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Nyt behandlingsalternativ til patienter med inflammatorisk psoriasis artrit (PsA)

Pressemeddelelser   •   2014-03-24 07:41 CET

Danske patienter med den komplekse sygdom psoriasisartrit (PsA) har fået et nyt behandlingsalternativ. STELARA (ustekinumab), alene eller i kombination med MTX, er nu godkendt til behandling af aktiv psoriasisartrit hos voksne patienter, når deres respons på tidligere behandling med ikke-biologiske sygdoms-modificerende antireumatika (DMARD) er utilstrækkelig.

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Janssen udvikler ny behandling til patienter med multiresistent tuberkulose – første nye behandling i over 40 år

Pressemeddelelser   •   2014-03-06 16:00 CET

Hvert år udvikler 450.000 patienter, som lider af tuberkulose (TB), resistens mod behandlingen, og risikoen for dødelighed stiger markant1. Nu er der nyt håb for disse patienter. SIRTURO (bedaquiline) er godkendt til behandling af patienter med multiresistent tuberkulose. Det er den første nye behandling på området i over 40 år.

SIRTURO er indiceret til anvendelse som led i en passende kombinationsbehandling af multiresistent lungetuberkulose (MDR TB) hos voksne patienter, når det ikke er muligt at sammensætte et andet virksomt behandlingsregime på grund af resistens eller tolerabilitet. SIRTURO har en unik virkningsmekanisme, der hæmmer enzymet mykobakteriel ATP-syntase, som er afgørende for tuberkelbakteriens energiproduktion.

– Stigningen i multiresistente tuberkulosestammer er et voksende problem, som medfører store udfordringer i behandling og kontrol af denne farlige og dødelige sygdom. SIRTUROs nye virkningsmekanisme minimerer den potentielle krydsresistens med eksisterende TB-lægemidler, siger overlæge Søren Thybo på Rigshospitalets Infektionsmedicinske Klinik.

Multiresistent TB (MDR-TB), som karakteriseres ved resistens mod mindst to af de fire lægemidler, der indgår i standardbehandlingen af tuberkulose, skal tages meget alvorligt på grund af den globale stigning i bakteriel resistens og de deraf følgende behandlingsmæssige problemer. EU-regionen står for næsten en fjerdedel af alle tilfælde af MDR-TB i verden[1]. I Danmark diagnosticeres kun få tilfælde hvert år, men MDR-TB er relativt almindeligt i nærliggende områder som f.eks. Baltikum og Rusland.

Som grundlag for godkendelse af SIRTURO ligger 24-ugers data fra to fase II-studier, et kontrolleret og randomiseret studie, som vurderede sikkerhed og effekt af SIRTURO sammenlignet med placebo i behandlingen af patienter med MDR-TB i kombination med en baggrundsbehandling, og et open label-studie (C209). Effektens varighed understøttes af 120-ugers data fra det kontrollerede, randomiserede Fase II-studie[2].

Udviklingen af SIRTURO ligger på linje med Janssens ambition om at udvikle nye, innovative lægemidler på områder, hvor der i dag måske ikke er nogen behandling for visse patientgrupper – som f.eks. MDR-TB-patienterne.

Indikation
SIRTURO er indiceret til anvendelse som led i en passende kombinationsbehandling af multiresistent lungetuberkulose (MDR TB) hos voksne patienter, når det ikke er muligt at sammensætte et andet virksomt behandlingsregime på grund af resistens eller tolerabilitet. Det anbefales at administrere SIRTURO under overvågning som DOT (directly observed therapy).

Multiresistent tuberkulose
Verden over er 2 milliarder mennesker inficeret med (latent) tuberkulose, og 10 % af dem udvikler aktiv sygdom. [3],[4] WHO’s anbefalede behandling består af fire forskellige lægemidler, som gives i seks måneder. Manglende behandlingseffekt er den mest almindelige årsag til den hastigt stigende lægemiddelresistens i forbindelse med tuberkulose.

