drugset / Press release

Press Release Sun Pharma announces the launch of ILUMYA for treatment of plaque psoriasis in Japan

2020-09-23 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

Sun Pharmaceutical Industries Limited 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 Reaching People. Touching Lives. FOR IMMEDIATE RELEASE S un Pharma Announces the Launch of ILUMYA® (tildrakizumab) for Treatment of Plaque Psoriasis in Japan Mumbai, India & Tokyo, Japan, September 23, 2020 – Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE :SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that its wholly-owned Japanese subsidiary has launched ILUMYA ® Subcutaneous Injection 100 mg Syringe (Nonproprietary name: tildrakizumab (genetical recombination), “ILUMYA”) in Japan for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies. ILUMYA is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of IL- 23 and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro- inflammatory cytokines and chemokines. Junichi Nakamichi, Country Head, Sun Pharma Japan, said, “ILUMYA is Sun Pharma’s first innovative drug to be launched in the Japanese market. We are pleased to introduce a new, safe and effective treatment option for plaque psoriasis to doctors and patients in our country. This is an important milestone for Sun Pharma as we expand our product portfolio in Japan.” ILUMYA® product outline Product name ILUMYA subcutaneous 100mg syringe Nonproprietary name Tildrakizumab (genetical recombination) Dosage form Injection (prefilled syringe) Effect / efficiency Plaque psoriasis, which does not respond adequately to conventional therapies Dosage and administration Normal administration: 100mg of subcutaneous administration to adults as tildrakizumab (genetical recombination) in the first dose, followed by doses 4 weeks later and every 12 weeks thereafter. National Health Insurance listed price ILUMYA subcutaneous injection: 100mg syringe 1 cylinder: 487,413 yen Marketing authorization date June 29, 2020 Date of listing in the National Health Insurance drug list August 26, 2020 Launch date September 23, 2020 Manufacturing Approval holder Sun Pharma Japan Limited Sun Pharmaceutical Industries Limited 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 Reaching People. Touching Lives. Product photo IMPORTANT SAFETY INFORMATION ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to ILUMYA or to any other excipients. Cases of angioedema and urticaria occurred in ILUMYA -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. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection 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 initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active 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 greater than 0.1% in the ILUMYA group and at a higher rate than in the placebo group included dizziness and pain in extremity. Sun Pharmaceutical Industries Limited 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 Reaching People. Touching Lives. About Psoriasis Psoriasis is a chronic immune disease that appears on the skin, affecting approximately 125 million people worldwide 1. The non-contagious disorder speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form, affecting about 80 to 90 percent of people with psoriasis, is called plaque psoriasis 2. 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. Twenty percent of people with plaque psoriasis are considered moderate-to-severe, and many continue to struggle w ith the ongoing, persistent nature of this chronic disease. Disclaimer: Statements in this Document describing the Company’ s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the interpreta tions of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed 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 deve lopments or circumstances after the date hereof. In case of any inconsistency or conflict between the English vers ion and Japanese version of this press release, English version shall prevail. Sun Pharmaceutical Industries Limited (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 ski lled team enables it to deliver high-quality produc ts, trusted by customers and patients in over 100 countries across the world, at affordable prices. 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 nationa lities. Sun Pharma fosters excellence through innov ation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6% of annual revenues in R&D. For further information, please vi sit www.sunpharma.com & follow us on Twitter @SunPharma_Live. References 1. National Psoriasis Foundation https://www.psoriasis.org/psoriasis-statistics/ 2. National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/plaque/ Contact information: For Investors: For Media: Nimish Desai Gaurav Chugh Telephone +91 22 4324 4324, Xtn 2778 Telephone +91 22 4324 4324, Xtn 5373 Direct +91 22 4324 2778 Direct +91 22 4324 5373 Mobile +91-98203 30182 Mobile +91 98104 71414 E mail [email protected] E mail gaurav. [email protected] Contact information: Japan Junko Sugimura [email protected]

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