Angelini Pharma today finalized the acquisition agreement of Arvelle Therapeutics
- Through the acquisition of Arvelle Therapeutcis, Angelini Pharma will be a major player in the market for treatment of central nervous system (CNS) and mental health disorders
- Finalization of the deal comes a few days after the announcement of EMA-CHMP positive opinion granted to cenobamate (ONTOZRY™) for the adjunctive treatment of uncontrolled focal seizures in adults with epilepsy
- Direct Angelini Pharma affiliates will be opened by 2022 in France, UK, Nordic countries and Switzerland
Rome, February 2, 2021 - Angelini Pharma, an international pharmaceutical company which is part of the private Italian Angelini Group, announced the finalization of the acquisition of Arvelle Therapeutics, a Swiss-based biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, in an all cash transaction for a total aggregate valuation of up to $960 million. Today at completion $370 million was paid, additional $240 million will be paid following regulatory approval of the deal.
Since its founding in 2019, Arvelle’s management team has focused on bringing cenobamate to people with epilepsy in Europe, whilst also creating significant value for shareholders. They have worked in close collaboration with the European regulators to advance the marketing authorization application (MAA), and they have successfully prepared for launch by building an organization throughout Europe and ensuring launch readiness across key areas of the business. Arvelle had held commercial rights to cenobamate under a licensing agreement with SK Biopharmaceuticals
"The acquisition of Arvelle represents a milestone in our growth path - says Pierluigi Antonelli, CEO Angelini Pharma – The recent Positive CHMP opinion of cenobamate - for the adjunctive treatment of focal onset seizures with or without secondary generalization in adult patients with epilepsy - represents another milestone for us and for patients. There are an estimated six million people in Europe with epilepsy and approximately 40% of adult people with epilepsy1 have inadequate control of seizures after treatment with two anti-seizure medications2. Cenobamate showed significant efficacy, with more patients achieving a 50% or greater reduction in seizure frequency and unprecedented rates of seizure freedom of up to 21% compared to placebo. We are impressed and excited about what Arvelle Therapeutics’ people have achieved and fully committed to bring Cenobamate to patients thanks to our distinctive medical capabilities and commercial presence”.
Through this acquisition, Angelini Pharma becomes a major player in the market for the treatment of central nervous system (CNS) and mental health disorders. In addition, direct affiliates of Angelini Pharma will open direct affiliate in France, UK, Nordic countries and Switzerland by 2022. Following the acquisition, Angelini Pharma will have the exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom).
For more information, please contact:
Angelini Pharma
Daniela Poggio - Global Communications Head - Email: Daniela.poggio@angelinipharma.com
Arvelle Therapeutics
Juan Vergez - Head of Marketing and Corporate Communications - Email: Juan.Vergez@arvelletx.com
SK Biopharmaceuticals
Hyongki Park - Head of Communications - Email: h.p.comm@sk.com
About Angelini Pharma
Angelini Pharma is an international pharmaceutical company, part of the Italian privately-owned Angelini Group. Angelini Pharma is committed to helping patients in the therapeutic areas of Mental Health (including Pain), Rare Diseases and Consumer Healthcare. 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 will acquire Arvelle Therapeutics. As a result, Angelini Pharma will have the exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom).
About Arvelle Therapeutics
Arvelle Therapeutics is an emerging biopharmaceutical company focused on bringing innovative solutions to patients suffering from CNS disorders. Arvelle is responsible for the development and commercialization of cenobamate, an investigational anti-seizure medicine, in the European market. Arvelle is headquartered in Switzerland and received start-up financing of $207.8 million, one of the largest initial financing commitments for a European-focused biopharmaceutical company, with investments from a global syndicate including NovaQuest Capital Management, BRV Capital Management, LSP, H.I.G. BioHealth Partners, Andera Partners, F-Prime Capital and KB Investments. More information is available at https://arvelletx.com.
About SK Biopharmaceuticals Co., Ltd.
SK Biopharmaceuticals and its U.S. subsidiary SK life science are global pharmaceutical companies focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS). The companies have a pipeline of eight compounds in development for the treatment of CNS disorders, including epilepsy. Additionally, SK Biopharmaceuticals is focused on early research in oncology. For more information, visit SK Biopharmaceuticals’ website at www.skbp.com/eng and SK life science’s website at www.SKLifeScienceInc.com.
About Cenobamate
Cenobamate was discovered 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 has been approved in the U.S. where it is commercially available under the trademark XCOPRI®.3 IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI® (cenobamate tablets) CV can be found on www.xcopri.com.
Cenobamate is a novel small molecule that provides a unique, dual, complementary mechanism of action aimed at treatment of seizures. 4,5,6 Cenobamate is the only anti-seizure medication which, 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.5,6 The unique dual mechanism of action of cenobamate suggests that it has the potential to both prevent seizure initiation and limit seizure spread. 7,8,9,10,11
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.12 Additionally, cenobamate is being assessed in an ongoing randomized, double-blind, placebo-controlled trial evaluating its safety and efficacy as adjunctive therapy in patients with primary generalized tonic-clonic seizures (NCT03678753).13
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 UK Medicines and Healthcare Products Regulatory Agency (MHRA) has designated cenobamate as a Promising Innovative Medicine (PIM). A PIM designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme.
In addition as of August 2020, the German Federal Institute for Drugs and Medical Devices (BfArM) has included cenobamate for the treatment of drug-resistant focal-onset seizures in adults in its list of confirmed drugs for compassionate use (CPU) programmes for one year within the country.
About Study 01714
Study 017 was a multicentre, double-blind, randomized, placebo-controlled, dose-response study to evaluate the safety and efficacy of cenobamate as an adjunctive therapy in adults (18 to 70 years old) with uncontrolled focal epilepsy despite treatment with 1-3 anti-epileptic drugs (AEDs). Following an 8-week baseline period, the study participants were randomized to one of three doses of cenobamate (100 mg, 200 mg and 400 mg once daily) or placebo for 18 weeks (6-week titration phase and 12-week maintenance phase). The primary outcomes were median percentage seizure reduction over the entire study and ≥50% responder rate (percentage of patients achieving ≥50% reduction in seizures) during the maintenance phase. Patients who had the option to enrol in an open-label extension of the 017 study will provide additional insight into the long-term clinical efficacy and safety profile of adjunctive cenobamate.
References
1. Epilepsy Alliance Europe. Background information. https://www.epilepsyallianceeurope.org/about/background/ Last accessed 03.12.2020.
2. Chen Z et al. JAMA Neurol. 2018 Mar 1;75(3):279-286.
3. Cenobamate prescribing information. FDA. Last accessed 20 July, 2020 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
4. Guignet M, Campbell A, White HS, Epilepsia. 2020 Oct 16. doi: 10.1111/epi.16718. Online ahead of print
5. Nakamura M, et al. Eur J Pharmacol 2019;855:175-182.
6. Sharma R, et al. Eur J Pharmacol 2020;879:173117.
7. Anderson LL et al., Epilepsia 2014; 55(8):1274-1283.
8. Piredda SG et al, J Pharmacol Exp Ther. 1985;232(3):741-745.
9. Stafstrom CE, Epilepsy Curr 2007; 7(1):15-22.
10. Vreugdenhil M et al., Eur J Neurosci., 2004; 19: 2769-2778.
11. White HS et al, Epilepsy Res. 1997;28(3):167-79.
12. Sperling MR, et al. Epilepsia, Feb 2020;61:1099–1108.
13. Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures NCT03678753.
14. Krauss GL et al. Lancet Neurol. 2020 Apr;19(4):288-289.