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24 May 2016

Michael Raya, CEO of West-Ward Pharmaceuticals, Hikma’s wholly-owned subsidiary in the US, joins GPhA Board

London, 24 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, today announces that Michael Raya, Chief Executive Officer of West-Ward Pharmaceuticals, Hikma’s wholly-owned subsidiary in the US, will join the Board of Directors of the Generic Pharmaceutical Association (GPhA).

London, 24 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, today announces that Michael Raya, Chief Executive Officer of West-Ward Pharmaceuticals, Hikma’s wholly-owned subsidiary in the US, will join the Board of Directors of the Generic Pharmaceutical Association (GPhA).

Michael Raya said:
“The GPhA’s Board and professional staff are terrific stewards of the industry. I am honored to add my voice to GPhA’s leadership on critical issues of medicine access and affordability.”

Chip Davis, President and CEO, GPhA, said:
“Michael Raya is a proven industry leader whose addition to our Board will accelerate our work with Congress, the FDA, stakeholders and others to ensure that generic drugs and biosimilars continue providing millions of Americans with safe, effective and more affordable alternatives to costly brand products.”

--ENDS--

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. Hikma currently employs over 7,000 staff members worldwide.

For further information and latest news updates, visit www.Hikma.com or contact:
Hana Darwazeh Ramadan
Email: Media@Hikma.com
Tel: +962 6 580 2900

About West-Ward Pharmaceuticals
West-Ward Pharmaceuticals, a wholly-owned subsidiary of Hikma Pharmaceuticals PLC, is a top ten generic pharmaceutical company in the US focused on providing a broad range of differentiated generic pharmaceutical products across a range of dosage forms. West-Ward has sites in New Jersey, Ohio and Tennessee.

For further information on US-centric news, visit www.West-Ward.com or contact:
Keri Butler
Email: kbutler@west-ward.com
Tel: 614.272.4774

About GPhA
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

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19 May 2016

Hikma wins Mitigare / Colchicine patent infringement case

London, 19 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, today announces that the United States District Court for the District of Delaware has ruled in favour of Hikma and its wholly-owned subsidiary in the United States, West-Ward Pharmaceutical Corp., by granting their motion to dismiss claims made by Takeda Pharmaceuticals USA, Inc. for alleged infringement of patents covering methods of use of Takeda's colchicine product, Colcrys®.

London, 19 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, today announces that the United States District Court for the District of Delaware has ruled in favour of Hikma and its wholly-owned subsidiary in the United States, West-Ward Pharmaceutical Corp., by granting their motion to dismiss claims made by Takeda Pharmaceuticals USA, Inc. for alleged infringement of patents covering methods of use of Takeda's colchicine product, Colcrys®.

Since January 2015, Hikma has been marketing its own colchicine product under the brand name Mitigare™, as well as selling an authorised generic, increasing patient access to this important product in the United States.

Said Darwazah, Chairman and CEO of Hikma, said:
"I am very pleased with the ruling of the Delaware Court. This is a successful outcome and demonstrates our commitment to bringing more differentiated products to the US market."

-- 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.

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12 May 2016

AGM Trading Update

London, 12 May 2016 – Hikma Pharmaceuticals PLC (“Hikma” or “the Group”)(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, will hold its Annual General Meeting today where the following statement will be made regarding its current trading.

London, 12 May 2016 – Hikma Pharmaceuticals PLC (“Hikma” or “the Group”)(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, will hold its Annual General Meeting today where the following statement will be made regarding its current trading.

Hikma has made a good start to the year and we are pleased to reiterate our guidance for 2016 for the Group overall and for each of our business segments.

Group
We continue to expect full year Group revenue to be in the range of $2.0 billion to $2.1 billion, including the contribution of ten months of revenue from Roxane, with continuing momentum into 2017.

Injectables
Our Injectables business is performing well. We are making good progress transferring the products acquired from Bedford Laboratories to our manufacturing facilities in New Jersey, Germany and Portugal and we have received three approvals for former Bedford products so far this year, making a total of six Bedford products approved since the acquisition.

We remain on track to deliver global Injectables revenue growth in the mid to high-single digits in 2016, with competition on marketed products being more than offset by new product launches from our R&D, business development and Bedford pipelines. We continue to expect core operating margin to return to a more normalised level of around 36%, due primarily to a change in product mix and higher R&D expenses.