MDR-TB ses også, når en person bliver inficeret med en tuberkulosestamme, som allerede er resistent mod et eller flere lægemidler mod tuberkulose.[5] Stammer af tuberkulose, der er resistente mod behandling med mindst isoniazid og rifampin, de to vigtigste lægemidler i den anbefalede standardbehandling, kaldes multiresistent tuberkulose.

Kontakt for yderligere information (Janssen):
Inger Sandberg, Public Affairs Leader, Janssen, isandberg@its.jnj.com, +45 29998256 
Mikael Själin, Therapeutic Area Head, Janssen, msjalin@its.jnj.com, +46 (0)8 626 51 73


Yderligere information:
ECDC (European Centre for Disease Prevention and Control): http://www.ecdc.europa.eu/


[1]  TB Europe Coalition, tilgængelig på:  http://www.tbcoalition.eu/what-is-tuberculosis/tb-in-europe/ Læst december 2013.

[2] Diacon A, et al. OP-176-02: Final 120-week results of a Phase II randomised, double-blind, placebo-controlled study of 24-weeks bedaquiline treatment for MDR-TB (C208). Int J Tuberc Lung Dis 2013;17 (Suppl 2):S234.

[3] American Thoracic Society and Centers for Disease Control and Prevention. Diagnostic Standards and Classification of Tuberculosis in Adults and Children. Am J Respir Crit Care Med. 2000;161:1376-1395.

[4] Tuberculosis fact sheet. World Health Organization. www.who.int/mediacentre/factsheets/fs104/en/index.html. Læst 3. december 2012.

[5] Zignol M, van Gernert W, Falzon D, et al. Modernizing surveillance of antituberculosis drug resistance: from special surveys to routine testing. Clin Infect Dis. 2011;52(7):901-906.


Om Janssen
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.

Hvert år udvikler 450.000 patienter, som lider af tuberkulose (TB), resistens mod behandlingen, og risikoen for dødelighed stiger markant1. Nu er der nyt håb for disse patienter. SIRTURO (bedaquiline) er godkendt til behandling af patienter med multiresistent tuberkulose. Det er den første nye behandling på området i over 40 år.

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Fortune Magazine Names Johnson & Johnson #1 in Pharmaceuticals

Nyheder   •   2014-03-04 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   •   2014-02-28 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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JOHNSON & JOHNSON OFFENTLIGGØR AFTALE MED YALE SCHOOL OF MEDICINE OM DELING AF KLINISKE DATA

Pressemeddelelser   •   2014-01-30 12:51 CET

Ifølge aftalen står YODA for uafhængigt at evaluere og træffe den endelige beslutning, hver gang der forespørges om virksomhedens kliniske testdata, herunder også vores kliniske testrapporter (CSR) og anonymiserede patientdata. Medlemmer af YODA-teamet kan godt henvende sig til forskere fra Janssen med spørgsmål, men den endelige beslutning om datadeling træffes af YODA. YODA-teamet hos Yale School of Medicine udpeger og nedsætter et uafhængigt, eksternt panel af ikke-Janssen-relaterede eksperter, der kan hjælpe med at evaluere forespørgsler.

Foruden deling af data fra kliniske tests af lægemidler via aftalen med YODA forpligter Johnson & Johnson sig også til at dele data fra kliniske tests af medicinske apparater og konsumentprodukter.

”Ansvarlig deling af kliniske testdata fremmer forskningen og lægevidenskaben og er en del af Johnson & Johnsons forpligtelse over for læger, sygeplejersker, patienter, forældre og alle andre, der anvender vores produkter,” siger Paul Stoffels, MD, Chief Scientific Officer hos Johnson & Johnson og Worldwide Chairman for Pharmaceuticals. ”Vores aftale med YODA betyder, at vi nu yderligere øger vores engagement i forskningen, lægevidenskaben og folkesundheden ved at skabe en standardiseret, uafhængig, gennemsigtig og reproducerbar proces til deling af vores kliniske data.”

Johnson & Johnson har desuden lanceret en ny, webbaseret funktion, der skal lette forskernes mulighed for at anmode om adgang til data fra virksomhedens kliniske tests. Eksterne forskere kan anmode om kliniske testdata for produkter fra Johnson & Johnsons medicinalvirksomheder via følgende link: www.clinicaltrialstudytransparency.com.

