drugset / Press release

Almirall and Sun Pharma Announce Regulatory Filing of Tildrakizumab in Europe

2017-03-24 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

FOR IMMEDIATE RELEASE Almirall and Sun Pharma Announce Regulatory Filing of Tildrakizumab in Europe Pivotal Phase 3 data demonstrated potential of Tildrakizumab to offer patients treatment for moderate-to-severe plaque psoriasis without burden of frequent injections Barcelona, SPAIN and Mumbai, INDIA - March 24, 2017 : Almirall S.L, (Spanish Stock Exchange ticker: ALM, “Almirall”) and Sun Pha rmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARM A, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies) announced today the validation of the Regulatory Filing of tildrakizuma b with the European Medicines Agency (EMA) by Almirall. Tildrakizumab is an inves tigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis. The filing includes efficacy and safety data from t he pivotal Phase III clinical trials (reSURFACE 1 and 2) that included over 1,800 patien ts across more than 200 clinical sites. "The filing of tildrakizumab in Europe is a signifi cant step forward for healthcare providers as many patients are still suffering from the disease. Tildrakizumab adds a novel biologic treatment option to our extensive and innovative portfolio, strengthening our position as a leading Dermatology player,” said Eduardo Sanchiz, Almirall´s CEO. According to Mr Jesper Jensen, Executive Vice Presid ent - Biologics & Dermatology, Sun Pharma, "Not all people living with psoriasis achieve long -term systemic control with currently available treatment s, there are those who continue to struggle every day with the chronic nature of psori asis. The European filing of tilidrakizumab is the next step in our effort to br ing a new treatment option to people suffering from psoriasis.” In July 2016, Almirall entered into a licensing agr eement with Sun Pharma for the development and commercialization of tildrakizumab for psoriasis in Europe. Under the terms of the signed agreement, Sun Pharma will continue to lead other indications, for which Almirall will have the right to primary negot iation. In addition, Almirall will be able to lead European studies, and participate in l arger Global clinical studies for psoriasis. About Psoriasis Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.5 million people in the U.S. and approximately 125 mi llion people worldwide. It is a non- contagious disorder that speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis, called pla que psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed. Despite existing treatment options, many peo ple with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease. About Tildrakizumab Tildrakizumab is an investigational humanized, anti -IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. With this pre cise targeting, tildrakizumab has the potential to help control the pathogenic cells responsible fo r the inflammatory process of psoriasis with limited impact on the rest of the immune system. Ph ase III tildrakizumab data provides further evidence for the role of the IL-23 pathway in helpi ng to control the inflammatory process of psoriasis. About Sun Dermatology Sun Pharma is committed to expanding our dermatolog y portfolio to bring healthcare providers and patients around the world more treatment option s and ongoing support for conditions with high unmet medical needs like psoriasis. Sun Pharma , along with its subsidiaries, is ranked fourth in dermatology prescription volume within th e U.S. per IMS and is fifth largest specialty generic pharmaceutical company globally. In additio n to the investigational candidate Tildrakizumab, an investigational anti-IL- 23p19 mo noclonal antibody, Sun Dermatology is comprised of several branded products indicated for the treatment of acne and actinic keratosis with a focus on other dermatologic conditions with unmet needs such as psoriasis and atopic dermatitis. For more information, visit www.SunPharmaDerm.com . About Sun Pharma, Almirall S.A, Europe, Agreement Sun Pharma and its wholly owned subsidiary and Almi rall (Spanish Stock Exchange ticker: ALM) entered into a licensing agreement in July 2016 for the development and commercialization of tildrakizumab for psoriasis in Europe. Under terms of the license agreement, Almirall is able to lead European studies, and participate in larger Gl obal clinical studies for psoriasis indication subject to the terms of the Sun Pharma – Merck agre ements, as well as certain cost sharing agreements. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payment s and royalties on net sales. Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe. The agreement between Sun Pharma and Almirall remains subject to the exclusive licen se agreement between Sun Pharma and Merck. Disclaimer: Statements in this “Document” describing the Compan y’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 regulatio ns. Actual results, performance or achievements cou ld differ materially from those expressed or implied. 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, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medici nes trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 49 manufacturing facilities spread across 6 continents , R&D centres across the globe and a multi- cultural workforce comprising over 50 nationalities . The consolidated revenues for 12 months ending March 2016 are approximately US$ 4.3 billion , of which US contributes US$ 2.1 billion. In India, the company enjoys leadership across 12 d ifferent classes of doctors with 31 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in We stern 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 AP I manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation su pported by strong R&D capabilities comprising about 2,000 scientists and R&D investmen ts of over 8% of annual revenues. For further information please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live About Almirall Almirall is a global pharmaceutical company with a strong focus in Dermatology and Aesthetics with the mission of providing valuable medicines an d medical devices to present and future generations. Our R&D is focused on Dermatology, wit h a wide range of programs including key indications. Through our innovative products, agree ments and alliances, our work covers the entire drug value chain. Almirall is continually gr owing as a specialist company in a wide range of skin diseases, in order to cover our customers unmet needs. Founded in 1943, headquartered in Barcelona, Spain, Almirall is listed on the Spanish Stock Exchange (ticker: ALM) and it has become a source o f value creation for society due to its vision and the commitment of its long-standing majo r shareholders. In 2016, its revenues totaled 859.3 million euros and, with more than 2.0 00 employees, it has gradually built up a trusted presence across Europe, as well as in the US. For more information, please visit www.almirall.com . Contacts: Sun Pharma Media Investors Frederick Castro Nimish Desai Tel +91 22 4324 4324, Xtn 2777 Tel +91 22 4324 432 4, Xtn 2778 Tel Direct +91 22 4324 2777 Tel Direct +91 22 4324 2778 Mobile +91 99206 65176 Mobile +91-98203 30182 E mail [email protected] E mail nimis [email protected] Contacts: Almirall Media contact: Investors & Corporate communication contact: Cohn & Wolfe Almirall Rebeca Rocha Pablo Diva sson del Fraile [email protected] Tel.: 00 34 93 291 30 87 Tel.: (+34) 91 531 42 67

The release as fetched from its publisher. sunpharma.com ↗