SwitzerlandSwitzerland

Novartis fails with Phase III osteoporosis drug

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 three-year Phase 3 trial, Study 2303, conducted by its license partner Nordic Bioscience, assessing an oral formulation of calcitonin (SMC021) in the treatment of post-menopausal osteoporosis. Study 2303 failed to demonstrate a significant difference between treatment groups at three years for the primary endpoint, with no statistically significant treatment effect observed on the reduction of the occurrence of new vertebral fractures. Similarly, no statistical significant response was observed on key secondary endpoints such as new non-vertebral fractures or new clinical fractures. In 2004, Novartis bought the right to manufacture calcitonin from US- based Unigene Laboratories using Unigene’s patented peptide production process. Unigene's own oral formulation of salmon calcitonin is more successful and has reached Phase 3 statistical significance for its primary endpoint. “Although today’s news reduces the likelihood of near-term royalties under our manufacturing license with Novartis, it ironically now places Unigene in an exceptionally strong leadership position with respect to our oral peptide drug delivery platform", said Asleigh Palmer, Unigene's CEO.
In contrast to the pharma giant Novartis, little biotech Nordic Bioscience leaves the battlefield with its head held high. In June, the Danes established a Joint Development Vehicle (JDV) with Unigene to progress up to three of Unigene’s internally developed, proprietary calcitonin analogs through Phase 2 proof-of-concept in humans for the treatment of Type 2 diabetes, osteoarthritis and osteoporosis. Unigene and Nordic will each own 50% of the resulting JDV.

SwitzerlandSwitzerland

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,...

SwitzerlandSwitzerland

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....

SwitzerlandSwitzerland

23.01.2012

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...

SwitzerlandSwitzerland

19.12.2011

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...

SwitzerlandSwitzerland

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...

SwitzerlandSwitzerland

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...

SwitzerlandSwitzerland

14.12.2011

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,...

SwitzerlandSwitzerland

22.11.2011

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...

SwitzerlandSwitzerland

11.11.2011

Ghent/Geneva - Ablynx rides the biotech rollercoaster. Only days after US-pharma company Pfizer pulled out of a rheumatoid arthritis pact, the Belgian bipharmaceutical outfit expanded its relationship with Merck Serono. Ablynx...

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