Sun Pharma's (Pr)ILUMYA™ (tildrakizumab injection) now available to help Canadians living with moderate-to-severe plaque psoriasis

• ILUMYA is the first IL-23p19 inhibitor to complete five years of study based on a pooled analysis of two Phase 3 efficacy and safety extension trials in moderate-to-severe plaque psoriasis.
• Study results for ILUMYA showed that patients with moderate-to-severe plaque psoriasis maintained consistent, high levels of skin clearance and a durable safety profile through five years of continuous treatment. In Canada, some patients involved in the study have reported still having clear skin eight years later.
• ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and has quarterly dosing after the initial loading doses at week 0 and week 4 – offering patients freedom and flexibility.

MUMBAI, India and BRAMPTON, ON, Oct. 28, 2021 /CNW/ - Sun Pharma Canada Inc., a wholly owned subsidiary of Sun Pharmaceuticals Industries Limited (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715), "Sun Pharma" including its subsidiaries and/or associate companies) is pleased to announce ^PrILUMYA™ (tildrakizumab injection), a treatment for adults living with moderate-to-severe plaque psoriasis, is now available in Canada.

"We are excited to introduce this important biologic treatment to Canadians living with this common, inhibiting and often-overlooked disease. This launch is an important milestone for Sun Pharma, as we expand our dermatology portfolio into Canada," said Abhay Gandhi, CEO North America, Sun Pharma. "With five years of effective treatment of moderate-to-severe plaque psoriasis, ILUMYA demonstrates our commitment to providing innovative medicines to support patient lifestyle and physician choice."

Plaque psoriasis is a chronic autoimmune disease that appears on the skin as red, raised areas of the skin covered with flaky white scales that can crack and bleed. It affects approximately one million Canadians.ⁱ Moderate-to-severe plaque psoriasis affects about 35% of patients.ⁱⁱ A key challenge is that many treatments stop working overtime and symptoms return. Durability of treatment in the long-term is an unmet need for many patients.

"Moderate-to-severe plaque psoriasis can make it difficult to feel comfortable in your own skin and the search for an effective treatment can be as challenging as the disease itself," said Dr. Melinda Gooderham, a board-certified Dermatologist and Medical Director at the SKiN Centre for Dermatology in Peterborough, Ontario. "Our patients need options for an effective, durable and continuous treatment in Canada and ILUMYA will help meet that need."

In a published peer reviewed journal of the pooled analyses of the two trials reSURFACE 1 and reSURFACE 2, the data shows that most patients on ILUMYA maintained response and a reassuring safety profile through 5 years of treatment.

In patients who were treated with ILUMYA 100 mg, nearly nine out of 10 maintained their response through Year 5.ⁱⁱⁱ ILUMYA 100 mg was well-tolerated during the Phase 3 trials. The three adverse reactions that occurred more frequently than placebo and ≥1% in clinical trials were upper respiratory infections (15.1% vs. 12.3%), injection site reactions (3.9% vs. 2.6%) and headache (3.2% vs. 2.9%).^iv 

In Canada, some patients involved in the study have reported still having clear skin eight years later.

"I have patients who have been treated with ILUMYA for the past eight years, and I have seen their skin improve to high levels of clearance, and stay clear for the long term. As a result, their lives have also improved," added Dr. Gooderham.

"All my life I struggled with moderate-to-severe plaque psoriasis, and I constantly rotated between creams and ointments that never worked and only added to my stress. Until I learned about ILUMYA, I thought I had run out of treatment options," said Ainsley Leween, psoriasis patient. "Since I started using ILUMYA eight years ago, my psoriasis has been under control."

Canadian Agency for Drugs and Technologies in Health (CADTH), through the Common Drug Review, has positively recommended to the provinces it deals with that the ILUMYA product be reimbursed for patients with moderate-to-severe plaque psoriasis, when prescribed by a dermatologist.^v

About ^PrILUMYA™

Tildrakizumab, the active ingredient in ILUMYA, is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in Canada. ILUMYA has also been approved for use in the United States, Japan and Australia, and under the brand name ILUMETRI^® in Europe.

For more information visit www.sunpharma.com/canada or call 1-833-388-0532.

TM - All brand names and trademarks are the property of their respective owners.

References:

ⁱ Psoriasis. (n.d.). Canadian Psoriasis - CAPP. https://www.canadianpsoriasis.ca/en/psoriasis/types-of-psoriasis/plaque-psoriasis

ⁱⁱ PSORIASIS JOURNEY TO STABILITY NATIONAL REPORT - Canadians' Journey Living with Psoriasis. (2018). Canadian Psoriasis Network. https://www.canadianpsoriasisnetwork.com/wp-content/uploads/2018/09/JTSFinal-r.pdf

ⁱⁱⁱ Thaçi D, Piaserico S, Warren RB, et al. Five-year efficacy and safety of tildrakizumab in patients with moderate to severe psoriasis who respond at week 28: pooled analyses of two randomised phase 3 clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021 Feb 5. doi: 10.1111/bjd.19866

^iv ILUMYA^TM (tildrakizumab injection) 100 mg/mL Product Monograph. Sharjah, U.A.E.; Sun Pharma Global FZE, 2021.

^v CADTH Reimbursement Recommendation (Final) Tildrakizumab (Ilumya) https://cadth.ca/sites/default/files/cdr/complete/SR0624%20Ilumya%20-%20CDEC%20Final%20Recommendation%20June%2023%2C%202021_for%20posting%20(1).pdf

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About Sun Pharma Canada Inc.
Sun Pharmaceutical Industries Limited is growing its presence in Canada, bringing together the power of a global network with localized research and care to address the unmet needs of Canadian patients and health care providers.

Sun Pharma Canada Inc., a wholly owned subsidiary of Sun Pharmaceutical Industries Limited, is focused on providing innovative medicines in dermatology, bringing greater access and support for patients.

Patients and healthcare providers are at the centre of everything and Sun Pharma's "passion is clear". Sun Pharma's commitment to listening, acting and caring means the team is able to respond to distinct needs, provide personalized care, while addressing important gaps in treatment and quality of life.

Sun Pharma offers a wide range of affordable medicines for the Canadian population. Together with Taro Pharmaceutical Industries Ltd. (a subsidiary of Sun Pharma) these complementary companies bring together capabilities in specialty and niche segments coupled with a presence in the top 15 Canadian generic products.

About 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 skilled team enables it to deliver high-quality products, 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 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6-7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

SOURCE Sun Pharma Canada Inc.

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