Apremilast was approved in the US in 2014 for treatment of adults with active psoriatic arthritis and moderate-to-severe plaque psoriasis. The molecule has been patented by US firm Celgene Corporation in developed markets. Its sales touched $1billion in 2016.
In India, Glenmark received approval to launch the product from the Drug Controller General of India after conducting clinical trials on psoriasis patients for 16 weeks.
The company will launch apremilast tablets in India this week and the treatment cost is expected to be Rs2,000 per month. “Glenmark is proud to be the first player to introduce apremilast, an advanced oral treatment for psoriasis in India. The introduction of this revolutionary treatment will open a new treatment paradigm for millions of patients across the country by overcoming several challenges of the existing therapies," said Sujesh Vasudevan, president and head of India Formulations and Africa Region at Glenmark.
According to the Indian Journal of Dermatology, Venereology and Leprology, about 33 million people in India suffer from psoriasis.
At present, the oral tablets prescribed for moderate-to-severe psoriasis are acitretin, methotrexate, and cyclosporine. Others are biologics such as etanercept, infliximab, adalimumab and secukinumab, which are injectables. For mild psoriasis, creams are prescribed generally.
“Biologics are expensive. The treatment cost for biologics ranges from Rs300,000 to Rs600,000 per annum. Oral tablets are relatively much cheap. Safety profile of apremilast is established through clinical trials and post marketing survey abroad but we will get more clarity once it starts getting prescribed in India. We will also have to monitor its efficacy," Dr. Sushil Tahiliani, a dermatologist in Mumbai, said.
According to Glenmark, apremilast is an immuno-modulator, while other drugs available in the country, including biologics, are immuno-suppressants, which can make the body susceptible to various infections. The company says apremilast does not have side effects on organs like the liver and the kidneys and that the patient does not require frequent diagnostic tests.
“The existing treatments pose several challenges like the need for medical professionals for administration, routine laboratory monitoring, and safety challenges. Apremilast is a safer and efficacious treatment which is administered orally thus does not require any professional help or routine laboratory monitoring," Vasudevan said.
Glenmark is the number two player in the dermatology market in India, with key brands such as Candid, Candid B, Elovera, Scalpe, Onabet, and Syntran. The dermatology segment contributes 25-27% to the company’s India business.
In financial year 2016-17, the company’s domestic business grew 9.2% to Rs2,303.8 crore, while total consolidated revenue was Rs9,185.7 crore, up 20.1% from a year earlier.
“It is difficult to project the impact of individual products but the launch of apremilast appears to be in line with the company’s strategy to launch one or two differentiated products every year. Given its strong presence in dermatology and the first mover advantage, the company could get a good market share in apremilast," an analyst said, requesting anonymity.
In 2015, the company was the first to launch teneligliptin for diabetes treatment at a cost that was 55% lower than other available gliptins in the country. Now there are about 100 teneligliptin brands in India and prices have come down significantly. It also launched Digihaler, India’s first digital dose inhaler for asthma and chronic obstructive pulmonary disease (COPD) patients in 2016.
Glenmark expects competition for apremilast to trickle in within three months of launch as the clinical trials done by the company will pave the way for other players in India to launch the product without having to conduct their own clinical trials. This means that price of apremilast could come down further, as happened with teneligliptin.
The company’s strategy for the Indian market is to focus on areas of dermatology, respiratory, oncology, cardiology and diabetes and bring new products and build brands in these segments.
“We believe timely new launches are one of the key differentiating factors for Glenmark. The growth on account of new launches is significantly higher for Glenmark compared to the broader market. We believe early entry into such new generation class of drugs will remain an important factor in driving growth for the company," Nomura Financial Advisory and Securities (India) Pvt Ltd. said in a report dated 18 September.