REG - Hikma Pharmaceutical - Hikma Launches 503B Sterile Compounding Business

Hikma PharmaceuticalsAnnouncement

10/01/2022 07:05

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RNS Number : 9016X  Hikma Pharmaceuticals Plc  10 January 2022

Hikma Launches New 503B Sterile Compounding Business

 

Builds on leading position in US sterile injectables market

 

Brings company's proven experience in quality and reliability to compounding

 

London, UK - 10 January 2022 - Hikma Pharmaceuticals PLC ("Hikma"), the
multinational pharmaceutical company, announces the launch of Hikma 503B - a
new outsourced sterile compounding business focused on providing high quality,
ready-to-administer injectable medications that are customized to the specific
needs of patients in the United States.

 

Sterile compounding - the process of combining, mixing, or altering
ingredients to create medications in ready-to-administer formats tailored to
the needs of health care providers - is an important specialized approach to
drug manufacturing that serves a critical role in patient care. Hospital
pharmacists, physicians and nurses increasingly need these medicines,
resulting in a growing US market for outsourced compounded sterile injectable
medications that is now estimated to exceed $2 billion annually.

 

The launch of Hikma 503B builds on the company's expertise and position as a
leading supplier of injectable medicines to US hospitals with a strong
reputation for quality and reliability. Today, Hikma is the second-largest
supplier by volume of generic injectables to US hospitals, and one out of
every six generic injectable medicines used by US hospitals is a Hikma
product. The company's extensive supplier relationships and access to raw
materials also provide a unique point of differentiation to existing players
in the outsourced sterile compounding space.

 

"Hikma 503B is a natural extension of our injectables business, building on
our strong relationships with US hospitals and excellent quality manufacturing
protocols to provide urgently needed product offerings to patients and health
care providers in the US," said Riad Mishlawi, President, Injectables, Hikma.
"There is substantial demand for outsourced sterile compounded medicines among
the thousands of hospitals we currently serve, representing a large
opportunity to meet a growing and not fully met need within the US health care
system. Hikma 503B is uniquely positioned to bring pharmaceutical
manufacturing standards to the space, which we believe will establish us as a
significant player in the market over time."

 

Hikma 503B will operate principally out of a 65,000 sq. ft., purpose-built
facility in Dayton, NJ, that was acquired by Hikma in 2020. Hikma has greatly
enhanced the Dayton site to create a state-of-the-art sterile outsourced
compounding and distribution facility in line with the company's high
standards of quality, adding automation and segregation for enhanced
productivity while minimizing risks.

 

"We are applying Hikma's expertise, talent, and engrained commitment to
quality to ensure our 503B business meets CGMP standards, which is what the
FDA requires of 503B outsourcing facilities," said Joel Rosenstack, Chief
Commercial Officer, US Injectables, Hikma. "Our 503B business is powered by
the same team and philosophy that is behind Hikma's reputation for quality
medicines."

 

Hikma 503B is registering for state licenses across the US and expects to be
operating nationwide by the end of 2022.

 

- Ends -

 

 

 

Enquiries

Hikma Pharmaceuticals PLC

 Investors:

 Susan Ringdal                                +44 (0)20 7399 2760/ +44 7776 477050

 EVP, Strategic Planning and Global Affairs   uk-investors@hikma.uk.com (mailto:uk-investors@hikma.uk.com)

 Media:

 Teneo (UK media)

 Charles Armitstead                           +44 (0)7703 330 269

 US Media

 Steve Weiss                                  +1 732 788 8279

 David Belian                                 +1 848 254 4875

 US Communications and Public Affairs         uscommunications@hikma.com (mailto:uscommunications@hikma.com)

 

About Hikma

(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and
BBB-/stable Fitch)

Hikma helps put better health within reach every day for millions of people
around the world. For more than 40 years, we've been creating high-quality
medicines and making them accessible to the people who need them.
Headquartered in the UK, we are a global company with a local presence across
the United States (US), the Middle East and North Africa (MENA) and Europe,
and we use our unique insight and expertise to transform cutting-edge science
into innovative solutions that transform people's lives. We're committed to
our customers, and the people they care for, and by thinking creatively and
acting practically, we provide them with a broad range of branded and
non-branded generic medicines. Together, our 8,600 colleagues are helping to
shape a healthier world that enriches all our communities. We are a leading
licensing partner, and through our venture capital arm, are helping bring
innovative health technologies to people around the world. For more
information, please visit: www.hikma.com
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