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

FundingEU

11.07.2014 Among the seven newly launched Horizon2020 programmes are two with deep roots in biotech: IMI is going into its second round while the newly established Bio-based Industries partnership invests in bioeconomy.

Stock marketNetherlandsUKBelgium

10.07.2014 Not one but two biopharma companies are seeking entry into the stock market: After Abzena raised €25m in an IPO earlier this week, Argen-x has followed suit and sold shares worth €40m.

M&AUKIreland

08.07.2014 Abbvie is determined to bring home British rare disease specialist Shire in a merger worth £30.1bn (€37.9bn). So far, Shire has rejected all offers from the US company.

M&ASwitzerland

04.07.2014 Genentech, a member of Swiss Roche Group, is set to acquire US-biotech Seragon Pharmaceuticals Inc. With the move, Genentech will obtain the rights to investigational breast cancer treatments.

M&AFranceGermany

03.07.2014 Nicox S.A. is stretching beyond the European market: The French eye health specialist is set to acquire Aciex Therapeutics Inc., a US-based pharma company with several ophthalmic therapeutics nearing market maturity.

FinanceBelgium

01.07.2014 Belgian antibody specialist Ablynx has raised €41.7m through a private placement of new shares and plans on boosting their range of nanobodies in development.

BioeconomyBelgiumUK

30.06.2014 Building on a £1.2m financing round, Celtic Renewables partners with a Belgian pilot plant to bring its bio-fuel made from whisky production residue to an industrial scale.

ConventionEUUK

25.06.2014 Sun, celebrities and a scandal - the world’s largest biotech convention is getting off to an explosive start in San Diego, California.

InvestmentGermanyNetherlands

24.06.2014 Bayer Healthcare is getting back into gene therapy with a US$252m deal aimed at the development of a haemophilia A treatment.

InvestmentNetherlands

20.06.2014 Tomtom founder Pieter Geelen invests in Dutch biotech Ocello, the company behind a 3D mapping technology used for predicting drug behaviour in patients.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • FLAMEL TECHNOLOGIES (F)14.70 USD11.28%
  • ADDEX (CH)4.54 CHF5.83%
  • NEUROVIVE PHARMACEUTICAL AB (S)58.75 SEK5.38%

FLOP

  • ANTISOMA (UK)1.32 GBP-14.84%
  • XENETIC BIOSCIENCES (UK)6.00 GBP-14.29%
  • NOVACYT (F)4.48 EUR-10.04%

TOP

  • SANTHERA (CH)70.65 CHF111.2%
  • ADDEX (CH)4.54 CHF108.3%
  • CELLECTIS (F)13.43 EUR98.1%

FLOP

  • THROMBOGENICS (B)8.67 EUR-51.8%
  • MERCK KGAA (D)63.67 EUR-50.5%
  • VERONA PHARMA (UK)1.20 GBP-43.4%

TOP

  • SANTHERA (CH)70.65 CHF3111.4%
  • GW PHARMACEUTICALS (UK)443.50 GBP843.6%
  • IXICO (UK)55.50 GBP314.2%

FLOP

  • CYTOS (CH)0.24 CHF-93.1%
  • EVOCUTIS (UK)0.21 GBP-92.6%
  • THROMBOGENICS (B)8.67 EUR-73.0%

No liability assumed, Date: 10.07.2014