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Adium announces exclusive distribution agreeement with REGENERON to commercialize CEMIPLIMAB (LIBTAYO®) in Brazil

Cemiplimab is currently approved in Brazil for certain patients as a monotherapy or in combination with chemotherapy for advanced non-small cell lung cancer (NSCLC), and for certain patients with advanced forms of cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC) and cervical cancer

[19 March 2024] Pharmaceutical company Adium announces an exclusive distribution agreement with Regeneron Ireland DAC, a wholly owned subsidiary of Regeneron, for Libtayo (cemiplimab), a monoclonal antibody indicated for advanced forms of non-small-cell lung cancer (NCSLC), as well as two non-melanoma skin cancers and cervical cancer.

The agreement is for the distribution of cemiplimab in Brazil. “Adium has a complete structure with a strong presence in 18 Latin American countries, to ensure efficiency in strategic regulatory and commercial partnerships to bring innovative therapies to patients. Selecting Adium to market cemiplimab recognizes our capacity and commitment to bringing the molecule to its full potential”, said Alexandre Seraphim, general manager of Adium in Brazil.

Adium has a dedicated business unit for oncology treatments, including innovative therapies for several types of cancer, such as bladder, prostate, ovarian, breast, and neuroblastoma, among others. With the arrival of cemiplimab, which will become the company’s primary oncology therapy in Brazil, Adium further expands its presence in the oncology therapeutic area.

“We are excited to help provide and expand access to cemiplimab for patients in Brazil”, highlights Seraphim.

In Brazil, cemiplimab, which was invented using Regeneron’s proprietary VelocImmune®  technology, has been indicated since 2022 as first-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer NSCLC, initially as monotherapy and currently also in combination with platinum-based chemotherapy¹. Considering all variations of lung cancer, the tumor has the highest incidence and mortality rate among men worldwide; third in incidence and second in mortality among women². In Brazil alone, the disease is expected to record more than 32 thousand new cases a year, with almost 29 thousand deaths, according to INCA (National Cancer Institute) ².

In most cases, the tumor is related to smoking – whether firsthand or secondhand –, although it can also be caused by exposure to chemicals such as arsenic, asbestos, beryllium, chromium, radon, uranium, nickel, cadmium, vinyl chloride, and chloromethyl ether. Often, the first symptoms and signs only appear when the tumor is advanced, such as persistent cough, chest pain, hoarseness, loss of weight and appetite, recurrent pneumonia and bronchitis².

Although there is no evidence to support the screening of the disease in the general population, studies show the possibility of performing low-dose radiation tomography on heavy smokers (one pack a day for 30 years) over the age of 55³.

In Brazil since 2019

ANVISA’s first approval for cemiplimab was granted in 2019 as monotherapy for certain patients with locally advanced or metastatic cutaneous squamous cell carcinoma who are not eligible for surgery or radiotherapy. Two years later, the monoclonal antibody was approved for certain patients with locally advanced or metastatic basal cell carcinoma, previously treated with a Hedgehog pathway inhibitor or for which a Hedgehog pathway inhibitor is not suitable².

Furthermore, the therapy is indicated for the treatment of cervical cancer, in cases that have progressed during or after previous platinum-based chemotherapy and those requiring additional systemic therapy for metastatic or recurrent disease³.

About ADIUM:

Adium is a pharmaceutical company with more than 40 years of experience, leader in Latin America. Our mission is to bring innovative treatments that change the paradigm of health and improve the quality of life of patients, families and caregivers. Through solid alliances, we are licensors of more than a dozen multinational innovation companies, which allows us to bring cutting-edge therapies and treatments to face the most challenging diseases in the world. We have five production centers in Argentina, Paraguay, Brazil, Mexico and Uruguay, where we research, develop and manufacture more than 110 million of our own high-quality products. This allows us to expand access to healthcare and touch the lives of millions of people throughout the region. For more information on the Adium Group: https://adiumpharma.com

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References:

  • Medication package insert. Libtayo (cemiplimab)
  • National Cancer Institute (INCA). Lung cancer. https://www.gov.br/inca/pt-br/assuntos/cancer/tipos/pulmao
  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 Feb 4.

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