Hikma Pharmaceuticals PLC - Back to Homepage

Keep yourself updated about Hikma

News Search

Search for a news item according to period of time or category.

Ensuring the Sustainability of our Business

Download Hikma's latest CR Report

04 May 2016

Hikma receives FDA approval for Leucovorin Calcium Injection

London, 04 May 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its supplemental Abbreviated New Drug Application (sANDA) for Leucovorin Calcium Injection, 350 mg Single-use vial has been approved by the U.S. Food and Drug Administration (FDA).

London, 04 May 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its supplemental Abbreviated New Drug Application (sANDA) for Leucovorin Calcium Injection, 350 mg Single-use vial has been approved by the U.S. Food and Drug Administration (FDA).

Leucovorin Calcium Injection is used for the prevention and treatment of certain blood cell disorders, and can be used in conjunction with other oncology drugs for the treatment of colorectal cancer. According to IMS Health, U.S. sales of Leucovorin Calcium Injection were approximately $35 million for the 12 months ending March 2016, of which the 350 mg presentation represented around $19 million.

Said Darwazah, Chairman and CEO of Hikma, said, “We are very pleased this product has been approved for the US market. We continue to leverage our strong R&D, regulatory and high-quality manufacturing capabilities and remain committed to prioritising the re-introduction of Bedford products for patients in need.”

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Zeena Murad, Investor Relations Manager +44 (0)20 7399 2768/
+44 7771 665277
FTI Consulting  
Ben Atwell / Matthew Cole          +44 (0)20 3727 1000

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: “Injectables”, “Branded” and “Generics”, based principally in the United States, the Middle East and North Africa (MENA) and Europe. In 2015, Hikma achieved revenues of $1,440 million and profit attributable to shareholders of $252 million.

Press Release
+ more
Print page

Product

04 May 2016

Hikma receives FDA approval for Fluphenazine Decanoate Injection

London, 04 May 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its supplemental Abbreviated New Drug Application (sANDA) for Fluphenazine Decanoate Injection USP, 125mg/5 mL (25 mg/mL) multiple-dose vial has been approved by the U.S. Food and Drug Administration (FDA).

London, 04 May 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its supplemental Abbreviated New Drug Application (sANDA) for Fluphenazine Decanoate Injection USP, 125mg/5 mL (25 mg/mL) multiple-dose vial has been approved by the U.S. Food and Drug Administration (FDA).

Fluphenazine Deconate Injection is a neuroleptic drug used in the treatment of chronic pysychosis. According to IMS Health, sales of Fluphenazine Deconate Injection in the US market were approximately $23 million for the 12 months ending March 2016.

Said Darwazah, Chairman and CEO of Hikma, said, “We are very pleased this product has been approved for the US market. We continue to leverage our strong R&D, regulatory and high-quality manufacturing capabilities, and remain committed to prioritising the re-introduction of Bedford products for patients in need.”

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Zeena Murad, Investor Relations Manager +44 (0)20 7399 2768/
+44 7771 665277
FTI Consulting  
Ben Atwell / Matthew Cole          +44 (0)20 3727 1000

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: “Injectables”, “Branded” and “Generics”, based principally in the United States, the Middle East and North Africa (MENA) and Europe. In 2015, Hikma achieved revenues of $1,440 million and profit attributable to shareholders of $252 million.

Press Release
+ more
Print page

Product

08 April 2016

Hikma’s ANDA for Generic Advair Diskus® accepted for filing by FDA

London, 8 April 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, today confirms that its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA).

London, 8 April 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, today confirms that its abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the U.S. Food and Drug Administration (FDA).

The FDA provided Hikma, through its wholly-owned subsidiary, West-Ward Pharmaceuticals, a GDUFA goal date of May 10, 2017. This product is the generic version of GlaxoSmithKline's Advair Diskus®, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) and is delivered using Vectura’s proprietary dry powder inhaler and formulation technology.

Said Darwazah, Chairman and CEO of Hikma said, “We are very pleased to have achieved this important milestone in the development of generic Advair Diskus®.  With our partner, Vectura, our team has worked closely with the FDA to ensure the quality of the ANDA submission.  Our interactions with the FDA have helped clarify the requirements for the development of a robust, patient friendly, (AB-rated) substitutable generic product for Advair Diskus®. We look forward to bringing to market this very important product for patients.”

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Zeena Murad, Investor Relations Manager +44 (0)20 7399 2768/
+44 7771 665277
FTI Consulting  
Ben Atwell / Matthew Cole / Julia Phillips                +44 (0)20 3727 1000

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: “Injectables”, “Branded” and “Generics”, based principally in the United States, the Middle East and North Africa (MENA) and Europe. In 2015, Hikma achieved revenues of $1,440 million and profit attributable to shareholders of $252 million.

Press Release
+ more
Print page

Product

29 March 2016

Hikma receives FDA approval for Temozolomide Capsules

London, 29 March 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its wholly-owned subsidiary West-Ward Pharmaceuticals, through its Columbus facility (the newest facility added to the Hikma network from the Roxane Laboratories acquisition), has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Temozolomide Capsules 5mg, 20mg, 100mg, 140mg, 180mg and 250mg.  Temozolomide Capsules are the therapeutic equivalent to the reference listed drug Temodar® Capsules of Merck Sharp & Dohme Corp.

London, 29 March 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its wholly-owned subsidiary West-Ward Pharmaceuticals, through its Columbus facility (the newest facility added to the Hikma network from the Roxane Laboratories acquisition), has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Temozolomide Capsules 5mg, 20mg, 100mg, 140mg, 180mg and 250mg.  Temozolomide Capsules are the therapeutic equivalent to the reference listed drug Temodar® Capsules of Merck Sharp & Dohme Corp.

