HAYWARD, Calif.--(BUSINESS WIRE)--Apr. 5, 2018--
Aradigm Corporation (NASDAQ: ARDM) (the "Company") today
announced the completed formal validation by the European Medicines
Agency (EMA) of the Marketing Authorisation Application (MAA) for
Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE)
patients with chronic lung infections with Pseudomonas aeruginosa
(P. aeruginosa). The completion of the MAA validation is
commensurate with the start date of the review procedure on March 29,
The EMA review of the MAA for Linhaliq will be according to standard
timelines, with an opinion of the Committee for Medicinal Products for
Human Use (CHMP) expected within 210 days (less any clock-stops for the
applicant to provide answers to question(s) from the CHMP). After the
adoption of a CHMP opinion, a final decision regarding the MAA
assessment is carried out by the European Commission on Day 277 of the
The validation of the MAA submission is a milestone event for Aradigm.
We look forward to working with EMA to gain approval for Linhaliq.
If approved by the European commission, Linhaliq will provide a
much-needed treatment for patients with NCFBE with chronic lung
infections with P. aeruginosa.
Additional Information about Linhaliq Phase 3 Trials and Regulatory
Linhaliq, formerly known as Pulmaquin®, is composed of a mixture of
liposome encapsulated and unencapsulated ciprofloxacin. There are
currently no treatments approved for NCFBE patients to prevent and
reduce the number of PEs.
Linhaliq was evaluated in two Phase 3 studies (ORBIT-3 and ORBIT-4) to
determine its safety and effectiveness as a once-a-day inhaled
formulation for the chronic treatment of patients with NCFBE who have
chronic lung infections with P. aeruginosa.
Aradigm discussed the results of the Phase 3 studies at pre-submission
meetings with EMA in October and November 2017. Based on these
discussions, the statistical analysis of the results was changed from
the pre-specified plan to stratification based on sex and the frequency
of pulmonary exacerbations in the prior year, as the stratum for current
smokers contained a small number of subjects.
Further information about the analyses of the Phase 3 results is
presented at Aradigm's website www.aradigm.com.
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. NCFBE patients who have chronic infections with P.
aeruginosa have a 6.5-fold increase in hospitalization, three times
higher mortality, and a worse quality of life compared with those
without P. aeruginosa infections.
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 has completed Phase 3
development of Linhaliq (an investigational proprietary formulation of
ciprofloxacin for inhalation) for the treatment of NCFBE. Aradigm's
inhaled ciprofloxacin formulations including Linhaliq 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.
More information about Aradigm can be found at www.aradigm.com.
Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including the risk that the regulatory authorities may
not agree with our interpretation of the data from our clinical trials
of Linhaliq and may require us to conduct additional clinical trials;
Linhaliq may not receive regulatory approval or be successfully
commercialized, either as a result of the FDA's or other regulatory
authorities' decisions regarding labeling and other matters that could
affect its availability or commercial potential, or due to the other
risks detailed from time to time in the Company's filings with the
Securities and 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.
Aradigm, Pulmaquin and the Aradigm Logo are registered trademarks of
Aradigm Corporation. Linhaliq is a registered trademark of Grifols, S.A.
1 Polverino E, Goeminne PC, McDonnell MJ, et al. European
Respiratory Society guidelines for the treatment of adult
bronchiectasis. Eur Respir J 2017; 50: 1700629 [https://doi.org/10.1183/13993003.00629-2017].
View source version on businesswire.com: https://www.businesswire.com/news/home/20180405005412/en/
Source: Aradigm Corporation
Meredith Callender, 510-265-8800