First To Approve Sanofi's Diabetes Drug


BMI View: Diabetes has become Mexico's number-one health problem, as a result of increasingly unhealthy lifestyles and rising obesity levels. The early and speedy approval of diabetes therapeutics by local authorities aims to meet the urgent epidemiological needs of the country, as well as demonstrates Mexico's improving competitiveness on the global pharmaceutical market. The high prevalence and poor management of disease in Mexico presents significant market opportunities for multinationals. However, COFEPRIS' efficient response to the high disease burden could introduce unexpected competition for companies already established in the market.

Mexico's Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has approved Sanofi's Lyxumia (lixisenatide), a once-daily injectable GLP-1 receptor agonist for the treatment of type 2 diabetes. Clinical studies of the medicine were carried out in Mexico and 40 other countries, including Canada, Australia, Germany, Japan and Morocco. Mexico is the first country to approve the drug in the world.

According to BMI's Burden of Disease Database (BoDD), disability-adjusted life years (DALYs) lost to diabetes ranks the highest among communicable and non-communicable diseases in the country, Mexico's DALYS lost to diabetes totalled over 30% of the total diabetes DALYs in Latin America. Diabetes is the country's most common cause of mortality in adults, and the number one cause of hospital discharge in the Mexican Institute of Social Security (IMSS). Local media has reported that diabetes accounts for 34% of Mexico's public health insurance spending.

A High Diabetes Burden
2012 DALYs Lost To Selected Diseases In Mexico

A survey carried out by Mexico's Instituto Nacional de Salud Publica reported that although the treatment coverage for type 2 diabetes is high (94%), only 5% of patients diagnosed with the disease are fall under the 'maintaining the condition well' category - in terms of A1c haemoglobin measurement (which should be below seven). The study showed that of the majority of patients being treated with anti-diabetic medication: 85% are receiving anti-diabetic agents, 7% are on insulin only and 3% are on combination of both, while and 6% are treated with no medication. Most patients are treated under a public healthcare institution, such as IMSS and Secretaria de Salud (SSA).

Low Insulin Use
Diabetes Treatment Prevalence (%)
Mainly Treated By Public Healthcare Service
Healthcare Providers That Treat Type 2 Diabetes

BMI's BoDD also showed that DALYS lost to diabetes among people between 30 and 60 years old increased by over 40% between 2007 and 2012. We believe that high disease prevalence and poor disease control indicates a need for the significant improvement of medicine access and quality in Mexico - creating significant revenue earning opportunitied for the producers of diabetes therapeutics.

In Q212, Mexico offered some mixed results for multinationals. Roche, Pfizer and GSK experienced negative effects from biosimilar competition, government purchase timing issues and generic drug price competition. However, sales of Sanofi's diabetes drug lantus (insulin) were particularly strong in Mexico (+25.8%).

Diabetes Not Under Control
DALYs Lost To Diabetes In Mexico

Sanofi's outperformance in Mexico is unsurprising, given its significant presence in the country. However, we believe it will face increasing competition from its international peers and local manufacturers. In order to address the high disease burden in Mexico, during 2012 alone, COFEPRIS approved Bristol Myers Squibb's Kombiglyze xr (saxagliptin and metformin hcl extended-release) for type 2 diabetes treatment and Novo Nordisk's Ryzodeg (insulin) and Tresiba (insulin) .

This article is tagged to:
Sector: Pharmaceuticals & Healthcare
Geography: Mexico, Mexico, Mexico, Mexico