”Vi har allerede veletablerede politikker for registrering og offentliggørelse af kliniske testresultater i eksterne registre og offentliggørelse af resultater i lægevidenskabelige tidsskrifter, og historisk set har vi også samarbejdet med eksterne forskere om andre typer dataforespørgsler,” siger Bill Hait, MD, PhD, Global Head hos Janssen R&D.

”Det er os en glæde, at vi nu via aftalen med YODA, kan dele data fra vores kliniske tests i form af kliniske testrapporter (CSR) og data på deltagerniveau på en systematisk og objektiv måde, der er med til at fremme lægevidenskaben og det lægefaglige vidensniveau, mens patientens anonymitet og fortrolighed samtidig beskyttes,” tilføjer Dr. Hait.

Yderligere information om YODA-projektet kan ses på http://medicine.yale.edu/core/projects/yodap/index.aspx


Om Johnson & Johnson

Omsorg for mennesker i hele verden, ét menneske ad gangen … er dét, der inspirerer og samler medarbejderne i Johnson & Johnson. Vi favner forskningen og videnskaben og bidrager med innovative idéer, produkter og ydelser for at fremme folkesundheden og den menneskelige trivsel. Vi har ca. 128.000 ansatte i over 275 Johnson & Johnson-virksomheder, der samarbejder med vores partnere i sundhedssystemet om at øge livskvaliteten for mere end en milliard mennesker hver dag, verden over.

Ved spørgsmål, kontakt:
Anna Käll, Public Affairs Leader, Janssen, akall@its.jnj.com, +46 (8)626 50 29 

Mikael Själin, Nordic Medical Affairs Director, Janssen, +46 (8)626 5173, msjalin@its.jnj.com

Om Janssen
Medicinalfirmaet Janssen bestræber sig konstant på at opfylde de største og mest presserende medicinske behov, der findes i verden i dag. Med ansatte i over 50 lande arbejder vi for at kunne tilbyde patienter i hele verden innovative idéer, produkter og ydelser.


Johnson & Johnson - via sit datterselskab Janssen Research and Development, LLC - har indgået en ny aftale med Yale School of Medicine’s Open Data-projekt (YODA) for at øge virksomhedens engagement i at dele kliniske data. Det er første gang i historien, at en virksomhed indgår samarbejde med en uafhængig tredjepart om at evaluere og træffe beslutninger vedrørende forespørgsler om kliniske data.

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CAELYX® SUPPLY RESTORED IN DENMARK

Pressemeddelelser   •   2013-04-30 10:28 CEST

The recent history of CAELYX® supply

CAELYX® is a drug approved for use in the treatment of a range of cancers, including metastatic breast cancer, advanced ovarian cancer, Kaposi’s sarcoma and multiple myeloma.[1] In March 2012, as a result of ongoing production problems at BenVenue Labs (BVL), the independent, contracted manufacturer for CAELYX®, the European Medicines Agency (EMA) announced an Article 20 procedure for CAELYX®.2 Based on this, CAELYX® in the EU was restricted for use only in patients who were currently already receiving treatment. However, in October 2012, an alternative manufacturing process for CAELYX® was approved by the Committee for Medical Products for Human Use (CHMP), part of the EMA, and the Article 20 restrictions were lifted. At that time, the CHMP recommended that healthcare professionals prioritise patients needing CAELYX® by supplying them in the following order: Firstly, existing patients to complete treatment courses that had already been initiated; secondly, to new patients for whom no alternative treatment was available; and, thirdly, to new patients for whom alternative treatment was available.

CAELYX® Managed Access (CMA)

In order to facilitate transparent and equitable access to CAELYX®, Janssen developed CMA; a web-based ordering and reservation system that enabled HCPs to guarantee a full course of treatment for their patients during a temporary period of limited stock. Following its activation in October 2012, CMA facilitated access to CAELYX® for more than 5,000 patients in 25 countries across the EEA and Switzerland.

