Alliance Pharma Regulatory News (APH)

ALLIANCE PHARMA PLC

("Alliance" or the "Group")

Xonvea® launch in the UK

Alliance Pharma plc (AIM: APH), the international specialty pharmaceutical company, announces that it has today launched Xonvea, its prescription product for the treatment of nausea and vomiting of pregnancy (NVP), in the UK. Xonvea is a new licensed medicine available in the UK for women with NVP where conservative management has failed.

NVP is the most common medical condition in pregnancy affecting approximately 751,923 women in the UK each year, according to the Office of National Statistics and the Royal College of Obstetricians and Gynaecologists1,2. Research shows that up to 40% of pregnant women report symptoms of NVP sufficiently severe to interfere with daily life3-6 and that symptoms can be compared in severity to the nausea associated with chemotherapy7. Reported feelings of anxiety and depression from NVP have been shown to approach levels seen in women with post-natal depression3,8.

The Royal College of Obstetricians and Gynaecologists states that severe NVP is one of the most common reasons for pregnant women to be admitted to hospital2. In 2016-2017, there were 33,071 hospital admissions for NVP in England, resulting in 36,171 bed days according to the NHS9.

Professor Catherine Nelson-Piercy, consultant obstetric physician, commented:

"I am delighted that at last the UK has a licensed medication for the treatment of nausea and vomiting of pregnancy where conservative treatment has failed. This delayed release formulation of doxylamine and pyridoxine has been used in millions of pregnant women worldwide. Primary and secondary care doctors caring for pregnant women in the UK are now able to prescribe Xonvea, affording women in the UK a licensed option when it comes to managing this often debilitating condition. In women who do not respond completely to Xonvea, doctors can prescribe other anti-sickness drugs recommended by National Clinical Guidelines."

Peter Butterfield, Alliance Pharma's Chief Executive Officer, said:

"The launch of Xonvea is a significant milestone for Alliance and I'm delighted that we have today made the product available in the UK. There is no other licensed treatment 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."

Alliance in-licensed Xonvea from Duchesnay Inc. of Canada for the UK in 2015. Xonvea's combination of doxylamine and pyridoxine is recommended as a first-line pharmacotherapy in the USA and Canada and has been prescribed to over 33 million women in more than 40 years3,10-15.

Éric Gervais, Duchesnay's Executive Vice-President, added:

"With the launch of Xonvea, Duchesnay is proud to provide women in the UK with something they have been without for years: a licensed treatment to help relieve nausea and vomiting of pregnancy."

For further information:

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.

References:

1. Office for National Statistics.: 2016. Statistical bulletin, 27 March 2018. Available at: https://www. ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages. Accessed May 2018.

2. Royal College of Obstetricians and Gynaecologists. The management of nausea and vomiting of pregnancy and hyperemesis gravidarum (Green-top Guideline No. 69). 22 June 2016. Royal College of Obstetricians and Gynaecologists: London. https://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg69/.

3. Association of Professors of Gynecology and Obstetrics. Nausea and Vomiting of Pregnancy. Continuing series on Women's Health Education. 2011; Jespersen & Associates, LLC, Boston, Massachusetts.

4. Mazzotta P. Psychosocial Morbidity Among Women with Nausea and Vomiting of Pregnancy: Prevalence: Prevalence and Association with Anti-Emetic Therapy. J. Psychosom Obstet Gynecol 2000;21: 129-136

5. O'Brien B et al. Nausea and vomiting during pregnancy: effects on the quality of women's lives. Birth 1992; 19:138-143.

6. Vellacott ID et al. Nausea and vomiting in early pregnancy. Int J Gynecol Obstet. 1988;27:57-62.

7. Lacroix R, Eason E, Melzack R. Nausea and vomiting during pregnancy: a prospective study of its frequency, intensity, and patterns of change. Am J Obstet Gynecol 2000; 182(4): 931-937.

8. Lacasse A, Rey E, Ferreira E, Morin C, Be´rard A. Nausea and vomiting of pregnancy: what about quality of life? BJOG 2008;115:1484-1493

9. NHS Digital. HES data 2016/17. Available at: https://digital.nhs.uk/data-and-information/ publications/statistical/hospital-admitted-patient-care-activity/2016-17. Accessed July 2018.

10. The Society of Obstetricians and Gynaecologists of Canada. J Obstet Gynaecol Can. 2016;38(12):1127-1137.

11. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 189, January 2018. Nausea and vomiting of pregnancy. Obstet. Gynecol. 2018;131:e15-e30.

12. Institute of Obstetricians & Gynaecologists Clinical Practice Guidelines, Royal College of Physicians of Ireland. Hyperemesis and nausea/vomiting in pregnancy. Guideline 12; v1 (Nov 2015).

13. Spanish Society of Gynecology & Obstetrics (SEGO) Consensus Document Hyperemesis Gravidarum; 2008:61-100.

14. Ornstein, M., Einarson, A., Koren, G. Bendectin/Diclectin for morning sickness: A Canadian follow-up of an American tragedy. Reproductive Toxicology. 1995; 9(1): 1-6.

15. Madjunkova S et al. The delayed-release combination of doxylamine and pyridoxine (Diclegis®/Diclectin®) for the treatment of nausea and vomiting of pregnancy. Pediatr Drugs 2014;16:199-211.