Hikma signs licensing and marketing agreement for Dance Biopharm’s inhaled insulin in MENA

London, 22 April 2013 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) today announces the signing of a licensing and distribution agreement with Dance Biopharm for its proprietary inhaled insulin product, Dance 01, for the Middle East and Africa. Dance 01 is currently under development for the treatment of patients with diabetes, with Phase 3 studies expected to begin next year.

Press Release Corporate 22 April 2013

Under the terms of the agreement, Hikma will have the exclusive rights to register, market and distribute Dance 01 across the Middle East and Africa.  The agreement will initially leverage Hikma’s strong local presence and regulatory expertise in the Middle East and North Africa (“MENA”), with over 1,600 sales and marketing representatives across the region.

Diabetes is a global epidemic, estimated to be affecting around 371 million patients worldwide.1 In the MENA region, the private market for diabetes products was valued at over $668 million2 in 2012, up 15% compared to 2011. Diabetes is the largest and fastest growing cause of morbidity in the MENA region and this agreement will enable patients in these countries to benefit from an innovative, easy-to-use insulin medication. Dance 01 will complement Hikma’s strong portfolio of prescription pharmaceuticals for the treatment of diabetes.

Said Darwazah, Hikma’s CEO said, "Hikma is committed to improving the treatment of diabetes in the MENA region through the development of our product portfolio.  We are extremely pleased to be partnering with Dance Biopharm in bringing this innovative treatment to the region, where we believe there is excellent market potential for inhaled insulin products.  This agreement supports our efforts in continuing to bring innovative and critically needed new products to our patients in MENA by working with a range of global partners at different stages in the product development cycle."

John Patton, Dance Biopharm’s CEO said, "Dance's mission is to bring affordable inhaled insulin to diabetes patients across the globe. We consider Hikma to be the most capable and well-positioned pharmaceutical partner in the MENA region, where the prevalence of diabetes is the highest in the world. Through this collaboration, Dance and Hikma will commercialise inhaled insulin in MENA as soon as possible."

International Diabetes Federation Atlas, Fifth Edition
IMS Health, YTD December 2012, private retail sales for the top nine MENA markets

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