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Nicox glaucoma drug meets endpoints in Phase IIb study

14.03.2012

Sophia Antipolis/ Madison – French NicOx S.A. and the global eye health specialist Bausch & Lomb have announced positive top-line results from their phase 2b dose finding study with BOL-303259-X, a nitric oxide-donating version of Pfizer’s prostaglandin F2-alpha analogue latanoprost, in 400 patients with open-angle glaucoma or ocular hypertension. As shown in two previous Phase II trials conducted during NiCox’s partnership with Pfizer, which ran from 2004-2009, BOL-303259-X (previously NCX 116, PF-3187207) was superior to Pfizer’s lipophilic prostaglandin F2-alpha formulation latanoprost (Xalatan®). In 2 of 4 dose regimes, the NO-donating drug lowered intraocular pressure (IOP) better than Xalatan. On top of that, the responder rate was 68.7% for the most efficacious dose of BOL-303259-X, compared to 47.5% for Xalatan®. The most frequent side effect was reddening of the eyes (hyperemia). The results triggered a US-$10m milestone from Bausch & Lomb to its French partner. The US eye specialist announced it will initiate a global phase 3 development program for the eye drops. The firms believe that NO improves the IOP lowering effect of prostaglandin F2-alpha. In two Phase II trials completed in 2008, the drug was reported to be at least 20% more effective than Xalatan®, according to Pfizer, which re-licensed all development and commercialisation rights to NiCox in August 2009 after having refocused its drug development priorities.

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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: 17.04.2014

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