SwedenSweden

MS treatment staggers – but is it out?

20.08.2011

Petach Tikva/Lund – Active Biotech AB suffered a severe setback in the development of its oral multiple sclerosis drug laquinimod. Together with ally Teva (Israel), the Swedish drugmaker announced that the substance failed in Phase III testing. A joint statement from the two companies stated that “results showed that the BRAVO study did not achieve its primary endpoint of reducing the annualised relapse rate.” However, there was data demonstrating significant reduction in brain-volume loss and the risk of disability progression. Teva said that study participants showed a 21.5% annual reduction in relapses, a 27.5% reduction in brain volume loss and a 33.5% reduction in the risk of disability progression – as measured by the Expanded Disability Status Scale – compared to those who received a placebo. Despite the setback, the drugmaker remains committed to laquinimod, Teva officials told analysts during a conference call. And data adjustment might do the trick. MRI scans showed patients in the laquinimod group had more brain lesions, which indicates they had more severe multiple sclerosis. If study results are adjusted to remove that imbalance, laquinimod might meet its primary goal of lowering the relapse rate. Analysts remained unconvinced: “We are not aware of a precedent case where an MS drug was approved without two statistically significant trials,” said Christopher Holterhoff from Oppenheimer & Co Inc. Analysts from Nordea Markets slashed the price target for Active Biotech to SEK40 from SEK70, while at the same time upgrading its recommendation from “Sell” to “Hold”. The company’s shares have dropped by about 60% since the beginning of August.

Politics / Law

23.03.2012

Brussels/Strasbourg – Health claims are set to be drastically limited in the EU. On Wednesday 21 March the Environment Committee of the European Parliament confirmed a proposal of the European Commission to prohibit 1,600 health...

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Parma/Stockholm – Foodborne bacteria such as Salmonella and Campylobacter are becoming more and more resistant to antimicrobial drugs, according to a joint report published by the European food watchdog EFSA and the European...

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In mid-February, scientists and entrepreneurs from nine EU countries met at the Center for Genomic Regulation (CRG) in Barcelona to launch the 4DCellFate project. Positioned within the FP7 Programme, the consortium will receive...

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Brussels – The EU’s Innovative Medicines Initiative (IMI) will establish the European Lead Factory, an EU-wide public-private partnership aiming to facilitate drug discovery efforts. The Lead Factory will comprise a...

Editorial

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T    he societal and economic challenges facing Europe and the world are complex and interconnected. The Bioeconomy Strategy and Action Plan “Innovating for Sustainable Growth: a Bioeconomy for Europe”, which was adopted by the...

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Intellectual Property (IP) is without question one of the most vital aspects of any bio­tech venture, a key and undisputed factor for success. However, most bio­tech companies are still incapable of unlocking the value of their...

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Schlieren – Swiss Cytos Biotechnology Ltd. has been authorised to restructure a convertible bond by Canton of Zurich authorities. The company does not have enough cash to pay it back. Negotiations with bond holders failed in a...

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Munich – German 4SC AG jumped 39% to €2.05/share after oncology drug candidate resminostat met the primary endpoint of at least a 20% progression-free survival rate in a Phase II trial to treat patients with hepatocellular...

Editorial

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The start of 2012 witnessed the tides turning in favour of small and mid-cap names in the European Life Sciences sector. Major global biotechnology indices like the NBI, BTK, and BIOTK are up over 15% year to date. The pace of...

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