SUNNYVALE, Calif., Jan. 8 /PRNewswire-FirstCall/ -- Speaking today before
the 20th Annual JP Morgan H&Q Healthcare Conference,
Aerogen, Inc. (Nasdaq: AEGN) outlined its progress during 2001 in its product
development and commercial activities. Aerogen is developing novel pulmonary
drug delivery products to advance the treatment of respiratory disorders and
for systemic drug delivery. Aerogen's products utilize its proprietary aerosol
generator, which can effectively and efficiently aerosolize virtually any drug
in liquid form, including peptides and proteins.
"Our accomplishments in 2001 include advancing products through phase 2
clinical testing and the launch of our first commercial product, the
Aeroneb(TM) Portable Nebulizer System. I look forward to the launch of our
second product, the Aeroneb(TM) Professional Nebulizer for use in the hospital
market, and gaining further momentum in product development and partnership
activities, in 2002," said Jane E. Shaw, Ph.D., Aerogen Chairman and CEO.
Presentation highlights:
Aerodose(R) Insulin Inhaler
Aerogen debuted its commercial Aerodose insulin inhaler, a pocket-sized,
breath-activated product designed to provide patients with a discreet, easy to
use alternative to insulin injections. The inhaler contains a titratable
cartridge that holds up to a one-week supply of insulin, eliminating the
inconvenience of carrying additional drug supplies. This proprietary feature
allows patients to adjust their dose based on their specific needs using three
simple steps: dial, dispense and dose. The titratable cartridge is being
developed and will be manufactured by the Disetronic Group (SWX: DISZn.S), one
of the world's leading innovators and producers of medical infusion and
injection systems for diabetes and other therapeutic areas.
Aerogen has successfully completed two Phase 2a inhaled insulin clinical
studies. A brief overview of the results of the second study was presented.
"Our product achieved an average relative bioavailability of 21% in patients
across varied dosage levels, when compared with subcutaneous administration of
insulin. We look forward to presenting the results in detail at the American
Diabetes Association meeting in San Francisco in June of 2002," Dr. Shaw
stated.
The company announced that it has signed an agreement with Diosynth, B.V.,
a business unit of Akzo Nobel N.V. (Nasdaq: AKZOY), for bulk supply of
recombinant human insulin for Aerogen's clinical and commercial use. Diosynth
is one of the world's leading manufacturers of active pharmaceutical
ingredients, with emphasis on biotechnology products and complex derivatives
like steroids and synthetic peptides.
Aerogen is conducting its final testing of the commercial inhaler in
preparation for definitive clinical trials for product registration. "The next
step in the advancement of the Aerodose insulin inhaler is to sign a marketing
partner to support preparation of the product for registration and
commercialization," explained Dr. Shaw.
Aeroneb Portable Nebulizer
Aerogen launched this first commercial product in the U.S. in June 2001.
The compact, silent system provides effective drug delivery for patients of
all ages who require nebulizer therapy.
Aerogen supports the product in the marketplace with a small sales force.
The Aeroneb system is available through home medical equipment dealers, and
pharmacies, and is available through the Internet. It is distributed by
Allegiance Healthcare, Dedicated Distribution and the Asthma and Allergy
Network Mothers of Asthmatics (AANMA), a non-profit health organization. The
product has received strong support and has been well accepted by clinicians,
patients and patient advocacy groups, including AANMA. Nancy Sander, President
of AANMA, comments, "People who use traditional nebulizers are extremely
pleased with the Aeroneb system because they will no longer be tethered to
noisy, heavy, bulky nebulizers. This product literally puts asthma control in
the palm of a patient's hand."
Aeroneb(TM) Professional Nebulizer (Aeroneb Pro)
The Aeroneb Pro is an autoclavable nebulizer system in development for use
in the hospital setting, for patients on mechanical ventilation and in other
locations on the hospital floor. The product is designed to provide efficient
drug delivery that saves time, lowers costs and expands options for
respiratory therapy. The Aeroneb Pro accepts commercially available nebulizer
solutions.
