Sun Pharma in $55.5-mn deal with Samsung BioLogics for psoriasis drug
05 Jul 2017
Generic drugs maker Sun Pharmaceutical Industries Ltd has entered into a long-term manufacturing agreement with Samsung BioLogics for biological drug Tildrakizumab, which is used in the treatment of psoriasis.
As per the agreement signed between Sun Pharma's wholly-owned subsidiary and Samsung BioLogics, Samsung BioLogics will manufacture Tildrakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate to severe plaque psoriasis.
Sun Pharma said the US Food and Drug Administration (USFDA) had accepted filings for this novel investigational biologic for review in May and the European Medicines Agency (EMA) in March 2017.
The agreement was signed at Samsung BioLogics' headquarters in Incheon, South Korea. The approximate value of the contract will be $55.5 million, other financial details of the agreement are confidential, Sun Pharma stated in a release.
''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,'' Dr TH Kim, president and CEO of Samsung BioLogics, said.
''Samsung BioLogics is a globally renowned CMO. Through this partnership we will leverage Samsung's manufacturing knowledge and world class quality systems to provide high quality products for the Tildrakizumab pipeline,'' Kirti Ganorkar, Global Head – Portfolio Management & Business Development, Sun Pharma, said.
''Tildrakizumab is an investigational humanised, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. 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.
''Phase-3 Tildrakizumab data provide further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis,'' the release added.
The regulatory filings associated with Tildrakizumab have been accepted for review by the FDA and EMA.
Sun Pharmaceutical Industries Ltd's wholly owned subsidiary received worldwide rights to Tildrakizumab from Merck (through a Merck subsidiary), known as MSD outside the United States and Canada, in 2014.
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 Licence Application to the United States Food and Drug Administration (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. Sun Pharma will also be responsible for all regulatory, pharmacovigilance, post approval studies, manufacturing and commercialisation of approved products for all non-US markets.
Merck is eligible to receive milestone payments and royalties on sales of Tildrakizumab.