Sun Pharma and Samsung BioLogics announce strategic manufacturing tie up for Tildrakizumab

FOR IMMEDIATE RELEASE Sun Pharma & Samsung BioLogics announce strategic manufacturing tie-up for Tildrakizumab Mumbai, INDIA & Incheon, KOREA - July 04, 2017: Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “S un Pharmaceutical Industries Ltd” and includes its subsidiaries or associate com panies) and Samsung BioLogics announced a strategic long-term manufacturing agree ment for Tildrakizumab. The agreement was entered into by Sun Pharma’s wholly-o wned subsidiary and Samsung BioLogics. According to the agreement, Sun Pharma h as appointed Samsung BioLogics to manufacture Tildrakizumab, an investigational IL-23 p19 inhibitor being evaluated for the treatment of moderate to severe plaque psoriasis. F ilings for this novel investigational biologic has been accepted for review by the U.S. Food and Drug Administration (FDA) (May 2017) and the European Medicines Agency (EMA) (Marc h 2017). The agreement was signed at Samsung BioLogics’ headquarter in Incheon, South Korea. The approximate value of the contract will be US$ 55.5 million, other fin ancial details of the agreement are confidential. Commenting on the development, Dr. TH Kim, Presiden t and CEO of Samsung BioLogics said, “Samsung BioLogics is pleased to join hands with Su n Pharma and is looking forward to delivering best-in-class manufac turing services with global quality standards. Our collaboration with Sun Pharma is an important milestone for Samsung as it is a testament of our ability to provide reliable supp ly through its GMP-certified manufacturing facility to pharmaceutical companies, which aim to expand their global market.” Commenting on its agreement with Samsung BioLogics, Mr Kirti Ganorkar, Global Head – Portfolio Management & Business Development, Sun Pharma 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.” About Tildrakizumab Tildrakizumab is an investigational humanized, 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 resp onsible for the inflammatory process of psoriasis with limited impact on the rest of the im mune 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 regulatory f ilings associated with tildrakizumab have been accepted for review by the FDA and EMA. About Sun Pharma, Merck & Co., Inc., Kenilworth, NJ, USA, Agreement Sun Pharmaceutical Industries Ltd.’s wholly owned s ubsidiary received worldwide rights to tildrakizumab from Merck (through a Merck subsidiar y), 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 p laque psoriasis and, as appropriate, submission of a Biologics License Application to the United States Food and Drug Administration (FDA). Merck is also responsible for manufacturing finished goods to sup port Sun Pharma’s initial product launch. Post- approval in the U.S., Sun Pharma will be responsibl e for all other regulatory activities, including subsequent submissions, pharmacovigilance, post app roval studies, manufacturing and commercialization of the approved product. Sun Phar ma will also be responsible for all regulatory, pharmacovigilance, post approval studies, manufactu ring and commercialization of approved products for all non-U.S. markets. Merck is eligibl e to receive milestone payments and royalties on sales of tildrakizumab. About Sun Pharma, Almirall S.A, Europe, Agreement Sun Pharma and its wholly owned subsidiary and Almi rall (Spanish Stock Exchange ticker: ALM) closed on July 2016 a licensing agreement on the de velopment and commercialization of tildrakizumab for psoriasis in Europe. Under terms of the license agreement, Almirall is able to lead European studies, and participate in larger Global clinical studies for psoriasis indication subject to the terms of the Sun Pharma – Merck agreements, as well as certain cost sharing agreements. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales . Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almir all will have right of first negotiation for certai n indications in Europe. The agreement between Sun Ph arma and Almirall remains subject to the exclusive license agreement between Sun Pharma and Merck. Disclaimer: Statements in this “Document” describing the Compan y’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws an d regulations. Actual results, performance or achievements could differ materially from those expressed or implied. About Samsung BioLogics Samsung BioLogics is a global full-service provider of quality-driven contract process development and cGMP manufacturing to the global biopharmaceuti cal industry. Our facilities are custom designed for monoclonal & recombinant production with maximu m flexibility. Our one-stop services include cell line generation, process and analytical method deve lopment, analytical services, clinical and commercial bulk cGMP manufacturing of drug substanc e and drug product including quality assurance, quality control, regulatory compliance s tandards & support for our customers. For additional information about the company, please visit http://www.samsungbiologics.com About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050): Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated bus iness, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provide s high-quality, affordable medicines trusted by custo mers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 42 manufacturing facilities spread across 6 continents, R&D centres across the globe and a mult i-cultural workforce comprising over 50 nationalities. In India, the company enjoys leaders hip across 11 different classes of doctors with 30 brands featuring amongst top 300 pharmaceutical bra nds in India. Its footprint across emerging markets covers over 100 markets and 6 markets in We stern Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 3 global m arkets. Its API business footprint is strengthened through 14 world class API manufacturi ng facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of approximately 8% of annual revenues. For further information please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live Contacts: Sun Pharma Media Investors Frederick Castro Nimish Desai Tel +91 22 4324 4324, Xtn 2777 Tel +91 22 4324 432 4, Xtn 2778 Tel Direct +91 22 4324 2777 Tel Direct +91 22 4324 2778 Mobile +91 99206 65176 Mobile +91 98203 30182 E mail [email protected] E mail nimis [email protected] Contacts: Samsung Biologics Media Investors I.Chan Hwang Soyoung Chung Phone 82 32 455 9332 Phone 82 32 455 3796 E mail [email protected] E mail soyoung.chu [email protected]

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