Sun Pharma announces Japan MHLW approval of ILUMYA for the treatment of Plaque Psoriasis

Sun Pharmaceutical In dustries 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 Reaching People. Touching Lives. FOR IMMEDIATE RELEASE Sun Pharma announces Japan MHLW approval of ILUMYA TM for the treatment of Plaque Psoriasis Mumbai, India & Tokyo, Japan, June 29, 2020 – Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 52 4715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that one of its wholly-owned subsidiaries has received approval from the Ministry of Health, Labo ur and Welfare (MHLW), Japan for ILUMYA (tildrakizumab) for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies. Japan has approximately 430,000 people currently suffering from psoriasis 1. ILUMYA is a humanized lgG1/k monoclonal antibody de signed to selectively bind to the p19 subunit of IL-23 and inhibit its interaction with the IL-23 re ceptor, leading to inhibition of the release of pro - inflammatory cytokines and chemokines. Junichi Nakamichi, Country Head, Sun Pharma Japan, said, “ILUMYA is the first innovative drug that Sun Pharma plans to launch in Japan. It was extensively tested in Japanese patients as part of ILUMYA’s global clinical development program. The drug offer s a new treatment option with only one injection every 12 weeks for Japanese patients who struggle e veryday with the chronic nature of plaque psoriasis. It showed sustained efficacy for over 4 years and has safety profiles over 4 years with low rates of severe infections, malignancies and MACEs. This approval adds a biologic product to our existing strong dermatology portfolio in Japan. We will leverage Sun Pharma Japan’s robust marketing network to make ILUMYA, a safe and efficacious prod uct, available to dermatologists and patients in Japan.” ILUMYA is one of the key specialty products of Sun Pharma and it was approved by US FDA in March 2018 while the European Commission approved it in September 2018. The MHLW approval of ILUMYA for the treatment of pl aque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development prog ram. In the two multicentre, randomized, double- blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), 1862 adult patients were enrolled and treated with ILUMYA (N=1238), etanercept (N=313) or placebo (N=310). Both Phase-3 studies met the primary efficacy endpoints, demonstrating significa nt clinical improvement with ILUMYA 100 mg compared to placebo or etanercept when measured by at least 75 percent reduction in baseline psoriasis severity (Psoriasis Area Sensitivity Index or PASI 75) and Physician’s Global Assessment (PG A) score of “clear” or “minimal” at week 12 after two doses. The most common adverse reactions observed with ILU MYA in the pooled data from one Phase 2 and two Phase 3 studies in psoriasis patients for the p lacebo controlled period (16 weeks for the Phase 2 study and 12 weeks for the Phase 3 studies) were na sopharyngitis, headache, and site injection pain. Most adverse reactions were considered mild and no adverse reaction led to discontinuation of treatment in >1% of patients. Sun Pharmaceutical In dustries 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 Reaching People. Touching Lives. After 64-week base study of reSURFACE 1, a total of 120 Japanese patients entered the reSURFACE 1 extension study and 101 patients completed the extension study for 148 weeks. IMPORTANT SAFETY INFORMATION ILUMYA is contraindicated in patients with a previo us serious hypersensitivity reaction to ILUMYA or t o any other excipients. Cases of angioedema and urticaria occurred in ILUMY A -treated subjects in clinical trial. If a serious hypersensitivity reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. ILUMYA may increase the risk of infection. Treatmen t with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Co nsider the risks and benefits of treatment prior to prescr ibing ILUMYA in patients with a chronic infection o r a history of recurrent infection. Instruct patients r eceiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute i nfection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue ILUMYA until the infection resolves. Evaluate patients for TB infection prior to initiat ing treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate trea tment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILU MYA in patients with a past history of latent or ac tive TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after ILUMYA treatment. Most common (≥1%) adverse reactions associated with ILUMYA include upper respiratory infections, injection site reactions, and diarrhea. Adverse reactions that occurred at rates less than 1% but grea ter than 0.1% in the ILUMYA group and at a higher rate than in the placebo group included dizziness and pain in extremity. About Psoriasis Psoriasis is a chronic immune disease that appears on the skin, affecting approximately 125 million people worldwide 2. The non-contagious disorder speeds the growth cyc le of skin cells 2 and results in thick scaly areas of skin 3. The most common form, affecting about 80 to 90 pe rcent of people with psoriasis, is called plaque psoriasis 4. It appears as red, raised areas of skin covered w ith flaky white scales which may be itchy and painful and can crack and bleed 3. Twenty percent of people with plaque psoriasis are considered moderate-to-severe, and ma ny continue to struggle with the ongoing, persistent nature of this chronic disease. Sun Pharmaceutical In dustries 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 Reaching People. Touching Lives. 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 exp ressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. 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 and a skilled team enables it to deliver high - quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufac turing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled w ith a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence throug h innovation supported by strong R&D capabilities across multiple R&D centers, with investments of ap proximately 7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live. References: 1. Kubota K, et al. BMJ Open 2015 Jan 14; 5(1) 2. National Psoriasis Foundation. Facts about psoriasis. www.psoriasis.org/sites/default/files/for- media/MediaKit.pdf. Accessed on February 22, 2018. 3. National Psoriasis Foundation. About Psoriasis. www.psoriasis.org/about-psoriasis. Accessed on February 22, 2018. 4. Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol 2008 May; 58(5):826-50. India Contacts: Investors: Media: Nimish Desai Gaurav Chugh Tel +91 22 4324 4324, Xtn 2778 Tel +91 22 4324 4 324, Xtn 5373 Tel Direct +91 22 4324 2778 Tel Direct +91 22 43 24 5373 Mobile +91-98203 30182 Mobile +91 98104 71414 E mail [email protected] E mail gaurav. [email protected]

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