Big Pharma turn spotlight on Multiple Sclerosis

A rare central nervous system disorder which has till now been bereft of oral medication is fast emerging as a focal point for Big Pharma.

Multiple Sclerosis (MS) occurs the body’s immune system attacks the nerve cells of the brain and spinal cord, stripping them off their myelin cover, is characterised by blurred vision, slurred speech, numbness in legs, problems in balance, difficulty in swallowing, cognition, bladder control, etc.

The cause is not clear, with genetic variations, stress, smoking, infections claimed as risk factors.

In later stages, it may cause severe paralysis or stiffness, with the patient becoming confined to a wheelchair or bed, says Uday Murgod, consultant, neurologist, Manipal Hospital, Bangalore.

Over 2.5 million people worldwide suffer from this disorder, says the World Health Organisation (WHO).

Current treatment options aid in slowing or modifying the progress of the disease, and are injected either intravenously, subcutaneously or intramuscularly.

There is at present no cure for MS and patients are desperate to get one, says Group Capt Prabal Malaker (Retd), a former fighter pilot in the Indian Air Force who was diagnosed with MS in 1998.

“My mobility is gradually being degraded as my legs are becoming spastic. I continue to fight MS by moving to the extent possible through swimming, physiotherapy, etc.”

Being a niche area, MS holds huge opportunity for targeted therapies, especially oral therapies which can change the dynamics of the market, says Sujay Shetty, associate director, PricewaterhouceCoopers (PwC).

Current drugs by pharma giants Biogen Idec, Teva, Schering and Serono SA such as interferon beta-1a, natalizumab, interferon beta-1b, mitoxantrone, glatiramer acetate, etc. do not cure MS but help reduce the frequency and severity of attacks and the development of new brain lesions.

“Current treatments can control the problem to some extent and prevent it from becoming worse. But monthly treatment costs can vary between Rs 20,000-60,000,” says J D Mukherjee, head of neurology, Max Hospital, New Delhi.

These drugs also carry side effects like fever and bodyache (interferons), cardiac side effects (mitoxantrone), brain disease (natalizumab), says Murgod from Manipal Hospital. “These treatments have to be monitored by neurologists.”

Research is going on to bring oral drugs which are the need of the hour for MS, which crops up anytime between 18-50 years, which is the most productive age-group, says  M V Padma, neurologist,
All India Institute of Medical Sciences (AIIMS), New Delhi.

Four oral drugs for MS, namely clabridine, teriflunomide, fingolimod, laquinimod are currently in Phase III of clinical trials, which a multi-centre trial on large groups of patients by drugmakers like Merck KGaA, Sanofi Aventis, Novartis, Teva &Active Biotech.

Industry data suggest that the MS market, which was approximately $8.7 million in 2008, is set to rocket to $11.4 billion by 2015.

PwC’s Shetty says that as MS is a high-value, low-volume business, the market would not be too crowded with any and every drugmaker eyeing a presence.