US FDA accepts application of Sun Pharma's partner Merck for tildrakizumab

Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis

Sun Pharma ropes in Mitsubishi Tanabe to distribute products in Japan

Last Updated : May 24 2017 | 2:07 PM IST

Sun Pharmaceutical Industries Ltd has announced that the US Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for tildrakizumab filed by its partner, Merck & Co Inc. The US FDA filing acceptance follows the acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis.

In 2014, Sun Pharma acquired worldwide rights to tildrakizumab from Merck, known as MSD outside the US and Canada. Funded by a Sun Pharma subsidiary, Merck is responsible for the completion of phase 3 trials in patients with mild-to-moderate plaque psoriasis and, as appropriate, submission of a biologics license application to the US FDA.

Merck is also responsible for manufacturing finished goods to support Sun Pharma’s initial product launch. Post-approval in the US, Sun Pharma will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product. Merck is eligible to receive milestone payments and royalties on sales of tildrakizumab.

Abhay Gandhi, CEO - North America Business, Sun Pharma, said, “At Sun Dermatology, we are committed to making a difference in the lives of patients and healthcare providers. The acceptance of the regulatory filing by the US FDA marks a significant milestone as we seek to advance for tildrakizumab as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis.”

For European market, Sun Pharma has a licensing agreement with Almirall for the development and commercialisation of tildrakizumab for psoriasis. Under terms of the license agreement, Almirall is able to lead European studies, and participate in larger global clinical studies for psoriasis indication. The agreement between Sun Pharma and Almirall remains subject to the exclusive license agreement between Sun Pharma and Merck.

Psoriasis, a chronic immune disease that appears on the skin, affects an estimated 7.5 million people in the US and approximately 125 million people worldwide. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed.