Rare disease partnership champions market access in South America

While the last year has been deemed a successful time for rare disease research with a growing number of drug approvals in the US, South America’s pharmaceutical industry still lags behind in receiving access to essential rare disease drugs. On 27 February, HRA Pharma Rare diseases (HRA RD) announced a partnership with Celnova Pharma to cement its place in the South American market and increase access to needed rare disease treatments.

The announcement came a day before Rare Disease Day, observed internationally to spread awareness around rare diseases. While research is expanding the pool of available therapies for rare diseases, access remains a serious challenge. According to GlobalData’s drugs database, only 5% of the globally marketed rare disease drugs are accessible in South and Central America.

GlobalData is the parent company of Pharmaceutical Technology.

Last May, Perrigo acquired the France-based HRA in a $1.9 billion deal. HRA RD has a portfolio of three marketed drugs that treat the rare diseases Cushing’s Syndrome and adrenocortical Carcinoma. Cushing’s syndrome is caused by an excess of the hormone cortisol in the body, leading to symptoms such as depression and excess fat on the chest or stomach. This disease affects approximately 13 individuals per million annually. Similarly, adrenocortical carcinoma is another rare condition affecting approximately one person per million each year. Both symptoms often occur due to tumour growth on the adrenal glands.

HRA RD’s new partnership will function to allow HRA RD to launch its rare disease products Ketoconazole HRA and Lysodren across Argentina, Chile and Peru. Celnova Pharma is an Argentina-based pharmaceutical company that centres its work around rare diseases, oncology, central nervous system, diabetes and critical care. The company currently has operations in Argentina, Colombia, Chile, Peru, and Uruguay.

In an email to Pharmaceutical Technology, Evelina Paberžė, the Chief Operating Officer of HRA RD, explains that “Celnova will not only be responsible for regulatory and distribution services to support product sales, but also will build the networks with healthcare providers and patient advocacy groups to raise the awareness of Cushing’s Syndrome and adrenocortical carcinoma”. In the press release, Celnova outlines future plans to continue expanding its presence in the region through more partnerships and acquisitions.

Rare disease market in South America

Thus far the only Latin American country with market access to any of HRA RD products is Brazil and Columbia. However, as the South American pharmaceutical market steadily grows, there is unlocked potential to be found in the continent. For example, GlobalData predicts that in Q1 2023, Argentina’s total health spend will grow by 29.1%. Furthermore, Argentina’s total pharmaceutical sales is expected to grow by 44.2 million pesos ($224,218) in the same period.

Argentina isn’t the only Latin American country showing continuous pharmaceutical growth; Brazil has been touted as a strong market for pharmaceutical drug manufacturing. Despite this, many companies neglect South and Central America, leaving it out of their commercialisation plans for new drugs. Currently, according to GlobalData, there are no marketed drugs for Cushing’s syndrome in the region. Moreover, only two of the seven marketed drugs for adrenocortical carcinoma are marketed in South and Central America.

This Celnova partnership is HRA’s third partnership in South America, following deals with Valentech in Colombia and Moksha8 in Brazil. Paberžė explained that the company also sees these partnerships as opportunities for growth saying, “The goal, as everywhere, is to make sure patients have access to the treatment, and we are delivering our business objectives. Besides this, opening a new market is always a learning experience for the HRA RD team, allowing improvement of know-how, and ideas for new development”.