Sun Pharma gets approval for psoriasis drug Ilumya, its first biologic drug

Sun Pharmaceutical Industries on Wednesday announced US Food and Drug Administration approval for psoriasis drug Ilumya, its first biologic drug in the market.

The market for psoriasis drugs in US is over $ 6 billion and the approval allows the drugmaker to expand its portfolio in dermatology space. Biologic drugs are made from living cells.

In 2014, Sun Pharma acquired rights for the drug (molecule name Tildrakizumab) for all its indications from US drugmaker Merck & Co on upfront payment of $ 80 million. The phase-3 trials and submission of an application to US drug regulator were done by Merck. Sun Pharma will market the product and will also pay milestone payments and royalties on its sale to Merck. The drug will be manufactured by Samsung BioLogics.

Psoriasis is a chronic immune disease that appears on the skin and the most common form affecting about 80 to 90 per cent of people living with psoriasis is called plaque psoriasis.

Currently, Janssen Biotech, Eli Lilly, Novartis and Valeant Pharmaceuticals market psoriasis drugs in the US and Sun Pharma will be the fifth company to enter into the category. 

“ Sun Pharma is quite late in the crowded market. Unless the company offers attractive price it will be difficult to make a mark. In the best case scenario the company can generate $ 200 million annually from this product in the fifth year,” Deepak Malik of Edelweiss Securities wrote in a note to investors. HDFC Securities pegs annual sales to touch $ 300 million from the fourth year. 

“ With the approval of Ilumya and our long-standing commitment in dermatology we are focused on making a difference for people living with moderate-to-severe plaque psoriasis,” said Abhay Gandhi, president and chief executive officer, North America, Sun Pharma. The company is ranked fourth in dermatology prescription volume in the US and its existing portfolio comprises of several other branded products to treat acne and actinic keratosis.