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08 January 2016

Hikma receives FDA approval for Azathioprine Sodium Injection

London, 8 January 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 Azathioprine Sodium Injection USP, 100mg/vial has been approved by the U.S. Food and Drug Administration (“FDA”).

London, 8 January 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 Azathioprine Sodium Injection USP, 100mg/vial has been approved by the U.S. Food and Drug Administration (“FDA”).

Azathioprine Sodium Injection is indicated as an adjunct for the prevention of rejection in renal homotransplantations. Azathioprine Sodium Injection is a niche product and Hikma will be the first to re-introduce this product to the market.  

Said Darwazah, Chairman and CEO of Hikma, said, “We are making good progress with the transfer of the Bedford products to our manufacturing facilitates, leveraging our strong R&D, regulatory and manufacturing capabilities. We are very pleased that azathioprine has been approved for the US market, 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 2014, Hikma achieved revenues of $1,489 million and profit attributable to shareholders of $278 million. 

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08 January 2016

Hikma receives FDA approval for Cyanocobalamin Injection

London, 8 January 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 Cyanocobalamin Injection USP, 1000 mcg/mL in 1mL, 10mL and 30 mL vials has been approved by the U.S. Food and Drug Administration (“FDA”).

London, 8 January 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 Cyanocobalamin Injection USP, 1000 mcg/mL in 1mL, 10mL and 30 mL vials has been approved by the U.S. Food and Drug Administration (“FDA”).

Cyanocobalamin Injection is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with certain conditions, including Addisonian (pernicious) anemia, gastrointestinal pathology, dysfunction, or surgery, small bowel bacteria overgrowth and folic acid deficiency. According to IMS Health, sales of Cyanocobalamin Injection in the US market were approximately $80 million for the 12 months ending November 2015.

Said Darwazah, Chairman and 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."

-- 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. 

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04 January 2016

Hikma receives FDA approval for Neostigmine Methylsulfate Injection

London, 4 January 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 Neostigmine Methylsulfate Injection USP, 5 mg/10 mL and 10 mg/10 mL, multiple-dose vials has been approved by the U.S. Food and Drug Administration (“FDA”)  and that it has launched this product in the US market.

London, 4 January 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 Neostigmine Methylsulfate Injection USP, 5 mg/10 mL and 10 mg/10 mL, multiple-dose vials has been approved by the U.S. Food and Drug Administration (“FDA”)  and that it has launched this product in the US market.

Neostigmine Methylsulfate injection, a cholinesterase inhibitor, is indicated for reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBA) after surgery. According to IMS Health, sales of Neostigmine Methylsulfate Injection in the US market were approximately $264 million for the 12 months ending November 2015.

Said Darwazah, Chairman and 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."

-- 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.

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21 December 2015

Hikma renews UN Global Compact membership

Amman, 21 December 2015 - Hikma Pharmaceuticals PLC, the fast growing multinational pharmaceutical group, renewed its membership in the United Nations Global Compact (UNGC) by submitting a Communication on Progress  on 9 December, 2015. The report contained a confirmation of continued commitment to the Global Compact’s principles by Hikma Chairman and CEO Said Darwazah. Through the report, the company demonstrated its progress in the areas of human rights, labour standards, environment and anti-corruption. It reported how it continued to align its operations across its businesses with the Compact’s ten universally accepted principles. The report was uploaded on the Hikma and UNGC websites and encourages readers to engage and share their feedback.

Amman, 21 December 2015 - Hikma Pharmaceuticals PLC, the fast growing multinational pharmaceutical group, renewed its membership in the United Nations Global Compact (UNGC) by submitting a Communication on Progress  on 9 December, 2015. The report contained a confirmation of continued commitment to the Global Compact’s principles by Hikma Chairman and CEO Said Darwazah. Through the report, the company demonstrated its progress in the areas of human rights, labour standards, environment and anti-corruption. It reported how it continued to align its operations across its businesses with the Compact’s ten universally accepted principles. The report was uploaded on the Hikma and UNGC websites and encourages readers to engage and share their feedback.

