Has obtained patent in the United States until 2033 for the combination of tesofensine and Metoprolol

Saniona, a leading biotech company in the field of ion channels, today announces that the United States Patent and Trademark Office has issued a patent covering the combination of tesofensine and Metoprolol. The patent for Tesomet expires in the U.S. in 2033.

“This is an important patent for Saniona. Tesomet represents an innovative new treatment opportunity for type 2 diabetes, which we believe has a significant potential. We are planning to start Phase 2a studies during the first half of 2016,” says Jørgen Drejer, CEO of Saniona.

Saniona has previously informed about the notice of allowance for U.S. patent application (US14/379,032) covering the combination of Tesofensine and Metoprolol. It is this patent which has been issued with the identification number US 9,211,271 B2.

The invention covered by the U.S. patent relates to the use of pharmaceutical compositions comprising a therapeutically effective combination of Tesofensine and Metoprolol for preventing the cardiovascular side effects of Tesofensine, while leaving the robust inhibitory efficacy on food intake and body weight loss unaffected. The patent claims cover a method of treatment, prevention or alleviation of obesity, a pharmaceutical composition of Tesofensine and Metoprolol for use as a medicament and a kit comprising Tesofensine and Metoprolol as well as the use hereof.

For more information, please contact

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

About Saniona

Saniona is a research and development company focused on drugs for diseases of the central nervous system, autoimmune diseases, metabolic diseases and treatment of pain. The company has a significant portfolio of potential drug candidates at pre-clinical and clinical stage. The research is focused on ion channels, which makes up a unique protein class that enables and controls the passage of charged ions across cell membranes. Saniona has ongoing collaboration agreements with Upsher-Smith Laboratories, Inc., Productos Medix, S.A de S.V and Saniona’s Boston based spinout Ataxion Inc., which is financed by Atlas Venture Inc. and Biogen Idec Inc. Saniona is based in Copenhagen, Denmark, where it has a research center of high international standard. Saniona is listed at AktieTorget since April 2014 and has about 3,000 shareholders. The company’s share is traded under the ticker SANION. Read more at www.saniona.com.

About Tesomet

Tesomet is a fix-dosed combination of tesofensine and metoprolol, which Saniona plans to position for treatment of type 2 diabetes. In addition to obesity, tesofensine has also the potential to reverse the progression of type 2 diabetes by reducing liver fat. The market for type 2 diabetes is estimated to grow from US $ 23 billion in 2014 to 43 billion USD 2023 due to the increasing problems with obesity. Type 2 diabetes is considered as a progressive chronic disease today. However, recent published research concludes that type 2 diabetes is reversible and that large patient populations may undergo long-term remission if they achieve a substantial weight loss through reduced food consumption.

Saniona believes that tesofensine represents an interesting new treatment option for type 2 diabetes, which not only may be used in parallel with existing treatments, but also may offer potentially long-term remission in many patients by contributing to a substantial weight loss. In general, tesofensine has been well tolerated in human clinical studies. However, an increase in heart rate has been observed at therapeutic relevant doses of tesofensine. Patent applications have been filed in respect of the combination tesofensine and a beta blocker. Saniona has received notice of allowance of a U.S. patent application, which includes a combination of tesofensine and metoprolol and which can provide protection in the United States until 2033, if issued. The combination product is covered by other recent Saniona patent applications with broad geographic coverage. Saniona has recently published new results from datamining of previous clinical studies, which show that tesofensine improved glycaemic parameters in prediabetes individuals participating in a Phase 2 obesity study and that metoprolol blunts the increase in heart rate caused by tesofensine in volunteers in a Phase 1 study. Saniona expects to initiate a Phase 2a study during the first half of 2016 for Tesomet in type 2 diabetes patients.

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