Sun Pharma Launches Ezallor Sprinkle (Rosuvastatin) in the U.S. for People Who Have Difficulty Swallowing

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 0 12. India FOR IMMEDIATE RELEASE Sun Pharma Launches Ezallor Sprinkle (Rosuvastatin) in the U.S. for People Who Have Difficulty Swallowing • First and only FDA-approved sprinkle formulation of rosuvastatin • Extended-release-coated granules designed to facilitate once-daily administration especially for the 30-35% of long term care residents who have difficulty swallowing • Ezallor Sprinkle™ (rosuvastatin) capsules is indicated for three types of lipid disorders in conjunction with diet in adults Mumbai, India, and Princeton, NJ, July 15, 2019 – Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) today announced the U.S. launch of Ezallor Sprinkle™ (rosuvastatin) capsules for the treatment of three types of elevated lipid disorders in people who have difficulty swallowing, a problem that is estimated to affect approximately 30- 35% of long-term care residents. Ezallor Sprinkle is indicated as an adjunct to diet for the treatment of adult patients with hypertriglyceridemia, as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type III hyperlipoproteinemia), and as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or as monotherapy if such treatments are unavailable, to reduce LDL-C, total cholesterol, and ApoB in adult patients with homozygous familial hypercholesterolemia. Ezallor Sprinkle has not been studied in Fredrickson type I and V dyslipidemias. “With the introduction of Ezallor Sprinkle, Sun Pharma continues our commitment of providing a portfolio of alternative formulation products to address the needs of people who have difficulty swallowing, which is especially prevalent among residents in long-term care facilities,” said Abhay Gandhi, CEO, North America, Sun Pharma. “These patients often encounter more medication errors and challenges with medication administration as compared to long-term care residents who do not have difficulty swallowing.” “The risk of medication errors increases when people have difficulty swallowing, due to crushing of medicines that shouldn’t be crushed, or from residual medication left over in crushing devices,” said Dr. Chris Chappel, certified Medical Director, Chappel Senior Care and Chappel Group Research. “This formulation will help in administering medication for patients with common types of elevated lipid disorders, especially in the geriatric population.” Ezallor Sprinkle is formulated as extended-release-coated pellets that may be sprinkled over soft food such as applesauce, can be swallowed whole, or administered via a nasogastric tube to facilitate long-term, once-daily administration. Ezallor Sprinkle joins Kapspargo Sprinkle™ (metoprolol succinate) extended-release capsules as the second product in the Sun Pharma portfolio designed for individuals in long-term care. 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 – 390 012. India Ezallor Sprinkle is contraindicated in patients with any known hypersensitivity to rosuvastatin, which may include rash, pruritus, urticaria, and angioedema; patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, and females who are pregnant or breastfeeding. In the controlled clinical trials database, the most common adverse reactions with rosuvastatin were headache, myalgia, abdominal pain, asthenia, and nausea. For more information about Ezallor Sprinkle, visit EzallorSprinkleRx.com About Ezallor Sprinkle (Rosuvastatin) Capsules Ezallor Sprinkle (rosuvastatin) capsules, for oral use, is an HMG Co-A reductase inhibitor (“statin”) indicated as: •An adjunct to diet for the treatment of adult patients with hypertriglyceridemia •An adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type III hyperlipoproteinemia) •An adjunct to other lipid-lowering treatments (e.g., LDL apheresis), or as monotherapy if such treatments are unavailable, to reduce LDL-C, total cholesterol, and ApoB in adult patients with homozygous familial hypercholesterolemia Ezallor Sprinkle capsules are available in 5-mg, 10-mg, 20-mg, and 40-mg dose strengths. The dose range is 5 mg to 40 mg once daily; the 40-mg dose is only for patients not reaching their LDL-C goal with a 20-mg dose. The product can be taken with or without food, at any time of day. Limitations and Use Ezallor Sprinkle has not been studied in Fredrickson type I and V dyslipidemias. Ezallor Sprinkle is indicated only for use in patients aged 18 years and older. IMPORTANT SAFETY INFORMATION Contraindications • Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin. • Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels. • Pregnancy: advise females of reproductive potential to use effective contraception during treatment with Ezallor Sprinkle. •Lactation: limited data indicate that rosuvastatin is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require Ezallor Sprinkle treatment should not breastfeed their infants. Warnings & Precautions • Skeletal Muscle Effects: Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including rosuvastatin. These risks can occur at any dose level, but are increased at the highest dose (40 mg). Ezallor Sprinkle should be prescribed with caution in patients with predisposing factors for Sun Pharmaceutical Industries L td. 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 – 390 012. India myopathy (e.g., aged ≥65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with Ezallor Spri nkle may be increased with concurrent administration of some other lipid-lowering therapi es (fibrates or niacin), gemfibrozil, cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir, or simeprevir. Ezallor Sprinkle therapy should be discontinued if markedly elevated creatine kinase (CK) levels occur or myopathy is diagnosed or suspected. There have been rare report s of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy associated with statin use. All patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and if muscle signs and symptoms persist after discontinuing Ezallor Sprinkle. • Liver Enzyme Abnormalities: It is recommended that liver enzyme tests be perfo rmed before the initiation of Ezallor Sprinkle, and if s igns or symptoms of liver injury occur. There have been rare post marketing reports of fatal and non-fatal hepatic failure in patients taking statins, including rosuvastatin. If serious liver i njury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Ezallor Sprinkle, promptly