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JANSSEN RECEIVES CHMP POSITIVE OPINION FOR STELARA® (USTEKINUMAB) RECOMMENDING APPROVAL FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE IN THE EUROPEAN UNION

Pressemeddelelser   •   Sep 16, 2016 16:05 CEST

FOR MEDICAL AND TRADE MEDIA ONLY

If Approved, STELARA® Will Be The First Interleukin (IL)-12/23 Inhibitor Licensed For Crohn’s Disease

Beerse, Belgium, 16 September 2016 – Janssen-Cilag International NV (“Janssen”) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorisation in the European Union for the use of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist or have medical contraindications to such therapies. If approved, ustekinumab will offer people with Crohn’s disease a new treatment option to induce and maintain remission of their disease symptoms.1

“Crohn’s disease is a debilitating chronic condition that has a huge impact on patients’ quality of life. Patients experience unpredictable disease flares and many have lost response tocurrently available treatments, so it is vital that new therapeutic options are made available to help control their symptoms,” saidFrederic Lavie, EMEA Therapeutic Area Leader Immunology, Cardiovascular and Metabolics, Janssen.“Ustekinumab has shown clinical benefit, is generally well tolerated, and hasa convenient dosing regimen for people living with Crohn’s disease who are eligible for a biologic therapy.”

The CHMP adopted the opinion based on data from three pivotal Phase 3 trials which included approximately 1,400 patients with moderately to severely active Crohn’s disease:2,3,4

  • UNITI-1 demonstrated significantly higher rates of clinical response at Week 6 for ustekinumab treatment groups compared with the placebo group (p=0.003) in patients who had failed on TNFα antagonist therapies.2 The major secondary endpoints of clinical remission at Week 8 and clinical response at Week 8 were each also significantly higher with IV ustekinumab induction versus IV placebo (p<0.001 for each).2 Clinical response was defined as a reduction from baseline in the Crohn’s Disease Activity Index (CDAI) score of ≥100 points or being in clinical remission.Clinical remission was defined as the CDAI <150.2The CDAI is a symptom-based disease assessment tool that quantifies symptoms of Crohn’s disease and measures improvement with treatment.5
  • UNITI-2 also demonstrated significantly greater clinical response at Week 6 with IV ustekinumab induction compared to IV placebo (p<0.001) in a population of patients who had previously failed conventional therapy, but who had not previously failed TNFα antagonist therapies. The secondary endpoints of clinical remission and response at Week 8 were also each both significantly higher in the ustekinumab groups compared to placebo (p<0.001 in each).3
  • IM-UNITI studied maintenance in patients who achieved clinical response 8 weeks after a single IV infusion of ustekinumab in the UNITI-1 and UNITI-2 Phase 3 induction studies. IM-UNITI showed that a significantly greater proportion of patients in the subcutaneous ustekinumab maintenance groups was in clinical remission at Week 44 versus placebo (p=0.005 in every 8 week and p=0.040 in every 12 week groups; primary endpoint. Clinical response at Week 44 was also significantly greater with both regimens versus placebo at Week 44. Other major secondary endpoints of clinical remission at Week 44 among patients in remission after induction and corticosteroid-free remission were significantly greater for every 8 week ustekinumab maintenance versus placebo.4

Ustekinumab was generally well tolerated as an induction and maintenance therapy in all three studies, and the safety profile of ustekinumabin the Crohn’s disease clinical development program remained consistent with the established safety profile of ustekinumab based upon current labelled indications. In the induction studies (UNITI-1 and UNITI-2), through Week 8 (placebo-controlled period), adverse events (AEs), serious AEs (SAEs) and infections were reported in similar proportions across ustekinumab and placebo treatment groups.2,3 Through Week 44 (placebo-controlled period) in the maintenance study (IM-UNITI), AEs were reported in similar proportions across ustekinumab and placebo treatment groups, the majority of which were related to gastrointestinal disorders, such as abdominal pain and diarrhoea, and infections/infestations, of which, nasopharyngitis and upper respiratory infection were the most common. SAEs occurred in 10 percent, 12 percent and 15 percent of patients receiving ustekinumab 90 mg subcutaneously every 8 weeks, ustekinumab 90 mg subcutaneously every 12 weeks and placebo, respectively; 2 percent, 5 percent and 2 percent of patients reported serious infections in these respective groups. Through the 8-week induction and 44-week maintenance phases (representing 1 year total of therapy), no deaths or major adverse cardiovascular events were reported. Only two randomised patients reported malignancies (one case of basal cell carcinoma in the subcutaneous placebo group and another in the subcutaneous ustekinumab every 8 weeks group).4

Followingthis positive opinion, a final decision from the European Commission is expected later this year. Janssen is also currently seeking approval for ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease in the U.S.

