Like pharma giants Pfizer, Eli Lilly and Merck & Co, US biotechnology major Biogen Idec also doesn’t want to miss the India opportunity.
The $4.4 billion Massachusetts-based company is looking at building its presence in the Rs 1 lakh crore Indian pharma markets through research & development and manufacturing activities.
Alpna Seth, managing director, Biogen Idec India, said since 2007 the company has integrated India in its global development efforts.
“Our plans have progressed well since we established a wholly owned subsidiary in India in 2007. We are including Indian sites and investigators for clinical studies in core line of work in neurology, oncology, etc.”
Seth said that activities in India would include R&D, small molecule chemistry based manufacturing, clinical data management, etc.
Biogen’s key presence has been in the area of multiple sclerosis (MS), which occurs when the body’s immune system attacks the nerve cells of the brain and the spinal cord, stripping them of their myelin cover, and is characterised by blurred vision, slurred speech, numbness in legs, problems in balance, difficulty in swallowing, cognition, etc.
MS affects about 2.5 million people globally, according to the World Health Organisation.
Recently, the company’s fastest growing drug, natalizumab (brand name Tysabri), which is used for MS, has been in the eye of a storm over reports of progressive multifocal leukoencephalopathy—a viral infection which damages the white matter of the brain. According to data from the US, about 35 cases of the infection have been detected.
In 2009, Tysabri, which is co-marketed by Biogen, along with Dublin-based Elan Pharma, had sales of $1.1 billion, an increase of 30% over the previous year. The drug carries a black box warning, the strongest type for prescription drugs by the US Food and Drug Administration (US FDA), stating that patients using it are at an increased risk of developing the brain infection.
The drug was temporarily withdrawn in 2005 because of its link to brain infection and was allowed to resume sales in 2006 by the US FDA after deciding its benefits outweighed its risks.
According to Seth, the risk of developing the brain infection is estimated at 1 in 1,000 globally. “Tysabri is not yet marketed in India. It is the only MS drug where more than one out of every three patients taking it didn’t get flare-ups of the disease, or progression of the disease.”
Treatments like natalizumab which cause brain disease have to be monitored by neurologists, says Uday Murgod, consultant neurologist, Manipal Hospital, Bangalore.
According to Sujay Shetty, associate director, PricewaterhouseCoopers, risks associated with drugs is a serious issue especially if the risks pertain to the heart or brain and can lead to huge sales wipe-outs.