News

Avastin less safe than Lucentis as AMD therapy
Enlarge image

BusinessSwitzerland

Avastin less safe than Lucentis as AMD therapy

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.

http://www.european-biotechnology-news.com/news/news/2012-02/avastin-less-safe-than-lucentis-as-amd-therapy.html

RegulationEU

21.01.2015 The EMA is asking for comments on how to implement the transparency rules of EU Clinical Trial Regulation, pointing to the new clinical trial portal and database as the main instrument.

Stock marketsEUGermany

21.01.2015 2014 was a record year for biotech companies on the European stock market, with a total of €2.4bn raised in the year - 25% more than in the year before.

ResearchEUUK

20.01.2015 Ebola research projects are set to receive €215m in funding from the European Commission’s IMI2 Ebola+ programme. Among the project partners are vaccine developers Glaxosmithkline, Johnson&Johnson and Merck. 

Stock ExchangeUKDenmarkFrance

16.01.2015 It's time to get used to weekly IPO plans by European biotechs. UK's drug discovery firm Redx Pharma Ltd, established just five years ago, has come of age with their £80m (€105m) IPO plans.

M&ASwitzerland

14.01.2015 Pharma kingpin Roche has launched a billion-dollar transaction for a total of US$1.2bn (€1bn), taking over the majority of US cancer specialist Foundation Medicine.

PoliticsEU

14.01.2015 The European Parliament has backed the legislation allowing individual countries to restrict or prohibit the cultivation of genetically modified crops that have been authorised at EU level.

M&AIrelandUK

13.01.2015 Shire beefs up its rare disease portfolio after acquiring NPS Pharma with the aim of becoming a leading biotech in a US$5.2bn deal. Part of the deal is the US biotech's lead portfolio of gastrointestinal and hormone replacement therapies.

M&ASwitzerlandFrance

09.01.2015 The excitement surrounding CRISPR genome editing shows no sign of abating. This month, Novartis and US biotech Intellia Therapeutics became the first ever biotech-pharma collaboration to use the groundbreaking technology.

PoliticsBelgium

08.01.2015 Belgian cell therapy specialist Cardio3 Biosciences joins the immuno-oncology arena with the acquisition of Celdara Medical's cancer division Oncyte for US$180m.

PoliticsIrelandEU

06.01.2015 With the aim to utilise Ireland’s many natural resources and keep abreast of the latest EU developments in bioeconomy, a multi-disciplinary team has been funded to maximise national income, exports and job creation related to Ireland’s bioeconomy.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • CYTOS0.39 CHF21.87%
  • THERAMETRICS0.07 CHF16.67%
  • SANTHERA97.50 CHF5.98%

FLOP

  • 4SC0.78 EUR-8.24%
  • ADDEX3.36 CHF-5.62%
  • BIOFRONTERA1.95 EUR-2.50%

TOP

  • CYTOS0.39 CHF77.3%
  • ADDEX3.36 CHF44.2%
  • BB BIOTECH253.50 EUR28.1%

FLOP

  • ACTELION99.25 CHF-16.3%
  • BIOFRONTERA1.95 EUR-15.2%
  • 4SC0.78 EUR-13.3%

TOP

  • SANTHERA97.50 CHF2355.9%
  • BB BIOTECH253.50 EUR110.1%
  • FORMYCON12.40 EUR60.0%

FLOP

  • CYTOS0.39 CHF-88.1%
  • 4SC0.78 EUR-51.6%
  • MOLOGEN5.79 EUR-50.1%

No liability assumed, Date: 26.01.2015