London, June 15, 2020 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, and a wholly-owned subsidiary of Sun Pharmaceutical Industries Ltd. (Sun Pharma), the world's fourth largest specialty generic pharmaceutical company, announced today that they have entered into an exclusive licensing and distribution agreement for ILUMYA™, an innovative biologic product, for the Middle East and North Africa (MENA) region.
15 June 2020
Corporate, Press Release
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 commercialisation 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. The term of this agreement is 15 years from first sale with two years automatic renewal periods. This agreement augments our dermatology and biotech-immunology strategy in MENA and adds an innovative biologic product to our psoriasis portfolio.
Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA said, “We are excited to partner with Sun Pharma and bring ILUMYA™ to our patients in MENA. ILUMYA™ is the first innovative monoclonal antibody product we add to our portfolio. As a pharmaceutical company whose mission is to put ‘better health within reach everyday’, this key collaboration strengthens our biotechnology and dermatology portfolio offering a wider array of treatment choices available in the MENA region, and enables us to increase patients’ access to targeted therapies and specialty products.”
About ILUMYA™ (tildrakizumab)
ILUMYA™ (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. ILUMYA™ 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 ILUMYA™ 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 ILUMYA™ 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. ILUMYA™ was well tolerated with low rates of adverse events.
ILUMYA™ has also been approved in Australia, and in Europe under the brand name ILUMETRI™.