Friday, July 29, 2016
India's largest drug maker Sun Pharma has signed a licensing agreement with Spanish firm Almirall for development and commercialization of tildrakizumab, its lead investigational compound for moderate-to-severe plaque psoriasis. Sun Pharma said it will build on the success of tildrakizumab and leverage the European capabilities of its partner. In return, the Indian company will receive an initial upfront payment of $50 million and be eligible for development and regulatory milestone payments in addition to sales milestones and royalties.
Almirall will be able to lead the European studies and participate in larger global clinical studies for the psoriasis indication. The agreement between Sun and Almirall remains subject to the exclusive license agreement between Sun Pharma and Merck signed in 2014.
Sun and Almirall have agreed for certain cost sharing agreements the details of which were not disclosed. Additionally, provisions are made for possible co-promotion agreement at some point in the future, subject to certain conditions, the two companies noted.
Sun's tildrakizumab, when successfully commercialized, will compete against a host of new generation drugs used to treat moderate-to-severe plaque psoriasis that are developed by large multinational companies like Novartis, J&J and Eli Lilly. Novartis is considered the strongest contender with its brand Cosentyx, J&J has an established brand Stelara and in March, Eli Lilly announced it secured the US FDA approval for Taltz, its latest drug for the same treatment.
Sun remains confident of the commercial prospects of its drug, backed by positive data from its multi-centric global clinical studies. In May, Sun said its monoclonal antibody met its primary endpoint in two pivotal phase three clinical trials for evaluating the efficacy and safety for anti-plaque psoriasis indication.
"Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe," a press statement from the company released late on Wednesday said.
"Sun Pharma is committed to growing our dermatology franchise, with tildrakizumab as our lead investigational compound. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are proud to be partnering with a regional leader in dermatology, like Almirall, to bring tildrakizumab to the European market," said Dilip Shanghvi, Managing Director, Sun Pharma.
"This agreement with Sun Pharma allows us to add a novel biologic for treatment of psoriasis to our extensive dermatology portfolio," said Jorge Gallardo, President of Almirall.
Sun is presently preparing for submission of a Biologics License Application to the US FDA. The detailed findings from the Phase three clinical trials will be presented at upcoming scientific meetings. As per the deal signed between Sun and Merck, the US drug maker will be responsible for manufacturing finished goods to support Sun Pharma's initial product launch. Post-approval in the US, the agreement makes Sun Pharma responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.
Source : economictimes.indiatimes.com
