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Johnson & Johnson : Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults

11/23/2020 | 01:09pm EST

News Release

Media Contact: Stela Meirelles +1 (732) 258-1540

Investor Contacts:

Chris DelOrefice

+1 (732) 524-2955

Jennifer McIntyre +1 (732) 524-3922

Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults

If approved, PP6M will be the first and only long-acting injectable schizophrenia

treatment with a twice-yearly dosing regimen

TITUSVILLE, N.J., November 2, 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for paliperidone palmitate 6-month(PP6M) for the treatment of adults diagnosed with schizophrenia. If approved, PP6M will be the first and only long-actinginjectable (LAI) schizophrenia medication with a twice- yearly dosing regimen.

Page 1 of 13

"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, Ph.D., Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. "We designed this unique dosing regimen so people with schizophrenia and their healthcare teams can focus less on medication intervals and more on other aspects of their treatment plans, such as psychosocial interventions. We look forward to working with the FDA to add a 6-month formulation to our family of paliperidone palmitate products."

The submission is based on the Route 6 Study, a randomized, double-blind, non- inferiority Phase 3 global study that enrolled 702 adults living with schizophrenia from 20 countries. Data showed non-inferior efficacy of PP6M compared to paliperidone palmitate 3-month (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.1 The safety profile observed for PP6M was consistent with previous studies of paliperidone palmitate 1-month (PP1M) and 3-month (PP3M) formulations with no new safety signals emerging.

"Antipsychotic medication plays an important role in schizophrenia symptom control; however, nonadherence to prescribed medicines has been recognized as a problem worldwide," said Mathai Mammen, M.D., Ph.D., Global Head of Janssen Research & Development, LLC. "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 stabilized on a shorter

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acting formulation of paliperidone palmitate (PP1M or PP3M), with the goal of administering fewer injections. The Janssen U.S. portfolio of LAI medicines currently approved to treat adults with schizophrenia includes RISPERDAL CONSTA® (risperidone 2-weekly)2, INVEGA SUSTENNA®3 and INVEGA TRINZA®4 (PP1M and PP3M formulations, respectively), all of which are administered in a clinical setting by a medical professional.

Janssen plans to submit a Marketing Authorization Application extension to the European Medicines Agency (EMA) for PP6M in the coming months.

INDICATIONS

INVEGA TRINZA® (3-month paliperidone palmitate) is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least 4 months. INVEGA SUSTENNA® (In-VEY-guhSuss-TEN-uh) (paliperidone palmitate) is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA® is used to treat schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about INVEGA TRINZA® and INVEGA SUSTENNA®?

INVEGA TRINZA® and INVEGA SUSTENNA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). INVEGA TRINZA® and INVEGA SUSTENNA® are not for treating dementia-related psychosis.

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Do not receive INVEGA TRINZA® or INVEGA SUSTENNA® if you

are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA TRINZA® or INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA TRINZA® and INVEGA SUSTENNA® ingredients.

Before you receive INVEGA TRINZA® or INVEGA SUSTENNA®,

tell your healthcare professional about all your medical conditions, including if you:

  • have had Neuroleptic Malignant Syndrome (NMS)
  • have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
  • have or have had low levels of potassium or magnesium in your blood
  • have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
  • have or have had kidney or liver problems
  • have diabetes or have a family history of diabetes
  • have had a low white blood cell count
  • have had problems with dizziness or fainting or are being treated for high blood pressure
  • have or have had seizures or epilepsy
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if INVEGA TRINZA® SUSTENNA® will harm your unborn baby.
  1. If you become pregnant while taking INVEGA TRINZA® or INVEGA SUSTENNA®, talk to your healthcare professional

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This is an excerpt of the original content. To continue reading it, access the original document here.

Disclaimer

Johnson & Johnson published this content on 02 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 November 2020 18:08:07 UTC


© Publicnow 2020
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Sales 2020 81 721 M - -
Net income 2020 15 924 M - -
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P/E ratio 2020 26,5x
Yield 2020 2,45%
Capitalization 426 B 426 B -
EV / Sales 2020 5,28x
EV / Sales 2021 4,78x
Nbr of Employees 132 200
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