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 Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies) announced today the validation of the Regulatory Filing of tildrakizumab with the European Medicines Agency (EMA) by Almirall. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis.
The filing includes efficacy and safety data from the pivotal Phase III clinical trials (reSURFACE 1 and 2) that included over 1,800 patients across more than 200 clinical sites.
"The filing of tildrakizumab in Europe is a significant 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 President - Biologics & Dermatology, Sun Pharma, "Not all people living with psoriasis achieve long-term systemic control with currently available treatments, there are those who continue to struggle every day with the chronic nature of psoriasis. The European filing of tilidrakizumab is the next step in our effort to bring a new treatment option to people suffering from psoriasis.”
In July 2016, Almirall entered into a licensing agreement 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 negotiation. In addition, Almirall will be able to lead European studies, and participate in larger 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 million 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 plaque 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 people 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 precise targeting, tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system. Phase III tildrakizumab data provides further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis.
About Sun Dermatology
Sun Pharma is committed to expanding our dermatology portfolio to bring healthcare providers and patients around the world more treatment options 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 the U.S. per IMS and is fifth largest specialty generic pharmaceutical company globally. In addition to the investigational candidate Tildrakizumab, an investigational anti-IL- 23p19 monoclonal 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 Almirall (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 Global clinical studies for psoriasis indication subject to the terms of the Sun Pharma – Merck agreements, as well as certain cost sharing agreements. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments 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 license agreement between Sun Pharma and Merck
Barcelona, SPAIN and Mumbai, INDIA, March 24, 2017: Almirall S.L, (Spanish Stock Exchange ticker: ALM, “Almirall”) and Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies) announced today the validation of the Regulatory Filing of tildrakizumab with the European Medicines Agency (EMA) by Almirall. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis.
The filing includes efficacy and safety data from the pivotal Phase III clinical trials (reSURFACE 1 and 2) that included over 1,800 patients across more than 200 clinical sites.
"The filing of tildrakizumab in Europe is a significant 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 President - Biologics & Dermatology, Sun Pharma, "Not all people living with psoriasis achieve long-term systemic control with currently available treatments, there are those who continue to struggle every day with the chronic nature of psoriasis. The European filing of tilidrakizumab is the next step in our effort to bring a new treatment option to people suffering from psoriasis.”
In July 2016, Almirall entered into a licensing agreement 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 negotiation. In addition, Almirall will be able to lead European studies, and participate in larger 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 million 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 plaque 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 people 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 precise targeting, tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system. Phase III tildrakizumab data provides further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis.
About Sun Dermatology
Sun Pharma is committed to expanding our dermatology portfolio to bring healthcare providers and patients around the world more treatment options 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 the U.S. per IMS and is fifth largest specialty generic pharmaceutical company globally. In addition to the investigational candidate Tildrakizumab, an investigational anti-IL- 23p19 monoclonal 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 Almirall (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 Global clinical studies for psoriasis indication subject to the terms of the Sun Pharma – Merck agreements, as well as certain cost sharing agreements. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments 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 license agreement between Sun Pharma and Merck