Aradigm's Proprietary Inhaled Ciprofloxacin Formulation is a
Potential New Therapy for Patients with Severe Respiratory Disease
BARCELONA, Spain & HAYWARD, Calif.--(BUSINESS WIRE)--
Grifols, S.A. (MCE:GRF, MCE:GRF.P and NASDAQ:GRFS) ("Grifols") and
Aradigm Corporation (OTC BB:ARDM.OB) ("Aradigm") today
announced the signing of an 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 about 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 this condition.
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 will be granted an option to license Aradigm's AERx®
pulmonary drug delivery platform for use with another molecule.
In conjunction with the licensing agreement, Grifols will (upon
receipt of Aradigm shareholders' approval) acquire 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 investors Great Point Partners, LLC will co-invest in the
stock purchase transaction and purchase an additional approximately
$15.4 million in Aradigm common stock.
The transaction is subject to certain closing conditions and is expected
to close in the second half of 2013. At that point, Grifols will be
entitled to designate two directors to serve on the Aradigm Board of
"Pulmaquin will complement Grifols existing Prolastin-C business. There
is significant overlap between Bronchiectasis and Alpha1 physicians and
patients," said Ramon Riera, President Global Commercial. When launched,
Grifols will leverage its existing Pulmonary sales team to commercialize
"Grifols is a great fit for us with their global reach of respiratory
physicians treating a number of conditions that could benefit from
Pulmaquin." 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 in CF patients. 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
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 use.
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 12,000 people
Grifols is the Global leader in the treatment of Alpha-1 antitrypsin
deficiency — a disease that often leads to emphysema. Grifols has a
dedicated Pulmonary sales force in the United States, Germany, Canada
and Spain with full coverage of COPD prescribers.
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
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.
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Nancy Pecota, 510-265-8800
Chief Financial Officer
North American Corporate Communications
Lumbreras, +34 91 311 92 89
Global Press Office
Source: Aradigm Corporation and Grifols S.A.
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