On Monday the company said that one of its wholly-owned subsidiaries got approval from Ministry of Health, Labour and Welfare (MHLW), Japan
for Ilumya (tildrakizumab) for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies. Japan has approximately 430,000 people currently suffering from psoriasis.
Psoriasis is a chronic immune disease that appears on the skin, affecting approximately 125 million people worldwide. The non-contagious disorder speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form, affecting about 80-90 per cent of people with psoriasis, is called plaque psoriasis. It appears as red, raised areas of skin covered with flaky white scales which may be itchy and painful and can crack and bleed.
Junichi Nakamichi, Country Head, Sun Pharma
Japan, said, “Ilumya is the first innovative drug that Sun Pharma
plans to launch in Japan. It was extensively tested in Japanese patients as part of Ilumya’s global clinical development program."
He added the drug offers a new treatment option with only one injection every 12 weeks for Japanese patients who struggle everyday with the chronic nature of plaque psoriasis. It showed sustained efficacy for over 4 years and has safety profiles over 4 years with low rates of severe infections, malignancies etc.
"This approval adds a biologic product to our existing strong dermatology portfolio in Japan. We will leverage Sun Pharma
Japan’s marketing network to make Ilumya, a safe and efficacious product, available to dermatologists and patients in Japan," Junichi said.
Ilumya is approved in the US and EU markets already. Ilumya has clocked sales of $94 mn in the first year of its commercialisation.
Sun is doing research to find out other indications of Ilumya apart from psoriasis.
Sun Pharma acquired Pola Pharma in Japan last year. The company already has a portfolio of specialty products and Sun Pharma plans to expand its presence in dermatology in Japan. As such Sun Pharma has a basket of nine specialty products including Ilumya, Absorica, Xelpros, Yonsa, Cequa etc.
The company did not disclose how many of these specialty products it aimed to launch in Japan.
A Mumbai based analyst said that as such Japan is not a very lucrative market as the generic medicines see price revision twice a year. "There is some oppotunity in the branded market that Sun is eyeing, but dermatology segment as such is witnessing price erosion. We do not see this as an upside for the stock," he said. He added that there are other options for psoriasis treatment in Japan and that Sun may see some competition.
In its post fourth quarter results note, Edelweiss said, "Sun Pharma has invested $2 bn in specialty. However, breakeven will likely take long as it has already lined up more investments. "
Sun had forayed into the Japanese prescription market in 2016 with the acquisition of 14 established prescription brands from Novartis. Most Indian players have lost interest in the Japanese market due to price competitiveness. Last year Lupin sold its Japanese subsidiary for generics Kyowa. Sun Pharma feels that branded products market has opportunities in Japan.