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8-K - FORM 8-K - Alexza Pharmaceuticals Inc. | d85041e8vk.htm |
Exhibit 99.1
NEWS RELEASE for immediate release
Alexza and Grupo Ferrer Establish Partnership for
the Commercialization of Adasuve (Staccato® Loxapine)
in Europe and Latin America
the Commercialization of Adasuve (Staccato® Loxapine)
in Europe and Latin America
Conference Call Scheduled for 9:00 a.m. Eastern Time, October 6, 2011
Mountain View, California and Barcelona, Spain October 6, 2011 Alexza Pharmaceuticals,
Inc. (Nasdaq: ALXA) and Grupo Ferrer International, S.A., announced today that they entered into a
commercial partnership for Adasuve (Staccato® loxapine). ADASUVE is Alexzas lead
program, based on the companys proprietary technology, the Staccato system. Grupo Ferrer is a
leading pharmaceutical company in Europe with extensive operations in the Americas, and will be
Alexzas partner in the registration, distribution and promotion of ADASUVE in Europe, Latin
America, Russia and the Commonwealth of Independent States countries. Alexza plans to file the
ADASUVE Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the
second half of 2011. ADASUVE is being developed for the rapid treatment of agitation in patients
with schizophrenia or bipolar disorder.
The treatment of agitation in patients with schizophrenia or bipolar disease continues to evolve
in the field of psychiatry, and we believe that ADASUVE could represent an important new
therapeutic option for these patients, said Thomas B. King, Alexzas President and CEO. Given
Grupo Ferrers extensive experience registering and selling specialty pharmaceuticals in Europe and
Latin America, and their ability to share our longer-term vision for ADASUVE, we believe they
represent an ideal multi-region partner for Alexza as we execute our global commercialization
strategy.
We welcome the opportunity to bring this innovative technology to our markets, said Mr. Jordi
Ramentol, CEO of Grupo Ferrer. ADASUVE fits perfectly into our specialty pharmaceutical
portfolio. We strongly believe that the unique therapeutic benefits ADASUVE provides will
capture physicians and patients interest, and establish it as an important new tool in the
treatment
of agitation.
Under the agreement, Alexza will receive an upfront payment of $10 million. Alexza is eligible to
receive additional milestone payments based upon regulatory approvals, individual country
commercial sales initiation and cumulative net sales targets. Alexza will be responsible for
filing the ADASUVE MAA with the EMA. Grupo Ferrer will be responsible for all subsequent
regulatory filings in the countries in its territories, as well as any required pricing and
reimbursement filings and
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approvals. Assuming regulatory approvals are obtained, Grupo Ferrer will
exclusively distribute, market and sell ADASUVE in the designated territory. Alexza will be the
exclusive supplier of ADASUVE to Grupo Ferrer for all of its commercial sales, at a per-unit
transfer price.
About ADASUVE (Staccato loxapine)
ADASUVE is an anti-agitation therapeutic that combines Alexzas proprietary Staccato system with
loxapine, an antipsychotic drug. Loxapine is currently available in oral and other formulations,
inside and outside of the U.S. and European Union. The Staccato system is a hand-held, single-dose
inhaler that delivers a drug aerosol to the deep lung that results in IV-like pharmacokinetics and
rapid systemic effects.
As an easy-to-use, non-coercive and highly reliable inhaled therapeutic that has been shown to
produce a rapid reduction in agitation, Alexza believes that ADASUVE meets the three key attributes
for the treatment of acute agitation as specified in the American Association of Emergency
Psychiatrists Expert Consensus Guidelines for the Treatment of Behavioral Emergencies: speed of
onset, reliability of medication delivery and patient preference. Similarly, the National
Institute for Health and Clinical Excellence (NICE) Clinical Practice Guidelines describe an ideal
treatment for agitation as having a low level of side effects and a rapid onset of action, and that
injections should be administered only in exceptional circumstances.
