PipelineResearch & Development

Nobelpharma has earnestly addressed the development of medicines that

other companies do not pursue, in order to fulfill the needs of society.

Nobelpharma has continuously aspired to perform research and development of medicines that have not been targets for the other pharmaceutical companies due to limited operating revenue opportunities for medicines with a small number of patients (medicines for unmet medical needs). The core of our development pipeline has been medicines such as orphan drugs (drugs for rare diseases) that have been strongly requested by patients, academic societies, or the government, as well as off-labeled medicines and pediatric medicines. Our efficient research and development approach, conducted by the dedicated and selected few, is what enables us to obtain approvals for such medicines that have only small sales potential.

We have engaged in the development of many unapproved drugs, that were already available in the US and Europe but that were not yet developed in Japan despite the high need for them, and we will now move forward to take on the challenges to develop medicines under new concepts as well.

Development Process of Nobelpharma

Development Process of
Conventional
Pharmaceutical Companies
Development Process of
Nobelpharma
(Proven Record)
2-3 years
Basic Research
  • Baseline Examinations
  • Screening Tests
  • Studies of Pharmaceuticals and their manufacturing processes/Pharmacological Studies

No baseline studies in principle. Research activities and licence negotiations based on patient needs.

3-5 years
Non-clinical Tests
  • Physicochemical Tests
  • Toxicity Tests according to the Ordinance on GLP (Good Laboratory Practice)
  • Pharmacological/Pharmacokinetic Testing

Collaboration with academia in some cases.

3-7 years
Clinical Trials
  • Phase 1 Trial
  • Phase 2 Trial
  • Phase 3 Trial
16-42 months
2-3 years
Application/
Approval
  • Application for Marketing Approval
  • Review
  • Approval [NHI (National Health Insurance) Price Listing]
7-21 months
Post-
Marketing
  • Early Post-Marketing Surveillance
    • Post-Marketing Surveillance
    • Post-Marketing Clinical Trials according to Ordinances on GVP (Good Vigilance Practice)/GPSP (Good Post-marketing Study Practice)
  • Re-examination
  • Re-evaluation

Future Development Projects

New Drugs/New Devices

As of December 2019

Compound Expected Indication Partner Phase Expected
Approval
NPC-15
melatonin
sleep disorders associated with neurodevelopmental disease in children in-house Filed Mar 2020
NPC-23
GM-CSF
pulmonary alveolar proteinosis Savara P-III
International Clinical Trial
Jun 2021
NPC-09
N-acetylneuraminic acid
distal myopathy in-house P-II/III -
NPC-21
CMV antibody
CMV infection Evec P-I -

Life Cycle Management

As of December 2019

Compound Expected Indication Partner Phase Expected
Approval
NPC-02
Nobelzin
pediatric formulation
(new formualtion)
National Center
for Child Health
and Development
P-III Dec 2020
NPC-05
Unitalc
intractable pneumothorax
(new indication)
Nagoya Univ P-II Sep 2021
NPC-12
Rapalimus
intractable lymphatic disorder
(new indication)
Gifu Univ P-III Dec 2020
NPC-12
Rapalimus
fibrodysplasia ossificans
progressive
(new indication)
Kyoto Univ P-II/III Dec 2020
NPC-12
Rapalimus
Pendred syndrome
(new indication)
Keio Univ P-I/IIa -
NPC-12
Rapalimus
Epilepsy with focal cortical
dysplasia type II
(new indication)
Showa Univ P-II -
NPC-12G
Rapalimus Gel
Neurofibromatosis type I
(new indication)
Osaka Univ P-II/III Dec 2021

Overseas Development

As of December 2019

Compound Expected Indication Partner Phase Expected
Approval
NPC-19
(NPC-SE36)
malaria vaccine
prevention of falciparum
malaria
Osaka Univ
GHIT
P-Ib -
NPC-18
bFGF, etc.
tympanic perforation MEEI/
Harvard Univ
P-II -
NPC-17
thyroid cartilage fixation device
TITANBRIDGE
adductor spasmodic
dysphonia
- trial in
preparation
-
NPC-12G
Rapalimus Gel
angiofibroma - trial in
preparation
-
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