03 February 2013
Amman - Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) today announces the signing of a licensing and distribution agreement with EffRx Pharmaceuticals SA for Binosto®, its innovative osteoporosis medication, for the Middle East and North Africa region. Binosto® is the first and only buffered solution for the treatment of osteoporosis, delivering fracture-risk reduction and offering the potential to improve adherence to therapy.  

Under the terms of the agreement, Hikma will have the exclusive rights to register, market and distribute Binosto® in 19 countries across MENA. The agreement will leverage Hikma's strong local presence and regulatory expertise in MENA, with over 1,600 sales and marketing reps across the region. 

Binosto® was developed by EffRx through an agreement with Merck & Co, Inc. granting EffRx the worldwide rights to all effervescent and related patents of Fosamax® (alendronate).   Patents have been granted to EffRx providing exclusivity for Binosto® through February 2023.  Additional patents are pending.   Binosto (buffered alendronate sodium 70mg) is an effervescent tablet for oral solution and has recently been approved in the United States, Europe and Australia[1] for the treatment of osteoporosis in postmenopausal women.  In the United States it is also approved for the treatment of men with osteoporosis to increase bone mass. 

Osteoporosis is a serious and often debilitating disease affecting more than 200 million people worldwide.  It is expected to become a growing problem in the MENA region as the population ages.  Efficacious and convenient treatments for patients at high risk of bone fractures are necessary to avoid disability and deaths and to minimise healthcare costs.  This agreement will enable patients in the MENA to benefit from an innovative, safe and easy-to-use medication. 

Mazen Darwazah, Hikma's Vice Chairman and CEO of MENA said, "We are pleased to be licensing this excellent product from EffRx.  The agreement supports our strategy to continue working with global partners to strengthen our product portfolio in growing therapeutic categories, including women's health.  Hikma is committed to bringing a broad range of high quality, pharmaceutical products to patients in MENA."  

Christian Rosén, Chairman and CEO of EffRx Pharmaceuticals said, "We are thrilled to announce this partnership with Hikma, a company who we believe to be an ideal partner for EffRx in MENA.  We believe Hikma's well-established sales force across the region can drive Binosto® to a market leadership position and we are extremely proud to have Hikma as a partner."

-Ends-

About Binosto®
Binosto® (buffered alendronate sodium 70mg) is an effervescent tablet for oral solution.  Binosto® represents a true breakthrough in the treatment of osteoporosis - especially for those patients who prefer not to or have difficulties swallowing tablets.  Taken just once a week, with a reduced volume of water compared with the requirements of the leading osteoporosis medication and no risk of a tablet getting lodged in the esophagus, Binosto® has the potential to improve long-term patient compliance and adherence to therapy, thereby decreasing the risk of disabling fractures. 

About EffRx
EffRx Pharmaceuticals SA is an innovative specialty pharmaceutical company that exploits its proprietary technology platform to improve the efficacy, tolerability and convenience of approved high volume medicines, thereby generating better products and improved quality of life for patients.  The primary focus is on metabolic bone disease, oncology supportive care, pediatric medications and support to larger companies in Life Cycle Management.

About Hikma
Hikma Pharmaceuticals is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non branded generic and in-licensed products.  Hikma's operations are conducted through three businesses: "Branded", "Injectables" and "Generics" based principally in the Middle East and North Africa (MENA) region, where it is a market leader, the United States and Europe.  In 2011, Hikma achieved revenues of US$918.0 million and profit attributable to shareholders of US$80.1 million.  

For more information
VARCC - Arabian Communications
Name: Sara Haddadin  
Email: Sara.haddadin@varcc.com  
Tel: (+962) 6 5547161
Fax:(+962) 6 5547162

HIKMA Pharmaceuticals
Name: Hana Ramadan, Dana Shekem
Email: hramadan@hikma.com, dshekem@hikma.com
Tel: Hana Ramadan (+962) 6 5802900 Ext. 313, 311

[1] Binosto® is known under the name of Steovess® in the European Union and Australia

© Press Release 2013