Launches new anti-epileptic drug Fycompa (perampanel) in India
Eisai Pharmaceuticals, in order to cater to the Japanese market, plans to manufacture finished dosage along with active pharmaceutical ingredients (APIs) from its Vizag facility. The company has also launched new anti-epileptic drug Fycompa (perampanel) in India.
The company also plans to expand its API facility besides expanding its CNS, oncology and GI therapeutics. Last year, the company exported 30 tonne of eperisone API for muscle relaxation and 10 tonne APIs for anti-fungal and hepatic disorder.
Commenting on the Indian pharma companies becoming self reliant at API front, Sanjit Singh Lamba, MD, Eisai Pharmaceuticals India said, “India is largely dependent on China for APIs as China supplies them at a low cost, which we cannot compete. However, under the Make in India campaign, the government is trying to bring down the dependency from them.”
Fycompa (perampanel) was launched five years back in the global markets. Commenting on the delay in launch of the drug in India, Lamba said, “The drug was already available in 55 different countries and from early 2013 till late 2016, we have been asked by the Indian regulatory agency to produce various reports on the conducted clinical trials and we have submitted those. However, we requested CDSCO to expedite phase III approval process of drugs, which are already available in the US, Europe, Japan and Canada and the authority is considering it.”
Fycompa is indicated as an adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalised seizures in patients with epilepsy aged 12 and older. It is first in class in-house developed anti-epileptic drug, available in tablet form as a once-daily oral dose. At present it is available in three different dosage form, 2mg, 4 mg and 6 mg priced at Rs 35, Rs 55 and Rs 70 respectively.
He further added, “Epilepsy has been a therapeutic focus area for Eisai and we will continue to use our strengths in research and development to create drugs that will improve and enhance the quality of life.”
Adding to this Dr Manoj Malhotra, Head of Medical Affairs, Americas Region, Global Head of Epilepsy Medical Affairs, Neurology Business Group, Eisai said “With the launch of many anti-epileptic drugs in the last decade we have seen a significant improvement in seizure freedom rate. However, almost 30-40 per cent of the seizures remain poorly controlled leading to low compliance. Fycompa will help to address these key therapeutic challenges and improve patient outcomes”.
Commenting on the new launches, Lamba informed that this year, we plan to launch five new products. A total of 15 NCEs are in the pipeline for the global market.
Commenting on low awareness of epilepsy, Saumil Mody- VP, Commercial Operations, Eisai India said, “Treatment outcome for epilepsy is very low because we are dealing with very challenging circumstances. A majority of epilepsy cases go undiagnosed because of numerous factors like social stigma associated with the disease, lack of awareness of the symptoms particularly in rural India. Our aim is to address these challenges and enable epileptic patients and their families to live a seizure-free life.”