Publicado 17/08/2020 11:01CET

Norgine B.V. Completes Important Regulatory Milestone For Angusta® (Misoprostol) In Europe For Oral Induction Of Labour

- Norgine will now seek to extend ANGUSTA(®)'s licence to a number of European countries

- ANGUSTA(®)'s licence extension for these countries will be subject to national approvals

AMSTERDAM, Aug. 17, 2020 /PRNewswire/ -- Norgine B.V. (Norgine) today announced the successful completion of the Repeat Use Procedure (RUP) for ANGUSTA(®) in a number of European countries including Austria, Belgium, Cyprus, Germany, Greece, Spain, Ireland, Italy, Luxemburg, Malta, Netherlands, Portugal and the UK. The procedure has been concluded by the Danish Regulatory Authority, the Reference Member State for the assessment. ANGUSTA(®) was approved in a number of countries in Europe including the Nordics, France and 10 other Central and Eastern European (CEE) countries in 2017. ANGUSTA(®) is currently the only approved oral treatment for the induction of labour in France, Denmark, Norway, Iceland, Finland and Sweden.([1])

There are a number of circumstances where the considered risk to foetal or maternal health outweighs the wait for spontaneous labour and in such cases, labour may be induced. ANGUSTA(®) will offer an oral treatment choice for the induction of labour in addition to vaginally administered options.([1],)([2])

Alastair Benbow, Chief Development and Medical Officer of Norgine, commented: "Norgine is proud to be offering women and healthcare professionals an oral treatment when induction of labour is required. Norgine would like to make ANGUSTA(®) available more widely in the future."

Misoprostol, the active substance in ANGUSTA(®), is a synthetic analogue of prostaglandin E1 (PGE1), a naturally occurring compound.([1] )Physiologically, misoprostol has been shown to increase mammalian collagenase activity, causing cervical ripening and uterine contractions.([1])

Norgine incorporated ANGUSTA(®)( )into its portfolio following the recent acquisition of Azanta, which has strengthened Norgine's position as a leading European specialist pharmaceutical company.

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Notes to Editors:

About ANGUSTA(®) (misoprostol)

ANGUSTA(®) (misoprostol) is indicated for the induction of labour. It is administered after careful assessment of the uterine cervix.([1])

Misoprostol is a synthetic analogue of prostaglandin E1 (PGE1), a naturally occurring compound. Prostaglandins of the F and E series have been shown to increase mammalian collagenase activity and to cause cervical ripening and uterine contraction.([1])

ANGUSTA(®) is taken orally with a glass of water and the recommended dosing regimen is either 25 micrograms every two hours or 50 micrograms orally every four hours according to hospital practice. The maximum dose is 200 micrograms over a period of 24 hours.([1])

ANGUSTA(®) is administered by trained obstetric personnel in a hospital setting where facilities for continuous foetal and uterine monitoring are available.([1])

ANGUSTA(®) can cause excessive uterine stimulation and if this continues, dosing is stopped and treatment according to local guidelines commenced.([1])

ANGUSTA(®) is a product recently acquired by Norgine Pharmaceuticals and has been licensed in the Nordics, France and 10 other Central and Eastern European (CEE) countries since 2017.

About induction of labour

Induction of labour is defined by the World Health Organisation (WHO) as the process of artificially stimulating the uterus to start labour. There are a number of methods to achieve this and may include pharmacological treatment such as administering prostaglandins or oxytocin or by manually rupturing the amniotic membranes.([2])

There are a number of circumstances where the considered risk to foetal or maternal health outweigh the wait for spontaneous labour. These may include gestational age of 41 completed weeks or more, pre-labour rupture of amniotic membranes, hypertensive disorders, maternal medical complications and fetal death among others. Each case is considered on its own merit.([2])

Induction of labour, may cause discomfort due to the procedure itself and due to the woman's restricted mobility. To avoid any potential risks, the woman and her baby should be monitored closely.([2])

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 more than EUR419 million in net product sales, a growth of 6% over 2018.

Norgine has a direct presence in 12 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 www.norgineventures.com [http://www.norgineventures.com/].

References

(1.) ANGUSTA(® )Summary of Product Characteristics (SmPC). Available at: https://mri.cts-mrp.eu/Human/Downloads/DK_H_2584_001_FinalSP... [https://mri.cts-mrp.eu/Human/Downloads/DK_H_2584_001_FinalSP...]. Accessed August 2020.(2.) WHO Recommendations for Induction of Labour 2011, WHO Press, World Health.

GL--WH-PR-2000002, Date of preparation August 2020

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CONTACT: For further information please contact: Clara Bentham: +44(0)1895 826654, 17 Ago. (0) - 7734 367883; Eleni Fistikaki: +44 (0)1895826227, +44(0)7825 389477, contact@norgine.com.

Web site: https://www.norgine.com/