Data Presentations Highlighting Pivotal Phase 3 Trial Analyses on Long-Term Safety, One-Year Efficacy and Pre-Treated Patients will Offer Further Insights on the Potential of the Investigational IL-23 Inhibitor Tildrakizumab
MUMBAI, India and PRINCETON, N.J., Feb. 12, 2018 /PRNewswire/ — Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) today announced that 12 abstracts featuring data on the investigational, high-affinity IL-23p19 inhibitor tildrakizumab will be presented at the 76th Annual Meeting of the American Academy of Dermatology (AAD) from February 16 – 20 in San Diego, CA.
Data to be presented includes safety insights such as treatment-emergent adverse events (e.g., infections) and gastric-related events (e.g., inflammatory bowel disease), as well as long-term treatment and treatment in patients who were previously treated with biologic etanercept and PDE4 inhibitor apremilast.
"We are pleased this broad range of tildrakizumab data, offering further insights on the potential of this investigational, high-affinity IL-23p19 inhibitor to become a treatment option for moderate-to-severe psoriasis, will be shared with the dermatology community at AAD," said Abhay Gandhi, President and Chief Executive Officer, North America, Sun Pharma. "For people who continue to struggle daily with the persistent, chronic nature of psoriasis, more treatment options are needed. At Sun Pharma, we look forward to moving ahead with the clinical development of tildrakizumab."
In May 2017, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) filing for tildrakizumab, which is supported by the two pivotal Phase 3 trials (reSURFACE 1 and 2) that included over 1,800 patients across more than 200 clinical trial sites. Data from these trials were presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting and the 25th European Academy of Dermatology and Venereology (EADV) Congress.
The following tildrakizumab data will be presented at the AAD 2018 Annual Meeting:
Oral presentations:
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Safety and Tolerability | |
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#7211 |
Safety and Tolerability of Tildrakizumab, an Anti-IL-23p19 Monoclonal Antibody, in Patients with Chronic Plaque Psoriasis Over Two Years of Treatment: Results from Long-Term Extensions of Two Phase III Clinical Studies (reSURFACE 1 and reSURFACE 2) |
|
#7092 |
Incidence of Serious Gastrointestinal Events and Inflammatory Bowel Disease Among Tildrakizumab-Treated Patients with Moderate-to-Severe Plaque Psoriasis: Data from Three Large Randomized Clinical Trials |
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Efficacy | |
|
#6869 |
Tildrakizumab Efficacy Over Time by Week 28 Response Levels in Two Phase 3 Clinical Trials in Patients with Chronic Plaque Psoriasis |
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Pre-Treated Patient Population | |
|
#7636 |
Efficacy of Tildrakizumab in Etanercept Partial or Nonresponders |
Poster presentations:
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Safety and Tolerability | |
|
#5937 |
Safety of Tildrakizumab for Moderate-to-Severe Chronic Plaque Psoriasis: Pooled Analysis of Three Randomized Controlled Studies |
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#7097 |
Incidence of Infections in Clinical Trials of Tildrakizumab for Moderate-to-Severe Chronic Plaque Psoriasis |
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#6133 |
Exposure-Response Analyses from a Phase 2b and Two Phase 3 Randomized Controlled Trials of Tildrakizumab for the Treatment of Chronic Plaque Psoriasis |
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#6137 |
Immunogenicity with Tildrakizumab, an Anti-IL-23p19 Monoclonal Antibody, in a Pooled Analysis of Three Randomized Controlled Trials in Patients with Chronic Plaque Psoriasis |
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#6721 |
Population Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-Interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis |
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Efficacy | |
|
#7690 |
Predictors of Response to Tildrakizumab for Moderate-to-Severe Chronic Plaque Psoriasis |
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#7682 |
Effect of Tildrakizumab on Personal Relationships in Patients with Moderate-to-Severe Chronic Plaque Psoriasis |
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Pre-Treated Patient Population | |
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#6886 |
Efficacy Responses with Tildrakizumab in Moderate-to-Severe Chronic Plaque Psoriasis Patients with Prior Exposure to Apremilast: Results of a Pooled Analysis of reSURFACE 1 and reSURFACE 2 |
About Tildrakizumab
Tildrakizumab is an investigational humanized, high-affinity 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 3 tildrakizumab data provide further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis. Tildrakizumab is an investigational product currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The safety and efficacy of tildrakizumab have not yet been established.
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 worldwide1. It is a non-contagious disorder that speeds the growth cycle of skin cells1and results in thick scaly areas of skin2. The most common form, affecting about 80 to 90 percent of people living with psoriasis, is called plaque psoriasis3. It appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed2. Many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease.
About Sun Dermatology
Sun Dermatology (the branded dermatology division of a wholly owned subsidiary of Sun Pharma) is committed to expanding its 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 fourth 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.
About Sun Pharma, Merck & Co., Inc., Kenilworth, NJ, USA, Agreement
Sun Pharmaceutical Industries Ltd.'s wholly owned subsidiary licensed worldwide rights to tildrakizumab from a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, in 2014. Funded by a Sun Pharma subsidiary, Merck & Co., Inc., Kenilworth, NJ, USA is responsible for the completion of Phase-3 trials in patients with moderate-to-severe plaque psoriasis and, as appropriate, submission of a Biologics License Application to the United States Food and Drug Administration (FDA), as well as manufacturing finished goods to support Sun Pharma's initial product launch. If the FDA approves tildrakizumab in the U.S., Sun Pharma will be responsible for all post-approval regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Sun Pharma will also be responsible for all regulatory, pharmacovigilance, post approval studies, manufacturing and commercialization of approved products for all non-U.S. markets. Merck & Co., Inc., Kenilworth, NJ, USA is eligible to receive milestone payments and royalties on sales of tildrakizumab.
About Sun Pharma, Almirall S.A, Europe, Agreement
Sun Pharma and its wholly owned subsidiary and Almirall (Spanish Stock Exchange ticker: ALM) closed on July 2016 a licensing agreement on the development and commercialization of Tildrakizumab for psoriasis in Europe. Under the terms of the licensing 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 & Co., Inc., Kenilworth, NJ, USA 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 licensing agreement between Sun Pharma and Merck & Co., Inc., Kenilworth, NJ, USA.
References
1. National Psoriasis Foundation. Facts about psoriasis. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed on December 13, 2017.
2. National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis. Accessed on December 13, 2017.
3. Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol 2008 May;58(5):826-50.
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