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19 Sep 2018

Tildrakizumab (Ilumetri): Discovery, Development to Commercialization Case Study

Brand Name: Ilumetri
Biomolecule: Tildrakizumab

Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing the immune system and autoimmune disease.

Biologic Development to Commercialization Timeline

Initial Development and Research

Originally developed by Schering-Plough, this drug became part of Merck’s clinical program, following that company’s acquisition of Schering-Plough.

As of March 2014, the drug was in phase III clinical trials for plaque psoriasis. The two trials enrolled nearly 2000 patients.

In 2016, tildrakizumab became the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials for the treatment of moderate-to-severe plaque psoriasis, further validating the importance of the role of IL-23 in psoriasis.

September, 2018

In September 2014 Sun Pharmaceutical acquired worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of U.S. $80 million. Upon product approval, Sun Pharmaceutical will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.

July, 2018

In July 2016, Sun Pharma out-licensed Ilumetri (tildrakizumab) to Almirall, for the development and commercialisation of the product in Europe.

USFDA approval in March, 2018

In March 2018, it was approved by the Food and Drug Administration for the treatment of moderate-to-severe plaque psoriasis as an injection for subcutaneous use in the United States.

EU market authorization in September, 2018

Almirall gets European Commission approval for Sun Pharma’s outlicensed psoriasis drug lumetri (tildrakizumab).

EU market Launch – Planned

As indicated by Almirall, rollout of Ilumetri in Europe will start in the next few weeks.

 

 

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