News

Stelara: FDA and  EMA to ballot
Enlarge image

RegulatoryEUNetherlands

Stelara: FDA and EMA to ballot

10.12.2012 - J&J subsidiary Janssen pushes its antibody Stelara for approval against psoriatic arthritis. FDA and EMA will decide over the filed application.

The Johnson & Johnson subsidiaries Janssen Research & Development, LLC, and Janssen Biotech, Inc, from Horsham (USA) as well as Janssen Biologics B.V. from Leiden (The Netherlands) announced on 6 December the submission of a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA), respectively. In both cases, the companies ask for the approval of Stelara (ustekinumab) for the treatment of adult patients with active psoriatic arthritis, a type of inflammatory arthritis that affects up to 30% of people suffering from psoriasis. Stelara is a human interleukin (IL)-12 and IL-23 antagonist, that is currently approved in 69 countries for the treatment of moderate to severe plaque psoriasis. After promising multicentre, randomised, double-blind, placebo-controlled Phase III trials (PSUMMIT I and II), J & J now hopes to expand the indication range for Stelara.

Jerome A. Boscia, Vice President at Janssen Research & Development, said: "The efficacy and safety of Stelara have been shown in a large Phase III clinical development programme for the treatment of active psoriatic arthritis, a disease for which tumour necrosis factor inhibitors are currently the only approved biologic therapies, and additional therapeutic options are needed." The trials included patients diagnosed with active psoriatic arthritis who had at least five tender and five swollen joints and C-reactive protein (CRP) levels of at least 0.3 mg/dl in spite of previous treatment with conventional therapy. Patients with previous exposure to tumour necrosis factor (TNF) inhibitors were also partially included. Stelara is also in a Phase III development for the treatment of moderately to severely active Crohn's disease.

Some weeks ago Janssen Biotech demonstrated its dedication to R&D by announcing collaborations with Danish Genmab A/S on the production of bi-specific antibodies as well as the development of daratumumab, a CD38 antibody.

© eurobiotechnews.eu/ml

http://www.european-biotechnology-news.com/news/news/2012-04/stelara-fda-and-ema-to-ballot.html

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.

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.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • MEDIGENE3.95 EUR2.33%
  • 4SC0.92 EUR2.22%
  • BIOTEST80.77 EUR1.62%

FLOP

  • CYTOS0.27 CHF-6.90%
  • CO.DON2.56 EUR-3.40%
  • WILEX2.10 EUR-2.78%

TOP

  • CYTOS0.27 CHF58.8%
  • EPIGENOMICS5.20 EUR36.8%
  • FORMYCON10.74 EUR36.1%

FLOP

  • 4SC0.92 EUR-13.2%
  • CO.DON2.56 EUR-12.6%
  • BIOFRONTERA2.59 EUR-9.4%

TOP

  • SANTHERA92.00 CHF2321.1%
  • CO.DON2.56 EUR156.0%
  • BB BIOTECH185.30 EUR63.0%

FLOP

  • CYTOS0.27 CHF-91.9%
  • 4SC0.92 EUR-48.3%
  • THERAMETRICS0.07 CHF-46.2%

No liability assumed, Date: 26.11.2014