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“.
19.11.2014 It’s not every day that a company is pushed into the top ten of its sector, but that day has come for Actavis. Christmas came early for the new pharma giant after completing a US$66bn (€53bn) takeover battle for the Botox manufacturer Allergan.
18.11.2014 Merck KGaA and US rival Pfizer have signed a immuno-oncology alliance worth billions: Merck will share the development and commercialisation of its cancer antibody with its US partner – for €2.3bn.
14.11.2014 Cosily coinciding with World Diabetes Day on 14th November, French biopharma Les Laboratories Servier has struck a US$1bn deal with US pharma Intarcia Therapeutics for the exclusive rights to Intarcia’s unprecedented therapy for type 2 diabetes.
12.11.2014 Glitz and glamour are not words often used to describe science and mathematics. But once a year, celebrities from the science and showbiz world come together at the Breakthough Prizes, a glitzy television bash that honours scientists for their achievements. French life scientist Emmanuelle Charpentier was among this year’s winners.
04.11.2014 Galecto Biotech has entered an agreement with Bristol-Myers Squibb for the acquisition of the company and its lead drug, providing the Swedish company with the potential of reaching over US$400m.