SwitzerlandSwitzerland

First personalised drug Zelboraf is approved in EU

21.02.2012

Basel/Berkeley – Europe enters into the age of personalised medicine. The European Commission has approved the melanoma drug Zelboraf. While the compound was developed by US-based Plexxikon Inc., owned by Daiichi Sankyo Group, the companion diagnostic is made by Roche. Zelboraf is a selective oral blocker of the oncogenic V600E mutant BRAF kinase RO5185426 in patients with metastatic melanoma. About half of patients carry the mutation. “We are very pleased that our strategy to co-develop Zelboraf along with a companion diagnostic helped accelerate the availability of this personalised medicine for these patients”, said Plexxikon'S CEO Peter Hirth. Roche claims that the companion diagnostic significantly reduced development and approval time of the treatment. The cobas 4800 BRAF V600 test is already commercially available in Europe. Roche Molecular Diagnostics developed the test following a 2005 agreement with Plexxikon. It is the first companion diagnostic designed simultaneously with the drug from scratch. The package has already been approved in the US, Switzerland, Israel, Brazil, New Zealand and Canada. In contrast to existing treatments with interleukin 2 or the chemotherapeutic agent dacarbazine, to which 10-20% of melanoma patients respond, targeted treatment with Zelboraf showed a response rate in more than 80% of patients. After a year of treatment, 55% of patients who received Zelboraf were alive, according to results from the Phase III study, as compared to 43% of patients who received chemotherapy.

SwitzerlandSwitzerland

10.11.2011

Alschwil - Actelion Ltd. gets a badly needed injection of fresh capital. Under the guidance of the two biggest Swiss banks, UBS and Credit Suisse, the Swiss biopharmaceutical company takes up €171 million agreeing to pay a 4,875%...

SwitzerlandSwitzerland

18.10.2011

Basel/San Diego –Swiss drug company Roche has announced it is buying biotech-company Anadys Pharmaceuticals for US$230 million. Under the terms of the merger agreement, Roche will commence an all cash tender offer for all...

Germany, SwitzerlandSwitzerland

12.10.2011

The Swiss technology transfer organisation Unitectra is the winner of the European Biotechnica Award 2011. The specialist for technology transfer received the award from hands of Lower Saxony's Minister for Economy Jörg Bode. The...

SwitzerlandSwitzerland

01.10.2011

Liestal – Swiss Santhera AG has announced strict savings measures. Out of a total of 21 employees, almost every second is now slated to be sacked. The biotech firm is closing its department of preclinical development and scaling...

SwitzerlandSwitzerland

01.10.2011

Schlieren – Swiss biotechnology company Cytos AG has finally devised a plan to help its lead candidate into Phase II, but to achieve it, the cash-strapped company is having to slash its workforce by a whopping 85%. To ensure the...

SwitzerlandSwitzerland

01.10.2011

Geneva – Swiss biotech Addex Pharmaceuticals AG has regained all rights to its metabotropic glutamate receptor 4 (mGluR4) positive allosteric modulator (PAM) programme from Merck&Co, (known as MSD outside the United States and...

SwitzerlandSwitzerland

01.10.2011

Hamburg – When the compound EVT302 failed proof-of-concept testing in the spring of 2009, investors began backing away from Evotec AG shares. Now the selective MAO-B inhibitor is back, and has powered a leap in the company’s...

SwitzerlandSwitzerland

15.09.2011

Zurich – The FDA has posted a manufacturing warning to Lonza following an inspection of the firm's microbial production site for Eisai’s cancer drug Ontak in Hopkinton. However, analysts at Vontobel said that the impact of the...

SwitzerlandSwitzerland

30.08.2011

Schlieren - Swiss biotechnology company Cytos has devised a plan to get its lead candidate into Phase II. To achieve this, the cash strapped company will slash its workforce, as previously announced, by 85%. To ensure the...

SwitzerlandSwitzerland

22.08.2011

Liestal – Swiss Santhera Pharmaceuticals and researchers from Newcastle University have published the results from a pivotal clinical trial demonstrating that the firm’s synthetic coenzyme Q10 derivative idebenone significantly...

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