Alliance Pharma PLC Marketing Authorisation for Diclectin (8285T)
06 July 2018 - 4:00PM
UK Regulatory
TIDMAPH
RNS Number : 8285T
Alliance Pharma PLC
06 July 2018
For immediate 6 July 2018
release
ALLIANCE PHARMA PLC
("Alliance" or the "Group")
Marketing Authorisation for Diclectin in the UK
Product to be marketed under the brand name Xonvea
Alliance Pharma plc (AIM: APH), the specialty pharmaceutical
company, announces that the Medicines and Healthcare products
Regulatory Agency (MHRA) has approved the UK Marketing
Authorisation Application for Diclectin(R) , a prescription product
for the treatment of nausea and vomiting of pregnancy.
Alliance also confirms that the MHRA has approved the brand name
Xonvea(R) , which will be used for marketing Diclectin in the UK.
As previously indicated, Alliance anticipates Xonvea's launch in
autumn this year as the only medicine licensed in the UK for the
treatment of nausea and vomiting of pregnancy.
Xonvea was in-licensed from Duchesnay Inc. of Canada
("Duchesnay") for the UK in 2015 and for a further nine European
countries in 2016 - Austria, Belgium, France, Germany, Italy,
Luxembourg, Netherlands, Republic of Ireland and Switzerland.
Nausea and vomiting of pregnancy is the most common medical
condition in pregnancy affecting approximately 690,000 women in the
UK each year according to the Office of National Statistics and the
Royal College of Obstetricians and Gynaecologists. Research shows
that up to 40% of pregnant women report symptoms of nausea and
vomiting of pregnancy sufficiently severe to interfere with daily
life whilst NHS data shows that at least 33,000 women with the
condition are hospitalised each year.
The Group estimates peak sales for Xonvea in the UK of
approximately GBP10m and across the other nine European countries a
further GBP30m approximately at peak sales. The Group will incur
both upfront costs ahead of the launches in the UK and EU markets
and further incremental costs to support in-market growth in these
countries. Alliance expects to generate meaningful sales of Xonvea
from H2 2019.
Xonvea is the most studied medicine in pregnancy, with a proven
efficacy and safety profile from use in more than 30 million women
over more than 30 years. Following marketing authorisation in the
UK, Alliance is preparing to file the necessary applications for
regulatory approvals in continental Europe.
Peter Butterfield, Alliance Pharma's Chief Executive Officer,
said:
"Confirmation of the marketing authorisation for Xonvea is
another positive step for Alliance and I'm delighted that we are
able to launch the product later this year. There are currently no
licensed treatments for nausea and vomiting of pregnancy in the UK
so this is excellent news for patients and clinicians as it fulfils
a significant unmet medical need."
Éric Gervais, Duchesnay's Executive Vice-President, added:
"Pregnant women across the UK will now have access to an
effective treatment for morning sickness with a proven safety
profile. Alliance Pharma's focus and drive will ensure that this
needed medication, used to date by more than 30 million women
worldwide, will provide pregnant women in the UK with a licensed
treatment option. Alliance is also preparing applications to ensure
the product's availability in continental Europe."
For further information:
Alliance Pharma plc + 44 (0) 1249 466966
Peter Butterfield, Chief
Executive Officer
Andrew Franklin, Chief Financial
Officer
www.alliancepharma.co.uk
www.alliancepharma.co.uk
+ 44 (0) 20 7466
Buchanan 5000
Mark Court / Sophie Wills
/ Gemma Mostyn-Owen
+ 44 (0) 20 7260
Numis Securities Limited 1000
Nominated Adviser: Michael
Meade / Freddie Barnfield
Corporate Broking: James
Black
+ 44 (0) 20 7597
Investec Bank plc 5970
Corporate Finance: Daniel
Adams / Ed Thomas
Corporate Broking: Patrick
Robb / David Herring
Notes to editors:
Alliance Pharma plc is an international specialty pharmaceutical
company.
Headquartered in Chippenham, UK, Alliance commenced trading in
1998 and has been listed on AIM since 2003. Alliance has a strong
track record of acquiring established niche products and it
currently owns or licenses the rights to approximately 90
pharmaceutical and consumer healthcare products. It has sales in
more than 100 countries either directly via its affiliates or
through its selected network of distributor partners. Alliance
joined the AIM market of the London Stock Exchange in December 2003
and trades under the symbol APH.
Duchesnay Inc. is a North American specialty pharmaceutical
company.
Headquartered in Blainville, Canada, Duchesnay is a specialty
pharmaceutical company with a long-standing commitment to women's
health. The company focuses on filling the void in terms of
scientific research and education and on developing pharmacological
solutions that have established safety and efficacy profiles for
use during pregnancy and breastfeeding. With offices in Canada and
the United States, Duchesnay also commercializes a broad portfolio
of products to offer proven therapeutic options that meet the
health and quality of life needs of women and their family members
at various stages of their lives.
This information is provided by RNS, the news service of the
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Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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