Novo Nordisk : Once-weekly somapacitan demonstrates similar one-year height gains compared to daily somatropin in a phase 2 trial in children with growth hormone deficiency

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Once-weekly somapacitan demonstrates similar one-year height gains compared to daily somatropin in a phase 2 trial in children with growth hormone deficiency

Vienna, Austria, 21 September 2019 - Novo Nordisk today announced that somapacitan, a novel growth hormone derivative in development as a once-weekly treatment option, demonstrated comparable efficacy, safety and tolerability to once-daily injections of Norditropin® (somatropin) after one year, with improved efficacy seen at the highest dose of somapacitan. The data, from the REAL 3 paediatric phase 2 trial in children with growth hormone deficiency (GHD), were presented today by Professor Lars Sävendahl at the 58th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE).1

The REAL 3 trial compared three different weekly somapacitan doses (0.04, 0.08 or 0.16 mg/kg/week) to daily somatropin (0.034 mg/kg/day) in children with GHD. The 1-year results supported the previously-reported6-month data, with the new finding at one year that mean standard deviation (SD) annualised height velocity (HV, cm/year) was statistically significantly higher with somapacitan 0.16mg/kg/week compared to daily somatropin. HV for the three doses of somapacitan was 7.8, 9.7 and 11.5 cm/year, respectively, compared to 10.0 cm/year for once-daily somatropin.1

Jamie Harvey, chief executive officer of International Coalition of Organizations Supporting Endocrine Patients (ICOSEP), said, "Growth hormone deficiency is a slow, devastating condition that affects more than a child's height - it insidiously and profoundly impacts their daily lives and long-term physical and emotional health. Once- weekly treatment options in comparison to daily injections could help patients comply with treatment, and therefore help to reduce the medical complications associated with this deficiency."

"At Novo Nordisk we are proud to develop once-weekly somapacitan for people with growth hormone deficiency with the aim of reducing their treatment burden and ultimately improving their lives," said Ludovic Helfgott, executive vice president of Novo Nordisk. "These results provide support for a phase 3 paediatric trial of somapacitan, and based on trials in adults with GHD, we have recently submitted somapacitan for approval for the treatment of adult GHD in the EU and US."

Novo Nordisk A/S	Novo	Allé	Telephone:	Internet:
Corporate Affairs	2880	Bagsværd	[phone]	www.novonordisk.com
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About the REAL 3 main trial and extension phase

REAL 3 is a multinational, randomised, parallel-group,active-controlled trial evaluating the efficacy of three different doses of once-weekly somapacitan after 26 weeks and 52 weeks of treatment in 59 growth hormone treatment-naïvepre-pubertal children with GHD, compared to daily Norditropin® (somatropin) administration. Participants were randomised to either a dose of somapacitan (0.04, 0.08 or 0.16 mg/kg/week) or somatropin 0.034 mg/kg/day. The REAL 3 trial has an ongoing extension period of up to 312 weeks.1,2

About somapacitan

Somapacitan is a long-acting derivative of human growth hormone that binds to circulating albumin and is under investigation as a possible treatment for GHD. Somapacitan is built on many years of protein technology applied for long-acting insulins, glucagon-likepeptide-1 and now growth hormone.3

About childhood growth hormone deficiency

Growth hormone, a protein produced by the pituitary gland in the brain, regulates growth and metabolism.4 Childhood GHD is a rare condition in which there is not enough growth hormone circulating in the blood to ensure normal growth.4,5 Affected children experience slowed or halted growth from the age of 2 to 3 years onwards, and metabolic irregularities.4,6

The impact of GHD is considerable, and it can affect multiple aspects of daily life for children with the condition, including physical effects, and social and emotional well- being.7 If treatment is started early, affected children could grow to a normal height.7,8

Currently available growth hormone treatments must be administered as a daily subcutaneous injection.6 Non-adherence to growth hormone treatment has been shown to negatively affect height outcomes in children with GHD.9

Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 80 countries and markets its products in more than 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Novo Nordisk A/S	Novo	Allé	Telephone:	Internet:
Corporate Affairs	2880	Bagsværd	[phone]	www.novonordisk.com
	Denmark		CVR no:
				24 25 67 90

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Further information
Media:
Mette Kruse Danielsen	[phone]	[e-mail]
Ken Inchausti (US)	[phone]	[e-mail]
Investors:
Peter Hugreffe Ankersen	[phone]	[e-mail]
Valdemar Borum Svarrer	[phone]	[e-mail]
Ann Søndermølle Rendbæk	[phone]	[e-mail]
Kristoffer Due Berg (US)	[phone]	[e-mail]

_______________________

References

1. Sävendahl L, Battelino T, Horikawa R, et al. Once-weekly somapacitan vs daily growth hormone (Norditropin®) in childhood growth hormone deficiency: One- year results from a randomised phase 2 trial. Presented at the 58th Annual Meeting of the European Society for Paediatric Endocrinology, Vienna, Austria, 19-21 September 2019.
2. Clinicaltrials.gov. Investigating Efficacy and Safety of Once-weeklyNNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency. Available online at https://clinicaltrials.gov/ct2/show/NCT02616562. Last accessed September 2019.
3. Battelino T, Rasmussen MH, De Schepper J, et al. Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial. Clin Endocrinol (Oxf). 2017; 87:350-358.
4. Growth Hormone Deficiency in Children. The Magic Foundation. Availble online athttps://www.magicfoundation.org/Growth-Disorders/Growth-Hormone-Deficiency- in-Children/. Last accessed September 2019.
5. Murray PG, Dattani MT and Clayton PE. Controversies in the diagnosis and management of growth hormone deficiency in childhood and adolescence. Arch Dis Child. 2016; 101:96-100.
6. Great Ormond Street Hospital For Children. Growth Hormone Deficiency. August 2014. Available online athttps://www.gosh.nhs.uk/conditions-and- treatments/conditions-we-treat/growth-hormone-deficiency. Last accessed September 2019.
7. Brod M, Alolga SL, Beck JF, et al. Understanding burden of illness for child growth hormone deficiency. Qual Life Res. 2017; 26:1673-1686.
8. Polak M, Blair J, Kotnik P, et al. Early growth hormone treatment start in childhood growth hormone deficiency improves near adult height: analysis from NordiNet(R) International Outcome Study. Eur J Endocrinol. 2017; 177:421-429.
9. Graham S, Weinman J and Auyeung V. Identifying Potentially Modifiable Factors Associated with Treatment Non-Adherence in Paediatric Growth Hormone Deficiency: A Systematic Review. Horm Res Paediatr. 2018; 90:221-227.

Novo Nordisk A/S	Novo	Allé	Telephone:	Internet:
Corporate Affairs	2880	Bagsværd	[phone]	www.novonordisk.com
	Denmark		CVR no:
				24 25 67 90