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

06.03.2012

London – The European Medicines Agency (EMA) calls it “the biggest change to the legal framework since the establishment of the Agency in 1995.” This year, the EU drug regulators are preparing new so-called pharmacovigilance...

Clinical Trial

06.03.2012

Norway’s Algeta ASA (Oslo) has updated its Phase III survival analysis of Alpharadin in patients with castration-resistant prostate cancer and bone metastases. The analysis showed an increase of 3.6 months in median overall...

Clinical Trial

06.03.2012

Genticel S.A. (Toulouse) has completed enrolment in its Phase Ib study of a lyophilised version of the world’s very first therapeutic vaccine ProCervix, which inhibits infection with the cancer-causing Human Papilloma Virus. The...

Clinical Trial

06.03.2012

The share value of French specialist for cardiometabolic diseases Genfit S.A. (Loos/Lille) took a jump after the company announced its candidate drug GFT505 had met all efficacy endpoints in a pilot Phase II study involving 22...

Clinical Trial

06.03.2012

The US Food and Drug Administration (FDA) has granted a Biologics License Application (BLA) to the HER2 dimerisation inhibitor pertuzumab developed by Roche (Basel) for previously untreated HER2­-positive metastatic breast...

Politics / Law

06.03.2012

A For years, the world’s major patent offices – including the EPO, USPTO and JPO – have been collaborating in the Patent Prosecution Highway (PPH) programme. Under the PPH, an applicant whose claims have been allowed in one...

BioFunding

06.03.2012

Berlin/Dublin – Two EU initiatives are seeking to better predict response to cancer treatments. Researchers from the a6m RESPONSIFY Project will develop biomarker-based breast cancer prognosis tests that could be used to predict...

BioFunding

06.03.2012

Bremen/Brussels – European researchers kicked-off the MicroB3 (Bio­diversity, Bioinformatics, Biotechnology) project in February. Thanks to a a9m EU fund, the 32 groups involved will create a unique bioinformatic resource that...

BioFunding

06.03.2012

A Brussels – The European Commission is boosting its investments and policy activities to foster sustainability. “Europe needs to make the transition to a post-petroleum economy,” said Máire Geoghegan-Quinn in Brussels. In...

Politics / Law

06.03.2012

Brussels – In February, I heard of a slightly mad and very worrying trend in decisions handed down by the Court of Justice of the European Union (CJEU) with regard to IP issues handed up from the national level for clarification....

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No liability assumed, Date: 19.04.2014

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