London - Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces a new strategic partnership and exclusive licensing agreement with SK Biopharmaceuticals, a global biotech company focused on the development of treatments for central nervous system (CNS) disorders and oncology, for the Middle East and North Africa (MENA).

Under the terms of the agreement, Hikma will have priority rights for the commercialisation and manufacture of SK Biopharmaceuticals' current and future pipeline of innovative products for 17 countries in the MENA region. The term of the agreement is for 20 years from the commercialisation of the first product. In addition, Hikma will have the exclusive rights to manufacture and commercialise SK Biopharmaceuticals' first pipeline product, cenobamate, an innovative anti-seizure medication for patients with epilepsy, in MENA markets.

Commenting on this agreement, Mazen Darwazah, Hikma's Executive Vice Chairman and President of MENA, said: 'This agreement gives us access to a strong pipeline of innovative products in CNS and oncology, two strategic areas of focus for us with a high unmet need in the MENA region. SK Biopharmaceuticals also aims to expand from small molecule targeted therapy into biologics and we are excited to be their partner to ensure patients' access to these innovative therapies in MENA.'

About Cenobamate

Cenobamate is an anti-seizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the -aminobutyric acid (GABAA) ion channel.

Cenobamate is approved in the United States for the treatment of partial-onset seizures in adults and is available under the brand name XCOPRI (cenobamate tablets) CV. Cenobamate can be combined with other ASMs or used alone. The recommended initial dosage of cenobamate is 12.5 mg once-daily, with titration every two weeks; it is available in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg.

Cenobamate is also approved in the European Union and the United Kingdom for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with seizures that have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products and is marketed by Angelini Pharma under the brand name ONTOZRY. Additionally, cenobamate is in clinical development in Asia. Ono Pharmaceutical and Ignis Therapeutics have the rights to develop and commercialize cenobamate in Japan and in the Greater China region, respectively.

Contact:

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