Sun Pharma inks exclusive pact with Hikma to distribute ILUMYA in Middle East, North Africa

Mumbai: Sun Pharmaceutical Industries Ltd. has 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 a 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 the 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." 

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-to-severe 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 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. 

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