drugs required to be taken through life.

The payments in many cases are taken on by governments through funds such as ‘orphan’ disease funds or ‘rare’ disease funds. For the paying customer, it is either full price or free. We have an India Compassionate Access Programme under which 63 children are receiving free treatment today. In our 28 years of operation, we have commercialised 17 products globally.

Of the 17 products launched globally, how many are available in India?
In India, we have four products that are commercially available. Four others are being given free. Next year, we will have two more products in the market. There are six products in the pipeline to be launched globally in the next three years. We expect to have one to two product launches every year in India from now. We have a lot of focus on India.

What has been the response to the products you have launched commercially?
They are well received. Seprafilm, one of our key products, used during transplant surgeries, has picked up well. Of the 3,500 kidney transplants that happen in a year, over 1,000 patients are on Seprafilm now. Similarly, sales of the osteoarthritis pain relief injection, Synvisc-One, are also encouraging.

You had announced a research collaboration with International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, last year. What is the progress? Are there more research tie-ups?
The research is progressing well and we have identified some lead candidates. ICGEB scientists are making use of our lab facilities in the US and our scientists are visiting ICGEB as part of the collaborative research. Country-focused research programmes are part of Genzyme’s Humanitarian Assistance for Neglected Disease initiative. We are also looking for ICGEB-like collaborations with other institutions and companies.

Besides institutional partnerships, which are the Indian companies seriously into biotech research that you could possibly partner with?
Indian companies are mostly into vaccines or into biosimilars. These are not our focus areas. However, there are companies, Biocon for instance, that are serious about innovative research in biotechnology.

Do you have any ongoing clinical trial programmes in India? Do you see India as an outsourcing hub for clinical trials?
We do have an ongoing clinical trial programme in India. We are also starting two more trials, of which one will be a large study involving over 2,000 post-dialysis patients. We are enrolling the 10 best nephrologists of the country to be part of this study.

Looking ahead, how do you see your Indian business growing?
We should be doing $50-75 million business in four to five years from now in India. Our employee strength should also go up from 50 to 200 by then.