Hikma Pharmaceuticals : and Sun Pharma enter into exclusive licensing agreement for ILUMYA for the Middle East and North Africa region

London - 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.

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.

Contact:

Hikma Pharmaceuticals PLC

Susan Ringdal

EVP, Strategic Planning and Global Affairs

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[e-mail]

Dana Alhusseini

Communication Manager

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About Hikma

Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com

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