Restoring a sustainable supply of CAELYX®

CAELYX® is a specific formulation requiring a highly complex and specialised manufacturing process. Since BVL announced its manufacturing issues, Janssen has had a dedicated project team on-site assisting them in resolving these. In order to re-establish supply of CAELYX® as quickly and safely as possible, Janssen developed a short-term production solution, which involved formulating product at BVL and then transferring it to another manufacturer to complete the process. Meanwhile, Janssen has also been putting into place a framework to support a longer-term, consistent supply of CALEYX®. New manufacturing partners have been identified and Janssen is in the process of finalising steps required to commence production at their sites.


References


[1] CAELYX SPC Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000089/WC500020180.pdf

2 European Medicines Agency (EMA) Press release: European Medicines Agency recommends transfer of manufacturing sites for Caelyx and Ceplene http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/03/news_detail_001470.jsp&mid=WC0b01ac058004d5c1


The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases.

Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.


The 29th of April (Janssen) announced that sufficient stock of CAELYX® (pegylated liposomal doxorubicin) - a drug approved in the EU for the treatment of a range of cancers1 – has been reached to enable the return to normal commercial supply of this medicine across the European Economic Area (EEA) and Switzerland.

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Opdaterede resultater med Zytiga®

Pressemeddelelser   •   2013-02-14 15:47 CET

Beerse, Belgien, 13. Februar 2013. Janssen Research & Development, LLC (Janssen) har presenteret opdaterede resultater som viser at Zytiga® (abirateroneacetat) givet sammen med prednisolon fortsat giver statistisk signifikante forbedringer af sygdomsprogressionen sammenlignet med placebo givet sammen med prednisolon. Yderligere fandt man også en længere overlevelsestid hos mænd med metastaserende kastrationsresistent prostatacancer.

For yderligere spørgsmål kontakt:

Kristina Sandström, +46 072 521 79 04

Nordic Medical Affairs, Therapeutic Area Head Haematology & Oncology

Læs hele pressemeddelelsen her:

http://www.businesswire.com/news/home/20130212006301/en/CORRECTING-REPLACING-Follow-up-Data-Show-ZYTIGA%C2%AE-Prednisone


Opdaterede resultater viser, at Zytiga® givet sammen med prednisolon forsinker progressionen af metastaserende kastrationsresistent prostatacancer hos patienter som ikke tidligere har fået kemoterapi.

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Zytiga® godkendt i Norden til behandling af metastaserende, kastrationsresistent prostatakræft før kemoterapi

Pressemeddelelser   •   2013-01-15 14:55 CET

Den godkendte, bredere indikation for ZYTIGA omfatter nu anvendelse i kombination med prednison eller prednisolon til behandling af metastaserende, kastrationsresistent prostatakræft (mCRPC) hos voksne mænd, som er asymptomatiske eller har lette symptomer efter manglende effekt af androgen deprivationsbehandling, og hvor der endnu ikke er klinisk indikation for kemoterapi.[i]

Indtil nu har ZYTIGA med prednison og prednisolon kun været godkendt til behandling af mænd med mCRPC, hvis sygdom har udviklet sig, mens de var i behandling med docetaxel-baseret kemoterapi eller derefter. Denne seneste godkendelse betyder, at egnede mænd potentielt vil kunne have gavn af behandlingen med ZYTIGA® tidligere i behandlingsforløbet. 

EC's beslutning følger anbefalinger fra det Europæiske Medicinagenturs Komité for Humanmedicinske Lægemidler (CHMP)[ii], som var baseret på data fra Fase III-studiet COU-AA-302.[iii] Det var det første randomiserede studie, som påviste en radiografisk, progressionsfri overlevelsesfordel (rPFS) og en stærk tendens i samlet overlevelse (OS) hos denne patientpopulation.

Kontaktoplysninger:Mikael Själin, Nordic Medical Affairs Director, Janssen, +46 (0) 8-626 5173, msjalin@its.jnj.com

Om ZYTIGA®[iv]

Siden godkendelsen i 2011 er ZYTIGA® blevet godkendt i mere end 60 lande verden over. Mange tusinde mænd har fået behandling med ZYTIGA, og det er hurtigt ved at blive en af grundpillerne i det onkologiske behandlingsudbud.

