Sameer Savkur MD, Biogen Idec, India

Biogen Idec, a global leader in the research and development (R&D) of multiple sclerosis (MS) therapies, started its operations in India in 2007. The Gurgaon-based company plans to further expand its clinical research in India in addition to bringing newer solutions for treatment of MS through multiple product launches in the next three-to-four years. Biogen Idec saw a change in leadership in August 2011, with Sameer Savkur taking over as new managing director from Dr Alpna Seth who moved to a bigger role at company's headquarters in the US. In a recent interview with BioSpectrum, Sameer Savkur discussed the current focus, R&D efforts, drug pipeline, and future strategies of the company.

Which are the key focus areas of Biogen Idec in India?
Savkur: Biogen Idec is committed to serving patients and the MS community. Seeing what scientific innovation can do for the patients has been very rewarding.

Looking ahead to 2012, our aim is to take the proper steps designed to result in exceptional growth. This includes making all our products available for the Indian patients as well as continuing to advance our late-stage pipeline and prepare for multiple product launches that are anticipated by the end of 2015. Being the global leader in MS, we are constantly evaluating ways to support patients through our innovative programs such as Reach.

What kind of R&D activities is the company pursuing?
We are working to enhance our R&D capabilities, drive innovation, and grow our early-stage pipeline through building world-class scientific teams in our core therapeutic areas.

We are increasing innovation and productivity of discovery efforts through greater focus; growing our early-stage pipeline through business development and internal discovery efforts; and increasing translational research efforts, including biomarker and imaging technologies.

We have been able to utilize our translational research to develop tools that are helping physicians in taking better clinical decisions in the management of MS.

What does Biogen Idec offer in India?
Biogen Idec has two products available in India to treat multiple sclerosis. These are Avonex (Interferon beta 1a IM) and Tysabri (nataliz umab).

What are the products in the drug pipeline?
Our late-stage pipeline includes numerous therapies that could help treat patients with MS. Among these are Fampridine-sustained release, which is approved in the United States and Europe to help treat walking impairment in MS patients. Also, there is BG-12 which is an investigational oral compound in phase III clinical development for the treatment of relapsing forms of MS.

There is PEGylated Interferon beta-1a, which is in phase III clinical trials and has the potential to reduce interferon dosing to as seldom as once per month. There's also the Daclizumab that has shown positive data in registrational trials and has an ongoing clinical trial program with a readout expected in 2014.

We also have therapies in phase III clinical trials for the other neuro-degenerative diseases, such as Amyotrophic Lateral Sclerosis (ALS), and haematological disorders, such as hemophilia. These therapies include the Dexpramipexole for ALS and long-lasting rFactor VIII and rFactor IX for hemophilia.

What is the company's strategy to achieve the targeted growth and goal?
In 2011, Biogen Idec's global revenues increased 7 percent to 2,500 crore ($5 billion) year-on-year. In 2012, our aim is to take steps designed to result in exceptional growth.

We will work to grow our existing product portfolio, continue to advance our late-stage pipeline, prepare for multiple product launches anticipated by the end of 2015, and grow our early-stage pipeline through internal research and strategic collaborations.

Do you think the biotechnology industry in India has been able to meet the growth expectations?
The biotech sector is one of the fastest growing knowledge-based sectors in the country. India's success in biotechnology will depend largely on how it implements policies for biopharmaceutical products (biologics) that balance innovation and access.

In a developing country such as India, we should remain sensitive to the needs for greater public access to safe and effective medicines. Scientific breakthroughs to treat diseases are driven by biotechnology. Becoming a global leader in this arena will require that we continue to attract innovative pharmaceutical and biotech sector investments by ensuring conducive regulatory and intellectual property environment. Some of the important milestones in this direction will be to have effective patent laws and guidelines for biosimilars registration.

Rahul Koul in New Delhi