São Paulo, July 2022 – Eurofarma, a pharmaceutical company with global presence in over 20 countries and the one that most invests in innovation in Brazil, brings an innovative drug to Latin America focused on the treatment of refractory focal/partial epilepsy in adults. Cenobamate, in a licensing partnership with Korean SK Biopharmaceuticals, is a milestone in the history of medicine, as it reduces the number of epileptic seizures by an average of 65% for all patients who have the condition.¹

This efficacy rate is unprecedented, considering all the products ever launched since the first anticonvulsant hit the market decades ago.² The drug already has FDA and EMA approval, from the U.S. and European regulatory agencies, respectively. 

"We are very happy to partner with SK Biopharmaceuticals. This agreement reinforces our plans to continue expanding our business worldwide, always in innovative ways. Our broad portfolio of central nervous system drugs will be further strengthened with cenobamate, now providing the most effective option among all those on the market for physicians and their patients," says Martha Penna, Vice President of Innovation at Eurofarma.

“We are extremely pleased to partner with Eurofarma, which has a proven track record in the region and an extensive network to drive the development and commercialization of cenobamate in Latin America. This partnership reaffirms our commitment to provide innovative treatments for people with epilepsy in this region. We will continue to expand our presence worldwide to support the patient community and maximize the value of cenobamate," comments Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals.

Efficacy and innovation

The launch of cenobamate reinforces Eurofarma's innovative propensity in closing partnerships for products that are truly innovative. The drug is the first in its class to be brought to Latin America, a drug with an innovative action mechanism that does not yet exist in the market and that provides an efficacy gain never before seen in previous classes of anticonvulsants. It is intended for patients who have refractory focal epilepsy, that is, a specific type of the condition that is highly resistant to conventional anticonvulsants.

Patients with uncontrolled focal epilepsy have poor quality of life, higher comorbidity (e.g., depression, pneumonias, vascular disease, osteoporosis, and fractures), cognitive/intellectual decline, higher health care costs, and have a higher risk of injury and premature death, including a three times higher risk of death than the general population (from status epilepticus, injury, and sudden unexpected death in epilepsy [SUDEP]).^3–9 

In clinical studies conducted on patients suffering from this pathology, the efficacy rates were the best ever seen among all the products already launched globally. Patients treated with the 400 mg/day dose had a median 65%¹ reduction in the frequency of their seizures, with a reduction of around 56% in the two studies evaluating the 200 mg/day dose^1,10. Furthermore, of the total number of patients in the efficacy studies, between 21%¹ and 28.3%¹⁰ did not experience even one epileptic seizure after the drug was inserted into their routine. This second rate is much higher than the results achieved by conventional products, since after the third attempt only 4% of patients will have a complete reduction of seizures.¹¹

For this type of epilepsy, precisely because it is resistant to conventional medication, two or more drugs are often considered in the treatment to combat the seizures. However, this combination ends up also amplifying the sedative adverse effects, making the patients sleepier and decreasing their productive activity, even hindering their quality of life on a daily basis.

In a study with a median follow-up of more than 6 years of treatment, it was observed that half of the patients stopped using one or more of the conventional drugs they had been using. Among these patients, 76% continued to benefit from the use of cenobamate at the end of the study, showing good tolerance to the drug.¹² Posologically, the product is easy to manage, as it requires a single daily dose for symptom control.

Epidemiology

Epilepsy is one of the most common serious neurological diseases, affecting about 68 million people worldwide¹³, and is characterized by abnormal brain cell activity. Epileptic seizures caused by transient alteration of neuronal activities can manifest themselves in different ways, the most commonly known of which is seizures, but also recurring sensory alterations (smells, seeing lights), perceptual (feeling of having already seen something – déjà vu –, feeling of fear), and behavioral (absence, hand movement without a purpose).

A study focused on Latin America analyzed 35 studies from 11 different countries, estimating the prevalence of active epilepsy to be around 1.24% of the population,¹⁴ and estimating that about 30% of patients with focal/partial epilepsy are refractory,11,15 i.e., they continue to have seizures, without remission, despite adequate treatment with different anticonvulsant medications. This is precisely where cenobamate comes in to make a difference, being able to reduce the frequency of epileptic seizures by 65% on average in a potential population of more than 8 million people in the region, exponentially improving their quality of life.

Partnership

Under the terms of the agreement with SK Biopharmaceuticals, Eurofarma will have exclusivity to develop, manufacture and market cenobamate in all Latin American countries listed below. In return, the Korean pharmaceutical will receive an upfront payment and may receive future milestones and royalties on net sales generated.

Cenobamate, under the trade names Ontozry® and Xcopri®, is already on the European and American markets, respectively, and in the United States the product has recently started to be sold. In both regions, due to the drug's high efficacy and instilled quality, both the FDA and the EMA, local regulatory bodies and two of the most credible globally, quickly approved its insertion in the market.

In Brazil and other Latin American countries, the product is expected to be available for purchase in 2025*. Check out right below the countries where Eurofarma will market cenobamate.

*Update in February 2025: the product is expected to be available in 2026.

About Eurofarma Group

Eurofarma has been operating in the healthcare industry since its establishment in 1972, producing and marketing innovative products and services to improve people’s quality of life. Focused on generating shared value, it operates in the areas of Prescription, OTC and Generic Drugs, Hospital and Oncology. The company offers more than 700 products, over 2,000 SKUs, and serves 42 medical specialties. In Brazil, the company covers 100 therapeutic classes, which represent 70% of the prescriptions in the entire market.

Present in 20 countries, with a manufacturing park in Brazil and plants in six other Latin American countries, it generated net sales of BRL 7.1 billion in 2021, growth of 23% over the previous year, and employs more than 8,100 people.

About SK Biopharmaceuticals

SK Biopharmaceuticals and its US subsidiary SK life science are global pharmaceutical companies focused on the research, development and commercialization of treatments for central nervous system (CNS) disorders. The companies have a pipeline of eight compounds in development for the treatment of CNS disorders, including epilepsy. In addition, SK Biopharmaceuticals is focused on early research in oncology. For more information, visit the SK Biopharmaceuticals website at www.skbp.com/eng and the SK life science website at www.SKLifeScienceInc.com.

Eurofarma in social media

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Press Information

G&A – Public Relations

Carolina Carone – +55 11 98578-1604 – carolina.carone@gaspar.com.br 

Guilherme Gaspar – +55 11 98285-6000 – guilherme@gaspar.com.br

References:

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2. Vossler, D. G. Remarkably High Efficacy of Cenobamate in Adults With Focal-Onset Seizures: A Double-Blind, Randomized, Placebo-Controlled Trial. Epilepsy Curr. 20, 85–87 (2020).

3. Lawn, N. D., Bamlet, W. R., Radhakrishnan, K., O’Brien, P. C. & So, E. L. Injuries due to seizures in persons with epilepsy: a population-based study. Neurology 63, 1565–1570 (2004).

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