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

LicensingSwitzerland

30.08.2016 Swiss biopharma company Ferring has acquired the exclusive development and commercialisation rights to Seikagaku’s Phase III chemonucleolytic leg pain treatment for €85m.

Clinical TrialsFrance

26.08.2016 Adocia said it would discontinue its diabetic foot ulcer programme after its lead product BioChaperone PDGF disappointed in Phase III. The French company will turn the focus on its earlier-stage products.

M&AUKSweden

24.08.2016 Pharma major Pfizer is putting the cherry on top of its multi-billion-dollar takeover of Medivation with the acquisition of AstraZeneca’s antibiotics for a cool US$1.5bn. With the divestment, AZ aims to further sharpen its focus.

FinancingUK

23.08.2016 Cambridge University-allied investor Cambridge Innovation Capital has raised £75m (€87m) to reinvest in technology and healthcare companies. Among the backers were Woodford Investment and Winton Ventures.

R&DDenmark

19.08.2016 Together with partner Johnson & Johnson, Danish biotech Genmab is now one step closer to FDA approval with its combination treatment for multiple myeloma after its submission of a supplemental Biologics License Application. In July, Genmab was granted a Breakthrough Therapy Designation (BTD) for its blood cancer therapy.

ResearchUKEU

17.08.2016 Philip Hammond, the UK’S chancellor has announced the government will guarantee funding for EU-backed "structural and investment fund" projects whose timelines extend beyond the UK’s departure from the EU, provided the projects are signed prior to this year's Autumn Statement on the UK budget. The decision ensures continued funding for farmers, companies and institutions involved in the EU’s Horizon 2020 project. The move could cost the UK government up to £6bn (€6.9bn).

Stock marketsGermany

15.08.2016 Back in April, the American FDA gave the green light for the colorectal cancer-screening test Epi procolon. Now Berlin-based diagnostics specialist Epigenomics is considering a secondary listing in the US. A draft of the required registration document was confidentially submitted to the US Securities and Exchange Commission (SEC).

LicensingDenmark

11.08.2016 Danish Genmab AS has granted Gilead Sciences license to use its DuoBody technology platform to develop bispecific antibodies for the treatment of HIV. The deal is worth up to €252m.

Clinical developmentHungaryIreland

09.08.2016 Hungarian Gedeon Richter and Irish Allergan are staying on course in the face of dissappointing Phase III results for depression drug cariprazine. The partners will now begin another Phase III study needed for approval.

ImmunotherapySpain

08.08.2016 Araclon Biotech’s Alzheimer’s vaccine ABvac40 is going forward into Phase II after showing a good safety profile in Phase I. The promising trial results were presented at the Alzheimer’s Association International Conference.

Quick news provided by GlobeNewswire

View more stock news

Events

All Events

Partner-Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • NEUROVIVE PHARMACEUTICAL AB (S)6.15 SEK8.85%
  • HYBRIGENICS (F)0.94 EUR8.05%
  • IXICO (UK)31.50 GBP5.00%

FLOP

  • ARGEN-X (B)13.70 EUR-3.52%
  • VECTURA (UK)132.10 GBP-3.17%
  • SAREUM HOLDINGS (UK)0.72 GBP-2.70%

TOP

  • NORDIC NANOVECTOR (N)33.60 NOK34.9%
  • MOLMED (I)0.42 EUR27.3%
  • NEUROVIVE PHARMACEUTICAL AB (S)6.15 SEK25.5%

FLOP

  • BIONOR PHARMA (N)0.42 NOK-22.2%
  • ACTIVE BIOTECH (S)12.20 SEK-18.4%
  • E-THERAPEUTICS (UK)11.50 GBP-14.1%

TOP

  • NICOX (F)10.31 EUR439.8%
  • SAREUM HOLDINGS (UK)0.72 GBP227.3%
  • GENMAB (DK)1095.00 DKK89.8%

FLOP

  • BB BIOTECH (D)44.55 EUR-82.4%
  • EVOCUTIS (UK)0.04 GBP-77.8%
  • CIRCASSIA LIMITED (L)96.20 GBP-71.7%

No liability assumed, Date: 31.08.2016