Hikma has been a member in the UNGC since 2007, reporting progress annually. Since its official launch on 26 July 2000, the UN Global Compact initiative has grown to more than 12,000 participants, in approximately 145 countries around the world. It involves all relevant actors: companies, whose actions it seeks to influence; governments, labour, civil society organizations, academic institutions, cities and the United Nations as an authoritative leader and facilitator.

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03 December 2015

Hikma awarded Best Company in an Emerging Market

London, 03 December 2015 – Hikma Pharmaceuticals PLC, the fast growing multinational pharmaceutical group, is pleased to announce that it was the recipient of the “Best Company in an Emerging Market Award” at the 11th annual SCRIP Awards held in London on 2 December 2015. The award was given in recognition of Hikma’s strong track record of growth and excellent operational performance across its businesses.

London, 03 December 2015 – Hikma Pharmaceuticals PLC, the fast growing multinational pharmaceutical group, is pleased to announce that it was the recipient of the “Best Company in an Emerging Market Award” at the 11th annual SCRIP Awards held in London on 2 December 2015. The award was given in recognition of Hikma’s strong track record of growth and excellent operational performance across its businesses.

-- 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 $299 million.

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25 November 2015

Hikma announces sale of Ben Venue manufacturing facilities to Xellia Pharmaceuticals

London, 25 November 2015 – 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 announces it has agreed the sale of manufacturing facilities previously owned by Ben Venue Laboratories, Inc (“Ben Venue”) based in Bedford, Ohio, to Xellia Pharmaceuticals (“Xellia”).

London, 25 November 2015 – 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 announces it has agreed the sale of manufacturing facilities previously owned by Ben Venue Laboratories, Inc (“Ben Venue”) based in Bedford, Ohio, to Xellia Pharmaceuticals (“Xellia”).

In 2014, Hikma acquired the Ben Venue assets from Boehringer Ingelheim, following its agreement to purchase the assets of Bedford Laboratories. Under the terms of the agreement announced today, Xellia has acquired substantial parts of the Ben Venue site, including four sterile injectable manufacturing plants. These plants are not currently operational. Hikma will retain the Quality and Development Centre (“QDC”), an independent building with research and development laboratories, which has been integral to the tech transfer of the Bedford products to Hikma’s own manufacturing facilities. Since Hikma acquired the Ben Venue site in September 2014, it has transferred a large number of modern, high quality machines, including lyophlisers and filling lines, to its manufacturing facilities in Portugal, Germany and the US.

Said Darwazah, Chairman and Chief Executive Officer of Hikma commented: “We are very pleased to see that Xellia plans to restart commercial operations at the Ben Venue site, which will create jobs and further support the Bedford community. We have successfully transferred equipment from Ben Venue to our different manufacturing sites, and will continue to benefit from the exceptional capabilities and skills of the Quality and Development Centre and the Bedford R&D teams on-site.”

-- 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 $299 million.

About Xellia

Xellia Pharmaceuticals is a specialty pharmaceutical company focused on providing important anti-infective treatments against serious and often life-threatening infections. With over 100 years of experience Xellia is a leading developer, manufacturer and trusted supplier of fermented and semi-synthetic Active Pharmaceutical Ingredients (APIs) and Injectable Finished Dosage Forms (FDFs) to the pharmaceutical industry. The Company has growing sales in more than 70 countries to over 500 customers across the healthcare industry. Headquartered in Copenhagen, Denmark, Xellia has global facilities including operational and manufacturing capabilities in Denmark, USA, Hungary and China, and currently employs over 1,000 people.
Xellia is a leading supplier of vancomycin and colistimethate sodium (CMS) which together combat life-threatening, multi-drug resistant bacterial infections across Gram-positive and Gram-negative species. Xellia is also developing novel antibiotics effective against MDR Gram-negative bacteria in a development project with SINTEF Materials and Chemistry (Trondheim) and the Statens Serum Institut (Copenhagen), supported by a grant from the Research Council of Norway. Since July 2013, Xellia has been wholly owned by Novo A/S, the holding Company of the Novo Group. Further information aboutXellia can be found at: www.xellia.com.

