FDA Grants QIDP Designation to Aradigm’s Inhaled Antibiotic

  FDA Grants QIDP Designation to Aradigm’s Inhaled Antibiotic

     Pulmaquin designated as a QIDP for Treatment of Non-Cystic Fibrosis
    Bronchiectasis Patients with Chronic Lung Infections with Pseudomonas

Business Wire

HAYWARD, Calif. -- May 20, 2014

Aradigm Corporation (OTC BB: ARDM.OB) (the “Company”)  today announced that
the U.S. Food and Drug Administration (FDA) has designated the Company’s lead
inhaled antibiotic candidate, Pulmaquin®, as a Qualified Infectious Disease
Product (QIDP). The QIDP designation, granted for treatment of non-cystic
fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with
Pseudomonas aeruginosa, will make Pulmaquin eligible to benefit from certain
incentives for the development of new antibiotics provided under the
Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include
priority review and eligibility for fast-track status. Further, if ultimately
approved by the FDA, Pulmaquin is eligible for an additional five-year
extension of Hatch-Waxman exclusivity.

The Phase III clinical program for Pulmaquin in non-CF BE consists of two
worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and
ORBIT-4) that are identical in design except for a pharmacokinetics sub-study
to be conducted in one of the trials. Each trial will enroll approximately 255
patients into a 48-week double blind period consisting of 6 cycles of 28 days
on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by
a 28-day open label extension in which all participants will receive Pulmaquin
(total treatment duration approximately one year). The superiority of
Pulmaquin vs. placebo during the double blind period will be evaluated in
terms of the time to first pulmonary exacerbation (primary endpoint), while
key secondary endpoints include the reduction in the number of pulmonary
exacerbations and improvements in the quality of life measures. Lung function
will be monitored as a safety indicator.

“We are very pleased that the FDA has granted QIDP designation to Pulmaquin,”
said Igor Gonda, Chief Executive Officer of Aradigm Corporation. “Persistent
lung infections with Pseudomonas aeruginosa are a key factor related to the
poor quality of life and untimely death in non-cystic fibrosis bronchiectasis
patients. The QIDP designation will accelerate the advancement of Pulmaquin
development as a potential treatment for these patients.”

About Aradigm’s inhaled ciprofloxacin formulation brand - Pulmaquin

Ciprofloxacin, available in oral and intravenous formulations, is a widely
prescribed antibiotic. It is used to treat acute and chronic lung infections
and is often preferred because of its broad-spectrum antibacterial activity
against various bacteria such as Pseudomonas aeruginosa. Pulmaquin is a dual
release formulation that is a mixture of liposome encapsulated (Lipoquin®) and
unencapsulated ciprofloxacin. It is being evaluated in two Phase III studies
(ORBIT-3 and ORBIT-4) to determine its safety and effectiveness as a
once-a-day inhaled formulation for the treatment of non-cystic fibrosis (CF)
bronchiectasis. The ORBIT-3 study began dosing patients in April 2014 and
ORBIT-4 will begin dosing patients in 1H 2014.

Pulmaquin has been extensively tested through preclinical studies and a Phase
IIb study (ORBIT-2). Previous studies have demonstrated no significant
clinical safety concerns.

Aradigm has been granted orphan drug designation for the combination of
liposomal ciprofloxacin and free ciprofloxacin for non-CF bronchiectasis in
the U.S.

In 2013, Aradigm granted an exclusive, world-wide license for the Company’s
inhaled liposomal ciprofloxacin product candidates for the indication of
non-CF BE and other indications to Grifols S.A. More information on the terms
of this license may be found in the Company’s Annual Report on Form 10-K for
the year ended December 31, 2013 filed with the SEC on March 13, 2014.

About the GAIN Act

The GAIN Act, Title VIII (Sections 801 through 806) of the FDA Safety and
Innovation Act, seeks to provide pharmaceutical and biotechnology companies
with incentives to develop new antibacterial and antifungal drugs for the
treatment of life-threatening, infectious diseases caused by drug resistant
pathogens. Qualifying pathogens are defined by the GAIN Act to include
multi-drug resistant Gram-negative bacteria, including Pseudomonas,
Acinetobacter, Klebsiella, and Escherichia coli species. It extends the length
of time an approved drug is free from competition and clarifies the regulatory
pathway for new antibiotics.

About Bronchiectasis

Bronchiectasis 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. Non-CF BE represents an
unmet medical need with high morbidity and mortality that affects more than
110,000 people in the U.S. and over 200,000 people in Europe. There is
currently no drug approved for the treatment of this condition.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the
development and commercialization of drugs delivered by inhalation for the
prevention and treatment of severe respiratory diseases. Aradigm has product
candidates addressing the treatment of non-CF BE, cystic fibrosis and
prevention of respiratory and other diseases in tobacco smokers through
smoking cessation. Aradigm is also developing Pulmaquin and a liposomal
ciprofloxacin formulation as potential medications for the prevention and
treatment of high threat and bioterrorism infections, such as inhaled
tularemia, pneumonic plague, Q fever and inhaled anthrax.

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

Forward-Looking Statements

Except for the historical information contained herein, this news release
contains forward-looking statements that involve risk and uncertainties,
including whether Pulmaquin will benefit from the QIDP designation; whether
Pulmaquin will advance through the clinical trial process on a timely basis;
whether the results of the clinical trials of Pulmaquin will warrant the
submission of applications for marketing approval, and if so, whether
Pulmaquin will receive approval from the U.S. FDA or equivalent foreign
regulatory agencies where approval is sought, as well as 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, 2013 filed with the SEC on March 13, 2014, and
the Company’s Quarterly Reports on Form 10-Q.

Aradigm, Pulmaquin and the Aradigm Logo are registered trademarks of Aradigm


Aradigm Corporation
Nancy Pecota, 510-265-8800
Chief Financial Officer
LifeSci Advisors
Andrew McDonald, 646-597-6987
Founding Partner
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