The latest pharma news from Brazil, including Daiichi Sankyo’s new plant; Bristol Myers Squibb’s re-entry into Brazil’s cardiology market; the Anvisa approval of HIV prevention drug, cabotegravir; Merck’s gamble on the Brazilian obesity market and Novo Nordisk’s patent extension denial.
Japanese drugmaker Daiichi Sankyo said it will invest around 400 million reais (USD 80 million) to expand its Brazilian operations, part of a plan to boost its healthcare unit including launching new products in the coming years. The company, which markets several types of medicines including Hirudoid cream, said in a statement it will use the funds to expand production, packaging and warehouse capacity at its Barueri city factory, located in southeastern Sao Paulo state.
Y-mAbs’ Danyelza injection receives marketing approval in Brazil (Pharmaceutical Technology)
Y-mAbs Therapeutics has received marketing authorisation for Danyelza (naxitamab-gqgk) 40mg/10mL injection from the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária, to treat high-risk neuroblastoma. Danyelza is a recombinant humanised monoclonal antibody that acts on the ganglioside GD2 that is highly expressed in several neuroectoderm-derived tumours and sarcomas.
Bristol Myers Squibb relaunches in the cardiology market in Brazil (Guia de Farmacia, in Portuguese)
Out of the Brazilian cardiology market since 2015, Bristol Myers Squibb (BMS) has just made its re-debut in this therapeutic area in the country. With the launch of an innovative drug to treat adults with obstructive hypertrophic cardiomyopathy (HCM), Camzyos, the multinational is positioned to compete in a market that moved around R$ 11.6 billion in 12 months until May, according to IQVIA data, which audits pharmaceutical retail.
Pharmaceutical industry in Brazil expands leadership (Panorama, in Portuguese)
In the pharmaceutical industry in Latin America, business points increasingly to Brazil. The country increased by five percentage points its regional leadership in business volume and now accounts for 47% of revenues in dollars. Laboratories operating on the Latin American continent registered US$ 64.6 billion in revenue in the last 12 months through March, an increase of 13.1% compared to the same previous period and already excluding sales of Covid-19 vaccines.
Anvisa approves new drug for HIV prevention (Guia de Farmacia, in Portuguese)
Anvisa registered, on June 5th, the drug Apretude (cabotegravir), in tablet and injectable dosage forms, with the indication of prevention of contagion by the HIV virus. Apretude® is approved for use in individuals weighing at least 35 kg. Cabotegravir is an antiretroviral from the integrase enzyme inhibitor class, which prevents the insertion of HIV viral DNA into human DNA. It is a mechanism of action that prevents replication, that is, the reproduction of the virus and its ability to infect new cells.
Merck joins race for Brazil’s obesity market (Valor international)
Merck has just made its debut in Brazil’s multi-billion obesity drugs market. With Contrave, a cutting-edge oral treatment, the multinational was surprised by the strong acceptance of the product, which reached more than 70 percent of its goal in the first month since launch, with only seven days in drugstores. The company intends to become the leader in this segment in three years, reaching more than 200,000 patients.
Brazilian federal court denies semaglutide patent extension (Pharmaceutical Technology)
Revenue prospects for Novo Nordisk’s blockbuster diabetes and weight-loss drug semaglutide in Brazil have been dealt a major blow after a federal court denied a request by the Danish firm for two patent extensions. The 5th Panel of the Federal Court of the 1st Region (Tribunal Regional Federal da 1ª Região, TRF-1) upheld the existing expiry dates of two patents—one for semaglutide itself (2026), and the other for the delivery mechanism for the oral formulation of the drug, Rybelsus (2031). Wegovy and Ozempic, subcutaneous formulations of semaglutide with the latter coming in a lower dose, are therefore expected to face the first generic competitors just three years from now.