Aradigm Announces Appointment of Dr. Juergen Froehlich as Chief Medical
HAYWARD, Calif. -- November 19, 2013
Aradigm Corporation (OTCBB:ARDM) (“Aradigm” or the “Company”) today announced
that Juergen Froehlich, MD has been appointed as Aradigm’s Chief Medical
Officer. He joins Aradigm from Vertex Pharmaceuticals where he was Head of
Regulatory Affairs, overseeing global submissions and approvals under
accelerated review timelines of Kalydeco (ivacaftor) and the granting of two
Breakthrough Designations for the orphan indication of cystic fibrosis.
Dr. Froehlich has more than 20 years of pharmaceutical industry experience in
preclinical, clinical and regulatory activities at Boehringer Ingelheim,
Genentech, Quintiles, Bristol-Myers Squibb, Ipsen and Vertex Pharmaceuticals.
While at Genentech, Dr. Froehlich directed the clinical development,
submission and approval of Activase for acute ischemic stroke and the early
development of Xolair for the treatment of allergic rhinitis and allergic
asthma. At Bristol-Myers Squibb, Dr. Froehlich oversaw the global life cycle
management for Plavix and Avapro. At Ipsen, he directed the FDA submission and
approval for Somatuline for acromegaly, oversaw U.S. development of Dysport
for cervical dystonia as well as global clinical studies and regulatory
strategies for recombinant porcine factor VIII in hemophilia. Dr. Froehlich
was closely involved in the commercialization of various drugs and biologics
and alliance activities with other companies.
Dr. Froehlich graduated from the Medical School at Wuerzburg University in
Germany. He is a Diplomate of the American Board of Clinical Pharmacology, a
Fellow of the American College of Clinical Pharmacology and a Fellow of the
Faculty of Pharmaceutical Medicine. He also holds a dual executive MBA degree
from the Graduate School of Business Administration in Zurich, Switzerland and
from the State University of New York at Albany.
“We are delighted that Dr. Froehlich joined our team at this critical juncture
when Pulmaquin® is entering Phase 3 clinical development for the management of
patients with non-cystic fibrosis bronchiectasis. His rich experience in the
late stage clinical development and approval of valuable treatments,
especially for orphan indications, is a particularly important addition to our
expertise,” said Igor Gonda, President and Chief Executive Officer, Aradigm
About inhaled ciprofloxacin (Pulmaquin and Lipoquin®)
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the
lung frequently experienced by cystic fibrosis (CF) and non-cystic fibrosis
bronchiectasis (BE) patients. It is often preferred because of its
broad-spectrum anti-bacterial action. The available oral and intravenous
formulations of the drug are used to treat episodes of acute exacerbations of
lung infections. Aradigm’s once-a-day novel inhaled formulations of
ciprofloxacin are encapsulated in liposomes, allowing for a sustained release
of the drug within the lung and improving airway tolerability. The
formulations are to be used for chronic maintenance therapy as they achieve
much higher antibiotic concentration at the site of infection and relatively
low systemic antibiotic concentrations to minimize side-effects. Lipoquin is a
liposomal formulation of ciprofloxacin. Pulmaquin is a dual release
formulation that is a mixture of Lipoquin with unencapsulated ciprofloxacin.
Pulmaquin has been tested extensively in preclinical tests, as well as in the
ORBIT-2 Phase 2b bronchiectasis study in which outstanding antimicrobial
activity coupled with good safety and tolerability was found, and, most
importantly, the positive impact on prevention of exacerbations compared to
placebo was also observed. Pulmaquin is entering Phase 3 clinical trials.
Aradigm has been granted orphan drug designation for liposomal ciprofloxacin
for cystic fibrosis in the U.S. and the E.U., and for the combination of
liposomal ciprofloxacin and free ciprofloxacin for BE in the U.S. Aradigm’s
inhaled ciprofloxacin has been also successfully tested in animal models of
the bioterrorism infections inhalational tularemia, pneumonic plague and
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 bronchiectasis, cystic fibrosis,
inhalation tularemia and anthrax infections, and prevention of respiratory and
other diseases in tobacco smokers through smoking cessation.
More information about Aradigm can be found at www.aradigm.com.
Disclaimer and Forward-Looking Statements
Except for the historical information contained herein, this news release
contains forward-looking statements that involve risk and uncertainties,
including the conduct and completion of clinical trials, as well as the other
risks detailed from time to time in Aradigm's filings with the Securities and
Exchange Commission (SEC), including its Annual Report on Form 10-K for the
year ended December 31, 2012 filed with the SEC on March 27, 2013, and
Aradigm’s Quarterly Reports on Form 10-Q.
Aradigm, Pulmaquin, Lipoquin and the Aradigm Logo are registered trademarks of
Nancy Pecota, Chief Financial Officer, 510-265-8800
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