Business Wire

Janssen Submits Marketing Authorisation Extension to the European Medicines Agency to Register Paliperidone Palmitate 6-Monthly (PP6M) for Treatment of Schizophrenia in Adults

Share

The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Marketing Authorisation Extension Application to the European Medicines Agency (EMA) to register paliperidone palmitate 6-monthly (PP6M) for the maintenance treatment of schizophrenia in adult patients who are clinically stable on paliperidone palmitate 1‑monthly (PP1M)1 or 3-monthly (PP3M)2 injectable products. If approved, this long‑acting injectable will provide adults living with schizophrenia a twice-yearly dosing regimen, the longest dosing interval available for an antipsychotic medication in the European Economic Area.3

“Janssen’s roots in neuroscience began with research and development of novel therapeutic options for schizophrenia, and this filing builds on that 60-year commitment,” said Bill Martin, Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. “We designed this unique dosing regimen so people with schizophrenia and their healthcare team can focus less on medication intervals and more on other aspects of their treatment plan, such as psychosocial interventions. We look forward to working with the European Medicines Agency to add a 6-month formulation to our family of paliperidone palmitate products.”

The extension application is based on the Route 6 Study, a randomised, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults living with schizophrenia from 20 countries, including Bulgaria, Czech Republic, France, Hungary, Italy, Poland and Spain.4 Of these individuals, 81.3 percent completed the 12-month double-blind phase without a relapse event.5 Data showed non-inferior efficacy of PP6M compared to PP3M on the primary endpoint of time to relapse at the end of the 12-month period in both intent-to-treat and per-protocol analysis sets.5 The safety profile observed for PP6M was consistent with previous studies of PP1M and PP3M with no new safety signals emerging.5 The most common treatment emergent adverse events in the study’s PP6M group were weight increase (8.4 percent), injection site pain (7.7 percent), headache (6.7 percent) and upper respiratory infection (5.0 percent).5 There were no unexpected serious adverse reactions.5

“Antipsychotic medication plays an important role in schizophrenia symptom control; however, non-adherence to prescribed medicines has been recognised as a problem worldwide,” said Mathai Mammen, Global Head of Janssen Research & Development, Johnson & Johnson. “Addressing this challenging aspect of treatment has been the catalyst for our research and development of long-acting injectable medications for people living with schizophrenia.”

PP6M is intended to be used only after patients have been stabilised on a shorter acting formulation of paliperidone palmitate such as XEPLION®1 (PP1M) or TREVICTA®2 (PP3M), with the goal of administering fewer injections.

#ENDS#

About the Route 6 Trial

The Route 6 Study was a randomised, double-blind, non-inferiority global Phase 3 study of 702 adults with schizophrenia, designed to demonstrate that injection of PP6M is not less effective than PP3M for the prevention of relapse in participants previously stabilised on corresponding doses of PP1M (100 or 150 mg dose) or PP3M (350 or 525 mg dose).4

The study consisted of mainly three phases: a screening phase (up to 28 days), a maintenance phase (of one or three months), and a double-blind phase (of 12 months). The maintenance phase was used to stabilise patients on PP1M or PP3M prior to the double-blind phase. Study evaluations included efficacy, pharmacokinetics, pharmacodynamics, and safety. The study’s duration varied from approximately 13 months to 19 months.4

About Long-Acting Injectables

Long-acting injectables (LAIs) allow for the slow release of a drug into the blood and have been on the market for more than 50 years.6 LAI antipsychotics offer a number of advantages compared with oral medication, including not having to remember to take drugs daily, improved patient outcomes, improved patient and physician satisfaction, and lower relapse rates.7

About Schizophrenia

Schizophrenia is a chronic and severe brain disorder affecting approximately 20 million people worldwide8 and an estimated 3.7 million people in the EU.9 The disease is characterised by distortions in thinking, perception, emotions, language, sense of self and behavior leading to neurological impairment, severe disability and increased mortality.7

Antipsychotic medication is recognised as an essential component in the treatment of schizophrenia, and adherence to medication plays a critical role in preventing symptoms and relapses.10 However, nearly 75 percent of patients with schizophrenia experience a relapse, often driven by non-adherence to prescribed medication.11 Early intervention in schizophrenia may improve patient outcomes as more than 69 percent of people with schizophrenia do not receive appropriate care.8

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/emea.

