SOURCE: Endo Pharmaceuticals
December 27, 2007 16:00 ET
Endo Pharmaceuticals to Develop and Commercialize Alexza's AZ-003 Staccato® Inhaled Fentanyl Product
Patented Drug/Device System in Development for Treatment of Breakthrough Pain
CHADDS FORD, PA--(Marketwire - December 27, 2007) - Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), a market leader in pain management, today announced that it has
entered into a license and development agreement with Alexza
Pharmaceuticals, Inc. (NASDAQ: ALXA) for the exclusive clinical development
and commercialization rights in North America for Alexza's AZ-003
(Staccato® fentanyl). Currently in Phase I clinical development, AZ-003
is a hand-held drug device system that uses Alexza's proprietary
Staccato® system inhalation technology to deliver fentanyl for the
treatment of breakthrough pain in cancer and non-cancer patients.
"We are delighted to partner with a leading-edge company such as Alexza to
further expand our penetration in the pain market and bring us another step
closer to our stated goal of becoming THE leading pain company," said Endo
President and Chief Executive Officer Peter A. Lankau. "Clearly, AZ-003
meets our criteria for clinically differentiated, innovative products that
fill an unmet medical need. Early clinical data suggest that AZ-003 could
potentially have a rapid onset of action comparable to intravenous
administration, and we believe that the formulation will be
tamper-resistant. We have evaluated many technologies and product
opportunities in the pain field and believe that the Alexza Staccato
technology is 'best in class' for an inhalation approach to pain
management." He also noted that AZ-003 is patent protected until 2022.
Under the terms of the agreement, Endo will pay Alexza an upfront fee of
$10 million, with additional payments of approximately $40 million upon
achievement of predetermined regulatory milestones. Endo will also pay
undisclosed royalties to Alexza on net sales of AZ-003. Effective
immediately, Endo will assume responsibility for, and funding of, all
remaining clinical trial development and regulatory filings. Alexza will
manufacture the product for Endo and will be responsible for completing
development of the device.
About AZ-003
AZ-003 is the combination of Alexza's proprietary Staccato system with
fentanyl, a drug belonging to the class of compounds known as opioid
analgesics. AZ-003 is a hand-held, electrically heated, multiple-dose
inhaler designed to generate and deliver excipient-free fentanyl aerosol
for deep lung delivery. The current product candidate consists of a
disposable dose cartridge containing 25 doses each of 25 mcg fentanyl,
which is inserted into a reusable controller. Development of additional
dosage strengths and quantities is anticipated. The controller consists of
software and hardware designed to allow safe, patient-controlled delivery
of the drug. Since the Staccato system can be designed to incorporate a
variety of lockout and dosing features, Alexza believes that AZ-003 may
reduce the potential for abuse and diversion, and facilitate patient-dose
titration to the minimum effective drug dose in a simple, convenient and
easy-to-use delivery system.
In October 2007, results from the AZ-003 Phase I clinical trial were
presented at the 2007 American Society of Anesthesiologists Annual Meeting,
in San Francisco. The clinical trial was conducted in 50 opioid-naive
healthy volunteers in two stages. In Stage 1, the arterial pharmacokinetics
(PK) of 25 mcg of AZ-003 was compared to a 25 mcg dose of fentanyl
administered intravenously (IV). The AZ-003 PK was equivalent to the IV
fentanyl PK, with similar peak plasma concentration (Cmax), time to maximum
plasma concentration (Tmax), and area under the curve concentration (AUC).
These data suggest complete bioavailability of the inhaled dose. Mean peak
arterial plasma concentrations were observed within 30 seconds for both
administration routes. In Stage 2 of the clinical trial, ascending doses of
AZ-003, controlled by the Staccato system, exhibited dose proportionality
of fentanyl throughout the dosing range from 50 mcg to 300 mcg, following
an AUC analysis.
No serious adverse events were attributable to AZ-003, and the results from
the clinical study showed that AZ-003 was generally safe and well tolerated
at all doses.
About Endo
Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty
pharmaceutical company with market leadership in pain management products.
Through its wholly owned Endo Pharmaceuticals Inc. subsidiary, the company
researches, develops, produces and markets a broad product offering of both
branded and generic pharmaceuticals, meeting the needs of healthcare
professionals and consumers alike. More information, including this and
past press releases of Endo Pharmaceuticals Holdings Inc., is available
online at www.endo.com.
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