Norgine B.V. and Korea Pharma Co., Ltd. enter into exclusive licence agreement for the commercialisation of PLENVU^® in the republic of Korea

CORPORATE MEDIA RELEASE

NORGINE B.V. AND KOREA PHARMA CO., LTD. ENTER INTO EXCLUSIVE LICENCE AGREEMENT FOR THE COMMERCIALISATION OF PLENVU^® IN THE REPUBLIC OF KOREA

• Norgine to receive a significant upfront payment and undisclosed sums in sales milestones along with double-digit percentage royalties
• Norgine retains full commercial rights to PLENVU^® in all unlicensed countries

Amsterdam, Netherlands and Seoul, Korea – 3 January 2019. 8.00 CET. NORGINE B.V. (Norgine), a leading European specialist pharmaceutical company and KOREA PHARMA CO., LTD. (Korea Pharma), a premier pharmaceutical manufacturer in Korea, today announced an exclusive licence and distribution agreement in the Republic of Korea by which Korea Pharma will commercialise Norgine’s product PLENVU^®.

PLENVU^® is a lower-volume (1L) polyethylene glycol (PEG) based bowel preparation for colonoscopy in adults. It is the first lower-volume bowel preparation to show superior segmental cleansing of the colon vs. standard of care.^[1]

Jae-Don Park, CEO and Chairman of Korea Pharma said, “Building on our strong presence and knowledge in the South Korea market, we look forward to making PLENVU^® available to healthcare professionals to help them to improve colonoscopy outcomes as well as patient experience and adherence to bowel cleansing instructions.”

“We are excited about our collaboration with Korea Pharma, a trusted player” said Peter Stein, Chairman and Chief Executive Officer of Norgine. “South Korea is an important market and this partnership reflects the breadth and scope of Norgine’s capabilities to build a strong network and reach out to more patients worldwide.”

PLENVU^® is currently available in mainland Europe (except France and Sweden) and Australia via Norgine and in the USA via its partner Salix Pharmaceuticals.^[2] For further information on PLENVU^® in the EU visit www.expertiseincolonoscopy.com/plenvu

ENDS

Job Code – GL/PLV/0119/0107

Media Contacts for Norgine:

Eleni Fistikaki +44 (0)1895826227 or +44 (0)7825389477

Clara Bentham +44 (0)1895 826654 or +44 (0)7734 367883

contact@norgine.it

www.norgine.it

Follow us @norgine

Media Contacts for Korea Pharma:

Youngchan Choi +82 2 2162 8418

youngchan.choi@koreapharma.co.kr

Notes to Editors:

About PLENVU^®

PLENVU^®, Powder for Oral Solution (PEG 3350, Sodium Ascorbate, Sodium Sulfate, Ascorbic Acid, Sodium Chloride, and Potassium Chloride), is indicated in adults for bowel cleansing prior to any procedure requiring a clean bowel.

About Colorectal Cancer and colonoscopy

Colorectal cancer is the second most common cause of cancer-related mortality world-wide.^[3] Colorectal cancer is largely preventable, with early detection being associated with a 90% cure rate.^[4] Colonoscopy is an effective method for colorectal cancer screening and has been shown to reduce both the incidence and mortality of colorectal cancer when applied in the general population. Inadequate pre-colonoscopy bowel cleansing reduces the diagnostic accuracy of colonoscopy, particularly for the detection of smaller lesions and sessile (slightly flattened) polyps. This may result in repeated procedures, thereby potentially increasing patient burden, resource requirement and costs and can possibly  delay the initiation of treatment.^[5],[6],[7]

About Norgine

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. Norgine specialises in gastroenterology, hepatology, cancer and supportive care.  In 2017, Norgine’s total net product sales were EUR 345 million, up 17 per cent.

Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.

In 2012, Norgine established a complementary business, Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com

NORGINE and the sail logo are trademarks of the Norgine group of companies.

About Korea Pharma

Since it was established in 1974, Korea Pharma has established a high-tech current good manufacturing practice (cGMP) facility for world-class GMP. Korea Pharma specialises in gastroenterology (including bowel preparation), antibiotics and diseases of the central nervous system (CNS). With this agreement signed today with Norgine, Korea Pharma has the opportunity to make a quantum leap in gastroenterology. Korea Pharma entered into a technology agreement for the treatment of dementia with Kyungsang national university in 2014.

References

[1] Repici A., Amlani B., Uebel P., Schreiber S. Superior high-quality colon cleansing with 1L NER1006 versus sodium picosulfate + magnesium citrate, 2L polyethylene glycol + ascorbate, or oral sulfate solution: Post hoc pooled analysis of three randomised phase 3 clinical trials. #P0159. Monday 22 October. 12:30 – 13:30 CET. UEGW 2018

[2] In Austria, Spain and the Netherlands it is known as PLEINVUE^® rather than PLENVU^® March 2018. Available at: https://www.medicines.org.uk/emc/medicine/31722. Accessed June 2018.

[3] World Health Organisation. https://www.who.int/news-room/fact-sheets/detail/cancer Last accessed December 2018

[4] American Cancer Society.  https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/detection.html Last accessed December 2018

[5] Bechtold ML, Mir F, Puli SR et al. Optimizing bowel preparation for colonoscopy: a guide to enhance quality of visualization. Ann Gastroenterol 2016; 29: 137 – 146

[6] Brenner H, Stock C, Hoffmeister M. Effect of screening sigmoidoscopy and screening colonoscopy on colorectal cancer incidence and mortality: systematic review and meta-analysis of randomised controlled trials and observational studies. BMJ 2014; 348: g2467

[7] Baxter NN, Warren JL, Barrett MJ et al. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol 2012; 30: 2664 – 2669