Aradigm Announces Submission of Responses to EMA Day 120 Questions and Meeting with FDA
January 30, 2019 at 08:00 AM EST
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.
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.
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.