Aradigm Announces Appointment of Dr. Robert A. Reed as Vice President, Regulatory (Chemistry, Manufacturing and Controls) and Quality
HAYWARD, Calif.--(BUSINESS WIRE)--
Aradigm Corporation (NASDAQ:ARDM) ("Aradigm" or the "Company") today
announced that Robert A. Reed, PhD has been appointed as Aradigm's Vice
President, Regulatory (CMC) and Quality, reporting to Igor Gonda,
President and Chief Executive Officer. Dr. Reed joins Aradigm from
Celsion Corporation where he was Senior Vice President of CMC and
Technical Operations, overseeing CMC Regulatory and Operations for a
liposomal delivery system under clinical development for the treatment
of primary liver cancer.
Dr. Reed has more than 25 years of pharmaceutical industry experience in
preclinical, CMC and regulatory activities spanning The Liposome
Company, Merck & Company, XenoPort Incorporated and Celsion Corporation.
While at Merck & Co., Dr. Reed directed the CMC activities of many late
stage products, such as Crixivan®, Singulair® and Januvia®. At XenoPort,
Dr. Reed oversaw CMC activities for their lead candidate, Horizant®.
Overall, Dr. Reed has supported the commercialization of 25 drugs for
Dr. Reed received his PhD from The University of North Carolina at
Chapel Hill, followed by a NIH Post Doctoral Fellow at Princeton
University. He has published 65 research articles and book chapters,
over 110 posters and presentations, and is inventor on 5 patents.
"We are delighted that Dr. Reed has joined our team at this critical
juncture when our investigational drug Pulmaquin® is in global Phase 3
clinical trials for the management of patients with non-cystic fibrosis
bronchiectasis. His rich experience in late stage product development
and approval, as well the commercial scale manufacturing of respiratory
and liposomal therapeutics, is a particularly important addition to our
expertise," said Igor Gonda, President and Chief Executive Officer,
Ciprofloxacin, available in oral and intravenous formulations, is a
widely prescribed antibiotic. It is used to treat acute lung infections
and is often preferred because of its broad-spectrum antibacterial
activity against various bacteria, such as Pseudomonas aeruginosa.
Pulmaquin is an investigational dual release formulation composed of a
mixture of liposome encapsulated and unencapsulated ciprofloxacin. It is
being evaluated in two ongoing Phase 3 studies to determine its safety
and effectiveness as a once-a-day inhaled formulation for the chronic
treatment of non-cystic fibrosis bronchiectasis (non-CF BE).
Pulmaquin has been tested in preclinical safety studies (up to 3 months
in rodents and 9 months in dogs).
Following Phase 2a development of the liposomal portion of Pulmaquin
(Lipoquin®) and Phase 1 development of Pulmaquin,
the Phase 2b study ORBIT-2 with Pulmaquin was a 24-week multicenter,
randomized, double-blind, placebo-controlled trial in 42 adult non-CF BE
subjects. This study demonstrated a significant reduction in P.aeruginosa
sputum activity (p=0.002) and a decrease in time to first exacerbation
in the per protocol population (p=0.046) and the mITT (p=0.057)
populations in the Pulmaquin treated subjects compared to placebo.
Overall, the incidence of all treatment emergent adverse events was
similar between groups. The most frequently reported treatment related
adverse events (reported by ≥ 3 patients in either treatment group)
included product taste abnormal and nausea in the Pulmaquin group and
wheezing in the placebo group. No serious adverse events were considered
treatment related. There were no deaths reported during ORBIT-2.
The Phase 3 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 is enrolling
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 is being 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 is being
monitored as a safety indicator.
Aradigm has been granted orphan drug designations for liposomal
ciprofloxacin, as well as for ciprofloxacin for inhalation for non-CF BE
in the U.S. In addition, the U.S. Food and Drug Administration (FDA) has
designated Pulmaquin as a Qualified Infectious Disease Product (QIDP).
The QIDP designation is granted for treatment of non-CF BE patients with
chronic lung infections with Pseudomonas aeruginosa. The QIDP
designation made Pulmaquin eligible for Fast Track designation which was
granted by the FDA in September 2014.
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 Non-Cystic Fibrosis Bronchiectasis
Non-CF BE 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.
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 under development for 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 patients with chronic lung infections with
non-tuberculous mycobacteria (NTM), and 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.
Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including those related to the ORBIT-3 and ORBIT-4
clinical trials and the ability to continue successful product
development of our potential product candidates, including Pulmaquin, 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,
2014 filed with the SEC on March 18, 2015, and the Company's Quarterly
Reports on Form 10-Q.
Aradigm, Pulmaquin, Lipoquin and the Aradigm Logo are registered
trademarks of Aradigm Corporation.
Nancy Pecota, 510-265-8800
Source: Aradigm Corporation
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