ZYTIGA® er den eneste godkendte behandling, som hæmmer produktion af androgen, som stimulerer prostatakræftens vækst ved at hæmme CYP17-enzymkomplekset i tre kilder: testiklerne, binyrerne og selve tumoren.


[ii]http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002321/WC500134841.pdf [iii] Ryan C.J et al. Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 30, 2012 (suppl; abstr LBA4518)

[iv] ZYTIGA® Produktresumé vil kunne ses på EMA's website: http://www.ema.europa.eu/ema/


Om Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson arbejder for at opfylde de vigtigste udækkede medicinske behov i vores tid inden for bl.a. onkologi, immunologi, neurovidenskab, infektionssygdomme samt kardiovaskulære og metaboliske sygdomme. Motiveret af vores ønske om at hjælpe patienterne udvikler vi innovative produkter, ydelser og løsninger inden for sundhedspleje for at hjælpe mennesker over hele verden.


Janssen-Cilag International NV (Janssen) meddelte i dag, at Europa-Kommissionen (EC) har godkendt en udvidelse af godkendelsen af det orale lægemiddel ZYTIGA® (abirateronacetat), som tages 1 gang dagligt.Prostatakræft er den mest almindelige kræftform hos mænd i Norden, og 5 % af alle dødsfald hos mænd kan henføres til prostatakræft.

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Canagliflozin Provided Substantial and Sustained Glycemic Improvements as Monotherapy and in Add-On Combinations in Adults with Type 2 Diabetes in Five Phase 3 Studies

Pressemeddelelser   •   2012-06-13 15:39 CEST

News Release

 

 

Canagliflozin Provided Substantial and Sustained Glycemic Improvements as Monotherapy and in Add-On Combinations in Adults with Type 2 Diabetes in Five Phase 3 Studies

 

Canagliflozin Provides Greater Reduction of A1C Levels in Adults with Type 2 Diabetes in 52-Week Head-to-Head Studies Compared to Sitagliptin and Glimepiride

 

PHILADELPHIA, JUNE 9, 2012 — Janssen Research & Development, LLC (Janssen) presented results from five Phase 3 clinical studies evaluating canagliflozin in monotherapy and in add-on combination use showing that canagliflozin provided substantial and sustained glycemic improvements in adult patients with type 2 diabetes, and was generally well tolerated. In two of these studies comparing canagliflozin to current standard treatments, sitagliptin and glimepiride, canagliflozin dosed once-daily at 300 mg provided significantly greater reductions in A1C levels relative to both comparators with similar overall incidence of adverse events. These studies were presented today as late-breaking poster presentations at the 72nd American Diabetes Association (ADA) Annual Scientific Sessions.

 

Canagliflozin is an investigational sodium glucose co-transporter 2 (SGLT2) inhibitor for the treatment of patients with type 2 diabetes. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic people, which may contribute to elevated glucose levels. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

“Type 2 diabetes is a chronic condition that over time may require the use of combinations of antihyperglycemic agents, including insulin, to maintain optimal glycemic control which is a primary goal of treatment,” said William T. Cefalu, M.D., Chief of the Joint Program on Diabetes, Endocrinology and Metabolism of the Pennington Biomedical Research Center & Louisiana State University Health Sciences Center School of Medicine, and lead investigator on the DIA3009 study. “The sustained glucose control and low rate of occurrence of hypoglycemia shown with canagliflozin, an SGLT2 inhibitor, as compared to glimepiride when evaluated over a 52-week period in this comparative study is very promising. When combined with the other clinical benefits, the data suggests that this class of agents may provide an additional and valuable treatment option for people with type 2 diabetes.”

 

The global Phase 3 canagliflozin clinical program enrolled more than 10,300 patients in nine studies, and is the largest late-stage development program for an investigational pharmacologic product for the treatment of type 2 diabetes submitted to health authorities to date. The Phase 3 clinical program evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes management, from adult patients treated only with diet and exercise to those requiring insulin injections to maintain glycemic control. The program also included three large studies in special populations: older patients with type 2 diabetes, patients with type 2 diabetes who had moderate renal impairment, and patients with type 2 diabetes who have or were considered to be at high risk for cardiovascular disease. On May 31, 2012, Janssen submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the use of canagliflozin as a treatment for adult patients with type 2 diabetes.

