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Tuesday, 4 July 2017

Sun Pharma to outsource manufacturing of its psoriasis drug candidate to Samsung BioLogics : 4 Jul 2017

Sun Pharma, India's largest drug maker on Tuesday, said it has entered into a strategic agreement with Samsung BioLogics to manufacture the former's psoriasis drug Tildrakizumab.

According to the agreement, Sun Pharma has appointed Samsung BioLogics to manufacture Tildrakizumab, an investigational IL-23p19 inhibitor which is being evaluated for the treatment of moderate to severe plaque psoriasis.

Filings for this drug has been accepted for review by US FDA in May 2017 and the European Medicines Agency (EMA) in March 2017.

The agreement was signed at Samsung BioLogics’ headquarter in Incheon, South Korea. The approximate value of the contract is pegged at USD 55.5 million. Other financial details of the agreement are confidential.

“Samsung BioLogics is a globally renowned CMO (contract manufacturing organisation)," said Kirti Ganorkar, Global Head, Portfolio Management & Business Development, Sun Pharma.

"Through this partnership we will leverage Samsung’s manufacturing knowledge and world-class quality systems to provide high quality products for the Tildrakizumab pipeline,” Ganorkar said.

Sun Pharma said it expects to launch Tildrakizumab drug next year.

"Our collaboration with Sun Pharma is an important milestone for Samsung as it is a testament of our ability to provide reliable supply through its GMP-certified manufacturing facility to pharmaceutical companies, which aim to expand their global market,” said TH Kim, President and CEO of Samsung BioLogics.

With this precise targeting, Tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system.

Sun Pharma has been developing a pipeline of specialty drugs that include Tildrakizumab (Merck), Odomzo (Novartis), MM-II (Moebius), Seciera (Ocular), Elepsia/Xelpros (SPARC), BromSite/DexaSite (Insite), Absorica (Ranbaxy), and Dusa drug products.

Sun Pharma acquired worldwide rights to Tildrakizumab from Merck - known as MSD outside the US and Canada - in 2014 for an upfront payment of USD 80 million.

Funded by Sun Pharma, Merck is responsible for the completion of phase-3 trials in patients with mild-to-moderate plaque psoriasis, and submission of a Biologics License Application to the US FDA.

Sun Pharma's key manufacturing facility at Halol, Gujarat has been under US FDA scanner for a while and the company has been working on resolution.

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