Aerogen announced that it has received the CE mark for the Aeroneb Pro,
permitting commercial introduction of the product in Europe. The company
intends to file a 510(k) during the first half of 2002, for clearance of the
product for commercialization in the U.S.
A next generation product is also in development; it is designed for use
with proprietary drug ampoules to be developed and marketed by Aerogen. This
nebulizer is intended to optimize delivery of a wide range of inhaled drugs in
the hospital setting. The product includes a programmable feature that will
recognize specific drug ampoules and administer the drug according to specific
protocols to optimize drug deposition. Aerogen intends to market the product
with branded generics and in-licensed drugs for its own product portfolio and
to collaborate with biotechnology and pharmaceutical companies for delivery of
their respiratory drugs.
"There are numerous opportunities for Aerogen to improve drug delivery and
the treatment of respiratory disorders in the hospital setting with the
Aeroneb Pro platform," said Dr. Shaw.
Aerodose Inhalers for Respiratory Therapy
Aerogen is developing, and will commercialize, novel inhaler products to
be used with proprietary dosage forms of branded generics and in-licensed
drugs for the treatment of asthma, chronic obstructive pulmonary disease and
cystic fibrosis in the home setting. The company's target market is young and
elderly patients for whom currently available products are inefficient, time
consuming and difficult to use. "Our Aerodose products will offer the young
and the elderly small, portable, easy to use products, with short treatment
times. These improvements over traditional inhalers and nebulizers are
necessary to effectively treat respiratory disease in this patient
population," said Dr. Shaw.
The company has successfully completed a phase 2 study using the Aerodose
albuterol inhaler; the data were presented at the 2001 American College of
Chest Physicians conference. A phase 2 study using the Aerodose ipratropium
inhaler was also completed in 2001; the results will be presented at the
American Thoracic Society conference in May 2002.
Products in Early Development
Aerogen is currently working with biotechnology and pharmaceutical
companies in the feasibility and pre-clinical stages of testing new compounds
for delivery via customized Aerodose inhalers.
Consumer Products
Aerogen is continuing its work with a large, global consumer products
company on the use of Aerogen's proprietary technology for low cost, high
value consumer products. The program is expected to progress the first
products to commercialization in the next 12 to 18 months.
Financial Outlook
Aerogen confirmed estimates for total sales of Aeroneb products in excess
of $3.0 million for 2002. The company anticipates cash on hand at year-end
2001 of approximately $36 million, and anticipates a loss in 2002 in the range
of $28-$34 million, including non-cash charges of approximately $3.5 million.
Fourth quarter and year-end results for 2001 will be announced on
February 14, 2002. Aerogen confirmed that its 2001 results would be in line
with previously disclosed guidance.
Aerogen, a pulmonary drug delivery company, is developing inhaler and
nebulizer products for the treatment of respiratory disorders. Aerogen is also
applying its technology to develop products in collaboration with
pharmaceutical and biotechnology companies for treatment of respiratory and
other disorders, including diabetes. The first Aeroneb nebulizer product has
been commercialized in the United States. Aerogen's Aerodose inhaler products
are currently in development and have advanced to the stage of Phase 2
clinical trials. Additional products are in the feasibility and pre-clinical
stages of development.
To the extent any statements made in this release deal with information
that is not historical, these statements are necessarily forward-looking. As
such, they are subject to the occurrence of many events outside Aerogen's
control and are subject to various risk factors that could cause the company's
results to differ materially from those expressed in any forward-looking
statement. The risk factors are described in the company's reports filed with
the Securities and Exchange Commission and include, without limitation, the
inherent risks of collaborative partnerships, market acceptance and
competition.
SOURCE Aerogen, Inc.
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Related links:
http://www.aerogen.com
CONTACT:
Michelle Levine of Aerogen, Inc.,
+1-408-543-2633
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