- The main value driver for the Saniona share is tesofensine/Tesomet (tesofensine and metoprolol)
- The greatest potential we perceive for Tesomet is in the US market, especially if improvement in glycemic parameters in obese type 2 diabetes patients can be shown in the upcoming clinical trial
- We expect a Phase IIb study for Tesomet in obese type 2 diabets patients to begin in mid-2018 and this will generate top-line data in 2019
- The stock continues to be relatively undiscovered by institutional investors, which is one explanation why the stock is trading significantly lower than fair value
The main value driver for the Saniona share is tesofensine/Tesomet (tesofensine and metoprolol), which represents about 60 percent of the company’s total value. A Phase III study is ongoing in Mexico, in which tesofensine is being evaluated in patients with obesity. Although tesofensine has shown very promising data in reducing weight in obese patients, a challenge has been the side effect profile with elevated heart rate. There is a substantial medical need in Mexico and the regulatory barriers are probably slightly lower, which, after all, is why Medix is performing this study. By adding beta blocker metoprolol, it has been shown that the negative increase in heart rate with tesofensine can be neutralized and even reduced. Saniona has developed a combination pill with these two substances for future development.
The greatest potential we perceive for Tesomet is in the US market, especially if improvement in glycemic parameters in obese type 2 diabetes patients can be shown in the upcoming clinical trial. We expect such a Phase IIb study to begin in mid-2018 and this will generate top-line data in 2019. If the results are in line with what has been shown in previous clinical trials for tesofensine, we believe that there are good opportunities to tie in a partner for the more extensive Phase III studies and commercialization. We estimate a peak sales potential for Tesomet in obese and pre-diabetic patients of USD 1.000 million, with a possible launch in 2022. If future studies show data that support Tesomet in treating type 2 diabetes, the potential is even greater.
In addition to these two indications, a limited Phase IIa study for Tesomet in Prader-Willi syndrome (PWS) is ongoing. We believe PWS is an attractive indication for which to pursue development of Tesomet in terms of time to market, costs for clinical trials and market opportunities. We estimate a peak sales potential for Tesomet in PWS of USD 240 million, with a possible launch in 2021.
The stock continues to be relatively undiscovered by institutional investors, which is one explanation why the stock is trading significantly lower than fair value in our base case scenario. The absence of significant near-term catalysts for the share, we believe, also is a reason why interest from investors is quite low.
Development of new innovative treatments is associated with high risk - the clinical trials are costly and it is common for projects to be delayed.
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- Press release Flaggningsmeddelande i Saniona AB
- Press release Saniona AB: Sanionas beslutar om interimsanalys av Tesomet-studien på patienter med Prader-Willi syndrom
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