Wired News – Aradigm Announced Rejection of Linhaliq(TM)’s New Drug Application by FDA

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LONDON, UK / ACCESSWIRE / January 31, 2018 / Active-Investors.com has just released a free research report on Aradigm Corp. (NASDAQ: ARDM). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ARDM as the Company’s latest news hit the wire. On January 29, 2018, the Company announced the receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Linhaliq™ as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas Aeruginosa. The FDA has determined that it cannot approve the NDA in its present form and has provided specific reasons for this action along with recommendations needed for resubmission. The areas of concern include clinical data, human factors validation study, and product quality. Register today and get access to over 1000 Free Research Reports by joining our site below:

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Recommendations Provided by the FDA

CRL’s recommendations included an independent third-party verification of the Phase-3 results via analyses of source data as per the statistical analysis plan, and an additional Phase-3 clinical trial that demonstrates a significant treatment effect on clinically meaningful endpoints which could evaluate the co-primary endpoints of frequency and severity of exacerbations to assess for durable evidence of efficacy over a period of two years, or more, if scientifically justified.

The CRL also included a request to conduct another Human Factors Study to demonstrate that the product packaging and instructions for use are effective, additional product quality information with respect to microbiology, and a new in vitro drug release method development report.

Aradigm to Develop Plans to Move Towards Resubmission of Linhaliq™ NDA

Igor Gonda, Ph.D., President and Chief Executive Officer (CEO) of Aradigm, stated that the Company remains confident in the efficacy, safety, and quality of Linhaliq™ and will request a meeting with the FDA to discuss the topics covered in the CRL with the view to developing plans to move towards a resubmission of the Linhaliq™ NDA as soon as possible. Gonda added that Aradigm is committed to continue working on the approval of Linhaliq™ for NCFBE patients. The Company is focusing on the resubmission in the near future for marketing approval in the European Union.

Aradigm Reported Results of the FDA Advisory Committee Meeting on Linhaliq™

On January 11, 2018, the Company announced that the FDA did not recommend approval for Linhaliq™ as a treatment for NCFBE patients with chronic lung Pseudomonas Aeruginosa infections. The Advisory Committee voted 3-12 (1 abstain) against approval, and stated that Aradigm did not provide substantial evidence of the safety and efficacy of ciprofloxacin dispersion for inhalation in delaying the time to first exacerbation after starting treatment in NCFBE patients with chronic lung infections with Pseudomonas Aeruginosa. Aradigm submitted the NDA for Linhaliq™ to the FDA in July 2017.

Linhaliq™ Application Based on Data from Three Clinical Trials

The Linhaliq™ application was based on data from three clinical studies. Two Phase-3 studies, ORBIT-3 and ORBIT-4, were identically designed, multinational, randomized (2:1), double-blind, and placebo controlled. Together with the Phase-2b ORBIT-2 study, these trials were part of the NDA submission to provide evidence of the clinical benefit of Linhaliq™ for patients with NCFBE who have chronic lung infections with Pseudomonas Aeruginosa.

About Non-Cystic Fibrosis Bronchiectasis (NCFBE)

NCFBE is a chronic inflammatory lung disease characterized by irreversible dilation of the bronchi and bronchioles, symptoms of persistent cough and expectoration, and recurrent infective exacerbations. It is often a consequence of a vicious cycle of inflammation, chronic lung infections, and bronchial wall damage. No licensed therapies are currently available for its treatment. NCFBE patients who have chronic infections with Pseudomonas Aeruginosa have a 6.5-fold increase in hospitalizations, three times higher mortality, and a worse quality of life compared to those without Pseudomonas Aeruginosa infections.

About Linhaliq™

Linhaliq™, formerly known as Pulmaquin®, is composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used often to treat acute lung infections because of its broad-spectrum antibacterial activity against various bacteria, such as Pseudomonas Aeruginosa.

About Aradigm Corp.

Founded in 1991 and headquartered in Hayward, California, Aradigm is an emerging specialty pharmaceutical Company developing and commercializing a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases. Bolstered by its depth of expertise in pulmonary drug delivery and an extensive intellectual property portfolio, the Company is uniquely positioned to fulfill unmet needs in pulmonary medicine.

Stock Performance Snapshot

January 30, 2018 – At Tuesday’s closing bell, Aradigm’s stock declined 5.66%, ending the trading session at $1.50.

Volume traded for the day: 477.76 thousand shares, which was above the 3-month average volume of 404.17 thousand shares.

Stock performance in the previous six-month period – up 7.11%

After yesterday’s close, Aradigm’s market cap was at $23.45 million.

The stock is part of the Healthcare sector, categorized under the Drug Delivery industry.

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