News

Algeta and Bayer file for MAA
Enlarge image

BusinessNorwayGermany

Algeta and Bayer file for MAA

13.12.2012 - Algeta ASA has baged a €50m milestone after its partner Bayer Healthcare AG submitted a MAA to the European Medicines Agency.

Last year, the companies demonstrated improved overall survival with radium-223 dichloride (radium-223, previously Alpharadin) as a treatment in castration-resistant prostate cancer (CRPC) patients with bone metastases. The milestone is part of a €560m licence deal signed in 2009 by the German drug developer and the Oslo-based specialist for alpha particle-emitting cancer pharmaceuticals.   

The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. In the study, radium-223 increased overall survival by 44%, resulting in a 30.5% reduction in the risk of death compared to placebo. The median overall survival (OS) benefit in patients with radium-223 was 3.6 months, based on 14.9 months OS with radium-223 plus best standard of care (BSoC) vs. 11.3 months with placebo plus BSoC. 

Prostate cancer is the most common non-cutaneous malignancy in men worldwide. In 2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000 died from the disease worldwide. Prostate cancer is the sixth leading cause of death from cancer in men. A majority of men with CRPC have radiological evidence of bone metastases.  

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2012-04/algeta-and-bayer-file-for-maa.html

RegulationItalyGermanyNetherlandsEU

28.11.2014 The first gene therapy for a rare genetic condition — UniQure's Glybera — is on its way to the European market. But there is a hefty price tag: Chiesi, responsible for the marketing of the orphan drug, is asking for a record price of €1.1m per patient.

New reportEU

25.11.2014 The European biotech IPO slump has finally come to an end. A brand new industry report shows that compared to previous years, the number of biotech IPOs more than doubled in 2014, with London and Paris exchanges leading the pack.

M&AIreland

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.

Drug DevelopmentGermany

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.

FinanceFrance

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.

AwardsFranceGermanySweden

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.

ResearchEU

10.11.2014 EFPIA’s specialised group Vaccines Europe and the Innovative Medicines Initiative (IMI) have launched a €280m Call for proposals aimed to address the Ebola crisis.

Trade fairGermanyEU

07.11.2014 3,200 participants from 54 countries attended the 20th issue of BIO-Europe. The overall mood of the European biotech sector was modestly optimistic.

AcquisitionGermanyUKSweden

05.11.2014 German Definiens AG has a new owner: Astrazeneca’s biologics R&D arm Medimmune has taken over all the shares of the imaging specialist for US$150m.

AcquisitionSwedenDenmarkUK

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.

Events

All Events

Current issue

All issues

Product of the week

Products