US FDA Filing Acceptance of Biologics License Application For Tildrakizumab

Sun Pharmaceutical Industries Ltd. SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office : SPARC, Tandalja, Vadodara – 390 020. India FOR IMMEDIATE RELEASE Sun Pharma Announces US FDA Filing Acceptance of Biologics License Application (BLA) For Tildrakizumab Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis Mumbai, INDIA and New Jersey, USA, May 24, 2017 – Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARM A, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies) announces the U.S. Food and Drug Administration (FDA) acceptance of the Biologics License Application (BL A) for tildrakizumab. The FDA filing acceptance follows the acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatmen t of moderate-to-severe plaque psoriasis. The BLA filing for tildrakizumab was submitted by Merck & Co., Inc., Kenilworth, NJ, USA. According to Abhay Gandhi, CEO - North America Business, Sun Pharma, “At Sun Dermatology, we are committed to making a difference in the live s of patients and healthcare providers. The acceptance of the regulatory filing by the U.S. FDA marks a significant milestone as we seek to advance for tildrakizumab as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis.” The BLA filing for tildrakizumab with the U.S. FDA is based on two pivotal Phase III trials (reSURFACE 1 and 2) which included over 1,800 patients across mo re than 200 clinical trial sites, including some patients who have been treated with tildrakizumab f or up to three and a half years. Data from these trials were most recently presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in March and previously presented at the 25 th European Academy of Dermatology and Venereology Congress. Future presentations and publ ications of the reSURFACE Phase-3 pivotal trials will include more scientific insights on the data t o week 52 and beyond. The clinical trials are desig ned to evaluate safety and efficacy for up to five year s, and to date, some clinical trial participants ha ve been treated with tildrakizumab for up to three and half years. About Psoriasis Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.5 million pe ople in the U.S. and approximately 125 million people worldwide 1. It is a non-contagious disorder that speeds the g rowth cycle of skin cells 1 and results in thick scaly areas of skin 2. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed 2. Despite existing treatment options, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease. 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 responsible for the inflammatory process of psoriasis with limited impa ct on the rest of the immune system. Phase-3 tildra kizumab data provide further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis. Sun Pharmaceutical Industries Ltd. SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office : SPARC, Tandalja, Vadodara – 390 020. India About Tildrakizumab Phase-3 reSURFACE Trial Design Tildrakizumab Phase-3 studies (reSURFACE 1 and 2) a re randomized, placebo-controlled, multicenter, thr ee-part studies designed to demonstrate efficacy of tildrakizumab i n moderate-to-severe plaque psoriasis compared to p lacebo and comparative drug and to assess safety and tolerability. Part one of the studies randomized patients into three or four treatment arms, including tildrakizumab 200mg, tildrakizumab 100mg, placebo and etanercept (reSURFACE 2 only). A fter Week 12 patients on placebo and etanercept were then re-randomized into tildrakizumab 200mg and 100mg treatment arms to proceed into part two of the studies. Finally, in part thre e of the studies, responders (PASI ≥75) and partial responders (PASI ≥50 and PASI <75) were re-randomized after Week 28 continue the same treatment, a different dose of tildrakizumab or placebo. The co-primary efficacy endpoint of the two placebo controlled studies were the proportion of patients with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participa nts with a Physician’s Global Assessment (PGA) score of clear or minimal w ith at least a 2 grade reduction from baseline at w eek 12 compared to placebo. The reSURFACE 2 also included a key secondary endpo int comparing tildrakizumab and etanercept on PASI 75 and PGA. Other co-secondary endpoint of both placebo controlled studies included PASI 90 and PASI 100 responses at week 12 and PASI 75, 90 and 100 and PGA responses from baseline at Week 28. PGA measures lesion thickness, erythem a and scaling across all of a patient’s psoriasis lesions in order to determine the disease activity on a six-point scale from “clear” to “severe.” A PASI score is a measure of psoriatic plaque redne ss, scaling and thickness and extent of the involve ment in each region of the body. Treatment efficacy is often measured by r eduction of PASI from baseline (i.e. 75 percent red uction is known PASI 75), a 90 percent reduction is known as PASI 90 and PASI 100 is total clearance of skin disease. About Sun Dermatology Sun Pharma is committed to expanding our dermatolog y portfolio to bring healthcare providers and patie nts around the world more treatment options and ongoing support for cond itions with high unmet medical needs like psoriasis . Sun Pharma, along with its subsidiaries, is ranked fourth in dermatol ogy prescription volume within the U.S. per IMS and is fifth largest specialty generic pharmaceutical company globally. In additio n to the investigational candidate tildrakizumab, a n investigational anti-IL- 23p19 monoclonal antibody, Sun Dermatology is compr ised of several branded products indicated for the treatment of acne and actinic keratosis with a focus on other dermato logic conditions with unmet needs such as psoriasis and atopic dermatitis. For further information, please visit www.sunpharmaderm.com About Sun Pharma, Merck & Co., Inc., Kenilworth, NJ, USA, Agreement Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary acquired 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 i n patients with mild-to-moderate plaque psoriasis a nd, as appropriate, submission of a Biologics License Application to th e 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-appr oval in the U.S., Sun Pharma will be responsible for all other regulatory activities, including subsequent submissions, phar macovigilance, post approval studies, manufacturing and commercializati on of the approved product. Sun Pharma will also be responsible for all regulatory, pharmacovigilance, post approval studie s, manufacturing and commercialization of approved products for all non- U.S. markets. Merck is eligible to receive mileston e payments and royalties on sales of tildrakizumab. The agreement between Sun Pharma and Almirall remains subject to the exclusive license agreement between Sun Pharma and Merck. About Sun Pharma, Almirall S.A, Europe, Agreement Sun Pharma and its wholly owned subsidiary and Almirall (Spanish Stock Exchange ticker: ALM) closed on July 2016 a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. Under ter ms of the license agreement, Almirall is able to lead European studie s, and participate in larger Global clinical studie s for psoriasis indication subject to the terms of the Sun Pharma – Merck agre ements, 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 Almirall will have right of first negotiation for certain indications in Europe . The agreement between Sun Pharma and Almirall rem ains subject to the exclusive license agreement between Sun Pharma and Merck. References 1. National Psoriasis Foundation. Facts about psori asis. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed on June 27, 2016. 2. National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis. Accessed on June 27, 2016. Sun Pharmaceutical Industries Ltd. SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office : SPARC, Tandalja, Vadodara – 390 020. India Disclaimer: Statements in this “Document” describing the Compan y’s objectives, projections, estimates, expectation s, plans or predictions or industry conditions or events may be “forward lo oking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. 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 business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quali ty, affordable medicines trusted by customers and p atients in over 150 countries across the world. Sun Pharma's global pre sence is supported by 42 manufacturing facilities s pread across 6 continents, R&D centres across the globe and a mult i-cultural workforce comprising over 50 nationaliti es. The consolidated revenues for 12 months ending March 2016 are approximately US$ 4.3 billion, of which US contributes US$ 2.1 billion. In India, the company enjoys leadership across 11 different classes of doctors with 30 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging mark ets covers over 100 markets and 6 markets in Wester n Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 4 global markets. Its API business footpr int is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence th rough innovation supported by strong R&D capabilities comprising abo ut 2,000 scientists and R&D investments of over 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 [email protected] FleishmanHillard (PR Agency | US) Sarah Connolly Tel +1 212-453-2034 Mobile +1 347-559-3671 E mail [email protected]

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