Sun Pharma and Hikma enter into exclusive licensing agreement for ILUMYA? for Middle East & North Africa regions
Mumbai, India, June 15, 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) announced that one of its wholly-owned subsidiaries
and Hikma Pharmaceuticals PLC (Hikma) have entered into an exclusive licensing and distribution
agreement for ILUMYA?, an innovative biologic product, for the Middle East & North Africa
(MENA) region.
ILUMYA? (tildrakizumab) is an USFDA approved innovative IL-23p19 monoclonal antibody used
for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for
systemic therapy or phototherapy.
Under the terms of the licensing agreement, Hikma will be responsible for the registration and
commercialization of the product in all MENA markets and Sun Pharma will be responsible for
product supply. Sun Pharma is eligible for upfront and milestone payments from Hikma. The term
of this agreement is 15 years from first sale, with two years? automatic renewal periods.
Aalok Shanghvi, Senior Vice President - Emerging Markets, Sun Pharma said, ?We are pleased to
partner with Hikma to offer ILUMYA? to patients in the MENA region. Hikma?s strong presence
in the MENA region will enable access to a new treatment option for people who are unable to
manage their moderate-to-severe plaque psoriasis.?
About ILUMYATM (tildrakizumab)
ILUMYATM (tildrakizumab) 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. ILUMYATM is
indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.
The U.S. Food and Drug Administration (USFDA) approved ILUMYATM in 2018 based on data from
the pivotal Phase-3 reSURFACE clinical development program. The Phase-3 studies (reSURFACE
1 and reSURFACE 2) were randomized, placebo-controlled, multicenter, three-part studies
designed to evaluate efficacy and safety of ILUMYATM 100 mg and 200 mg in moderate-tosevere plaque psoriasis compared to placebo and comparative drug, and to assess safety and
tolerability. Researchers evaluated (Psoriasis Area Sensitivity Index or PASI 75) and Physician?s
Global Assessment (PGA) response (score of 0 or 1 with =2 grade reduction from baseline) and
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incidence rates for pre-specified adverse events, including severe infections, cardiovascular
events and drug-related hypersensitivities.
Both Phase-3 studies met the primary efficacy endpoints, demonstrating significant clinical
improvement with ILUMYA? 100 mg compared to placebo when measured by at least 75 percent
of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) and Physician?s Global Assessment
(PGA) score of ?clear? or ?minimal? at week 12 after two doses. ILUMYATM was well tolerated
with low rates of adverse events.
ILUMYATM has also been approved in Australia, and in Europe under the brand name ILUMETRITM.
Disclaimer:
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
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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 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 www.sunpharma.com & follow us on Twitter @SunPharma_Live.
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