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 this condition.
Under the terms of the transaction:
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The parties have agreed to advance Aradigm’s proprietary inhaled
ciprofloxacin formulations into Phase III clinical trials in BE.
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Grifols will be responsible for all development and clinical expenses
up to a maximum of $65 million for the BE indication.
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Aradigm is entitled to receive cash payments of up to $25 million upon
achievement of development milestones.
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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.
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Grifols was granted an option to license Aradigm’s AERx®
pulmonary drug delivery platform for use with another molecule.
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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.
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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, Global Commercial.
“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.
About Grifols
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 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
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 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.
Copyright Business Wire 2013