Exhibit 99.1
February 21, 2019
Aradigm Announces Receipt of Final FDA Minutes for the Type B Meeting on January 25, 2019
HAYWARD, Calif., February 21, 2019—(BUSINESSWIRE)—Aradigm Corporation (Pink Market: ARDM) (“Aradigm” or the “Company”).
At the Type B meeting, Aradigm presented the results of the Third Party Evaluation (TPE) completed in December 2019 that addressed the clinical issue raised by the FDA in the complete response letter (CRL) received in January 2018. As previously announced, the TPE results confirm the primary and secondary pulmonary exacerbation (PE) endpoint analyses of theORBIT-3 andORBIT-4 trials as submitted in the NDA in July 2017.
Based on the Orphan Drug Designation in bronchiectasis for Apulmiq, Aradigm asked the FDA to exercise its flexibility and allow a resubmission of the NDA. Aradigm requested that this submission focus on obtaining marketing approval for the rare clinical phenotype ofnon-cystic fibrosis bronchiectasis (NCFBE) patients with chronicPseudomonas aeruginosa (P. aeruginosa) infection and frequent exacerbations. These patients were defined as having experienced four (4) or more pulmonary exacerbations in the twelve (12) months prior to enrollment in the trials and suffer from severe disease with a consistently high number of PEs, poor quality of life and high mortality (up to 30% over a five-year period).* Aradigm presented data for this severely affected and clinically distinct phenotype that indicate concordant results across both Phase 3 trials, including a 34-49% reduction of all PEs in combination with a good safety profile.
The Agency stated that based on the TPE information presented by Aradigm it appears the TPE findings are consistent with the original Phase 3 trial results. However, they continue to have concerns over the discordance in the results of thepre-specified primary and secondary endpoints between theORBIT-3 andORBIT-4 trials.
The Agency did agree that chronic lung infection withP. aeruginosa innon-cystic fibrosis bronchiectasis (NCFBE) patients is a serious and potentially life threatening condition that affects a small population with high unmet medical need. Since products with orphan drug designation remain subject to the statutory requirements for obtaining marketing approval, the Agency recommended that Aradigm conduct an additional adequate and well-controlled trial to demonstrate a significant treatment effect of Apulmiq on a clinically meaningful endpoint. The Agency acknowledged that appropriate endpoints for clinical trials have evolved over time, and, therefore, frequency of exacerbation as the primary endpoint in a future clinical trial is reasonable.
Aradigm also indicated they have been addressing all issues in the CRL. Following FDA guidance provided in a Type C meeting, a new Human Factor study and work to address the product quality deficiencies are currently nearing completion. A comprehensive method development report for the in vitro release assay has been submitted for FDA review.
Aradigm remains confident in the efficacy, safety and quality of Apulmiq (US)/Linhaliq (EMA). We are committed to continue working toward the approval of Apulmiq (US)/Linhaliq (EMA) forNon-Cystic Fibrosis Bronchiectasis (NCFBE) patients who have chronic infection withP. aeruginosa, resulting in severe disease with frequent exacerbations, high morbidity and mortality, and no available treatment options.
As announced previously, Aradigm has filed for protection under Chapter 11 of the U.S. Bankruptcy Code. Aradigm intends to commence a process of selling its assets to interested parties, subject to Bankruptcy Court approval.
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 withP. 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.
