Hikma Pharmaceuticals Regulatory News (HIK)

London and Salt Lake City, UT, July 23, 2019 - Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's / BB+ S&P, both stable), the multinational generic pharmaceutical company and Civica Rx (Civica, Inc.) today announce a five-year agreement to manufacture and supply Civica's growing membership of US health systems with medications that are often in short supply in US hospitals.

Under the agreement, Hikma will produce 14 essential sterile injectable medications for Civica as a private label distributor, using Hikma's Abbreviated New Drug Applications (ANDAs) and Civica's labeling and National Drug Code (NDC). These medicines are used daily by hospitals in emergency care, surgery, pain management and in treating hypertension. The list of products included in the agreement will be publicly announced in the near future, and initial shipments are expected to begin before the end of 2019.

Civica was founded in 2018 by leading US hospital systems concerned about generic drug shortages and philanthropic organisations passionate about improving healthcare. To date more than 30 health systems are Civica members, representing more than 900 US hospitals and approximately 30 percent of all licensed US hospital beds.

Hikma is the third largest US supplier of generic injectable medicines with a growing portfolio of more than 100 injectable products. Today, one in every six generic injectable medicines used in US hospitals is a Hikma product. During the last three years, Hikma has launched more than 20 medications into US shortage situations and in 2016 the company received a Drug Shortage Assistance Award from the US Food and Drug Administration (FDA) for its role in preventing or alleviating drug shortages.

"Hikma is thrilled to be partnering with Civica to reduce drug shortages, and we share their commitment to providing hospitals and doctors with a steady and reliable supply of high-quality injectable medicines needed for successful patient care," said Daniel Motto, Hikma's EVP of Commercial & Business Development, US Injectables. "This agreement recognises both our ability to deliver a large and consistent supply of quality medicines, and the significant investments we have made to expand our injectable manufacturing capacity and capabilities."

"We applaud Hikma's clear commitment to reducing drug shortages," said Martin VanTrieste, President and CEO of Civica Rx. "Our partnership will help us make an impact as quickly as possible. We specifically chose Hikma because of their strong manufacturing capabilities and believe their excellent quality and supply record will be key to our success in ensuring vital medications are consistently available for hospitals and patients who need them."

 "We are privileged to be working with Civica and we appreciate their five-year commitment to guaranteed demand and fair and sustainable pricing, which supports more effective production planning and long-term investments in manufacturing," said Riad Mishlawi, President, Hikma Injectables. "We believe Hikma's size and scale, broad portfolio of medicines and robust pipeline across growing therapeutic areas will enable us to build on this partnership in the future. We are committed to working with Civica and all of our customers as a reliable partner, capable of serving the growing needs of US hospitals and clinics for a wide-range of essential medicines."

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About Civica Rx

Civica was established in 2018 to reduce chronic generic drug shortages in the US and exists in the public interest as a non-profit, non-stock corporation committed to stabilising the supply of essential generic medications in a hospital setting. Civica's membership includes a Governing Board and Founding and Partnering Members.

Civica will act in the best interest of patients to eliminate uncertainty in the generic drug supply chain through long-term contracts with health system members as well as its manufacturing partners. Civica is committed to transparency and will offer fair and sustainable prices to its member hospitals. It will also ensure it has dedicated manufacturing capacity for the medications that are most desperately needed in hospitals across the country through redundant manufacturing and strategic stockpiling of medications to prevent drug shortages in the future.

Civica aims to stabilise the supply of antibiotics, anesthetics, cardiac medications, pain management medications, and other essential sterile injectable medicines used in hospitals daily. It is actively pursuing a three-pronged product supply strategy:

·; Working with multiple generic drug manufacturers that have the US FDA approved manufacturing facilities and capacity to produce Civica labeled generic drugs, allowing manufacturers to re-enter the market or increase existing capacity

·; Developing and acquiring Abbreviated New Drug Applications (ANDAs) for generic drugs and working with contract manufacturing organizations to produce Civica medications

·; Acquiring and building Civica manufacturing facilities using Civica's ANDAs

More information about Civica can be found at www.civicarx.org and https://civicarx.org/media/.

About Hikma

Hikma helps put better health within reach every day for millions of people in more than 50 countries 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. 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 8,400 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