Market Overview

Aradigm Announces Submission of Responses to EMA Day 120 Questions and Meeting with FDA

Share:

Aradigm Corporation (OTCQB:ARDM) ("Aradigm" or the "Company") submitted
responses to the European Medicines Agency (EMA) Day 120 questions on 23
January 2019. The due date for response to the questions was 25 January.
The submission of the responses to the questions triggers the restart of
the regulatory clock. As part of the EMA regulatory review calendar for
marketing authorization application submissions to the EMA for approval,
Aradigm will expect a Day 180 List of Outstanding Issues in late March.
The clock will stop again until Aradigm responds to those issues,
usually within thirty to sixty days. One month later, Aradigm could
expect an opinion by the Committee for Medicinal Products for Human Use
(CHMP) to our request for approval or a presentation to the CHMP during
a formal hearing, which will be followed by the CHMP opinion a month
later.

As previously announced, a clinical US Food and Drug Administration
(FDA) meeting took place on 25 January 2019, with formal minutes
expected within a month.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the
development and commercialization of drugs for the prevention and
treatment of severe respiratory diseases. Aradigm is currently in Phase
3 development of Apulmiq (an investigational proprietary formulation of
ciprofloxacin for inhalation) for the treatment of patients with NCFBE
and chronic lung infection with P. aeruginosa. Aradigm's inhaled
ciprofloxacin formulations are also product candidates for treatment of
patients with cystic fibrosis and non-tuberculous mycobacteria, and for
the prevention and treatment of high threat and bioterrorism infections,
such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and
inhaled anthrax.

About Non-Cystic Fibrosis Bronchiectasis

NCFBE is a severe, chronic and rare disease characterized by abnormal
dilatation of the bronchi and bronchioles, frequently associated with
chronic lung infections. It is often a consequence of a vicious cycle of
inflammation, recurrent lung infections, and bronchial wall damage.
NCFBE represents an unmet medical need with high morbidity and mortality
that affects more than 150,000 people in the U.S. and over 200,000
people in Europe. There is currently no drug approved for the treatment
of this condition.

Forward-Looking Statements

Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including the risk that Apulmiq may not receive
regulatory approval or be successfully commercialized, as well as the
other risks detailed from time to time in the Company's filings with the
Securities Exchange Commission (SEC), including the Company's Annual
Report on Form 10-K for the year ended December 31, 2017 filed with the
SEC on March 23, 2018, and the Company's Quarterly Reports on Form 10-Q.

More information about Aradigm can be found at www.aradigm.com.

Aradigm and the Aradigm Logo are registered trademarks of Aradigm
Corporation. Apulmiq is a registered trademark of Grifols, S.A.

View Comments and Join the Discussion!