Sun Pharma Launches Drizalma Sprinkle in the US

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 FOR IMMEDIATE RELEASE Sun Pharma Launches Drizalma Sprinkle in the U.S. • First and only FDA-approved sprinkle formulation of delayed-release duloxetine capsules • Only formulation of duloxetine that can be swallowed whole, sprinkled on applesauce or administered via nasogastric tube • Third product in company portfolio designed for the 30-35% of long-term care residents who have difficulty swallowing Mumbai, India, and Princeton, NJ, October 16, 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 that one of its wholly owned subsidiaries has launched Drizalma Sprinkle™ (duloxetine delayed-release capsules) in the U.S. for oral use. Drizalma Sprinkle is a serotonin and norepinephrine reuptake inhibitor (SNRI) designed for the treatment of various neuro-psychiatric and pain disorders in patients who have difficulty swallowing – a problem that is estimated to affect approximately 30-35% of long-term care residents. The U.S. Food and Drug Administration (F DA) approved Drizalma Sprinkle on July 19, 2019. The availability of Drizalma Sprinkle expands Sun P harma’s portfolio of alternative formulation products designed for individuals with swallowing d ifficulties, the risk of which increases with age and exposure to age-related diseases and conditions - including depression, anxiety, and pain disorders. 1-2 Drizalma Sprinkle joins Ezallor Sprinkle™ (Rosuvas tatin) and Kapspargo Sprinkle™ (metoprolol succinate) extended-release capsules as the third product in Sun Pharma’s US portfolio designed for individuals in long-term care. It is common practice in long-term care facilities to crush medications to ease administration, but crushing ta blets introduces additional risks into the administration process. 3 The Joint Commission International Accreditation Standards for Long Term Care urges facilities to dispense medications in forms that require minimal manipulation. 4 “The launch of Drizalma Sprinkle is an important milestone for people with difficulty swallowing, as this formulation of duloxetine can facilitate treatment of common neuro-psychiatric disorders while preserving the quality of the medicine,” said Abhay Gandhi, CEO, North America, Sun Pharma. ”This launch further underscores our commitment to provid ing a portfolio of alternative formulation products to treat common diseases – especially in long-term care, where 30-35% of individuals have difficulty swallowing. These patients often encount er medication errors and challenges with medication administration.” Drizalma Sprinkle is indicated for the treatment of major depressive disorder (MDD) in adults, generalized anxiety disorder (GAD) in adults and pediatric patients 7-17 years old, diabetic peripheral neuropathic pain (DPNP) in adults, and chronic musculoskeletal pain in adults. It is available in four dosage strengths (20mg, 30mg, 40mg, and 60mg). Driz alma Sprinkle is the first and only FDA- 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 approved formulation of duloxetine that can be swal lowed whole, sprinkled on applesauce or administered via nasogastric tube. Drizalma Sprinkle carries a boxed warning for suici dal thoughts and behaviors. In clinical trials of Drizalma Sprinkle, the most common adverse reactions (in at least 5% of participants and at least twice the incidence of placebo) were nausea, dry mo uth, somnolence, constipation, decreased appetite, and hyperhidrosis. For more information about Drizalma Sprinkle, visit DrizalmaSprinkle.com INDICATIONS AND USAGE Drizalma Sprinkle (duloxetine delayed-release capsules) for oral use is indicated for the treatment of major depressive disorder in adults; generalized anxiety disorder in adults and pediatric patients aged 7 to 17 years; diabetic peripheral neuropathy in adults, and chronic musculoskeletal pain in adults. IMPORTANT SAFETY INFORMATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS: Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and you ng adult patients in short-term studies. Closely monitor all antidepressant-treated patients for cli nical worsening and for emergence of suicidal thoughts and behaviors. Contraindications Serotonin syndrome and MAOIs: Do not use MAOIs inte nded to treat psychiatric disorders with Drizalma Sprinkle or within 5 days of stopping treatment with Drizalma Sprinkle. Do not use Drizalma Sprinkle within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Drizalma Sprinkle in a patient who is being treated with linezolid or intravenous methylene blue. WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatic failure, sometimes fatal, has been reporte d in patients treated with duloxetine delayed-release capsules. Duloxetine delayed-release capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Drizalma Sprinkle should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. Orthostatic Hypotension, Falls, and Syncope: Cases have been reported with duloxetine delayed-release capsules therapy. Syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during treatment, particularly after dose increases. Serotonin Syndrome: There is increased risk when coadministered with other serotonergic agents (eg, SSRIs, SNRIs, triptans), but also when taken alone. The concomitant use of Drizalma Sprinkle with MAOIs is contraindicated. Do not initiate Driz alma Sprinkle in a patient who is being treated 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 with MAOIs such as linezolid or intravenous methyle ne blue. Monitor all patients taking Drizalma Sprinkle™ for the emergence of serotonin syndrome. If it occurs, discontinue Drizalma Sprinkle and initiate supportive treatment. Increased Risk of Bleeding: Duloxetine may increase the risk of bleeding event s. Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and anticoagulants may increase this risk. Severe Skin Reactions: Severe skin reactions, including erythema multifor me and Stevens- Johnson Syndrome, can occur with duloxetine. Drizalma Sprinkle should be discontinued at the first appearance of blisters, peeling rash, mucosal erosi ons, or any other sign of hypersensitivity if no other etiology can be identified. Discontinuation Syndrome: Adverse reactions after discontinuation of seroton ergic antidepressants, particularly after abrupt disconti nuation, include nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduct ion in dosage rather than abrupt cessation is recommended whenever possible. Activation of Mania or Hypomania: In patients with bipolar disorder, treating a depr essive episode with duloxetine delayed-release capsules or another antidepressant may precipitate a mixed/manic episode. Use cautiously in patients wit h bipolar disorder. Prior to initiating treatment with Drizalma Sprinkle, screen patients for any personal or family history of bipolar disorder, mania, or hypomania. Angle-Closure Glaucoma: Duloxetine may trigger an angle-closure attack in patients with anatomically narrow angles who do not have a patent iridectomy. Avoid use of antidepressants, including Drizalma Sprinkle, in patients with anatomically narrow angles. Seizures: Drizalma Sprinkle should be prescribed with care i n patients with a history of seizure disorder. Blood Pressure: Monitor blood pressure prior to initiating treatme nt and periodically throughout treatment Hyponatremia: Can occur in association with SIADH. Cases of hyponatremia have been reported Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose and HbA1c have been observed ADVERSE REACTIONS The most common adverse reactions (≥5% and at least twice the incidence of placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis. DOSING AND ADMINISTRATION 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 Drizalma Sprinkle may be taken with or without food . Drizalma Sprinkle may be swallowed whole (do not crush or chew capsule); opened and sprinkle d over applesauce; or administered via nasogastric tube. DRUG INTERACTIONS • Avoid concomitant use with potent CYP1A2 inhibitors • Consider dose reduction with concomitant use with CYP2D6 substrates USE IN SPECIFIC POPULATIONS Hepatic Impairment: Avoid use in patients with mild, moderate, or severe hepatic impairment Renal Impairment: Avoid use in patients with severe renal impairment Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Drizalma Sprinkle. Third trimester use may increase risk of symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate Please see Full Prescribing Information by clicking here. 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 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 pric es. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pha rma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live 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 looking statements” within the meaning of applicable securities laws and regulations. Actu al results, performance or achievements could diffe r materially from those expressed or implied. References: 1. Zis, P, Daskalaki, A, Bountouni, I, Sykioti, P, Varrassi, G, Paladini, A. Depression and chronic pain in the elderly: links and management challenges. Clinical Interventions in Aging. 2017;12:709–720. doi: 10.2147/CIA.S113576. 2. Wolitzky-Taylor KB, Castriotta N, Lenze EJ, Stanley MA, Craske MG. Anxiety disorders in older adults: a comprehensive review. Depression and Anxiety. 2010;27(2):190-211. doi:10.1002/da.20653. 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 3. Hughes, PJ, Freeman, MK, Slaton, RM. Common Issues in the medication use processes in nursing homes: a review of medication use quality improvement strategies. Journal of Nursing Education and Practice. 2016;6(7):81-90. DOI: 10.5430/jnep.v6n7p81 4. Joint Commission International. Joint Commission International Accreditation Standards for Long Term Care. 1st ed. Oak Brook, IL: Joint Commission International; 2012. 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] U.S. Media: Vinita Alexander Tel Direct +1 609-720-8197 Mobile +1 732-258-6725 E mail [email protected]

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