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

2014EU

19.12.2014 We took a look back at 2014: which European Biotechnology News stories topped the charts this year?

R&DEUBelgium

18.12.2014 IMI has launched a €115m call for proposals involving a project in collaboration with the Bill and Melinda Gates Foundation to improve vaccines against whopping cough in children.

PoliticsEUPolandItalySpainUK

16.12.2014 Two consortia combined of 144 European companies, research institutes and universities have been selected for funding by the EIT in the areas of health and raw materials. Both clusters are set to acquire €1.1bn over the next seven years.

M&ALuxembourg

11.12.2014 Luxembourg bio-analytical testing company Eurofins Scientific has signed an agreement to acquire Boston Heart Diagnostics Corp. for an initial €112m.

StudySwitzerlandEU

10.12.2014 When it comes to the biggest investors in Research and Development (R&D) Swiss pharma top dogs Novartis and Roche have defended their positioning among the top ten companies worldwide – according to a recently published EU study.

FinancingUKSpain

09.12.2014 British drug delivery specialist Midatech Pharma plc floated on the London stock market. It is the third biotech IPO on the AIM market this year.

CooperationAustria

05.12.2014 Austrian contract research company VTU has entered into a development and commercialisation agreement with US company RCT. The partners want to combine both companies' Pichia pastoris protein production technologies under VTU's roof.

FinancingDenmark

03.12.2014 Danish biotech pharma Ascendis has successfully completed a €48m Series D financing round. The funding is expected to support its late-stage clinical trials to push its lead drug into Phase III trials.

Events

All Events

Current issue

All issues

Product of the week

Products