News and press releases

London, 4 February 2013 –Hikma Pharmaceuticals PLC (“Hikma”) (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 (“MENA”) 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."

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Enquiries

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.

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

London, 7 January 2013 – Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (“Hikma”), the fast growing multinational pharmaceutical group, today announces the approval of its New Drug Application (NDA) for Phenylephrine HCl Injection, USP, 10mg/mL, 1mL vial by the US Food and Drug Administration (FDA).

Hikma’s Phenylephrine is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. This NDA has been approved under Section 505(b)(2) of the US Federal Food Drug and Cosmetic Act and it is the only FDA approved version of Phenylephrine HCl Injection, USP.

Said Darwazah, CEO of Hikma, said, “This approval demonstrates our strong regulatory capabilities and the successful execution of our strategy to develop a more differentiated injectable product portfolio."

According to IMS Health, sales of Phenylephrine Injection in the US market were approximately $14 million for the 12 months ending November 2012.

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Enquiries

About Hikma

Hikma Pharmaceuticals PLC is a fast growing multinational pharmaceutical 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 $918.0 million and profit attributable to shareholders of $80.1 million.

London, 13 December 2012 – Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (“Hikma”), the fast growing multinational pharmaceutical group, today announces the US launch of argatroban injection, following the approval of its New Drug Application (NDA) by the US Food and Drug Administration (FDA) earlier this year.

Hikma’s argatroban is indicated for the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in adult patients with or at risk of HIT undergoing percutaneous coronary intervention (PCI).

Said Darwazah, CEO of Hikma, said, “Hikma is pleased to be bringing argatroban injection to market. Argatroban will expand our injectables product line and help to differentiate our product portfolio in the US."

According to IMS Health, sales of argatroban injection were approximately $105 million for the 12 months ending October 2012. Hikma is marketing argatroban injection in 100mg/ml vials. Hikma’s argatroban was developed through Hikma’s partnership with the specialty pharmaceutical company, Exela Pharma Sciences, LLC.

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Enquiries

Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate Strategy and Investor Relations
+44 (0)20 7399 2760

FTI Consulting
Ben Atwell /Julia Phillips/Jonathan Birt/Matthew Cole
+44 (0)20 7831 3113

About Hikma
Hikma Pharmaceuticals PLC is a fast growing multinational pharmaceutical 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 $918 million and profit attributable to shareholders of $80.1 million.

London, 22 October 2012 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) today announces the signing of a license and supply agreement for the registration and marketing of Lutrate^® 1 month, GP Pharm’s leading anti-cancer compound, for the Middle East and North Africa (“MENA”) region. Lutrate^® 1 month (leuprolide acetate 3.75 mg) is a hormonal androgen deprivation therapy to prevent tumor growth in patients with advanced prostate cancer.

Cancer is one of the leading causes of death in MENA. Prostate cancer is the third most prevalent type of cancer in the region, with an estimated 25,000 new cases diagnosed each year. With men over 60 most often affected, the incidence of prostate cancer is expected to increase dramatically as the population in MENA ages.

Under the terms of the agreement, Hikma will have the licensing rights to register, market and distribute Lutrate^® 1 month in 23 countries across MENA. Hikma will also become the partner of choice in the MENA region for GP Pharm’s pipeline of oncology products.

Mazen Darwazah, Hikma’s Vice Chairman and CEO of MENA said, “Hikma is committed to improving the treatment of cancer in the region through the development of our oncology product portfolio. We are pleased to be licensing this innovative injectable treatment, which has excellent potential and complements our portfolio and pipeline. It is in line with Hikma’s aim to deliver a reliable supply of high quality pharmaceutical products to MENA that reduce patients’ dependency on a single source for treatment.”

Dr. Berta Ponsati, GP Pharm’s CEO said, "The success of Lutrate^® 1 month is a direct reflection of GP Pharm's dedication and commitment to the development of new oncology treatments. We are excited about the potential for this important product in the MENA region and we look forward to working with Hikma."

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Enquiries

About Lutrate^®
Lutrate^® (leuprolide acetate 3.75 mg) belongs to a group of drugs called agonists of luteinising hormone-releasing hormone (LHRH), which are drugs that reduce testosterone (sex hormone).

Lutrate^® 1 month has been approved in 23 countries in the European Union, including Spain, Germany, the UK and Italy. It is expected to be filed in the USA shortly and in a number of other countries worldwide. Other presentations of Lutrate^® are currently under development by GP Pharm in 3 Month and 6 Month depots.

