News May 26, 07:48 Eastern Time
ARADIGM AND GENENTECH SIGN AGREEMENT TO DEVELOP AERX(TM)
SYSTEM FOR
PULMOZYME(R)
Advanced Technology Could Save Hours of Treatment Time Per Week for
Patients With Cystic Fibrosis
HAYWARD, Calif., May 26 /PRNewswire/ -- Aradigm Corporation (Nasdaq: ARDM) and
Genentech, Inc. (NYSE: GNE) announced today that the companies have signed an
exclusive agreement to jointly develop an advanced pulmonary delivery system for
Genentech's Pulmozyme(R) (dornase alfa) Inhalation Solution in the U.S., a recombinant
human protein that is used in the management of cystic fibrosis (CF) to improve lung
function, using Aradigm's proprietary AERx(TM) pulmonary drug delivery technology.
(Photo: newscom.com ) "This is an important
addition to our development portfolio," said Richard P. Thompson, President and Chief
Executive Officer of Aradigm. "Pulmozyme is a proven molecule, and relative to our other
projects, the planned development program and timelines are much shorter." Thompson
added, "Our morphine and insulin programs demonstrate the ability of our AERx
technology to deliver small molecules and peptides through the lung to the bloodstream for
systemic effects. The Pulmozyme project, if successful, will show that we can deliver
larger proteins to the lung for topical treatment of lung disorders. While Pulmozyme is only
indicated for CF, additional proteins are being developed for other respiratory diseases,
such as asthma and COPD, that could be optimally delivered with our AERx System. Our
partnership with this world leader in biotechnology, and the opportunity to continue to
demonstrate the broad applicability of our technology, should establish the AERx System
as the advanced pulmonary delivery method of choice for the industry."
"We are excited to partner with Aradigm to potentially bring cystic fibrosis patients an
easier, faster way to receive Pulmozyme," said William D. Young, Chief Operating Officer
at Genentech. "Aradigm shares our vision of developing innovative products to optimize
patient care, and this project will give us first hand experience with the AERx System
which will help us evaluate the technology for other molecules in our pipeline."
Under the terms of the agreement Aradigm will receive upfront and milestone payments
during development. Genentech will provide bulk Pulmozyme to Aradigm and Aradigm will
manufacture the unit dose liquid formulations and "electronic inhalers." Aradigm will be
responsible for clinical development and manufacturing of the System and Genentech will
be responsible for marketing and commercialization. There will also be a mutual right of
first negotiation for additional products administered by pulmonary delivery for use in CF.
Cystic fibrosis patients and their families spend three hours or more each day managing
their illness, including medication administration and frequent physical treatment sessions
whereby excess lung secretions are loosened and expelled. Currently, Pulmozyme is
delivered to patients' lungs as an aerosol mist via a nebulizer and compressor. The entire
process can take between 15 to 30 minutes per session, with up to two sessions per day.
The AERx System optimizes delivery of medicine to the lung via a patented electronic
design. If the AERx System works successfully with Pulmozyme, patients will be able to
deliver their doses in only about two minutes per session, allowing patients and their
families valuable time to pursue a more normal lifestyle.
"Rigorous compliance with medication, though time-consuming and often a challenge to
families, is vital to the health of a person with cystic fibrosis," says Robert J. Beall, Ph.D.,
President and Chief Executive Officer of the Cystic Fibrosis Foundation. "The ability of
patients to dose Pulmozyme with about a 90 percent reduction in treatment time could
tremendously improve their quality of life."
CF is an inherited disorder that affects about 25,000 Americans, 3,000 Canadians and
9,000 Europeans. A faulty gene in CF patients leads to the production of thick, viscous
secretions that can cause persistent bacterial infection and congestion. As white blood
cells attempt to destroy bacteria, they release DNA, which further thickens the secretions.
These thick secretions also encourage and prolong respiratory tract infections that damage
lung tissue and ultimately lead to death. Today, the average life span of patients with CF is
31 years, compared to 14 years in 1969.
In December 1993, Pulmozyme(R) (dornase alfa) Inhalation Solution received its first
marketing approval by the Food and Drug Administration for use in CF patients.
Pulmozyme, in conjunction with standard therapies, is indicated in the management of CF
patients to improve lung function. In patients with mild or moderate CF, Pulmozyme also
has been shown to reduce the incidence of respiratory tract infections requiring IV
antibiotics. The label also includes safety and administration of Pulmozyme to pediatric
patients.
Located in Hayward, California, Aradigm is engaged in the development of novel pulmonary
drug delivery systems designed to enhance the delivery and effectiveness of a number of
existing and development-stage drugs and reduce the need for injectable drug therapy.
Aradigm's principal product development programs are based on its AERx Pulmonary Drug
Delivery System, which uses proprietary technologies to create aerosols from liquid drug
formulations for delivery locally to the lung or systemically via the lung. The AERx Pain
Management System for the treatment of breakthrough and acute pain, being
commercialized in collaboration with SmithKline Beecham, is in phase II development. In
addition, the AERx Diabetes Management System, also in phase II development, is being
commercialized in partnership with Novo Nordisk A/S, the world's leading diabetes therapy
company. Investors can learn more about the company on its web site at
aradigm.com. Investors may also request company information via email by
directing inquiries to investor@aradigm.com.
Please note: Except for the historical information contained
herein, this news release contains forward-looking statements that
involve risk and uncertainties, including the timely availability and
acceptance of new products, the impact of competitive products and
pricing, and the management of growth, as well as the other risks
detailed from time to time in Aradigm Corporation's Securities and
Exchange Commission (SEC) Registration Statements, including the
company's Annual Report on Form 10-K filed with the SEC on March 9,
1999.
SOURCE Aradigm Corporation |
