Sun Pharma Announces Positive Results of Two Pivotal Phase-3 Clinical Trials of Tildrakizumab in Patients with Moderate-to-Severe Plaque 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 Corporate Office : SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India. FOR IMMEDIATE RELEASE Sun Pharma Announces Positive Results of Two Pivotal Phase-3 Clinical Trials of Tildrakizumab in Patients with Moderate-to-Severe Plaque Psoriasis First IL-23p19 Therapeutic Antibody Meets Primary Endpoints in Both Placebo-Controlled Studies and Secondary Endpoint in Active-Comparator Etanercept Arm Mumbai, May 04, 2016: Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, N SE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) today announce d that two pivotal Phase-3 clinical trials evaluating the effi cacy and safety of the investigational IL-23p19 inh ibitor antibody tildrakizumab (MK-3222) in patients with moderate-t o-severe plaque psoriasis met their primary endpoin ts for both evaluated doses. The co-primary efficacy endpoints of the placebo co ntrolled studies (MK-3222-010 and MK-3222-011) were : the proportion of participants with Psoriasis Area Sens itivity Index 75 (PASI 75) response at week 12 comp ared to placebo and the proportion of participants with a P hysician's Global Assessment (PGA) score of clear o r minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The overall safety pro file of tildrakizumab in both Phase-3 clinical trials was c onsistent with the safety data observed in previous ly reported studies. The second study (MK-3222-011) also included an eta nercept comparator arm, with a key secondary endpoi nt comparing tildrakizumab and etanercept on PASI 75 a nd PGA. Tildrakizumab 200mg was superior to etanerc ept on both PASI 75 and PGA endpoints at week 12, while th e 100 mg dose showed superiority to etanercept on P ASI 75 only. “Tildrakizumab is the first IL-23p19 inhibitor to d emonstrate positive results in Phase-3 clinical tri als for the treatment of moderate-to-severe plaque psoriasis, f urther validating the importance of the role of IL- 23 in psoriasis. We are encouraged by these results and t he potential to provide a new treatment option to p atients with moderate-to-severe plaque psoriasis, a disease that often takes both a physical and emotional toll on their lives,” stated Dilip Shanghvi, Managing Director, Sun Pharm a. “We would like to thank the over 1,800 patients who participated as well as the investigators at more than 200 clinical sites.” “While there are existing treatment options for pso riasis, many patients continue to struggle with the debilitating impact this chronic disease can have on their bodie s, their lives and their families,” said Kim Papp, MD, clinical trial investigator and president, Probity Medical Researc h, Inc. “Tildrakizumab works by selectively targeti ng IL-23, specifically the p19 component of the cytokine. Blo cking this key cytokine helps control the pathogeni c cells responsible for the inflammatory process of psorias is. These new data are encouraging and support the potential of tildrakizumab as a new treatment option for patients.” The preparations for submission of a Biologics Lice nse Application to the U.S. Food and Drug Administr ation are proceeding. The detailed findings from the Phase-3 clinical trials will be presented at upcoming scientific meetings. 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 Corporate Office : SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India. Tildrakizumab Study Design Tildrakizumab Phase-3 studies are randomized, place bo-controlled, multicenter studies designed to demo nstrate efficacy of tildrakizumab in moderate-to-severe pla que psoriasis compared to placebo and comparative d rug and to assess safety and tolerability. Psoriasis Area Seve rity Index (PASI) and Physician Global Assessment ( PGA) were the primary endpoints in the studies. A PASI score is a measure of psoriatic plaque redness, scaling a nd thickness and extent of the involvement in each region of the body. Treatment efficacy is often measured by redu ction of PASI from baseline (i.e. 75 percent reduction is kn own PASI 75,) a 90 percent reduction is known as PA SI 90 and PASI 100 is total clearance of skin disease. PGA me asures lesion thickness, erythema and scaling acros s all of a patient’s psoriasis lesions in order to determine the disease activity on a six-point scale from “clear” to “severe.” About Sun Pharma and Merck & Co., Inc., Kenilworth, NJ, USA, Agreement Sun Pharmaceutical Industries Ltd.’s wholly owned s ubsidiary, acquired worldwide rights to tildrakizum ab from Merck, known as MSD outside the United States and C anada, in 2014. Funded by Sun Pharma subsidiary, Me rck is responsible for the completion of Phase-3 trials in patients with mild-to-moderate plaque psoriasis an d, as appropriate, submission of a Biologics License Appl ication to the United States Food and Drug Administ ration (FDA). Merck is also responsible for manufacturing finished goods to support Sun Pharma’s initial prod uct launch. Post-approval in the U.S., Sun Pharma will be respo nsible for all other regulatory activities, includi ng subsequent submissions, pharmacovigilance, post approval studi es, manufacturing and commercialization of the appr oved product. Sun Pharma will also be responsible for al l regulatory, pharmacovigilance, post-approval stud ies, manufacturing, and commercialization of approved pr oducts for all non-U.S. markets. Merck is eligible to receive milestone payments, and royalties on sales of tildrakizumab. About Tildrakizumab Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selective ly block the cytokine IL-23. Evidence from human genetics studies suggest that inhibition of IL-23 may provide an approach for the treatment of some inflammatory conditions. 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 cov ered with flaky white scales, which may be itchy an d painful and can crack and bleed 2. Currently, there is no cure for psoriasis 1. About Sun Pharma’s Dermatology Franchise Sun Pharma is committed to bringing patients new tr eatment options for dermatologic conditions with un met needs such as psoriasis, acne and actinic keratosis . In addition to the investigational candidate tild rakizumab, an investigational anti-IL-23p19 monoclonal antibody, Sun Pharma’s branded dermatology business is compri sed of several products including Absorica® and Levulan®. Sun Pharma, along with its subsidiaries is ranked f ourth in dermatology prescription volume within the U.S per IMS. References 1. National Psoriasis Foundation. Facts about psori asis. https://www.psoriasis.org/sites/default/files /for- media/MediaKit.pdf. Accessed on March, 17, 2016. 2. National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis. Accesse d on March, 17, 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 Corporate Office : SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India. About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050): Sun Pharma is the world's fifth largest specialty g eneric pharmaceutical company and India's top pharm aceutical 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 49 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 2015 are approximately US$ 4.5 billion, of which US contributes US$ 2.2 billion. In India, the company enjoys leadership across 12 different c lasses 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 7% of annual revenues. For further information please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live. Contacts Nimish Desai Frederick Castro Tel +91 22 4324 4324, Xtn 2778 Tel +91 22 4324 432 4, Xtn 2777 Tel Direct +91 22 4324 2778 Tel Direct +91 22 4324 2777 Mobile +91-98203 30182 Mobile +91 99206 65176 E mail [email protected] E mail frederick [email protected] FleishmanHillard Faith Moresco Tel +1 646-659-0642 E mail [email protected]

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