 

“The results in each of these studies suggest that canagliflozin could provide an effective therapeutic option for adults with type 2 diabetes in a range of clinical settings,” said Kirk Ways, M.D., Ph.D., Vice President and Compound Development Team Leader for canagliflozin at Janssen. “Canagliflozin has the potential to be administered as monotherapy in patients who are inadequately controlled with diet and exercise alone, as an add-on therapy in patients being treated with metformin alone or in combination with sulfonylureas, and in patients with moderate renal impairment. As part of our commitment to develop new therapeutic options for unmet patient needs in the treatment of type 2 diabetes, we look forward to presenting data from the remaining Phase 3 canagliflozin clinical trials in the near future.”

 

About the Studies

DIA3015 is a52-week randomized, double-blind, active-controlled Phase 3 study in 755 adult patients with inadequate glycemic control on maximally effective doses of metformin and sulfonylurea. Patients were given once-daily doses of canagliflozin (300 mg) or sitagliptin (100 mg). Patients treated with canagliflozin had a substantial and sustained decrease in A1C levels, with a significantly greater reduction relative to sitagliptin after 52 weeks (-0.37, 95% CI -0.50; -0.25). Based on protocol-specified withdrawal criteria, more subjects discontinued from the study due to loss of glycemic control in the sitagliptin treatment arm (22.5%) than the canagliflozin arm (10.6%). In the key secondary endpoint measures, patients treated with canagliflozin 300 mg also had greater weight loss compared to sitagliptin (percent changes of -2.5 and 0.3, respectively); reductions in fasting plasma glucose changes were consistent with the primary A1C endpoint (-29.9 and -5.9 mg/dL, respectively); systolic blood pressure was reduced with canagliflozin (-5.1 and 0.9 mmHg, respectively). Canagliflozin raised HDL-C relative to sitagliptin (% change, 7.6 and 0.6, respectively), and also LDL-C (% change 11.7 and 5.2, respectively).

 

The overall incidence of treatment-emergent adverse events (AEs) was similar in the canagliflozin (76.7%) and sitagliptin (77.5%) groups. The incidence of serious AEs were low and similar in both groups (6.4% and 5.6%, and respectively, in the canagliflozin and sitagliptin groups); discontinuations due to AEs were low in both groups but higher in the canagliflozin than in the sitagliptin group (5.3%, and 2.9%, respectively). AEs related to genital mycotic infections in men and women, and AEs related to an osmotic diuresis such as increased urination, were more frequent in patients treated with canagliflozin than sitagliptin; a similar incidence of urinary tract infections was seen in the two treatment groups. The genital infections and osmotic diuresis related AEs were generally mild to moderate in intensity and infrequently led to discontinuation; most genital infections responded to topical or oral antifungal therapy. A similar incidence of hypoglycemic episodes was reported with canagliflozin and sitagliptin.

 

To access the abstract, visit http://www.abstractsonline.com/plan/AdvancedSearch.aspx and search for abstract number 50-LB.

DIA3009 is a 52-week randomized, double-blind, active-controlled Phase 3 trial in 1,450 adult patients with inadequate glycemic control on maximally effective doses of metformin. Patients were randomized and treated once daily with either canagliflozin (100 mg or 300 mg) or glimepiride (with up-titration of glimepiride allowed throughout the 52-week period). Patients treated with canagliflozin had a sustained decrease in A1C, with statistically greater A1C-lowering for canagliflozin 300 mg after 52 weeks when compared to glimepiride (-0.93% and -0.81%, respectively, with the between group difference of -0.12%, 95% CI -0.22; -0.02); the decrease in A1C with canagliflozin 100 mg (-0.82%) was similar to that for glimepiride (between group difference of -0.01%, 95% CI -0.11; 0.09). In the key secondary endpoint measures, both the 300 mg and 100 mg canagliflozin dose groups provided reductions in body weight, with  no notable change in the glimepiride group (body weight % change, -4.7 and -4.2 and 1.0, respectively). Hypoglycemia episodes occurred at a low incidence with canagliflozin 300 mg and 100 mg, and at a higher incidence with glimepiride (% of patients with 1 or more episodes: 4.9 and 5.6 and 34.2, respectively). Reductions in fasting plasma glucose were consistent with the primary endpoint for canagliflozin 300 mg and 100 mg and glimepiride (-27.5 and -24.3 and -18.3 mg/dL, respectively); other secondary endpoints included reductions in systolic blood pressure with both doses of canagliflozin and no notable change with glimepiride (-4.6 and -3.3 and 0.2 mmHg, respectively); HDL-C increased with both 300 mg and 100 mg doses of canagliflozin, with no notable change with glimepiride (% change, 9.0 and 7.9 and 0.3, respectively); LDL-C rose with both doses of canagliflozin more than with glimepiride (% change, 14.1 and 9.6 and 5.0, respectively).