Follow us at https://twitter.com/JanssenEMEA. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of 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 6-monthly paliperidone palmitate (PP6M). 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, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; 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; changes in behavior and spending patterns 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 descriptions 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 December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, 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 nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

# # #

References

1 Xeplion SmPC 2018. Available at: https://www.ema.europa.eu/en/documents/product-information/xeplion-epar-product-information_en.pdf (last accessed November 2020).

2 Trevicta SmPC 2019. Available at: https://www.ema.europa.eu/en/documents/product-information/trevicta-epar-product-information_en.pdf (last accessed November 2020).

3 Berwaerts J et al. Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial. JAMA Psych. 2015; 72(8):830–9.

4 European Clinical Trials Register. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-001941-28/ES (last accessed November 2020).

5 Data on file. RF-148071.

6 National Alliance on Mental Illness. Long-Acting Injectables. Available at: https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Long-Acting-Injectables (last accessed November 2020).

7 Brissos S, et al. The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Ther Adv Pyschopharmacol. 2014 Oct; 4(5):198–219.

8 World Health Organization. Schizophrenia. Available at: https://www.who.int/news-room/fact-sheets/detail/schizophrenia (last accessed November 2020).

9 Athanasopoulou C, et al. An analysis of online health information on schizophrenia or related conditions: a cross-sectional survey. BMC Med Inform Decis Mak. 2013; 13:98.

10 Higashi K, et al. Medication adherence in schizophrenia: factors influencing adherence and consequences of nonadherence, a systemic literature review. Ther Adv Psychopharmacol. 2013 Aug; 3(4):200–18.

11 Weiden PJ, et al. Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia. Psychiatr Serv. 2004 Aug; 55(8):886–91.

EM-44952

December 2020

Contact information

Media contact:
Cristiana Maria
Mobile: +32-473-11-28-10

Investor Relations:
Christopher DelOrefice
Office: +1-732-524-2955

Jennifer McIntyre
Office: +1-732-524-3922

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Verimatrix Releases Advanced Code Protection Service for Android Application Bundles20.1.2021 19:45:00 EETPress release

Regulatory News: Verimatrix, (Paris:VMX), the leader in powering the modern connected world with people-centered security, today announced general availability of version 2.2 of the Verimatrix Application Protection service for Android. The company’s latest Code Protection service for Android applications now supports the forthcoming Android ecosystem change that will mandate the use of Android Application Bundles (AABs) in the second half of 2021. A significant shift for developers, the upcoming AAB mandate creates a need for simple, reliable software security that prevents app attacks. In addition to traditional APKs, the Verimatrix Application Protection service now also supports AABs defined by Google Play’s publishing guidelines. Other new features and in enhancements in Verimatrix Application Protection service for Android include: AAB support through the Verimatrix App Shield service or on-premise tool Upgraded whole app integrity verification based on certificate binding for pu

LG CHEM TO SEEK INNOVATIVE IDEAS FOR SUSTAINABLE TECHNOLOGIES WORLDWIDE THROUGH 3rd GLOBAL INNOVATION CONTEST20.1.2021 17:00:00 EETPress release

LG Chem (KRX: 051910) announced on 20th January that it will host the 3rd Global Innovation Contest (GIC) for leading universities and research institutions worldwide. Being the first of its kind in the Korean chemical industry, Global Innovation Contest invites organizations around the world to discover innovative ideas for sustainable technologies. The contest is open for entry from 25th January to 31st March in 4 categories: Energy, Sustainability, Advanced Materials, and Digital Transformation (DX). Under the new vision of the company “We connect science to life for a better future,” Sustainability and DX are 2 categories newly added this year. All scholars and researchers interested in developing the next generation’s innovative technology and industry-academia collaboration research are welcome to participate and submit their research proposals through the official GIC website. (www.rnd.lgchem.com/global/gic) LG Chem will form a judging panel of internal experts to evaluate the r

