News

EMA greenlights Novo’s degludec
Enlarge image

BusinessDenmarkFrance

EMA greenlights Novo’s degludec

22.10.2012 - The EMA has paved the road to EU approval for Novo Nordisk’s long-acting insulin Tresiba – set to become a competitor of Sanofi’s diabetes medicine Lantus.

On October 19, the European regulator said yes to the ultra long-acting insulin analogon Tresiba (insulin degludec) which had outcompeted Sanofi’s diabetes blockbuster Lantus (insulin glargine) in a Phase III head-to-head trial published this spring (Lancet). In the trial, the rate of nocturnal confirmed hypoglycaemia was 25% lower with degludec than with glargine.

Analysts estimated that Novo Nordisk’s diabetes medicine could hit peak sales of €2-3bn annually in the global €35bn diabetes market. The drug, which is also slated for FDA panel review in early November, could take a big slice of the cake in a growing diabetes market. According to market estimate, the market could reach US$58bn by 2018, according to Standard & Poor.

Novo Nordisk’s degludec, which is injected subcutaneously trice a week, lasts up to 40 hours, unlike the 18 to 26 hours provided by current marketed long-acting insulins such as insulin glargine and insulin detemir, which is also marketed by the Danes.  Degludec has one single amino acid deleted from the human form of insulin, and is conjugated to hexadecanedioic acid via gamma-L-glutamyl spacer at the amino acid lysine at position B29

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2012-04/ema-greenlights-novos-deglutec.html

BioeconomyEU

26.08.2015 In its second call for proposals, the Bio-Based Industries Joint Undertaking has earmarked €106m for the research and development of useful bio-based products.

OncologyNorway

25.08.2015 Oslo Cancer Cluster is inaugurating its NOK1bn (€107m) Innovation Park. None other than Norwegian prime minister Erna Solberg officially opened the doors to the research park on August 24th.

LicensingUKSwitzerland

21.08.2015 Novartis Pharma AG has secured all remaining rights to antibody hopeful ofatumumab. Seller GlaxoSmithKline is set to receive up to US$1bn (€919m) for the treatment for MS and other autoimmune indications.

LicensingDenmark

18.08.2015 Danish Novo Nordisk is climbing on the antibody therapeutics bandwagon in a US$500m licensing agreement with antibody-specialist Genmab.

M&ASwitzerland

13.08.2015 Roche is stepping up its commitment in the fight against drug resistant “superbugs” with its takeover of US diagnostics play Geneweave, for up to US$425m.

M&AUK

11.08.2015 Biotech bug controllers Oxitec has been bought by US biotech Intrexon Corporation for $160m (€145m). The Oxford University spin-out specialises in environmentally friendly technology to control pests such as mosquitoes, which cause dengue fever and other diseases.

Research and DevelopmentFranceGermany

07.08.2015 In a deal worth more than €300m, Sanofi has partnered up with German drug discovery and development company Evotec in order to develop beta cell-modulating diabetes therapies.

M&AIrelandUK

05.08.2015 Irish pharma and biotech major Shire wants to be number one in orphan diseases, and is setting out to acquire US-American Baxalta in a US$30bn deal – by any means necessary.

R&DUKSweden

04.08.2015 In a deal worth US$65m upfront, AstraZeneca is again teaming up with long-time partner Isis Pharmaceuticals Inc., this time to discover and develop RNA antisense drugs for cardiovascular, metabolic and renal diseases.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • NEUROVIVE PHARMACEUTICAL AB (S)23.00 SEK25.00%
  • BAVARIAN NORDIC (D)41.03 EUR20.85%
  • TIGENIX (B)1.02 EUR17.24%

FLOP

  • BIOTIE THERAPEUTICS (FI)0.20 EUR-9.09%
  • THROMBOGENICS (B)2.90 EUR-6.15%
  • EVOCUTIS (UK)0.19 GBP-5.00%

TOP

  • KARO BIO (S)38.10 SEK2296.2%
  • TRANSGENE (F)5.08 EUR77.0%
  • BIOTECH PHARMACON (N)12.60 NOK33.3%

FLOP

  • CHRONTECH PHARMA (S)0.01 SEK-50.0%
  • THROMBOGENICS (B)2.90 EUR-42.5%
  • BIONOR PHARMA (N)1.28 NOK-37.6%

TOP

  • KARO BIO (S)38.10 SEK4546.3%
  • ADOCIA (F)86.70 EUR432.2%
  • VERONA PHARMA (UK)4.92 GBP339.3%

FLOP

  • CHRONTECH PHARMA (S)0.01 SEK-85.7%
  • BIOTEST (D)19.92 EUR-76.0%
  • NEOVACS (F)0.96 EUR-72.7%

No liability assumed, Date: 30.08.2015