Sun Pharma announces Japan MHLW approval of ILUMYA for the treatment of Plaque Psoriasis

Mumbai, India & Tokyo, Japan, June 29, 2020 – 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 one of its wholly-owned subsidiaries has
received approval from the Ministry of Health, Labour and Welfare (MHLW), Japan for ILUMYA
(tildrakizumab) for the treatment of plaque psoriasis in adult patients who have an inadequate response
to conventional therapies. Japan has approximately 430,000 people currently suffering from psoriasis1.

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 proinflammatory
cytokines and chemokines.

Junichi Nakamichi, Country Head, Sun Pharma Japan, said, “ILUMYA is the first innovative drug that Sun
Pharma plans to launch in Japan. It was extensively tested in Japanese patients as part of ILUMYA’s
global clinical development program. The drug offers a new treatment option with only one injection
every 12 weeks for Japanese patients who struggle everyday with the chronic nature of plaque
psoriasis. It showed sustained efficacy for over 4 years and has safety profiles over 4 years with low
rates of severe infections, malignancies and MACEs. This approval adds a biologic product to our
existing strong dermatology portfolio in Japan. We will leverage Sun Pharma Japan’s robust marketing
network to make ILUMYA, a safe and efficacious product, available to dermatologists and patients in

ILUMYA is one of the key specialty products of Sun Pharma and it was approved by US FDA in March
2018 while the European Commission approved it in September 2018.

The MHLW approval of ILUMYA for the treatment of plaque psoriasis was supported by data from the
pivotal Phase-3 reSURFACE clinical development program. In the two multicentre, randomized, doubleblind,
placebo-controlled trials (reSURFACE 1 and reSURFACE 2), 1862 adult patients were enrolled and
treated with ILUMYA (N=1238), etanercept (N=313) or placebo (N=310). Both Phase-3 studies met the
primary efficacy endpoints, demonstrating significant clinical improvement with ILUMYA 100 mg
compared to placebo or etanercept when measured by at least 75 percent reduction in baseline
psoriasis severity (Psoriasis Area Sensitivity Index or PASI 75) and Physician’s Global Assessment (PGA)
score of “clear” or “minimal” at week 12 after two doses.

The most common adverse reactions observed with ILUMYA in the pooled data from one Phase 2 and
two Phase 3 studies in psoriasis patients for the placebo controlled period (16 weeks for the Phase 2
study and 12 weeks for the Phase 3 studies) were nasopharyngitis, headache, and site injection pain.
Most adverse reactions were considered mild and no adverse reaction led to discontinuation of
treatment in >1% of patients.

After 64-week base study of reSURFACE 1, a total of 120 Japanese patients entered the reSURFACE 1
extension study and 101 patients completed the extension study for 148 weeks.


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.

About Psoriasis
Psoriasis is a chronic immune disease that appears on the skin, affecting approximately 125 million
people worldwide2. The non-contagious disorder speeds the growth cycle of skin cells2 and results in
thick scaly areas of skin3. The most common form, affecting about 80 to 90 percent of people with
psoriasis, is called plaque psoriasis4. It appears as red, raised areas of skin covered with flaky white
scales which may be itchy and painful and can crack and bleed3. Twenty percent of people with plaque
psoriasis are considered moderate-to-severe, and many continue to struggle with the ongoing,
persistent nature of this chronic disease.

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 meaning 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 developments/circumstances after the date hereof.

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 and a skilled team enables it to deliver highquality
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 7% of annual revenues in R&D. For
further information, please visit & follow us on Twitter @SunPharma_Live.

1. Kubota K, et al. BMJ Open 2015 Jan 14; 5(1)
2. National Psoriasis Foundation. Facts about psoriasis.
MediaKit.pdf. Accessed on February 22, 2018.
3. National Psoriasis Foundation. About Psoriasis. Accessed on February 22,
4. 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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