Norgine B.V. Enters Into Exclusive Licence and Distribution Agreements for the Commercialisation of PLENVU® in a Number of Countries in Latin America, Southern Africa, Central and Eastern Europe

News provided by

12 Feb, 2020, 09:00 GMT

- Norgine to receive upfront payments, undisclosed milestone payments along with double-digit percentage royalties

- Norgine retains full commercial rights to PLENVU^® in all unlicensed countries

AMSTERDAM, Feb. 12, 2020 /PRNewswire/ -- Norgine B.V. (Norgine), a leading European specialist pharmaceutical company, today announced a number of deals for the commercialisation of Norgine's product PLENVU^® around the world. Norgine entered into exclusive licence and distribution agreements with:

Faes Farma S.A. in Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama and Peru.
Pharmacare Limited T/A Aspen Pharmacare in the Republic of South Africa, Lesotho, Eswatini, Botswana and Namibia.
Swixx Biopharma in Central and Eastern Europe including Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Hungary, Kosovo, Montenegro, North Macedonia, Poland, Romania, Serbia, Slovakia, and Slovenia.

Peter Stein, Chairman and Chief Executive Officer of Norgine said, "Colonoscopy plays a critical role in the prevention of gastrointestinal diseases including colorectal cancer. Through these partnerships with Faes Farma, Aspen Pharmacare and Swixx Biopharma PLENVU^®will be able to help more patients around the globe."

Gonzalo Lopez, General Manager of Faes Farma commented, "We are pleased to include PLENVU^® in our portfolio and are convinced that it will contribute to the development and improvement of colonoscopy in Latin America, a region where our company invests significantly to bring added value treatments to patients. We hope this collaboration with Norgine will be a first step and new cooperation opportunities may materialize in the future."

Lorraine Hill, Aspen Pharmacare Group Chief Operating Officer said, "The agreement completed between Pharmacare Limited, a wholly owned subsidiary of Aspen Holdings and the Group's primary South African trading company, and Norgine is a positive extension of our relationship locally. The inclusion of the PLENVU^®brand will supplement our existing portfolio in this therapeutic area."

Swixx CEO, Jean-Michel Lespinasse noted, "Adding PLENVU^® to our gastrointestinal (GI) portfolio, represents a great opportunity for Swixx, building on our existing excellent collaboration with Norgine. PLENVU^® has the potential to help improve colonoscopy outcomes, patient experience and adherence."

Following the announcement of Norgine's exclusive licence agreement with Korea Pharma in January 2019, PLENVU^® has now launched in South Korea.

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]

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

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 that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people's lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 22 million patients around the world in 2019 and generated €419 million in net product sales, a growth of 6% over 2018.

Norgine has a direct presence in 14 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.

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

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

About Faes Farma

Founded in 1933, Faes Farma is a Spanish pharmaceutical company with wide international experience that researches, produces and markets pharmaceutical products and raw materials, exporting them to many countries.

The identity of the company is defined by an unwavering search of excellence, the constant pursuit of a maximum pharmacological quality of all its products and the consequent effort to always offer highly effective solutions for patients in selected therapeutic areas among which gastro enterology is one of the most important for the company, as well as allergy treatments.

Faes Farma operates in many countries, employing more than 1.200 people. Its headquarters, manufacturing and R&D centre are located in Leioa, (Bizkaia). Faes Farma also has facilities in Madrid and subsidiaries in Portugal, Laboratorios Vitoria, in Barcelona, Diafarm Laboratories and also in Italy, France, Chile, México, Colombia, Peru, Ecuador and Nigeria.

About Aspen

Aspen is a leading global player in specialty, branded and generic pharmaceuticals with an extensive basket of products that provide treatment for a broad spectrum of acute and chronic conditions experienced through all stages of life.

With an acknowledged presence of nearly 2 decades in the pharmaceutical sector, Aspen remains committed to its core values of providing quality and effective healthcare solutions to millions of patients in more than 150 countries, with its core focus being in the Thrombosis, Anaesthetic and High Potency & Cytotoxic therapeutic categories.

Aspen has a strong presence in both emerging and developed countries. Its emerging market footprint includes Sub-Saharan Africa, Latin America, China, South East Asia, Eastern Europe and the Commonwealth of Independent States, comprising Russia and the former Soviet Republics. It is also a leading pharmaceutical company in developed countries including Australia and most notably in Western Europe.

Aspen operates with an established business presence in approximately 50 countries spanning 6 continents and employs more than 10,000 people. The Group operates 26 manufacturing facilities across 18 sites. Aspen holds international manufacturing approvals from some of the most stringent global regulatory agencies including the FDA, TGA and EMA. Aspen's manufacturing capabilities are scalable to demand and cover a wide variety of product-types including oral solid dose, liquids, semi-solids, steriles, biologicals, APIs and infant nutritionals.

With a market capitalisation of approximately $10 billion, Aspen is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and ranks amongst the top 20 listed companies on this exchange. For more information visit: http://www.aspenpharma.com/

About Swixx BioPharma AG

Swixx now operates fully-owned subsidiaries across Central and Eastern Europe, offering coverage from Moscow to Prague and from Tallinn to Sofia. Net sales in 2019 were 143 million Euros and in 2020 should reach 225 million Euros. Established in 2014, Swixx has gathered outstanding specialty pharmaceutical, rare disease, medical device and OTC / consumer healthcare talent under one roof. The company specializes in representing research-based pharmaceutical, biotech, orphan, medical equipment and self-care brands. For more info about Swixx, please visit: www.swixxbiopharma.com

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 February 2020

[4] American Cancer Society. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/detection.html Last accessed February 2020

[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

Logo - http://mma.prnewswire.com/media/597589/Norgine_Logo.jpg