H.I.G. Capital Sells RGIB's Bathroom Furniture Division to Roca20.1.2021 16:20:00 EETPress release

H.I.G. Capital, ("H.I.G."), a leading global private equity investment firm with over €35 billion of equity capital under management, and the Royo family have entered into an agreement to sell the bathroom furniture division of RG International Bathroom (“RGIB or the “Company”) to Roca Sanitario, S.A. The Royo family will retain a minority stake in the division. Both H.I.G. and the Royo family will continue as shareholders of the shower tray business of RGIB, operating under the Fiora brand. H.I.G. partnered with the Royo family in December 2016 and has achieved a number of important milestones, including: Developing a new factory and brand in Poland (Maximus) that contributed to strengthening the leading position that RGIB already had in the Polish market under the Elita brand Entering new segments, channels and countries; one of the most relevant achievements was the entry into the DIY channel in Germany where RGIB is now a leading player Consolidating RGIB’s leading position in Spai

Thales NS50 Radar to Equip the Belgium Navy and the Royal Netherlands Navy Next Generation Mine Counter Measures Vessels (MCMV)20.1.2021 12:00:00 EETPress release

The navies of Belgium and the Netherlands rely on Thales, Naval Group and KERSHIP shipyard to equip the 12 next generation Mine Counter Measures Vessels with NS50 radars for Air & Surface Surveillance with Fire Control capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210120005024/en/ NS50 radar © Thales The NS50 provides for the first time a complete and superior level of self-protection capability against air and surface threats for this category of high value MCM vessels. A strategic choice for small to medium vessels, the NS50 offers dual functions between air and surface surveillance and fire control. The nature of threats faced by Navies has never been more varied nor more challenging, ranging from next generation anti-ship missiles, robotic warfare and swarm attacks, to electronic warfare (jamming) as well as, overall, having to operate in a simultaneously conventional, asymmetric and hybrid threat environm

SmartStream Reveal Their Latest API Suite With a Complete Range of Reference Data Services20.1.2021 12:00:00 EETPress release

SmartStream Technologies, the financial Reference Data Utility (RDU) solutions provider, today announces the launch of its Application Programming Interface (API) suite – for quicker access to services providing accurate data, with improved customer service, operational efficiency, greater agility and competitiveness. The new fully comprehensive API service will benefit financial institutions by saving huge amounts on infrastructure costs, as well as an affordable service which is straightforward to deploy. Financial institutions are now realising the need for change, with many currently engaging in digital transformation projects including the implementation of APIs. RDU services currently fall into two categories: security reference data and regulatory reference data. Security reference data solutions available on an API basis will include a listed derivatives service, with data sourced from over 100 exchanges and comprehensive coverage for options, futures, options on futures and ca

ENHERTU® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer20.1.2021 10:00:00 EETPress release

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. In Europe, approximately 531,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2 positive.1,2,3 The impact of the disease is significant, with breast cancer responsible for more than 141,000 deaths per year in Europe.1 “One in five women with breast cancer have HER2 positive disease and those with previously-treated metastatic disease often progress quickly,” said Professor Fabrice André, Head of Research, Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France. “One of the biggest challenges in this setting has been identifying treatment strategies that produce

Bureau Veritas Further Expands Cybersecurity Offer by Joining Forces With Secura20.1.2021 10:00:00 EETPress release

Bureau Veritas , a world leader in testing, inspection and certification, announced today that it has completed the acquisition of Secura B.V. (starting with a majority stake), an independent service company specializing in cybersecurity services. Secura will be a cornerstone in the cybersecurity strategy of Bureau Veritas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210119006117/en/ Rising demand in digital security and new regulations drive a growing need for conformity assessments. As a result, Testing, Inspection and Certification (TIC) services for cybersecurity are an emerging market with substantial expected growth and significant momentum. In this promising new conformity market, Secura is a recognized cybersecurity player with a strong orientation toward TIC activities. Established in 2000 in the Netherlands, Secura has 100 employees located in two technological centers in Eindhoven and Amsterdam. The company pos

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom