News

EU approves Sanofi’s Lyxumia
Enlarge image

RegulatoryEUFranceDenmark

EU approves Sanofi’s Lyxumia

05.02.2013 - The European Commission has granted EU market authorisation to Sanofi’s GLP-1 receptor agonist licisenatide as a diabetes therapy.

The first in class once-daily prandial GLP-1 (glucagon-like peptide-1) receptor agonist, is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as a second line therapy. The decision of the Commission to approve the drug for patients that do not respond to a combination of oral glucose-lowering medicinal products plus basal insulin as well as diet and exercise is based on results from the GetGoal clinical programme

In 11 studies on 5,000 patients, the Paris-based drug maker demonstrated significant HbA1c reductions, a pronounced post-prandial glucose lowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes. GetGoal results also showed that Lyxumia (licisenatide) had a favourable safety and tolerability profile in most patients, with mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycaemia, according to Sanofi.

The therapy, which was licensed from Danish Zealand Pharma A/S in a €170m deal, is indicated when first-line therapy proves no longer effective over time. It strengthens Sanofi’s leading position in the €12bn diabetes market. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells

© eurobiotechnews.eu/tg 

http://www.european-biotechnology-news.com/news/news/2013-01/eu-approves-sanofis-lyxumia.html

FinancingPoland

24.03.2015 Poland has announced the closing of a new venture capital fund at US$42m (€32m). The fund, which is the first of its kind in Poland, is dedicated to the Life Sciences with a strong connection to Central and Eastern Europe.

BioeconomyFranceSwedenGermanyNetherlandsFinland

23.03.2015 A BASF-led consortium aims to decrease bio-based production costs using industrial biotechnology. The Horizon2020 funded consortium is the sixth project of the SPIRE Public Private Partnership and has a budget of €14m.

Stock MarketsFranceSwedenUKNorwayIreland

20.03.2015 There are no signs of inertia creeping into the European biotech industry this spring. A total of eight IPOs are set to go public by the end of the year’s first quarter.

FinancingUKEU

17.03.2015 Pharma giants GlaxoSmithKline (GSK) and Johnson & Johnson (J&J) will be key collaborators in a new global fund for dementia research to address the rising threat posed by dementia and Alzheimer’s disease.

FinancingFranceDenmarkSwedenGermany

19.03.2015 French venture capital firm Seventure Partners has raised a further €25m for its microbiome-focused Health for Life Capital Fund. It now stands at €100m.

EventsFranceEUSwitzerlandUKGermany

12.03.2015 With around 1,400 companies and 2,400 participants, the springtime counterpart of BIO-Europe enjoyed a successful premiere in France this year. The overall mood of the European biotech industry was positive, and the French hosts in particular reported new initiatives.

M&ABelgium

11.03.2015 Belgian cell-based therapeutics developer and CMO MaSTherCell SA has been acquired by US biotech Orgenesis Inc. for €23m.

FinancingGermany

10.03.2015 The Gates Foundation has dipped into its purse to bring infectious diseases vaccines to the poorest countries. German vaccine specialist CureVac is set to receive US$52m for their mRNA platform technology.

Stock MarketsIrelandUK

05.03.2015 The IPO wave in the biotech sector shows no signs of slowing down. An Irish life sciences fund set up by former Elan executives plans to raise €325m with its IPO, whilst Summit Therapeutics has announced its IPO pricing of US$34m on Nasdaq.

LicencingDenmark

05.03.2015 Bavarian Nordic is outlicensing its Phase 3 prostate cancer immunotherapy Prostvac to pharma heavyweight Bristol Myers Squibb for a tidy €881m.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • 4SC1.28 EUR52.38%
  • THERAMETRICS0.08 CHF14.29%
  • WILEX2.96 EUR1.37%

FLOP

  • MOLOGEN5.68 EUR-28.01%
  • MORPHOSYS54.71 EUR-22.45%
  • MEDIGENE11.65 EUR-13.70%

TOP

  • CYTOS1.40 CHF311.8%
  • MEDIGENE11.65 EUR174.1%
  • 4SC1.28 EUR64.1%

FLOP

  • MORPHOSYS54.71 EUR-26.8%
  • WILEX2.96 EUR-13.7%
  • BASILEA106.70 CHF-12.7%

TOP

  • SANTHERA92.00 CHF2259.0%
  • WILEX2.96 EUR393.3%
  • FORMYCON23.15 EUR232.6%

FLOP

  • CYTOS1.40 CHF-54.2%
  • MOLOGEN5.68 EUR-49.9%
  • PAION2.35 EUR-29.6%

No liability assumed, Date: 26.03.2015