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Helsinn announces EUR6 million investment in Helsinn Birex Pharmaceuticals to safeguard the quality and authenticity of its products

Lugano, Switzerland, May 24, 2018 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announced a €6million investment at its drug product supply centre, Helsinn Birex Pharmaceuticals Ltd (HBP) in Dublin Ireland, as part of its ongoing commitment to ensuring high quality products, safeguarding its supply chain and in compliance with regulatory requirements worldwide.

Unauthorized distribution of adulterated or counterfeit products is high on the global regulatory agenda, and protecting the quality of its products during distribution is a key priority for Helsinn and its partners. The investment is designed to safeguard Helsinn’s supply of quality products that comply with the stringent quality standards for our markets, and that are safe for patient use.

The investments provide HBP with the capability to apply unique serial numbers and tamper evidence features, which meet requirements of the US Drug Quality and Security Act (DQSA), the EU Falsified Medicines Directive (FMD), and other relevant local requirements in markets where Helsinn cancer care products are sold.

The enhancements to products across all markets in which Helsinn is active demonstrates Helsinn’s clear commitment to comply with regulatory requirements while providing partners and the patients who use the products with the assurance that the products supplied are authentic and fit for purpose.

Giorgio Calderari, Helsinn Group General Manager & Chief Operating Officer, commented: “The presence of counterfeit medicines in the global pharmaceutical supply chain denotes a clear and present threat to patient safety, fraud against healthcare payers and a global reputational risk to the industry. This major investment by Helsinn reinforces our commitment to patients worldwide, who deserve assurance that they are receiving authentic Helsinn products, developed, manufactured and supplied by our team of professional staff”

Padraig Somers, Helsinn Birex Local General Manager, commented: “Detecting and eliminating counterfeit medicines from the pharmaceutical supply chain is a major challenge for our industry. This initiative ensures that Helsinn Birex’s reputation for world-class quality products is enhanced going forward for the benefits of our patients as well as Helsinn.”

About the Helsinn Group

Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco, and China, as well as a product presence in approximately 190 countries globally.

To learn more about Helsinn Group please visit www.helsinn.com.

For more information:

Helsinn Group Media Contact

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel: +41 (0) 91 985 21 21

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