News

Blow for Novo’s insulin Tresiba
Enlarge image

RegulatoryDenmarkEUFrance

Blow for Novo’s insulin Tresiba

08.11.2012 - Novo Nordisk’s shares dropped after the FDA said that its long-acting insulin degludec had heart safety risks prior to a meeting of agency advisers.

With the ultra-long acting insulin analogon Tresiba (insulin degludec) filed for market authorisation, the Danish drugmaker wanted to take a piece of the cake of Sanofi’s bestseller Lantus, which made €3.9bn in sales last year. But after the US Food and Drug Administration (FDA) released a report questioning whether more safety studies should be conducted, analysts had doubts over Novo’s plans. “We see the risk of a significant delay to the U.S. approval as being substantially higher than before,” stated Jeffrey Holford, an analyst at Jefferies & Co. in New York. and downgraded the stock to "hold" from "buy". Prior to the news, Tresiba, which must be only taken once daily, was expected to make €1.1bn annually. After it shares dropped by almost 7%, the lowest value since last August.

In the FDA staff document, the cardiovascular risk of degludec is higher than previously published reports. However it is not clear if the FDA advisors will recommend them to conduct additional studies pre- or post-approval.  According to analyst Martin Voegtli from Zurich-based Kepler Capital Markets, the most probable scenario is market authorisation in early 2013 with the obligation to conduct post-marketing studies to investigate the cardiovascular risk of degludec.

In summer, Novo claimed Tresiba to have a benefit over Sanofi’s Lantus in reduction of hypoglycemia but analysts seem sceptic. Tresiba has already gained market authorisation in Japan and was recommended for market approval by the EU CHMP in mid-October. Morgan Stanley analysts Peter Verdult and Chris Eccles said in mid-October that the see a 3% annual growth of Lantus in the €12bn diabetes market even after expiry of the patent in 2015 and competition by degludec. With Lantus Sanofi makes 20% of its profits. The analysts value Sanofi’s value at „overweight“.

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2012-04/blow-for-novos-insulin-tresiba.html

FinancingSwedenNorway

31.10.2014 Another biotech is leaving the European market place in favour of a US IPO. Swedish Cortendo is now planning to go public in the US after raising €8.8m in bridge financing.

FinancingUK

29.10.2014 British VC fundraiser Advent Life Sciences has raised €184m with its second fund. The money will help seed and build life sciences companies in the UK, Europe and the US, the company said.

BusinessSwitzerlandGermanyUK

28.10.2014 Swiss pharma company Novartis is selling its influenza vaccines business to Australian biopharma specialist CSL Ltd for US$275m.

PoliticsSwitzerland

23.10.2014 Just one day before its planned initial listing, Swiss Molecular Partners has cancelled its IPO. The reason: "unfavourable market conditions".

PoliticsEU

23.10.2014 Jean-Claude Juncker can breathe a sigh of relief as MEPs voted “yes” by a large majority to his team of European Union Commissioners. Previous to the vote, Juncker had shifted the EMA back to the health commissioner in response to protests.

FinancingFrance

21.10.2014 Yet another European company is looking for money on the US stock exchange – French DBV Technologies SA is all set up for its secondary listing on NASDAQ. The French biotech company hopes to rake in US$98m for its peanut allergy patches.

FinancingDenmark

18.10.2014 After raising US$220.5m (€172m) with its IPO, fast Forward Pharma’s lucky streak hits an obstacle on the road to success with shares falling 17% on its first day of trading.

M&AUKItaly

17.10.2014 Abandoned at the altar: Abbvie has dropped plans to acquire UK’s Shire following new US tax rules. This puts a stop to one of the biggest pharma mergers planned this year.

FinancingUKBelgium

15.10.2014 Bicycle Therapeutics wins €25m backing by major pharma venture capitalists for the development of a new class of oncology drugs.

FinancingGermanySwitzerlandNetherlands

13.10.2014 Biotechnology IPOs are back in fashion – German Probiodrug AG wants to raise €32m with its IPO, whilst Swiss Molecular Partners AG hopes the launch of its IPO will gain a revenue of €145m.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • THERAMETRICS0.08 CHF14.29%
  • CYTOS0.17 CHF13.33%
  • MORPHOSYS75.99 EUR4.89%

FLOP

  • EPIGENOMICS4.15 EUR-4.38%
  • EVONIK26.20 EUR-2.42%
  • PAION2.80 EUR-2.10%

TOP

  • BIOFRONTERA2.82 EUR28.2%
  • HBM91.50 CHF8.6%
  • EPIGENOMICS4.15 EUR8.4%

FLOP

  • MAGFORCE5.55 EUR-19.6%
  • CO.DON2.65 EUR-15.6%
  • PAION2.80 EUR-13.0%

TOP

  • SANTHERA89.00 CHF2318.5%
  • CO.DON2.65 EUR167.7%
  • WILEX2.25 EUR81.5%

FLOP

  • CYTOS0.17 CHF-95.7%
  • MERCK KGAA71.68 EUR-41.5%
  • 4SC0.98 EUR-41.0%

No liability assumed, Date: 30.10.2014