The incidence of AEs and discontinuations due to AEs were generally similar across all treatment arms. AEs were mild to moderate and the overall incidence was balanced across treatment arms. Adverse events related to osmotic diuresis such as increased urination, genital mycotic infections in men and women, and urinary tract infections were more frequent in patients treated with canagliflozin than glimepiride; these specific adverse events were generally mild or moderate in intensity and infrequently led to discontinuation.

To access the abstract, visit http://www.abstractsonline.com/plan/AdvancedSearch.aspx and search for abstract number 38-LB.

 

Janssen presented results from three additional Phase 3 studies at this year’s ADA meeting,which also demonstrate the potential value of canagliflozinacross thespectrumoftype 2diabetesmanagement including use in monotherapy, in add-on combination, and in patients with moderate renal impairment.

  • o     “Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Improves Glycemia and is Well Tolerated in Type 2 Diabetes Mellitus Subjects with Moderate Renal Impairment” on June 10 (http://www.abstractsonline.com/plan/AdvancedSearch.aspx, abstract 41-LB).
  • o     “Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Improves Glycemic Control and Lowers Body Weight in Subjects With Type 2 Diabetes Inadequately Controlled With Diet and Exercise” on June 9 (http://www.abstractsonline.com/plan/AdvancedSearch.aspx, abstract 81-OR).
  • o     “Canagliflozin, a Sodium Glucose Co-Transporter 2 Inhibitor, Improves Glycemic Control and Reduces Body Weight in Subjects with Type 2 Diabetes Inadequately Controlled With Metformin and Sulfonylurea” on June 9 (http://www.abstractsonline.com/plan/AdvancedSearch.aspx, abstract 1022-P).

 

Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.

 

 

About Janssen Research & Development, LLC

Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

For more information about Janssen Research & Development, LLC visit www.janssenrnd.com.

 

About Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world.

More information can be found at www.janssen-emea.com

 

Media contacts:

Anders Almqvist

Medical Advisor

Janssen-Cilag AB

Phone: (+46)86265113

                  

Inger Sandberg

Public Affairs

Janssen-Cilag A/S

Phone: 29998256                              

###

 

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of healthcare products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Research & Development, LLC nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

PHILADELPHIA, JUNE 9, 2012 — Janssen Research & Development, LLC (Janssen) presented results from five Phase 3 clinical studies evaluating canagliflozin in monotherapy and in add-on combination use showing that canagliflozin provided substantial and sustained glycemic improvements in adult patients with type 2 diabetes, and was generally well tolerated.

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Fremskridt i behandlingen af prostatakræftpatienter

Pressemeddelelser   •   2012-06-06 09:46 CEST

Fremskridt i behandlingen af prostatakræftpatienter:

 

Længere liv uden kemoterapi

Et fase III forsøg, hvor prostatakræftpatienter blev behandlet med Zytiga® (Abirateron Acetat) og prednisolon, viser klare fremskridt for patienterne. I forsøget blev patienterne behandlet inden de modtog kemoterapi. Forsøget viser både, at patienterne lever længere uden at sygdommen forværres, og at alle andre mål med behandlingen var bedre for gruppen, der modtog Zytiga®, sammenlignet med kontrolgruppen.