Temozolomide is an important chemotherapy agent used to treat a severe form of brain cancer.  According to IMS, total U.S. sales of Temozolomide Capsules 5mg, 20mg, 100mg, 140mg, 180mg and 250mg were approximately $200 million for the 12 months ending January 2016.

Said Darwazah, Chairman and CEO of Hikma said, “We are very pleased to announce our first approval from the Columbus portfolio (formerly Roxane Laboratories) since we closed the transaction on 29 February 2016. West-Ward has an excellent pipeline of differentiated products and proven R&D, supply chain and operational capabilities that we expect will drive accelerated and sustainable future growth."

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Zeena Murad, Investor Relations Manager +44 (0)20 7399 2768/
+44 7771 665277
FTI Consulting  
Ben Atwell / Matthew Cole                 +44 (0)20 3727 1000

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: “Injectables”, “Branded” and “Generics”, based principally in the United States, the Middle East and North Africa (MENA) and Europe.  In 2015, Hikma achieved revenues of $1,440 million and profit attributable to shareholders of $252 million.

Press Release
+ more
Print page

Product

16 March 2016

Hikma Pharmaceuticals Preliminary Results

Hikma Pharmaceuticals PLC (“Hikma”, “Group”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today reports its preliminary results for the year ended 31 December 2015.

Hikma Pharmaceuticals PLC (“Hikma”, “Group”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today reports its preliminary results for the year ended 31 December 2015.

Press Release
+ more
Print page

Corporate

09 March 2016

Hikma receives FDA approval for Etomidate Injection

London, 9 March 2016 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its  abbreviated new drug application  (“ANDA”) for Etomidate Injection USP, 2mg/mL (10 mL and 20 mL single-dose vials) , has been approved by the U.S. Food and Drug Administration (“FDA”).

London, 9 March 2016 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its  abbreviated new drug application  (“ANDA”) for Etomidate Injection USP, 2mg/mL (10 mL and 20 mL single-dose vials) , has been approved by the U.S. Food and Drug Administration (“FDA”).

Etomidate Injection is an anaesthetic agent used for the induction of general anaesthesia and sedation. According to IMS Health, sales of Etomidate Injection in the US market were approximately $11.2 million for the 12 months ending January 2016.

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Zeena Murad, Investor Relations Manager +44 (0)20 7399 2768/
+44 7771 665277
FTI Consulting  
Ben Atwell / Matthew Cole                 +44 (0)20 3727 1000

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: “Injectables”, “Branded” and “Generics”, based principally in the United States, the Middle East and North Africa ("MENA") and Europe.  In 2014, Hikma achieved revenues of $1,489 million and profit attributable to shareholders of $278 million.

Press Release
+ more
Print page

Product

09 March 2016

Hikma receives FDA approval for Acyclovir Injection

London, 9 March 2016 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its  abbreviated new drug application  (“ANDA”) for Acyclovir Injection USP, 500mg/vial and 1 gm/vial, single dose vials, has been approved by the U.S. Food and Drug Administration (“FDA”).

London, 9 March 2016 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its  abbreviated new drug application  (“ANDA”) for Acyclovir Injection USP, 500mg/vial and 1 gm/vial, single dose vials, has been approved by the U.S. Food and Drug Administration (“FDA”).

Acylcovir Injection is used to treat initial and recurrent herpes simplex, shingles (varicella zoster) infection, genital herpes and herpes simplex encephalitis. According to IMS Health, sales of Acyclovir Injection in the US market were approximately $14.7 million for the 12 months ending January 2016.

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Zeena Murad, Investor Relations Manager +44 (0)20 7399 2768/
+44 7771 665277
FTI Consulting  
Ben Atwell / Matthew Cole                 +44 (0)20 3727 1000

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: “Injectables”, “Branded” and “Generics”, based principally in the United States, the Middle East and North Africa ("MENA") and Europe.  In 2014, Hikma achieved revenues of $1,489 million and profit attributable to shareholders of $278 million.

Press Release
+ more
Print page

Product

09 March 2016

Hikma receives FDA approval for Methylprednisolone Sodium Succinate Injection

London, 9 March 2016 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its  abbreviated new drug application  (“ANDA”) for Methylprednisolone Sodium Succinate Injection USP, 500mg/vial and 1 gm/vial has been approved by the U.S. Food and Drug Administration (“FDA”).

London, 9 March 2016 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its  abbreviated new drug application  (“ANDA”) for Methylprednisolone Sodium Succinate Injection USP, 500mg/vial and 1 gm/vial has been approved by the U.S. Food and Drug Administration (“FDA”).

Methylprednisolone Sodium Succinate Injection is a corticosteroid hormone indicated to treat conditions such as arthritis, blood disorders, skin and kidney diseases and other system disorders. According to IMS Health, sales of Methylprednisolone Sodium Succinate Injection in the US market were approximately $123.5 million for the 12 months ending January 2016.

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Zeena Murad, Investor Relations Manager +44 (0)20 7399 2768/
+44 7771 665277
FTI Consulting  
Ben Atwell / Matthew Cole                 +44 (0)20 3727 1000

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: “Injectables”, “Branded” and “Generics”, based principally in the United States, the Middle East and North Africa ("MENA") and Europe.  In 2014, Hikma achieved revenues of $1,489 million and profit attributable to shareholders of $278 million.

Press Release
+ more
Print page

Product

Get adobe reader Most computers will open PDF documents automatically, but you may need to download Adobe Reader.