Categorical Response and Clinical Relevance as Assessed in a Phase III Study of HP-3070 (Asenapine) Transdermal Patch for the Treatment of Schizophrenia to be Presented at the American Psychiatric Association 172nd Annual Meeting

New Drug Application for HP-3070 under FDA review

MIAMI & JERSEY CITY, N.J.–(BUSINESS WIRE)–Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu
Pharmaceutical Co., Ltd., announced today that secondary endpoint data
from the pivotal Phase III study for HP-3070 (asenapine) transdermal
drug delivery system (TDDS), an investigational product for the
treatment of schizophrenia, will be featured as a poster presentation at
the American Psychiatric Association (APA) 172^nd Annual
Meeting in San Francisco, May 18 – 22, 2019.

This poster will feature data from the randomized, double-blind,
placebo-controlled pivotal HP-3070 Phase III clinical study that have
not been previously presented at scientific conferences, including the
categorical response and clinical relevance of the efficacy of HP-3070
for the treatment of schizophrenia as well as the transdermal patch’s
safety and tolerability profile.

Details for the upcoming conference presentation are below:

• Poster Title: HP-3070 Asenapine Transdermal System in Adults
  with Schizophrenia: Categorical Response and Clinical Relevance as
  Assessed in a Phase 3 RCT
• Abstract Number: 5508
• Poster Number: P7-078
• Session Date/Time: Poster Session 7; May 21, 2019; 10:00
  AM–12:00 PM
• Location: Moscone Center, Rooms 3/4, Exhibition Level

“In treating persons with schizophrenia, it is useful to be able to
offer different options,” said Dr. Leslie Citrome, MD, MPH, presenting
author of the above-mentioned APA poster. “Presented here are analyses
supporting a potentially new way of administering antipsychotics using a
transdermal drug delivery system that uses a patch placed on the skin.
The primary outcome data from the pivotal Phase III study of HP-3070
have been previously presented and demonstrated the safety and efficacy
of this approach in adults with schizophrenia. New analyses examining
response rates support the clinical relevance of these results, and may
help the clinician in appraising this new option for their patients.”

Secondary and exploratory data to be presented in the APA poster show
outcomes for categorical response based on responder analyses performed
for Positive and Negative Syndrome Scale (PANSS) total score and
Clinical Global Impression–Improvement (CGI-I) change from baseline to
Week 6 vs placebo. Responder rates for both PANSS and CGI-I assessments
were statistically significantly higher in HP-3070-treated patients
versus placebo at various time points, indicating a clinically relevant
treatment response in adults treated with either high- or low-dose
HP-3070.

Systemic treatment-emergent adverse events (TEAEs) were mostly mild or
moderate in severity and consistent with sublingual asenapine. The most
common TEAEs observed in the clinical trial were application site
reaction, headache and extrapyramidal disorder.

About HP-3070

Asenapine is a second generation atypical antipsychotic currently
available as a sublingual formulation for the treatment of schizophrenia
in adults. HP-3070 is an investigational asenapine-containing
Transdermal Drug Delivery System (TDDS), developed by Hisamitsu
Pharmaceutical, to be applied to the skin for the treatment of
schizophrenia. If approved by the U.S. Food and Drug Administration
(FDA), HP-3070 may provide a novel treatment option for patients,
caregivers, and physicians, as the first and only transdermal patch
antipsychotic available for the treatment of schizophrenia in the U.S. A
New Drug Application (NDA) for supporting HP-3070 is under review by the
FDA. The NDA is supported by a robust clinical program including nine
clinical studies performed establishing the safety and efficacy profile
of HP-3070. The development of HP-3070 represents Noven and Hisamitsu
Pharmaceutical’s commitment to improving the lives of patients with
schizophrenia.

About Schizophrenia

Schizophrenia is a severe, chronic psychiatric disease with a
heterogeneous course and symptom profile. The symptoms associated with
schizophrenia are disabling and lifelong, and greatly affect a patient’s
quality of life and social functioning. Symptoms such as hallucinations
and delusions usually start between ages 16 and 30. Schizophrenia
presents clinically as negative (affective flattening, social
withdrawal, and restriction in the fluency and productivity of thought
and speech and in the initiation of goal-directed behavior), positive
(delusions, hallucinations, disorganized speech, and disorganized or
catatonic behaviors) and cognitive symptoms. Cognitive symptoms such as
impairment in sustained attention, impaired executive functioning, and
impaired working memory may also be present.¹

About Noven Pharmaceuticals, Inc.

Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in the research, development, manufacturing, marketing and sale
of prescription pharmaceutical products. Noven’s mission is to develop
and offer pharmaceutical products that meaningfully benefit patients
around the world, with a commitment to advancing patient care through
transdermal drug delivery. Noven is a stand-alone operating subsidiary
of Japan-based Hisamitsu Pharmaceutical Co., Inc., serving as
Hisamitsu’s U.S. platform in prescription pharmaceuticals, and helping
Hisamitsu bring the benefits of patch therapy to the world. For
information about Hisamitsu, visit http://global.hisamitsu/.

¹ National Institute of Mental Health. Schizophrenia.
[Internet]. Available from: https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml
Accessed April 2019.

Contacts

Monica Lara
Noven Pharmaceuticals, Inc.
305-253-1916