* Ends *

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Information for Editors

About Crohn’s Disease

More than five million people worldwide are living with Crohn’s disease and ulcerative colitis – collectively known as inflammatory bowel disease (IBD).6 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects nearly 250,000 Europeans.7 The cause of Crohn’s disease is not known, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors. Symptoms of Crohn’s disease can vary but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn’s disease.8,9

About Ustekinumab10

Ustekinumab, a human IL-12 and IL-23 antagonist, is approved in the European Union for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A. Ustekinumab is also indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies. In addition, ustekinumab is approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug therapy has been inadequate.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to ustekinumab, which is currently approved for the treatment of moderate to severe plaque psoriasis in 87 countries, psoriatic arthritis in 71 countries and paediatric psoriasis in 34 countries.

Important Safety Information

For complete European Union (EU) prescribing information, please visit: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000958/human_med_001065.jsp&mid=WC0b01ac058001d124

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/EMEA. Follow us on Twitter: @JanssenEMEA.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding potential regulatory approvals and benefits of a new treatment option. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

# # #

References

1.EMA. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP). Summary of opinion 15 September 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000958/WC500212877.pdf (last accessed September 2016).

2.Sandborn W, et al. AIBD 2015:Abstract O-001.

3.Feagan B, et al. UEGW 2015:Abstract UEG15-LB-5668.

4.Sandborn W, et al. DDW 2016:Abstract 768.

5.Best WR, et al. Gastroenterol 1976;70(3):439–44.

6.World IBD Day. Home. Available at http://www.worldibdday.org/index.html (last accessed September 2016).

7.European Federation of Pharmaceutical Industries and Associations. Inflammatory Bowel Disease. Available at http://www.efpia.eu/diseases/78/59/Inflammatory-Bowel-Disease (last accessed September 2016).

8.Crohn’s and Colitis UK. Crohn’s disease. Available at http://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/crohns-disease (last accessed September 2016).

9.IBD Determined. IBD & Colorectal Cancer. Available at http://www.ibdetermined.org/ibd-information/ibd-complications/colorectal-cancer.aspx (last accessed September 2016).

10.Summary of Product Characteristics Stelara 45 mg solution. Janssen-Cilag International NV. Last updated June 2015.

September 2016
PHGB/STE/0716/0003

Lægemiddelvirksomheden Janssen arbejder for at opfylde vore dages store og vigtige medicinske behov. Vi arbejder med forskning og udviklingen inden for følgende alvorlige sygdomme:  prostatakræft, skizofreni, Alzheimers sygdom, hiv/aids, hepatitis C, tuberkulose, psoriasisartrit og diabetes. Vores medarbejdere er engagerede i at medvirke til at tilbyde patienter nye medicinske løsninger, produkter og ydelser. Janssen er en verdensomspændende virksomhed med medarbejdere i godt 50 lande, inklusive de nordiske lande.  

If Approved, STELARA® Will Be The First Interleukin (IL)-12/23 Inhibitor Licensed For Crohn’s Disease

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Trevicta® fire gange om året til behandling af skizofreni

Pressemeddelelser   •   Aug 31, 2016 12:25 CEST

TREVICTA® (paliperidonpalmitat 3-måneders injektion) til vedligeholdelsesbehandling af skizofreni.

TREVICTA® (paliperidonpalmitat): Et nyt behandlingsregime til skizofreni lanceres i Danmark i dag. TREVICTA® er den første behandling til skizofreni som kun skal gives fire gange årligt.

EU-kommissionen har godkendt TREVICTA® (3-månedlig paliperidonpalmitat til injektion) til vedligeholdelsesbehandling af skizofreni hos voksne patienter1.

“Godkendelsen af TREVICTA® er et stort fremskridt for patienter, der lever med skizofreni,” siger Dr. Andreas Schreiner, European Therapeutic Area Leader, Neuroscience and Pain, Janssen: “Med færre administrationer om året, sammenlignet med andre godkendte behandlinger, kan TREVICTA® give patienter med skizofreni større frihed til at fokusere på andre vigtige aspekter i deres liv og mindre på deres medicinske behandling. Denne nye mulighed har potentiale til at mindske risikoen for tilbagefald og sygdommens udvikling. Samtidig giver det også sundhedspersonalet en mulighed for at sikre patienter med skizofreni de fordele en behandling med en kontinuerlig frigivelse af medicinen giver.

