Angelini Pharma, a new partner in Epilepsy

PARIS--(BUSINESS WIRE)--On the occasion of World Epilepsy Day (14^th of February 2022), Angelini Pharma, international Italian pharmaceutical company, is committed to provide patients and healthcare professionals with innovative solutions improving the care of patients with epilepsy.

Epilepsy is a common neurological disorder that typically results in seizures of various types, with focal seizures being the most common.¹ The essential treatment goal of epilepsy therapy is freedom from seizures.²

The global disease burden of epilepsy is high.^3,4 A diagnosis of epilepsy confers significant disability on the individual, including physical, psychological, and social issues that negatively impact self-esteem, family environment, relationships, leisure and working life.^3,5

Long-term outcomes for patients who have not responded to at least 2 antiepileptic drugs remain without significant improvement for more than 2 decades despite the availability of many new antiepileptic drugs.^6,7 Indeed, even today 40% of all patients with epilepsy do not achieve seizure freedom despite treatment with 2 different drugs.^6,8 The probability of achieving the therapeutic goal of seizure freedom decreases significantly with each failed treatment.⁶

Aware of the existence of an unmet medical need, Angelini Pharma is committed to make available a new anti-epileptic drug, (cenobamate - Ontozry®) for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adult patients who have not been adequately controlled despite an history of treatment with at least two anti-epileptic medicinal products.⁹ The efficacy and tolerability of the product have been evaluated in three key trials involved over 1,900 adult patients with uncontrolled focal onset seizures.^10-12

The product has received in March 2021 the Market Authorization from the European Commission (EC) and many Early Access Program authorization across European countries, especially in France. The product is already marketed in Germany, Austria, United Kingdom, Sweden, and Denmark.

The treatment represents a therapeutical breakthrough in the management of the disease and offers new hope for patients living with epilepsy.¹³

About Angelini Pharma

Angelini Pharma is an international pharmaceutical company, part of the Italian privately group owned Angelini Industries. Angelini Pharma is committed to helping patients in the therapeutic areas of Mental Health (including Pain), Rare Diseases and Consumer Healthcare. In particular, Angelini Pharma is committed to brain health – working every day to reduce and mitigate neurological disorders, while restoring and protecting mental health and cognitive function.

Over the past 50 years, in the field of mental health, Angelini Pharma has gained international recognition for its substantial efforts to improve the management of patients with mental health disorders thanks to important, internally developed molecules (such as trazodone) and its commitment to fighting mental-health stigma.

Angelini Pharma operates directly in 15 countries employing almost 3,000 people and commercializes its products in more than 50 countries through strategic alliances with leading international pharmaceutical groups.

In January 2021, Angelini Pharma announced that they concluded a definitive merger agreement under which Angelini Pharma acquired Arvelle Therapeutics. As a result, Angelini Pharma has the exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the UK).

About Cenobamate

Cenobamate was discovered and developed by SK Biopharmaceuticals and SK life science and is an FDA-approved ASM for the treatment of partial-onset seizures in adults (also known as focal-onset seizures). Cenobamate is commercially available in the US under the trademark XCOPRI®.¹⁴

Cenobamate is a novel small molecule that provides a dual, complementary mechanism of action aimed at treatment of seizures.^15,16 Cenobamate at clinically relevant concentrations, acts both as a positive allosteric modulator of GABAA receptors at a non-benzodiazepine binding site and preferentially blocks the persistent sodium current.^9,17 The dual mechanism of action of cenobamate suggests that it has the potential to both prevent seizure initiation and limit seizure spread.^18,19,20

Long-term data of cenobamate is being studied in the open-label extensions of the double-blind placebo control trials as well as the open-label safety study in adults with uncontrolled focal-onset seizures.²¹ Additionally, the product is being assessed in an ongoing randomised, double-blind, placebo-controlled trial evaluating its safety and efficacy as adjunctive therapy in patients with primary generalized tonic-clonic seizures. (NCT03678753)²²

Cenobamate has recently gained recognition by healthcare regulatory bodies in the United Kingdom and Germany given its potential use in treatment resistant focal-onset seizures in epilepsy. The drug is available in Europe including Germany, Sweden, Denmark and UK under the trademark ONTOZRY®.

REFERENCES

1. Schmitz B, et al. Epilepsia. 2010;51(11):2231–2240

2. Kwan P, et al. Epilepsia. 2010;51(6):1069–1077.

3. Epilepsy: a public health imperative. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO.

4. ILAE/IBE/WHO. Global Campaign Against Epilepsy: Out of the Shadows. 2003.

5. Kaiser S, et al. Long-term follow-up of topiramate and lamotrigine: a perspective on quality of life.

6. Chen Z, et al. JAMA Neurol. 2018;75(3):279–286.

7. Costa J, et al. Epilepsia. 2011;52(7):1280–1291.

8. Kwan P and Brodie MJ. N Engl J Med. 2000;342(5):314–319.

9. ONTOZRY SmPC

10. Krauss GL et al. Lancet Neurol. 2020;19(1):38–48.

11. Sperling MR et al. Epilepsia. 2020;61(6):1099–1108.

12. Chung SS et al. Neurology. 2020;94(22):e2311–e2322.

13. Specchio N, et al. Int. J. Mol. Sci. 2021, 22, 9339.

14. Cenobamate prescribing information. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf Last accessed: January 2022.

15. Guignet Met al, Epilepsia. 2020 Oct 16. doi: 10.1111/epi.16718.

16. Sharma R, et al. Eur J Pharmacol 2020;879:173117.

17. Anderson LL et al., Epilepsia 2014; 55(8):1274-1283.

18. Stafstrom CE, Epilepsy Curr 2007; 7(1):15-22.

19. Vreugdenhil M et al., Eur J Neurosci., 2004; 19: 2769-2778.

20. White HS et al, Epilepsy Res. 1997;28(3):167-79.

21. Sperling MR, et al. Epilepsia, Feb 2020;61:1099-1108

22. ClinicalTrials.gov. NCT03678753