Norgine UK launches ANGUSTA® (misoprostol) in the UK for oral induction of labour

LONDON, March 1, 2021 /PRNewswire/ -- NORGINE UK a leading European specialist pharmaceutical company today announced the launch of ANGUSTA^®  (misoprostol) in the UK.

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. Misoprostol will now offer an oral treatment option for the induction of labour in addition to the currently available vaginally administered methods.^[1]  The safety and efficacy of misoprostol 25 micrograms has been assessed using both dosing regimens and a range of studies including a compassionate use programme, these showed common side effects to be nausea, vomiting, meconium stain and postpartum haemorrhage.^[2]

Andy Crichton, General Manager of Norgine in the UK, commented: "We are pleased to be offering women and healthcare professionals in the UK an oral treatment when induction of labour is required and support women, obstetricians and midwives with this additional oral treatment option."

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

Misoprostol 25 micrograms should only be administered by trained obstetric personnel in a hospital setting where facilities for continuous fetal and uterine monitoring is available and the cervix should be assessed carefully before product use.^[2]

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^® (misostropol)

Misoprostol 25 micrograms is indicated for the induction of labour. It is administered after careful assessment of the uterine cervix.^[1] It 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] It 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]

Misoprostol 25 micrograms should be administered by trained obstetric personnel in a hospital setting where facilities for continuous foetal and uterine monitoring are available.^[1]

Misoprostol 25 micrograms can cause excessive uterine stimulation and if this continues, dosing is stopped and treatment according to local guidelines should be commenced.^[1]

Misoprostol 25 micrograms is a product recently acquired by Norgine B.V. 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 2020 and generated €448 million in net product sales, a growth of 7% over 2019.

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.

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

References

[1] ANGUSTA® Summary of Product Characteristics (SmPC). Available from www.emc.com

[2] WHO Recommendations for Induction of Labour 2011, WHO Press, World Health

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