About GP Pharm
GP Pharm, is a Spanish biopharmaceutical company located in Barcelona. Its activities are focused on research, development, production and marketing of injectable products within the urology and oncology fields, some of them based on proprietary drug delivery systems. These technological platforms include microspheres and liposomes. The company works on the complete development of these drugs, from the preclinical studies until the launch to the market. These specialities are marketed either under GP’s brands or through licenses.

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.

About Hikma Oncology
Hikma is considered one of the pioneers in the oncology therapeutic category in the MENA region, through both its in-house R&D capabilities and through its strong and continuous partnerships with multinational companies. Hikma’s mission is to provide the health sector with a wide variety of oncology products covering innovative therapies, biosimilars and branded generics on a global scale. Currently Hikma has two oncology manufacturing facilities located in Germany and Jordan, with registrations in many countries including the United States, Germany, Portugal and in the MENA region.

Amman, 24 January 2012 – Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK), the fast growing multinational pharmaceutical group, announced the initiation of a partnership agreement with Ergomed, an international provider of drug development services headquartered in Germany. The agreement will see Ergomed manage clinical trials of Hikma treatments in a pilot project in Jordan.

The agreement was signed in September 2011, and a meeting between the CEO and CFO of Ergomed and Hikma’s CEO and management team was held on Wednesday January 18. Ergomed will be conducting the first clinical trials for one of Hikma’s key oncology (anti-cancer) products in Jordanian hospitals with plans of potential expansion in the MENA region. In turn, Hikma will provide Ergomed with an expanded insight into the regional pharmaceutical sector.

Mr. Said Darwazah, CEO of Hikma Pharmaceuticals, stated, “We are very pleased to announce the commencement of our partnership with Ergomed. They have a well-deserved reputation for excellence in the pharmaceutical sector and they will enhance Hikma’s ability to provide the best treatments for patients in Jordan and across the MENA region. As organisations, Hikma and Ergomed complement each other well, with great potential for operational synergies.”

“Our decision to work with Ergomed comes from a strong commitment to continuous medical advancement through the use of clinical trials, especially in the field of oncology. We are the leading company in our sector, and we want to continue providing the optimum treatments to our patients. Collaborating with Ergomed will ensure that we do so.”

Dr. Miroslav Reljanovic, CEO of Ergomed, stated, “We are very pleased to be working with Hikma on these initiatives. Ergomed has over thirteen years experience of international drug development and is currently developing a full service MENA business managed from its Dubai head office.

We share Hikma’s proven commitment to quality and to meeting the needs of doctors and patients and we look forward to working on this and future projects”

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Enquiries:

About Hikma
Hikma Pharmaceuticals PLC 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 operates through three businesses: “Branded”, “Injectables” and “Generics”, based principally in the Middle East and North Africa ("MENA"), where it is a market leader, the United States and Europe.

About ERGOMED
ERGOMED is a specialised international clinical development company offering contract clinical research and co-development partnerships to biotechnology and pharmaceutical companies worldwide in the fields of neurology, oncology and immunology. ERGOMED's approach to clinical research ensures effective patient recruitment, reducing the time and costs of clinical trials and complementing the drug discovery capabilities of its customers and partners. The Company has a dual business model offering standard clinical trial management contracts and also co-development partnerships to share the risks and rewards of clinical development.

ERGOMED is headquartered in Frankfurt, Germany and also has offices in UK, Russia, Croatia, Poland, Spain, Serbia, Italy and the USA. ERGOMED MENA is an integrated part of the group and is currently working for a range of local and international clients in the region.
www.ergomed-cro.com

London, 9 January 2012 - Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (“Hikma”), the fast growing multinational pharmaceutical group, today announces the approval of its New Drug Application (NDA) for argatroban injection, 100mg/mL vial by the US Food and Drug Administration (FDA).

Hikma’s argatroban is indicated for the prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in adult patients with or at risk of HIT undergoing percutaneous coronary intervention (PCI).

Said Darwazah, CEO of Hikma, said, “Argatroban will expand and strengthen our injectables product line and will help to differentiate our product portfolio in the US."

According to IMS Health, sales of argatroban injection were approximately $130 million for the 12 months ending November 2011.

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Enquiries:

About Hikma
Hikma Pharmaceuticals PLC is a fast growing multinational pharmaceutical 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 2010, Hikma achieved revenues of $731 million and profit attributable to shareholders of $99 million.