interrupt therapy. If an alternate etiology is not found, do not restart Ezallor Sprinkle. Ezallor Sprinkle should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease. Active liv er disease, which may include unexplained persistent transaminase elevations, is a contraindication to the use of Ezallor Sprinkle. • Concomitant Coumarin Anticoagulants: Caution should be exercised when anticoagulants are given in conjunction with Ezallor Sprinkle beca use of its potentiation of the effect of coumarin-type anticoagulants in prolonging the prot hrombin time/international normalized ratio (INR). In patients taking coumarin anticoagulants and Ezallor Sprinkle concomitantly, INR should be determined before starting Ezallor Sprink le and frequently enough during early therapy to ensure that no significant alteration of INR occurs. • Proteinuria and Hematuria: Dipstick-positive proteinuria and microscopic hematuria were observed among patients treated with CRESTOR. These findings were more frequent in patients taking rosuvastatin 40 mg, though it was generally transient and was not associated with worsening renal function. Although the clinical sig nificance of this finding is unknown, dose reduction should be considered for patients on Ezal lor Sprinkle therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing. • Endocrine Effects: Increases in HbA1c and fasting serum glucose levels have been reported with statins, including rosuvastatin. Based on clin ical trial data with rosuvastatin, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus. ADVERSE REACTIONS In the controlled clinical trials database, the mos t common adverse reactions were headache, myalgia, abdominal pain, asthenia, and nausea. Ther e have been rare reports of immune- mediated myopathy associated with statin use. There have been rare post marketing reports of cognitive impairment (e.g., memory loss, forgetfuln ess, amnesia, memory impairment, and confusion) associated with statin use. These cognitive issues have been reported for all statins. Sun Pharmaceutical Industries L td. 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 – 390 012. India The reports are generally nonserious, and reversibl e upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks). Please see Full Prescribing Information by clicking here . About Hypertriglyceridemia, Primary Dysbetalipoprot einemia, and Homozygous Familial Hypercholesterolemia Hypertriglyceridemia is a common disorder character ized by elevated levels of triglycerides, a type of blood fat that requires insulin to remove i t from the blood. i It is often caused or exacerbated by uncontrolled diabetes, obesity, and a sedentary lifestyle, all of which are prevalent in industrialized societies.ii Among U.S. adults aged 20 years and older, an estimated 35% of men and 25% of women have hypertriglyceridemia (defined as triglyceride levels of at least 150 mg/dL iii).iv Dysbetalipoproteinemia (also known as type III hype rlipoproteinemia) is a rare metabolic disorder characterized by abnormally elevated concentrations of intermediate-density lipoprotein (IDL), and by the body’s decreased ability to convert very low-density lipoprotein (VLDL) and IDL (a VLDL remnant) to low-density lipoprotein particl es in the blood. Patients with dysbetalipoproteinemia typically have elevated total cholesterol (from 300 to 600 mg/dL) and triglyceride levels (usually above 400 mg/dL, though some may exceed 1000 mg/dL).2 Homozygous familial hypercholesterolemia (HoFH) is the most severe form of familial hypercholesterolemia v, an autosomal dominant (a pattern of inheritance in which a child inherits one copy of a mutated [changed] gene from one parentvi) disorder that causes severe elevations in total cholesterol and LDL-C.vii The disorder results in aggressive atherosclerosis (narrowing and blockage of the arteries). If left untreated, HoFH can lead to heart attack and sudden death in childhood and adulthood. HoFH is a rare disease, es timated to affect up to 1 in 160,000 individuals around the world.5 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 a skilled team enable us to deliver quality products in a timely manner a t affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 100 countries across the world. Sun Pharma's global presence is supported by 44 manufacturing facilities spread across 6 continents, R&D centres across th e globe and a multi-cultural workforce comprising ove r 50 nationalities. In India, the company enjoys leadership across 10 different classes of doctors with 30 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 3 global markets. Its API business footprint is strengthened through 14 world class API manufacturing 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 approximate ly 8% of annual revenues. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live. Sun Pharmaceutical Industries L td. 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 – 390 012. India Disclaimer Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or even ts may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. References: i Triglyceride. Diabetes Dictionary. T-1 Today, Inc. (d/a/a/ Children with Diabetes); 2018. Available at: https://archive.childrenwithdiabetes.com/dictionary/t.htm#triglycerides . Accessed May 17, 2019. ii Sweeney MET. Hypertriglyceridemia. Medscape.com; 2018. Available at: https://emedicine.medscape.com/article/126568-overview #showall. Accessed May 17, 2019. iii Executive Summary of the Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA . 2001;285(19):2486-97. iv Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002;287(3):356-9. v Homozygous familial hypercholesterolemia. The FH Foundation; 2019. Available at: https://thefhfoundation.org/familial-hypercholesterolemia/homozygous-familial-hypercholesterolemia . Accessed May 17, 2019. vi Autosomal dominant inheritance. NCI Dictionary of Cancer Terms; 2019. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/793860 . Accessed May 17, 2019. vii July M. Familial hypercholesterolemia. Medscape.com; 2018. Available at: https://emedicine.medscape.com/article/121298-overview#showall. Accessed May 17, 2019. Contacts: Investors: Media: Nimish Desai Gaurav Chugh Tel +91 22 4324 4324, Xtn 2778 Tel +91 22 4324 432 4, Xtn 5373 Tel Direct +91 22 4324 2778 Tel Direct +91 22 4324 5373 Mobile +91-98203 30182 Mobile +91 98104 71414 E mail [email protected] E mail gaurav.ch [email protected]

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