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28 June 2016

Hikma Pharmaceuticals to participate in The World Economic Forum’s Industry Strategy Meeting

Amman, [28] June 2016 - Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces its participation in the World Economic Forum, Industry Strategy Meeting being held Tianjin, China from 26 to 28 June 2016.

Amman, [28] June 2016 - Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces its participation in the World Economic Forum, Industry Strategy Meeting being held Tianjin, China from 26 to 28 June 2016. 

In 2016, Hikma became one of the World Economic Forum’s Health Industry Partners, with the objective of exploring new and improved ways of developing the standard of healthcare offered to patients globally. The upcoming strategy meeting in Tianjin is one of  the many initiatives established by the World Economic Forum to enable policy makers to focus on the industry challenges and to collaborate to enhance the quality of and access to healthcare.

Mazen Darwazeh, Hikma Executive Vice Chairman, President and CEO of MENA and Emerging Markets said:

“We are pleased to build on our partnership with the World Economic Forum reinforcing our shared vision of improving people’s lives around the globe. Through the forum’s platform, we are given the opportunity to converse with worldwide health leaders to develop new solutions that contribute to enhancing global healthcare. We share our rich experience as a multinational pharmaceutical company in understanding patients' needs in different regions."

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24 June 2016

Hikma acquires six injectable products in Europe

London, 24 June 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 it has agreed to acquire a portfolio of six injectable products and their related customer contracts from Pfizer Inc. (NYSE: PFE).

London, 24 June 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 it has agreed to acquire a portfolio of six injectable products and their related customer contracts from Pfizer Inc. (NYSE: PFE).

The acquired portfolio includes one anti-infective, one anti-fungal and four oncology products. Five of the products are currently sold across several markets in Europe. The divestiture of these products was mandated by the European Commission as a condition to Pfizer’s acquisition of Hospira and the European Commission has announced its approval of Hikma as purchaser of the portfolio.

Said Darwazah, Chairman and Chief Executive Officer of Hikma, said: “This acquisition supports our strategy to strengthen our marketed product portfolio of specialised generic injectables and create new opportunities for growth across our markets.”

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Lucinda Baker, Deputy Director of Investor Relations +44 (0)20 7399 2765/
+44 7818 060211
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 revenue of $1,440 million and profit attributable to shareholders of $252 million.

About Pfizer
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

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13 June 2016

Hikma receives FDA approval for Letrozole Tablets

London, 13 June 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, has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Letrozole Tablets 2.5mg.

London, 13 June 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, has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Letrozole Tablets 2.5mg.

Letrozole is a chemotherapy drug indicated for the treatment of breast cancer. According to IMS Health, total U.S. sales of Letrozole Tablets 2.5 mg were approximately $21 million for the 12 months ending April 2016.

Said Darwazah, Chairman and CEO of Hikma said, “We are very pleased to have our first FDA approval from Hikma’s dedicated oncology plant in Sahab, Jordan. We continue to leverage our strong global R&D teams and high-quality operational capabilities, to enhance our growing portfolio of more differentiated products."

-- ENDS --

Enquiries

Hikma Pharmaceuticals PLC  
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/
+44 7776 477050
Lucinda Baker, Deputy Director of Investor Relations +44 (0)20 7399 2765/
+44 7818 060211
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 revenue of $1,440 million and profit attributable to shareholders of $252 million. 

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03 June 2016

Hikma receives FDA approval for Ketamine Hydrochloride Injection

London, 03 June 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 Ketamine Hydrochloride Injection USP, 500 mg (base)/10 mL (50 mg (base)/mL) and 500 mg (base)/5 mL (100 mg (base)/mL) multi-dose vials have been approved by the U.S. Food and Drug Administration (FDA).

London, 03 June 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 Ketamine Hydrochloride Injection USP, 500 mg (base)/10 mL (50 mg (base)/mL) and 500 mg (base)/5 mL (100 mg (base)/mL) multi-dose vials have been approved by the U.S. Food and Drug Administration (FDA).

Ketamine Hydrochloride is indicated as an anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. According to IMS Health, total U.S. sales of Ketamine Injection were approximately $11 million for the 12 months ending April 2016, of which the Hikma approved presentations represented around $5 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 facilities 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
Lucinda Baker, Deputy Director of Investor Relations +44 (0)20 7399 2765/
+44 7818 060211
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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31 May 2016

Hikma announces FDA approval and launch of Fluticasone 50 MCG Spray, the store brand equivalent of Flonase®

London, 31 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 the approval of Fluticasone 50 MCG Spray, the store brand equivalent of Flonase®, by the U.S. Food and Drug Administration (FDA).

London, 31 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 the approval of Fluticasone 50 MCG Spray, the store brand equivalent of Flonase®, by the U.S. Food and Drug Administration (FDA).

Flonase® (fluticasone propionate nasal spray USP, 50 mcg per spray) is indicated for the temporary relief of hay fever or other upper respiratory allergies in adult and paediatric patients 4 years of age and older. Combined generic and branded sales for the twelve months ending May 2016 were $343 million.

Hikma, through its wholly-owned subsidiary West-Ward Pharmaceuticals, has partnered with Perrigo Company plc, a leading supplier of over-the-counter (OTC) products, for the launch of this product in the OTC market.  Perrigo expects to begin customer shipments immediately. 

Michael Raya, Chief Executive of West-Ward Pharmaceuticals, said:
“We are very pleased to be working with Perrigo to improve access to this important product for consumers interested in purchasing fluticasone propionate nasal spray over-the-counter.”

-- ENDS --

Enquiries

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

West-Ward Pharmaceuticals

 
Keri Butler, Public Affairs & Communications            +1 614 272 4774
FTI Consulting  
Ben Atwell/ Matthew Cole / Julia Phillips                 +44 (0)20 3727 1000

About Hikma Pharmaceuticals
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.

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.

About Perrigo
Perrigo Company plc, a top five global over-the-counter ("OTC") consumer goods and pharmaceutical company, offers patients and customers high quality products at affordable prices. From its beginnings in 1887 as a packager of generic home remedies, Perrigo, headquartered in Ireland, has grown to become the world's largest manufacturer of OTC products and supplier of infant formulas for the store brand market. The Company is also a leading provider of generic extended topical prescription products and receives royalties from Multiple Sclerosis drug Tysabri®. Perrigo provides Quality Affordable Healthcare Products® across a wide variety of product categories and geographies primarily in North America, Europe, and Australia, as well as other markets, including Israel, China and Latin America. Visit Perrigo online at (http://www.perrigo.com).

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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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