Branded
Our Branded business is also continuing to perform well. Growth in the year to date is being driven by higher sales in Algeria, Egypt, Iraq and Jordan. We continue to expect full year 2016 Branded revenue to be in line with historical trends, on a constant currency basis, driven by our focus on strategic products and the strength of our sales and marketing teams.  Improvement in the Branded core operating margin is expected to be driven by revenue growth and operational leverage.

Since reporting our preliminary results in March, negative movements in exchange rates have persisted, particularly in the Algerian Dinar, Egyptian Pound and Sudanese Pound. Assuming these rates prevail, we would expect a further impact on Branded revenue and operating profit. As in previous years, we expect Branded revenue to be stronger in the second half, reflecting the usual seasonality of this business.

Generics
The integration of the Roxane is proceeding swiftly and we are very happy with the progress our teams have made. In April, we received notification from the U.S. Food and Drug Administration (FDA) that our abbreviated new drug application (ANDA) for fluticasone propionate and salmeterol inhalation powder (the generic version of GlaxoSmithKline's Advair Diskus®) has been accepted for filing. The FDA has provided a GDUFA goal date of May 10, 2017. We are very pleased to have achieved this important milestone in the development of generic Advair Diskus®.  Our team has worked closely with the FDA to ensure the quality of the ANDA submission and we are confident that we have developed a robust, patient friendly, (AB-rated) substitutable generic product for Advair Diskus®.

As anticipated, revenue in our legacy Generics business has declined compared to the same period in 2015, due to the divestiture of certain legacy products associated with the acquisition of Roxane and to the expected decline of certain market opportunities.

We continue to expect 2016 revenue for the combined Generics to be in the range of $640 million to $670 million, including ten months of contribution from Roxane and taking into account the divestiture of certain legacy products.  We also continue to expect the core Generics operating margin to be in the low double-digits.

On a Group level, as previously guided, our statutory results in 2016 will be impacted by a number of exceptional, non-cash and other charges including the amortisation of intangible assets, an inventory step up, the revaluation of the fair value of future royalty payments and one-off acquisition and integration costs. In aggregate, these charges are currently estimated to impact net income by around $115 million.

Said Darwazah, Chairman and Chief Executive Officer of Hikma said:

“Hikma has made a good start to the year. We have performed well in each of our businesses and we are pleased to be reiterating our 2016 guidance for the Group overall and for each of our business segments.

Our focus this year is on integrating Roxane and delivering high value, differentiated product launches. Moving forward, we expect the benefits from the investments that we have made in recent years – in R&D, M&A, co-development partnerships and licensing agreements – to accelerate. We have an exciting pipeline across our business segments that will drive accelerated and sustainable future growth.”

We will announce our interim results for the six months to 30 June 2015 on 24 August 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 2015, Hikma achieved revenues of $1,440 million and profit attributable to shareholders of $252 million.

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09 May 2016

Hikma receives Drug Shortage Assistance Award from US FDA

London, 09 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, is pleased to announce that its wholly owned subsidiary, Eurohealth International Sarl, has been selected to receive a Drug Shortage Assistance Award from the US Food and Drug Administration (FDA) for its role in preventing or alleviating drug shortages.

London, 09 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, is pleased to announce that its wholly owned subsidiary, Eurohealth International Sarl, has been selected to receive a Drug Shortage Assistance Award from the US Food and Drug Administration (FDA) for its role in preventing or alleviating drug shortages.

This award recognises Hikma’s efforts to alleviate the shortages of Thiotepa for Injection and Phentolamine Mesylate for Injection. Hikma acquired both of these products from Bedford Laboratories in 2014. At the time of the acquisition, both products were on shortage. Since then, Hikma was able to tech transfer these products to its FDA compliant manufacturing facilities and expedite the submission of post-approval supplements to the FDA. Both products were relaunched by Hikma in 2015. Hikma markets these products through West-Ward Pharmaceuticals, its wholly owned subsidiary in the US.

The FDA established this award programme to recognise companies for making a substantial contribution to preventing or alleviating critical drug shortages, as well as recognising companies’ commitments to public health and quality manufacturing.

Said Darwazah, Chairman and CEO of Hikma, said, “We are delighted to have received this award. We have been working closely with the FDA to alleviate drug shortages, ensuring critical care products are reaching patients in need. Our continued investment in quality across our manufacturing plants has positioned us as reliable partner for the FDA, and are very pleased our efforts have been recognised.”

-- 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.

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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.

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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.

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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.

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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.

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