Grifols and Aradigm Corporation Complete the Closing of Worldwide Licensing
Agreement to Develop and Commercialize Pulmaquin®
Aradigm’s Proprietary Inhaled Antibiotic for the Chronic Therapy of Patients
with Severe Respiratory Disease is Advancing Into Phase III
BARCELONA, Spain & HAYWARD, Calif. -- August 28, 2013
Grifols, S.A. (MCE:GRF, MCE:GRF.P and NASDAQ:GRFS) (“Grifols”) and Aradigm
Corporation (OTC BB:ARDM.OB) (“Aradigm”) today announced the closing of the
transaction that includes the exclusive, worldwide license for Aradigm’s
proprietary formulations of inhaled ciprofloxacin (Pulmaquin and Lipoquin®)
for the treatment of severe respiratory diseases, including non-cystic
fibrosis bronchiectasis (BE). Aradigm has completed Phase 2b clinical trials
in BE patients with Pulmaquin and Lipoquin.
BE is a chronic condition that affects more than 110,000 people in the United
States and many more in other countries and is characterized by abnormal
dilatation of the bronchi and bronchioles associated with chronic respiratory
infections. Aradigm has been granted orphan drug designation for BE in the
U.S. and there is currently no drug specifically approved for the treatment of
Under the terms of the transaction:
*The parties have agreed to advance Aradigm’s proprietary inhaled
ciprofloxacin formulations into Phase III clinical trials in BE.
*Grifols will be responsible for all development and clinical expenses up
to a maximum of $65 million for the BE indication.
*Aradigm is entitled to receive cash payments of up to $25 million upon
achievement of development milestones.
*Grifols is responsible for all commercialization activities and will pay
Aradigm tiered royalties on worldwide sales of products utilizing
Aradigm’s proprietary inhaled ciprofloxacin formulations.
*Grifols was granted an option to license Aradigm’s AERx^® pulmonary drug
delivery platform for use with another molecule.
*In conjunction with the licensing agreement, Grifols acquired 35% of
Aradigm’s common stock on a fully diluted basis at a price per share of
$0.124 for a total investment of approximately $26 million.
*Existing Aradigm shareholders, including Tavistock Life Sciences Company
and accounts managed by First Eagle Investment Management, LLC, and new
investor Great Point Partners, LLC co-invested in the stock purchase
transaction and purchased an additional approximately $15.4 million in
Aradigm common stock. Ladenburg Thalmann & Co. Inc., a subsidiary of
Ladenburg Thalmann Financial Services (NYSE MKT:LTS) acted as placement
agent for this transaction.
With the closing of the transaction Grifols is entitled to designate two
directors to serve on the Aradigm Board of Directors.
“Grifols is pleased to have finalized this transaction. We look forward to
working with Aradigm to bring this important treatment to patients and
healthcare providers. Pulmaquin will build on the existing presence Grifols
has in Pulmonary treatment with Prolastin C,” said Ramon Riera, President,
“The completion of this transaction is a major milestone for Aradigm. We look
forward to working with Grifols to finalize the Pulmaquin global development
by completing the Phase III program and filing a New Drug Application that
could result in approval of a much needed therapy for bronchiectasis
patients,” said Igor Gonda, President and CEO, Aradigm Corporation.
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 ready to begin 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 Q-fever.
Grifols is a global healthcare company with a 70-year legacy of improving
people’s health and well being through the development of life-saving plasma
medicines, hospital pharmacy products and diagnostic technology for clinical
As a leading producer of plasma medicines, Grifols has a presence in more than
100 countries and is the world leader in plasma collection, with 150 plasma
donation centers across the U.S. Grifols is committed to increasing patient
access to its life-saving plasma medicines through significant manufacturing
expansions and the development of new therapeutic applications of plasma
proteins. The company is headquartered in Barcelona, Spain and employs more
than 11,000 people worldwide.
In 2012, Grifols’ sales exceeded 2,620 million euros. The company’s class A
shares are listed on the Spanish Stock Exchange, where they are part of the
Ibex-35 (MCE:GRF). Its non-voting class B shares are listed on the Mercado
Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more
information visit www.grifols.com
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
The facts and figures contained in this news release which do not refer to
historical data are “projections and forward-looking statements”. The words
and expressions like “believe”, “hope” “anticipate”, “predict”, “expect”,
“intend”, “should”, “try to achieve”, “estimate”, “future” and similar
expressions, insofar as they are related to Aradigm, Grifols, the prospects
for Aradigm’s inhaled ciprofloxacin product formulations to successfully
complete clinical trials and to result in approved products, and the ability
of Grifols to successfully commercialize these products, are used to identify
projections and forward-looking statements. These expressions with respect to
Aradigm reflect the assumptions, hypothesis, expectations and anticipations of
the management team of Aradigm at the date of preparation of this news
release, which are subject to a number of factors that could make the real
results differ considerably, such as the uncertainties associated with
clinical trials including lack of effectiveness, lack of statistical
significance of results, adverse side effects or other safety issues,
uncertainties regarding the process of obtaining regulatory approval for the
sale of new drugs, uncertainties concerning the development of demand for new
products, uncertainties regarding the level of reimbursement for new products,
manufacturing and supply issues and the like. The future results of Grifols
Group could be affected by events related to its own activity, such as
shortages of raw materials for the manufacture of its products, the launch of
competitive products or changes in the regulations of markets in which it
operates, among others. At the date of the preparation of this news release
Grifols Group has adopted measures it considers necessary to offset the
possible effects of these events. Grifols, S.A. does not assume any obligation
to publicly inform, review or update any projections and forward-looking
statements to adapt them to facts or circumstances following the preparation
of this news release, except as specifically required by law.
Except for the historical information contained herein, this news release
contains forward-looking statements that involve risk and uncertainties,
including the closing of the transaction, 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, AERx and the Aradigm Logo are registered
trademarks of Aradigm Corporation.
SOURCE: Aradigm Corporation and Grifols S.A.
Nancy Pecota, 510-265-8800
Chief Financial Officer
Punkaj Amin, 919-316-6664
North American Corporate Communications
Raquel Lumbreras, +34 91 311 92 89
Global Press Office
Press spacebar to pause and continue. Press esc to stop.