TREVICTA® er den antipsykotiske medicinske behandling, der tilbyder det længste dosisinterval i EU. Det lange doseringsinterval betyder, at patienterne kan opretholde et optimalt niveau af medicin i blodet med færre antal medicinadministrationer sammenlignet med andre nuværende antipsykotiske behandlinger. Dette kan forbedre vilkårenefor patienterne, deres pårørende og de sundhedsprofesionelle.2,3

TREVICTA® er godkendt til vedligeholdelsesbehandling af skizofreni hos voksne patienter, der er klinisk stabile på XEPLION®­, et paliperidonpalmitat produkt der gives én gang om måneden, og som blev godkendt i 2011 i EU til vedligeholdelsesbehandling af skizofreni.1

TREVICTA®´smarkedsføringstilladelse er baseret på to fase 3-studier.2,3

  • Det første er et randomiseret, multicenter, dobbeltblindet, placebo-kontrolleret tilbagefaldsforbyggende studie med mere end 500 skizofrenipatienter.3
  • Det andet studie er et randomiseret, multicenter, dobbeltblindet studie, der sammenlignede effektiviteten og sikkerheden ved behandling af henholdsvis TREVICTA® og XEPLION®­.2

Resultaterne viste, at TREVICTA® var lige så effektiv i forebyggelse af tilbagefald som XEPLION® og at behandlingen ikke var forbundet med nogle nye eller uventede bivirkninger.2,3

Som ved alle former for medicinsk behandling kan nogle patienter opleve bivirkninger. De hyppigste bivirkninger observeret hos ≥5 % af patienterne i de to dobbeltblindede kontrollerede kliniske forsøg med TREVICTA®var: Øget vægt, øvre luftvejsinfektion, angst, hovedpine, søvnløshed og reaktion omkring injektionsstedet.1,2

Om skizofreni

Skizofreni er en kronisk og kompleks lidelse i hjernen. Symptomerne kan være alvorlige og invaliderende samt påvirke alle aspekter af den ramtes hverdag. Sygdommen rammer personer fra hele verden uafhængig af kultur og socioøkonomisk status. Forekomsten er ens over hele verden - næsten én ud af 100 udvikler skizofreni, før de bliver 60 år, og med overvægt af mænd. 4,5

Den underliggende årsag til skizofreni kendes ikke fuldt ud. Sammenfald af forskellige faktorer menes at bidrage til udviklingen af sygdommen. Både genetiske og miljømæssige faktorer syntes at være vigtige6. Symptomer på skizofreni kan omfatte hallucinationer, vrangforestillinger, mangel på følelsesmæssig reaktion, social tilbagetrækning, depression, apati og manglende initiativ4.

Skizofreni er typisk en livslang tilstand, men der findes muligheder for behandling. Kliniske retningslinjer anbefaler, at den optimale behandling består af en kombination af antipsykotisk medicin, psykoterapi, psykoedukation og hjælp til selvhjælp. Effektiv behandling kan give patienter med skizofreni mulighed for at leve et for dem mere tilfredsstillende liv. Det kunne fx være at fastholde sit arbejde eller studie, leve uafhængigt og skabe sociale relationer, som alt sammen er vigtige led i en rehabilitering7.

For mere information om skizofreni samt nyttige ressourcer og interaktive værktøjer til dem, der er ramt af sygdommen, se venligst www.schizophrenia24x7.com. Siden er sponsoreret af Janssen Pharmaceutica NV.

Om Janssen Pharmaceutical Companies

I Janssen Pharmaceutical Companies, Johnson & Johnson arbejder vi for at skabe en verden uden sygdom. Vi stræber efter at finde nye og bedre måder til at forhindre, opfange, behandle og helbrede sygdom. Vi samler de dygtigste kræfter og forfølger den mest lovende videnskab. Vi er Janssen. Vi samarbejder med hele verden for at skabe sundhed for alle. Læs mere på www.janssen.com/EMEA. Følg os på www.twitter.com/janssenEMEA.

Janssen-Cilag International NV er en del af Janssen Pharmaceutical Companies, Johnson & Johnson.

###

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding a newly approved product. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

For yderligere information kontakt:

Public Affairs Leader Inger Sandberg, e-mail: isandber@its.jnj.com, telefon: +45 29 99 82 56.