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19 November 2015

Hikma Receives High Score in CDP Global Climate Change Report 2015

Amman, 19 November 2015 - Hikma Pharmaceuticals, Jordan’s leading pharmaceutical manufacturer, received a high score on its CDP (formerly the Carbon Disclosure Project) Global Climate Change Report 2015. Hikma has scored 90 ‘B’ in the rating of healthcare sector responding companies, marking a steady improvement during the reporting year of 2014.

Amman, 19 November 2015 - Hikma Pharmaceuticals, Jordan’s leading pharmaceutical manufacturer, received a high score on its CDP (formerly the Carbon Disclosure Project) Global Climate Change Report 2015. Hikma has scored 90 ‘B’ in the rating of healthcare sector responding companies, marking a steady improvement during the reporting year of 2014.

Additionally, Hikma was nominated for a CDP award. It was placed on the short-list of FTSE 350 companies in the “Biggest relative reduction in emissions (from emissions reduction activities)” category.

Hikma has been actively committed to reporting to the CDP, which expertly scrutinizes carbon emissions and provides analysis for better operational functionality. This self-generated reporting is in line with Hikma’s efforts towards minimizing its environmental impact and global carbon footprint.

“As a global manufacturer, we are highly aware of our impact on the environment, which is why we constantly seek methods to minimize waste, analyze carbon emissions, promote the responsible usage of energy and electricity consumption, and reduce demands for water consumption. We report climate change data to the CDP so as to increase transparency to our stakeholders and manage both risks and opportunities arising from climate change,” commented Vice President of Corporate Communication at Hikma Pharmaceuticals, Hana Darwazeh Ramadan.

“At Hikma, we are also keen on educating our staff and raising their awareness about the effects they have on the environment in everything they do. I would like to congratulate and thank all Hikma employees, who have always been the cornerstone of our success, for their excellent teamwork and dedicated efforts.”

In 2015, Hikma was among almost 2,000 companies to report climate change data to the CDP.  Participating companies were scored against two parallel assessment schemes: performance and disclosure. The performance band (E to A) assesses a company’s reported level of action on climate change mitigation, adaptation and transparency. In turn, the disclosure score (one-100) assesses the comprehensiveness and transparency of a company’s response to the CDP’s questions regarding the measurement and management of its carbon footprint, climate change strategy and risk management processes and outcomes.

The CDP is an independent, not-for-profit organization holding the world’s largest public database of self-reported climate change, water and forest-risk data. This global initiative aims at encouraging large organizations and their suppliers to transparently disclose their carbon emissions and climate change strategies. By gathering such information, the CDP strives to integrate strong environmental awareness in all companies across various sectors in order to improve the management of environmental risks such as climate change, deforestation risks and sustainable water use.

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18 November 2015

Hikma announces successful resolution to FDA Warning Letter at its Portugal facility

London, 18 November 2015 – 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 announces that it has received a letter from the US Food and Drug Administration (“US FDA”) closing out the Warning Letter it received in October 2014 in respect of its injectables manufacturing plant in Portugal. This letter demonstrates that the corrective actions that were taken in response to the Warning Letter were fully reviewed and accepted by the US FDA.

London, 18 November 2015 – 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 announces that it has received a letter from the US Food and Drug Administration (“US FDA”) closing out the Warning Letter it received in October 2014 in respect of its injectables manufacturing plant in Portugal.  This letter demonstrates that the corrective actions that were taken in response to the Warning Letter were fully reviewed and accepted by the US FDA.

Said Darwazah, Chairman and Chief Executive Officer of Hikma commented: “I am very pleased that we have brought our Portuguese facility back into compliance with the US FDA.  We have worked very hard to meet the FDA’s requirements and remain committed to maintaining the highest standards of quality and compliance across all our facilities.  We believe that the resolution of the Warning Letter will enable us to accelerate the introduction of new products to the market, ensuring we continue to broaden the range of critical medicines we supply to patients in the US.”

 --  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 $299 million. 

Press Release
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Corporate

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