Zandu Pharmaceutical Works Ltd and CMI India Pvt Ltd will jointly develop Zandu's anti-Parkinson's drug HP-200, one of the few plant-based formulations to receive investigational new drug status from the US Food and Drug Administration.
CMI India is a wholly owned subsidiary of Centers for Medical Innovation, Germany. The German company has committed to invest $10 million in India initially.
The two companies have signed a joint development agreement under which CMI will finance clinical and pharmaceutical development of HP-200. The two companies will also work together to obtain new drug marketing approval in the US, Europe and other countries. Zandu will supply the raw material for the drug.
CMI intends to conduct phase one and two clinical trials in the US this year and expects to market the drug in five years. Zandu owns the patent for HP-200 and has agreed to share the marketing receipts with CMI.
HP-200 is sourced from Mucuna pruriens, a plant belonging to the leguminous family. According to Dr Ashok Vaidya, director of Zandu and a key official involved with pre-clinical and clinical studies on HP-200 in India, says the usefulness of Mucuna pruriens is known to treat Parkinson's disease, a progressive neuro-degenerative movement disorder affecting over one million people worldwide.
A World Bank study conducted in the US estimates $4 billion in annual cost savings if Parkinson's disease can be delayed by five years. The worldwide market for treatment of Parkinson's disease is in the range of $400-500 million.
There is no cure available for Parkinson's disease. Many patients are only mildly affected and need no treatment for several years after the initial diagnosis. When symptoms grow severe, doctors usually prescribe levodopa, or L-dopa. Levodopa helps supplement the brain's neurotransmitter dopamine. Dopamine is a chemical that transmits electrical signals to and from the brain. With old age the dopamine secretions get depleted, causing involuntary body movements and impair coordinated movements of the limbs.
Current medical management is considered largely unsatisfactory, as it is limited to symptom alleviation, says a CMI release. "Effectiveness diminishes with long-term use and is associated with motor complications (dyskinesia) and unpleasant side-effects, such as vomiting and nausea. None of the current available compounds are capable of delaying or stopping the disease's progression", the release adds.
"Approximately 50 per cent of the patients treated with available medicines have reported side-effects. Clinical experiences have shown that an equivalent amount of L-dopa is available in Mucuna pruriens and its side-effect profile is definitely lower compared to L-dopa formulations," Dr Vaidya says.
However, there is not enough evidence to show that Mucuna pruriens can delay or stop the progression of the disease. "We are going to evaluate clinically if Mucuna pruriens can be effective in delaying or stopping the progression of the disease," says Dr Christoph Von Keudell, director of CMI India and chief scientific officer of CMI Germany.
Dr C Warren Olanow, managing director of Mount Sinai Medical Centre, New York, and Dr Peter Jenner of King's College London – two of the world leading experts in the experimental and clinical aspects of Parkinson's disease – will actively participate in the clinical trials of HP-200, according to Dr Keudell.
HP-200 is marketed in India under the brand name Zandopa.