Grunenthal Agrees US$ 922 m Deal With AstraZeneca for Nexium and Vimovo

PR76029

AACHEN, Germany, October 30, 2018 /PRNewswire=KYODO JBN/ --

- Biggest single investment in Gruenenthal's history that will significantly

strengthen the company's leading position in pain management

- Gastroprotective therapies to address a high unmet medical need[1] in pain

patients on non-steroidal anti-inflammatory drugs (NSAIDs)

    Gruenenthal today announced that it has agreed to acquire AstraZeneca's

European rights to Nexium and the global (ex US and Japan) rights to Vimovo for

a total consideration of up to US$ 922 m (EUR 811 m). Nexium (esomeprazole) is

a proton pump inhibitor (PPI) that helps to reduce the amount of acid produced

by the stomach in patients with gastroesophageal reflux conditions and ulcers.

It has a number of indications, including the prevention and treatment of

gastric ulcers induced by pain-relieving non-steroidal anti-inflammatory drugs

(NSAIDs). Vimovo is a fixed-dose combination tablet of naproxen, a

pain-relieving non-steroidal anti-inflammatory drug (NSAID) and esomeprazole,

the same gastroprotective active ingredient as in Nexium. It is indicated for

the symptomatic treatment of osteoarthritis, rheumatoid arthritis and

ankylosing spondylitis in patients at risk of developing NSAID-associated

gastric and/or duodenal ulcers.

    "This acquisition is the biggest single investment in Gruenenthal's history

and an important step in pursuing our vision of creating a world free of pain

for patients," explained Gruenenthal CEO Gabriel Baertschi. "There is a high

unmet medical need[1] for patients on long-term high-dose NSAIDs. Despite all

guidelines recommending gastrointestinal protection for these patients,

evidence suggests that many remain unprotected and 1 out of 4 may develop

stomach ulcer with its serious health complications [2]. Therefore, combining

Gruenenthal's extensive pain expertise with the well-established products

Nexium and Vimovo is a perfect strategic fit." Gruenenthal is a worldwide

leader in innovative pain management and related therapies.

    Under the terms of the agreement, Gruenenthal will acquire the exclusive

rights to market Nexium for the approved indications in 33 European countries.

Nexium continues to generate significant revenues despite having lost

exclusivity. Total prescription Nexium 2017 sales for in-scope markets were US$

248 m (EUR 220 m). Gruenenthal will obtain Vimovo global commercialization

rights with the exception of the US and Japan. Vimovo is available in over 30

countries and is patent protected in most European markets until 2025. Vimovo

achieved revenues of US$ 79 m (EUR 70 m) in in-scope markets in 2017.

    With this acquisition Gruenenthal is expected to double its EBITDA

performance. Moreover, Gruenenthal will significantly enhance its business

across multiple pain related therapeutic categories and geographies. The

transaction is subject to approval from the relevant antitrust authorities,

with closing expected in December 2018.

    The financing for Gruenenthal has been secured by the underwriting banks

BBVA, BNP Paribas, Commerzbank and ING.

    About Nexium

    Nexium (esomeprazole) is used to treat gastroesophageal reflux disease,

ulcers, and Zollinger-Ellison syndrome. It is also used for the prevention and

treatment of gastric ulcers induced by pain-relieving non-steroidal

anti-inflammatory drugs (NSAIDs). It is a member of the drug class of proton

pump inhibitors (PPIs), which reduce the production of stomach acid. It works

by binding to and inhibiting the acid pumps of a particular type of cells

lining the stomach wall to reduce the production of stomach acid. In doing so,

it lowers the level of acidity in the stomach and helps to heal erosions in the

esophagus or ulcers in the stomach and duodenum. Nexium is available in several

formulations: Nexium gastro-resistant granules for oral suspension, Nexium

gastro-resistant Multi-Unit Pellet System (Nexium MUPS(TM)) tablets, and Nexium

injection/infusion with varying approved indications. Please consult your local

label for specific approved uses in adults and children.

    About Vimovo

    Vimovo (naproxen/esomeprazole) modified-release tablet is a fixed-dose

combination of naproxen, a pain-relieving non-steroidal anti-inflammatory drug

(NSAID) and esomeprazole, the same gastroprotective active ingredient as in

Nexium. It is indicated for the symptomatic treatment of osteoarthritis,

rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of

developing NSAID-associated gastric ulcers and/or duodenal ulcers and where

treatment with lower doses of naproxen or of other NSAIDs is not considered

sufficient. The fixed dose combination reduces the incidence of gastric ulcers

by up to 70% compared to Naproxen alone [3] and therefore provides patients the

benefit of both effective pain relief and adequate gastroprotection. Please

consult your local label for specific approved uses.

    About Gruenenthal

    Gruenenthal is an entrepreneurial, science-based pharmaceutical company

specialized in pain, gout and inflammation. Our ambition is to deliver four to

five new products to patients in diseases with high unmet medical need by 2022

and become a EUR 2 bn company. We are a fully integrated research & development

company with a long track record of bringing innovative pain treatments and

state-of-the-art technologies to patients. By sustainably investing in our R&D

above the industrial average, we are strongly committed to innovation.

    Gruenenthal is an independent, family-owned company headquartered in

Aachen, Germany. We are present in approx. 30 countries with affiliates in

Europe, Latin America and the US. Our products are sold in more than 100

countries and approx. 5,200 employees are working for Gruenenthal worldwide. In

2017, Gruenenthal achieved revenues of approx. EUR 1.3 bn.

    More information: http://www.grunenthal.com

    Follow us on:

    LinkedIn: Grunenthal Group

[http://www.linkedin.com/company/grunenthal_164071]

    Twitter: @grunenthalgroup [https://twitter.com/grunenthalgroup]

    Instagram: gruenenthal [https://www.instagram.com/gruenenthal]

    1. Scheiman, J.M., Unmet needs in non-steroidal anti-inflammatory

drug-induced upper gastrointestinal diseases. Drugs, 2006. 66 Suppl 1: p.

15-21; discussion 29-33.

    2. Lanza, F.L., F.K. Chan, and E.M. Quigley, Guidelines for prevention of

NSAID-related ulcer complications. Am J Gastroenterol, 2009. 104(3): p. 728-38.

    3. Angiolillo, D.J., et al., Impact of concomitant low-dose aspirin on the

safety and tolerability of naproxen and esomeprazole magnesium delayed-release

tablets in patients requiring chronic nonsteroidal anti-inflammatory drug

therapy: an analysis from 5 Phase III studies. J Thromb Thrombolysis, 2014.

38(1): p. 11-23.

    For further information, please contact:

    Stepan Kracala,

    Head Global Communications

    Tel.: +49-241-569-1335,

    Stepan.Kracala@grunenthal.com

    Gruenenthal GmbH, 52099 Aachen, Germany

    Kerstin Nacken,

    Head Editorial Management and Media Relations

    Tel.: +49-241-569-2710,

    Kerstin.Nacken@grunenthal.com

    Gruenenthal GmbH, 52099 Aachen, Germany

    Source: Grunenthal Group