Sun Pharma Receives USFDA Approval For BromSite™

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 Receives USFDA Approval For BromSite™ First NSAID approved for prevention of ocular pain in patients undergoing cataract surgery Mumbai, April 09, 2016: Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, N SE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and inclu des its subsidiaries or associate companies) today announced that one of its wholly owned subsidiaries has recei ved approval from USFDA for its New Drug Applicatio n (NDA) related to BromSite™ (bromfenac ophthalmic solution ) 0.075% for the treatment of postoperative inflamm ation and prevention of ocular pain in patients undergoin g cataract surgery. BromSite™ is the first non-ster oidal anti- inflammatory drug (NSAID) approved by the USFDA to prevent pain and treat inflammation in the eye for patients undergoing cataract surgery; other NSAIDs in this c lass are currently indicated for the treatment of i nflammation and reduction of pain. BromSite™ developed by InSite Vision, is the first bromfenac ophthalmic solution formulated in DuraSit e™, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies. Sun Pha rma acquired InSite Vision in November 2015 and is likely to commercialize BromSite™ through its newly formed, U S-based division, Sun Ophthalmics, in the second ha lf of 2016. As per IMS MAT January 2016, the U.S. NSAID Ophthalmic market grew by 8%, generating approximat ely US$400mn in sales and about 4 million prescriptions, providing an attractive market for Sun Pharma to participate. Sun Ophthalmics has crossed a key business mileston e through BromSite’s approval. Sun Ophthalmics targ ets to provide eye care practitioners products that enhanc e their practice patterns and treatment options and to deliver those products through its unique, concierge level approach to customer care. With BromSite’s approval and additional late-stage candidates in its pipeline, S un Ophthalmics is strongly positioned to offer a ra nge of beneficial products and establish itself as a respected and trusted partner. In two multi-center, randomized, placebo-controlled Phase-3 studies, a significantly higher proportion of BromSite- treated patients were pain-free at Day 1 post-surge ry (77% and 82%) compared to patients treated with vehicle control (48% and 62%) (p<0.001). Additionally, a si gnificantly higher proportion of subjects administe red BromSite™ were inflammation-free at day 15 post-cataract surgery (57% and 38%), compared to a vehicle control group (19% and 22%) (p<0.001 and p=0.035). “Over the years, I’ve worked closely with the InSite team and watched them develop multiple high quality products using the DuraSite platform,” commented Dr. Richard L. Lindstrom, MD, founder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Eme ritus at the University of Minnesota Department of Ophthalmology. “Today, I am pleased to see BromSite ™ advance from development to market. I am confiden t there will be significant clinician interest in thi s new product. As the first NSAID labeled to preven t pain and reduce inflammation post-cataract surgery, BromSite’s appr oval is timely and will be welcomed by patients and clinicians alike.” About Sun Ophthalmics Sun Ophthalmics is likely to launch BromSite™ (brom fenac ophthalmic solution) 0.075% in US in second h alf of 2016, indicated for the treatment of postoperative inflammation and prevention of ocular pain in patie nts undergoing cataract surgery. Other pipeline candida tes include Xelpros™ (latanoprost ophthalmic soluti on) 0.005%, being explored for the reduction of elevate d intraocular pressure in patients with open angle glaucoma or ocular hypertension, and DexaSite™ (dexamethasone) 0.1%, being explored for the treatment of blepharit is. Sun Ophthalmics is based in Princeton, NJ. 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 were appro ximately US$ 4.5 billion, of which US contributed U S$ 2.2 billion. In India, the company enjoys leadership across 12 diff erent classes of doctors with 30 brands featuring a mongst top 300 pharmaceutical brands in India. Its footprint acros s emerging markets covers over 100 markets and 6 ma rkets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 4 global markets. Its API business footprint is strengthened through 14 world class API manufact uring facilities across the globe. Sun Pharma foste rs excellence through innovation supported by strong R&D capabilities com prising about 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 USA Corporate Contact Sanjay Malieckal Media Contact Mike Elofer – Pascale Communications Tel Direct +1 732 754-6979 Tel Direct +1 484 620-6 167 E mail [email protected] E mail mike@ pascalecommunications.com India 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]

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