###

References

  1. TREVICTA Produktresumé, www.ema.europa.eu
  2. Savitz A et al. Efficacy and safety of paliperidone palmitate 3-month formulation for patients with schizophrenia: A randomized, multicenter, double-blind, non-inferiority study. Int J Neuropsychopharmacol 2016 (Feb 22). doi: 10.1093 [Epub ahead of print].
  3. Berwaerts J et al. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomiszed Clinical Trial.JAMA Psych 2015;72(8):830–9.
  4. American Psychiatric Association (APA). Practice guideline for the treatment of patients with schizophrenia. Second edition 2004;42. Available at http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/schizophrenia.pdf (last accessed May 2016).
  5. Picchioni MM et al. Schizophrenia. BMJ 2007;335(7610):91–5.
  6. Lang U et al. Molecular mechanisms of schizophrenia. Cell Physiol Biochem 2007;20:687.
  7. National Institute for Clinical Excellence: Psychosis and schizophrenia in adults: prevention and management; National Clinical Practice Guidelines Number CG178. Available at https://www.nice.org.uk/guidance/cg178 (last accessed May 2016).

Lægemiddelvirksomheden Janssen arbejder for at opfylde vore dages store og vigtige medicinske behov. Vi arbejder med forskning og udviklingen inden for følgende alvorlige sygdomme:  prostatakræft, skizofreni, Alzheimers sygdom, hiv/aids, hepatitis C, tuberkulose, psoriasisartrit og diabetes. Vores medarbejdere er engagerede i at medvirke til at tilbyde patienter nye medicinske løsninger, produkter og ydelser. Janssen er en verdensomspændende virksomhed med medarbejdere i godt 50 lande, inklusive de nordiske lande.  

TREVICTA® (paliperidonpalmitat): Et nyt behandlingsregime til skizofreni lanceres i Danmark i dag. TREVICTA® er den første behandling til skizofreni som kun skal gives fire gange årligt.

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Professor Bengt Jönsson om forslag til forbedret kræftbehandling

Nyheder   •   Aug 28, 2014 17:14 CEST

Ud over at påvise ulighederne foreslås også forskellige forbedringer med det formål at mindske forskellene. Blandt andet anbefales øget finansiering af innovativ forskning på kræftområdet. I denne film fortæller professor Bengt Jönsson, hvordan han ønsker at forbedre den nuværende kræftbehandling.

I IHE rapporten " Access to high-quality oncology care across Europe " fremgår det, at adgangen til god kræftbehandling varierer betydeligt mellem EU-landene.

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Fortune Magazine Names Johnson & Johnson #1 in Pharmaceuticals

Nyheder   •   Mar 04, 2014 08:10 CET

Fortune Magazine Names Johnson & Johnson #1 in Pharmaceuticals

Johnson & Johnson has been ranked as the #1 company in the Pharmaceuticals category on Fortune Magazine’s 2014 list of the World’s Most Admired Companies.  

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we collaborate with the world for the health of everyone in it. The last several years transforming our business – focusing on five core therapeutic areas, investing in innovation wherever it resides, seeking medical breakthroughs wherever they occur and collaborating with top minds around the world. Recently we have also invested in industry-leading initiatives, including:

Read more in our Newsroom (Johnson & Johnson): http://t.co/X7eYBdnzDJ $JNJ

Johnson & Johnson has been ranked as the #1 company in the Pharmaceuticals category on Fortune Magazine’s 2014 list of the World’s Most Admired Companies. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we collaborate with the world for the health of everyone in it.

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Hvad er Rare Disease Day (28. februar 2014)?

Nyheder   •   Feb 28, 2014 09:00 CET

Sjældne-dagen (Rare Disease Day) er en årlig, international dag, der skal gøre offentligheden og beslutningstagere opmærksomme på sjældne sygdomme og deres betydning for patienternes liv. Dagen koordineres af EURORDIS – en europæisk sammenslutning af patientorganisationer for sjældne sygdomme – på internationalt niveau sammen med nationale sammenslutninger og patientorganisationer.

Fredag den 28. februar er 7. år, Sjældne-dagen afholdes.

Temaet for 2014 er "Join Together for Better Care."

Yderligere oplysninger: www.rarediseaseday.org

Sjældne-dagen (Rare Disease Day) er en årlig, international dag, der skal gøre offentligheden og beslutningstagere opmærksomme på sjældne sygdomme og deres betydning for patienternes liv.

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