Saniona’s partner Medix submits new drug application in Mexico for tesofensine in obesity

PRESS RELEASE

December 23, 2019

Saniona (OMX: SANION), a clinical stage biotech company focused on eating disorders and CNS, today announced that its partner Medix has submitted a new drug application to the Mexican food and drug administration (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS) for approval of tesofensine for the treatment of patients with obesity.

“The filing of this new drug application in obesity represents an important milestone for Saniona and rounds off a year in which we have made tremendous progress. As well as addressing a major market in Mexico, with the potential for a new revenue stream, this filing also supports development of our proprietary product Tesomet, in which tesofensine is the key active ingredient,” says Jørgen Drejer, CEO of Saniona.

Saniona’s priority is to develop and gain market approval for Tesomet in the U.S. and Europe for Prader-Willi syndrome (PWS) and hypothalamic obesity, two rare eating disorders. Tesomet has the potential to significantly reduce weight and body mass index, and treat debilitating hyperphagia in these severe, rare and underserved orphan disease indications. Saniona has reported positive results in PWS and is planning to initiate Phase 2b and Phase 3 studies with the aim to independently commercialize Tesomet for these indications in the U.S. and Europe.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: tf@saniona.com

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 13:10 p.m. CET on December 23, 2019.

About Saniona

Saniona is a research and development company focused on drugs for treatment of eating disorders and diseases of the central nervous system. The company has five programs in clinical development. Saniona intends to develop and commercialize treatments for orphan indications such as Prader-Willi syndrome and hypothalamic obesity on its own. The research is focused on ion channels and the company has a broad portfolio of research programs. Saniona has partnerships with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona is based in Copenhagen, Denmark, and the company’s shares are listed at Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com .

About Productos Medix, S.A de S.V (Medix)

Medix is a Mexican pharmaceutical company established in 1956. Medix is primarily focused on treatment of overweight and obesity. The company is the market leader for treatment of overweight and obesity in Mexico where it offers the most comprehensive product and service line. Medix’s leading product for treatment of overweight and obesity is among the top ten pharmaceutical products in Mexico overall. Medix has earned several recognitions for its social responsibility through its participation in philanthropic programs for the benefit of the Mexican population and for its educational efforts involving thousands of doctors in Mexico. The company has subsidiaries in Argentina and certain other South American countries.

About Obesity - clinical condition

Obesity is characterized by severe excess weight in the form of fat and is defined on the basis of a measure referred to as Body Mass Index (BMI). A BMI of more than 30 is referred to as clinical obesity, while a BMI of between 25 and 30 expresses overweight. According to the World Health Organization (WHO), obesity has reached epidemic proportions globally, with up to 1.6 billion adults (over 15 years old) overweight and at least 400 million of them clinically obese.

According to the American Obesity Association (Obesity Fact Sheet), patients with obesity are at risk of developing one or more serious medical conditions, which can cause poor health and premature death. Obesity has been found to be the largest environmental influence on the prevalence of diabetes and it complicates the management of type 2 diabetes by increasing insulin resistance and glucose intolerance, which makes the medical treatment for type 2 diabetes less effective. Approximate 90 per cent of individuals with type 2 diabetes are reported to be overweight or obese. In addition, obesity increases the risk of cardiovascular disease, and is a major risk factor for heart attack. Over 75 per cent of hypertension cases are reported to be directly attributed to obesity. A weight loss of as little as 5 per cent can reduce high blood sugar and blood cholesterol.

About overweight and obesity in Mexico

Mexico ranks among the most obese country in the world. It is estimated that more than 70 per cent of the 128 million Mexicans are overweight and that more than 30 per cent are clinical obese. Since the 1990s, fat has become the principal source of energy in the Mexican diet and it is assumed that the consumption of highly processed food will continue increasing. Consequently, Mexico has seen the same kind of health issues that other countries with overweight populations have. Standardized mortality rates (SMR) for diabetes, acute myocardial infarction (AMI), and hypertension have increased dramatically. As of 2012, diabetes - associated with obesity - was the largest single killer in Mexico.

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• 20191223 - PR - Viking NDA - ENG

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