SwitzerlandSwitzerland

Santhera publishes pivotal trial results of idebenone and goes for EU approval

26.07.2011

Liestal/Newscastle – Swiss Santhera Pharmaceuticals and researchers from Newcastle University have published results from a pivotal clinical trial demonstrating that the firm’s synthetic coenzyme Q10 derivative idebenone significantly improves vision and perception of colour in a subgroup of patients with the rare mitochondrial disease Leber's Hereditary Optic Neuropathy (LHON). The 10,000 to 20,000 patients in Europe and the US, which suffer from the maternally inherited condition, initially lose the sight in one eye due to a malfunction of complex I of the mitochondrial respiratory chain and subsequent retinal apoptosis. Typically, they lose the sight in their other eye within the next 3 to 6 months (so called discordant visual acuity). Researchers from Newcastle, Munich, and Montreal now demonstrated for the first time in 85 patients, that treatment with a 900mg dose of idebenone over two years could significantly improve visual acuity in a patient subgroup carrying the G11778A or G3460A mitochondrial DNA mutations, which are found in 80% of all LHON patients.
The Newscastle group led by Professor Patrick Chinnery reported that idebenone treatment resulted in a marked improvement of vision in severely affected patients, who were not able to read any letter on a chart. In nine blind patients (12 eyes) out of 36 patients (61 eyes) taking idebenone, vision improved to an extent that patients were able to read at least one row of letters on the chart (20%). In contrast not a single patient of the 26 who were taking the placebo improved to that extent.
The results published in yesterday’s issue of BRAIN are part of a data package accepted by the EU drug authority on July 22th which now reviews the firm’s MAA in this indication. Market approval in LHON could be expected at the end of 2012 earliest, according to the Swiss specialist for neuromuscular diseases. The drug will be available trough a Named Patient Programme until the EMA has come to a decision. The greatest improvement was seen in patients who had deteriorated in one eye more than the other. The RHODOS study does not deliver data from patients who have been affected from the disease for more than 5 years. Idebenone has already gotten market approval in Canada as treatment for Friedreichs ataxia but was rejected the the EMA in this indication.

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26.01.2012

Basel – The rumours started just before Christmas. Roche wants Illumina. Just how dearly, has just become clear. The Swiss drugmaker made a $5.7b hostile bid for Illumina, the current market leader in Next-Generation sequencing....

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Basel – Good and bad news for Swiss drugmaker Novartis. First a look on the bright side: Signifor, for the treatment of Cushing's disease, is on its final stretch to approval. The Committee for Medicinal Products for Human Use...

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Basel - It is a further push for Roche's ambitions in medicine concerning the treatment of skin cancer: The European Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug Zelboraf and its companion...

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17.12.2011

Allschwil – Europe’s largest stand-alone biotech company Actelion Ltd. is receiving an injection of fresh capital. Under the guidance of the two biggest Swiss banks – UBS and Credit Suisse – the Swiss company will be issued a...

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14.12.2011

Stans – Due to the current financial market conditions and the lack of significant progress with currently available options, Swiss drug developer Mondobiotech says it will be implementing restructuring measures. Together with...

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Geneva – There's is life in Swiss biotechnology beyond big pharma. Genentech has launched a First-in-Human study with anti-IL-17, an antibody made by the Swiss biotechnology company NovImmune. The fully human monoclonal antibody,...

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Basel – The FDA has withdrawn the accelerated approval for Roche's Avastin (bevacizumab) to treat metastasising breast cancer. The US regulatory authority had originally granted accelerated approval for Avastin's use in treating...

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16.11.2011

Basel/Hervel – It may be the end of Novartis' lucky streak in osteoporosis. While the once a year osteoporosis injection Aclasta (a bisphosphonate) sells well, the Swiss pharma company had to break disastrous news from a...

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