Hikma Pharmaceuticals Regulatory News (HIK)

London, 25 July 2019 - Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's / BB+ S&P, both stable), the multinational pharmaceutical company, and Gedeon Richter PLC (Richter) today announced the signing of an exclusive license agreement to commercialise cariprazine, a novel antipsychotic, in certain Middle East and North African (MENA) markets.

Under the terms of the agreement, Richter will be responsible for product supply and Hikma will proceed with the registration and commercialisation of the product in the following markets: Bahrain, Egypt, Jordan, Iraq, Saudi Arabia, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Sudan, Syria and United Arab Emirates. According to IQVIA, sales for atypical antipsychotics in these markets were $153 million for the 12 months ending March 2019. Richter will receive from Hikma an upfront payment. In addition, Richter will be entitled to sales related milestone payments on achievement of certain targets.

Mazen Darwazah, Hikma's Executive Vice Chairman and President of MENA said, "We are very pleased to form a partnership with Richter, adding a novel product to our portfolio in a key therapeutic area. CNS disorders are becoming more prevalent across the MENA and this partnership enables us to meet the needs of a growing number of patients."

Mr Gábor Orbán, Chief Executive Officer of Richter said, "We consider this recent partnership agreement as a further step to achieve a global presence of cariprazine in the treatment of patients suffering from schizophrenia".

About cariprazine

Cariprazine is an oral, once daily atypical antipsychotic approved by the FDA for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults and for the treatment of schizophrenia in adults. Apart from having been available on the US market for more than three years cariprazine is also approved in the EU for schizophrenia indication and has already been marketed in 15 European countries.

Cariprazine was discovered by Gedeon Richter PLC and was licensed out to Allergan in the United States. For more than a decade both companies have co-developed the molecule by conducting over 50 clinical trials enrolling thousands of patients worldwide to evaluate the efficacy and safety of cariprazine for people living with a broad range of mental health illnesses. While Gedeon Richter PLC markets the molecule on its own in Central-Eastern Europe, Western European marketing rights were licensed to Recordati and other license agreements have been signed with further strong local partners to ensure that cariprazine would be a treatment option to many patients globally suffering from these debilitating diseases.

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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're 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 8,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner in the MENA region, 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.

About Richter

Gedeon Richter PLC (www.richter.hu), headquartered in Budapest / Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, China and in Latin America. Having reached a market capitalisation of EUR 3.2 billion (USD 3.6 billion) by the end of 2018, Richter's consolidated sales were approximately EUR 1.4 billion (USD 1.6 billion) during the same year. The product portfolio of Richter covers many important therapeutic areas, including Women's Healthcare, Central Nervous System and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the Women's Healthcare field worldwide. Richter is also active in biosimilar product development.