’Dette er et klinisk gennembrud. Det her betyder, at patienterne kan udskyde den kemoterapi, der ellers kan give bivirkninger – eller endda helt undgå den’, siger professor ved Rigshospitalet, Peter Iversen, som er en af landets førende eksperter på prostatakræft.

Han fremhæver, at undersøgelsen er så omfattende, og at de to grupper er så sammenlignelige, at resultaterne er overbevisende.

’I dag dør 1100 danske mænd af prostatakræft hvert år og mange gennemgår forinden kemoterapi, der også for dem er et signal om, at de er i en alvorlig slutfase af sygdommen. Mange af dem vil kunne få et længere og bedre liv med denne behandling. Det eneste hjertesuk fra mig er, at dette er en dyr medicin,” siger professor Peter Iversen.

 

Koden blev brudt

De 1088 patienter i forsøget er alle mænd, hvor prostatakræften har spredt sig, og som ikke reagerer positivt på medicinsk kastration. Den ene gruppe fik Zytiga® sammen med prednisolon, mens kontrolgruppen fik placebo sammen med prednisolon. Den første gruppe fik flere bivirkninger, men samlet set et bedre helbred.

’Bivirkningerne her er ikke overraskende og kan i de allerfleste tilfælde behandles. Jeg bemærker også, at man i forsøget valgte at bryde koden og tilbyde også patienterne i kontrolgruppen at få den egentlige medicin. Selvom man måske kan betvivle visdommen i at bryde koden, bekræfter studiets resultater dog vores hypotese om at hvis behandlingen hjælper efter kemoterapi, så hjælper den nok også før,” forklarer professor Peter Iversen.

Resultaterne fra undersøgelsen blev offentliggjort på kongressen for American Society for Clinical Oncology (ASCO) i Chicago i sidste weekend.

 

Om Zytiga®

Zytiga® er godkendt til behandling af metastatisk kastrationsresistent prostatakræft, hvor sygdommen er forværret under eller efter kemoterapi med Docetaxel 1. Zytiga® virker ved at hæmme produktionen af det mandlige kønshormon testosteron, som stimulerer væksten af prostatakræft. Testosteron dannes i testiklerne og binyrerne, men hos patienter med prostatakræft udskiller selve tumoren også det mandlige kønshormon2. Zytiga®  er det første lægemiddel, som hæmmer hormonproduktionen alle tre steder3.

 

Om prostatakræft4

Én ud af 10 mænd får på et eller andet tidspunkt stillet diagnosen prostatakræft. Prostatakræft er en af de mest almindelige former for kræft i Danmark totalt set. Hvert år får ca. 4000 mænd diagnosen prostatakræft og næsten en fjerdedel af al kræft som bliver opdaget hos mænd er prostatakræft. Antallet af diagnosticerede tilfælde af prostatakræft er øget markant de seneste årtier og antallet af årlige dødsfald som følge af sygdommen er estimeret til mere end 1000.

 

For mere information kontakt:

Johan Aschan, Therapeutic Area Head Hematology & Oncology, jaschan@its.jnj.com, +46 8626 50 38

Inger Sandberg, Public Affairs Leader, isandber@its.jnj.com, 29 99 82 56

 

 

 

Om Janssen
Lægemiddelfirmaet  Janssen bestræber sig på at imødekomme de største og vigtigste medicinske behov i dag. Fælles for vores medarbejdere er deres passionerede drivkraft, der ligger til grund for den forskning og udvikling, som kan forbedre patienterne sundhedstilstand. Med ansatte i mere end 50 lande arbejder vi for at kunne tilbyde patienter i hele verden innovative ideer, produkter og serviceydelser.

 

Nyt fra ASCO i Chicago:Et fase III forsøg blev præsenteret, hvor prostatakræftpatienter blev behandlet med Zytiga® (Abirateron Acetat) og prednisolon. Patienterne blev behandlet inden de modtog kemoterapi. Forsøget viser både, at patienterne lever længere uden at sygdommen forværres, og at alle andre mål med behandlingen var bedre for gruppen, der modtog Zytiga®, sammenlignet med kontrolgruppen.

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  • Pressekontakt
  • Inger Sandberg, Public Affairs Leader
  • Public Affairs & Tender
  • isandber@its.jnj.com