Home » Economy » Pharma – Santhera with setback at Raxone's application for authorization News

Pharma – Santhera with setback at Raxone's application for authorization News

Friday, September 15th, 2017 | Economy

The shares of the pharmaceutical company Santhera have to plug in on Friday quite nicely: They pay more than half the value. The trigger for the downtrend is the negative assessment of a preliminary commission of the European Medicines Agency (EMA) for the core product Raxone. An important future cure driver could now be eliminated.
The Santhera shares will drop 51% to CHF 34.65 at 10 am at very high volumes. As a reminder, the papers had cost CHF 134 more than two years ago. The SPI total market is currently losing 0.24% at week-end.
Raxone is now approved in Europe against the rather rare eyelid Lebersche optic atrophy (LOHN). However, the much larger area of ​​application would be the disease Duchenne muscular dystrophy (DMD). However, the EMA Committee on Human Medicines (CHMP), Santhera, has broken the bar after an oral hearing on Wednesday.
The CHMP doubted that the study of Santhera provided sufficient evidence of the efficacy of Raxone in DMD and gave a negative assessment for the extension of the indications. Santhera intends to oppose the CHMP's assessment and to request a re-examination.
Already in the past it was not always around for Santhera with Raxone at DMD. The health authorities in Europe and the USA had requested further efficacy data on the product on previous occasions. The approval decision in Europe now threatens to be negative. When he is felled in the US is still open.
June was still very promising: at the time, the first positive evaluation for Raxone for the treatment of DMD was made by the British drug regulator MHRA. The drug received the status of a "promising innovative drug".
Now an important future Kurstreiber falls away at Santhera, explain dealers and speak of a "bitter setback" for the company. In addition, most analysts expected a positive decision from the European regulatory authority. Many investors were caught on the wrong foot.
(AWP / cash)

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