02.05.2012 - Results from a NIH study confirm that treating wet AMD with unlicensed Avastin (bevacizumab) leads to more adverse effects than Novartis’ Lucentis.
Basel - Novartis AG has highlighted results from a head-to-head study comparing safety and efficacy of the VEGF antibody fragment Lucentis (ranibizumab) with the full VEGF antibody Avastin (bevazizumab) in wet AMD therapy. According to the NIH-funded CATT study (Comparison of Age-related macular degeneration Treatment Trials), Lucentis showed superior safety when compared to Avastin, which has been not approved as treatment for wet AMD but has been broadly used off label by ophtalmologists due primarily to a 50fold lower price.
According to Novartis, which has licensed marketing rights from Roche for Lucentis, two year data from 1107 patients confirm 30% higher risk of serious systemic adverse events with unlicensed bevacizumab versus Lucentis. Additionally, the Swiss pharma major pointed to reports of arteriothrombotic events, systemic haemorrhage, congestive heart failure, venous thrombotic events, hypertension and vascular death, which were more frequent in bevacizumab treated patients. These events have been previously associated with systemic anti-VEGF treatment.
"The apparent differential safety risk between the two medicines may be due to differences in the molecules and their commercial formulation“, said Tim Wright, Global Head of Development, Novartis Pharma. Previously published retrospective Medicare analyses compared the safety of unlicensed ocular bevacizumab and Lucentis for treating wet AMD. The primary analysis from the Curtis study showed that unlicensed bevacizumab and Lucentis were not associated with increased risks of death, heart attack, bleeding or stroke compared with photodynamic therapy or pegaptanib. A secondary analysis in the Curtis et al study, which included approximately 40,000 patients, showed a significantly higher risk of mortality (16%) and stroke (28%) with unlicensed intravitreal bevacizumab than with Lucentis. Gower et al. assessed 77,886 Medicare beneficiaries with wet AMD over 10 months. In this study patients treated with unlicensed intravitreal bevacizumab experienced an 11% significantly increased risk of death and a 57% significantly increased risk of haemorrhagic stroke compared to patients treated with Lucentis. The risk of ocular inflammation was 80% higher with unlicensed intravitreal bevacizumab than with Lucentis.
24.05.2016 One of the pioneering companies developing pharmaceuticals and diagnostics based on the gut microbiome, Enterome Bioscience, has raised €14.5m in a Series C financing round. Among the investors were Seventure and Lundbeckfond as well as Nestlé.
20.05.2016 The long awaited global review on antimicrobial resistance by economist Lord Jim O’Neill has been published. It sets out an action plan to defeat superbugs with a huge awareness campaign and rapid diagnostics to be used before antibiotics are prescribed.
18.05.2016 Bayer is deepening its involvement in CRISPR with a licensing agreement for genome editing patents. Irish partner ERS Genomics holds the rights to the CRISPR/Cas9 tech from Emmanuelle Charpentier, one of the inventors.
11.05.2016 Newly spun out company OxStem has raised £16.9m (€21.5m) to develop regenerative meds for the treatment of age-related disease. It is the largest financing for an Oxford spin-out – or any UK academic spin-out – to date.
09.05.2016 Swiss Genentech partner AC Immune has raised CHF42.7m (€38.6m) in order to advance its therapeutic and diagnostic product pipeline in Alzheimer’s disease. The news follows a recently announced R&D collaboration with Biogen.
04.05.2016 Barcelona-based epigenetics expert Oryzon Genomics has closed a debt funding round of €10.5m, bringing the total money raised since last year to €27m. The funds will serve to advance the company’s two LSD1 inhibitors in cancer and neurodegeneration.
03.05.2016 Ipsen is strengthening its ties to long-time development partner Oncodesign, a Dijon-based cancer treatment biotech. The French pharma is handing over the pre-clinical pharmacology for its oncology research programmes to Oncodesign.
29.04.2016 Swiss bank Group UBS has raised US$471m (€412m) for the UBS Oncology Impact Fund, which was set up to invest in early-stage cancer treatments. The money raised by the fund, nearly half of which comes from investors in Asia, is the largest amount ever raised for such a cancer investment fund.
27.04.2016 More revenue, more jobs, more financing, more R&D expenditure – all signs point towards sustainable growth in the German biotech sector. These are the results of the most recent company survey 2016, published by biotechnologie.de. The report was once again conducted alongside the biotech standards defined by the organisation for economic cooperation and development (OECD).