About the Staccato System
Alexzas proprietary Staccato system was rationally designed to optimally treat acute and
intermittent conditions. A single breath triggers vaporization and delivers a dose of
excipient-free aerosolized, highly bioavailable drug deep into the lungs, where it is quickly
absorbed into the blood stream to begin providing therapeutic effect. The Staccato system delivers
medication that is comparable to intravenous administration, but with greater ease, patient comfort
and convenience.
The Staccato system is unique among inhalers because it uses no excipients, requires no special
breathing maneuvers and there are no controls to deal with. When the patient draws a single normal
breath through the Staccato device, the substrate surface instantly heats to create a condensation
aerosol of optimally-sized particles of drug that are drawn into the patients lungs. The entire
Staccato system actuation and drug delivery occur in less than one second. The system produces a
consistently high emitted pre-set dose, regardless of the patients breathing pattern.
Alexza has screened more than 400 drug compounds and more than 200 drug compounds exhibit initial
vaporization feasibility with the Staccato system. Since the filing of the Companys first IND in
2004, Alexza has dosed more than 2,600 patients and subjects with its Staccato technology, in 22
different clinical trials under six different INDs for Staccato-based product candidates.
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Conference Call Information
Alexza will host a conference call on Thursday, October 6, 2011, at 9:00 a.m. Eastern Time. A
replay of the call will be available for two weeks following the event. The conference call and
replay are open to all interested parties.
To access the conference call via the Internet, go to www.alexza.com, under the Investor
Relations link. Please join the call at least 15 minutes prior to the start of the call to ensure
time for any software downloads that may be required. Interested parties may also register to
avoid pre-call delays at
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=196151&eventID=4213500.
To access the live conference call via phone, dial +1.800.299.7928. International callers may
access the live call by dialing +1.617.614.3926. The reference number to enter the call is
72215077.
The replay of the conference call may be accessed via the Internet, at www.alexza.com, or via phone
at +1.888.286.8010 for domestic callers or +1.617.801.6888 for international callers. The
reference number for the replay of the call is 96463030.
About Grupo Ferrer
Grupo Ferrer is a privately-held European R&D-based pharmaco-chemical and medical device company
headquartered in Barcelona, Spain. Founded in 1959, the group encompasses today 45 companies
developing its activities in Europe, Latin America, Africa, Middle East, Asia and the United
States. In total, Grupo Ferrers human healthcare products are being commercialized in 93
countries through 26 direct subsidiaries (including Joint Ventures) and 70 partners and
distributors.
Grupo Ferrer carries out activities throughout the full value-chain of the pharma business, from
R&D to international marketing, including fine chemicals development and both raw material and
pharmaceutical product manufacturing. For this purpose, Grupo Ferrer has research centres in Spain
and Germany, as well as manufacturing sites in Europe and Latin America.
Grupo Ferrers regulatory expertise has resulted in more than 800 active registration dossiers
worldwide, including high added-value products for orphan and life-threatening diseases. The aim
of Grupo Ferrers corporate strategy is to establish alliances and long-term relationships with
biotechnology and pharmaceutical companies within its strategic therapeutic areas. The company
holds a long track record of agreements signed with big multinationals, as well as with medium size
pharmaceutical companies and small biotech or R&D-based companies.
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The company has experience with high value-added products, for very specific indications (i.e.,
Remodulin® (Treprostinil) for PPH, Egrifta® (tesamorelin) for HIV
lipodistrophy) that may have specific requirements in terms of administration (injectables,
subcutaneous pumps, etc.).
For more information about Grupo Ferrer, visit the Companys web site at www.ferrergrupo.com.
About Alexza Pharmaceuticals, Inc.
Alexza is a pharmaceutical company focused on the research, development and commercialization of
novel, proprietary products for the acute treatment of central nervous system conditions. Alexzas
technology, the Staccato® system, vaporizes unformulated drug to form a condensation
aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.
The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic
onset that is comparable to intravenous administration, but with greater ease, patient comfort and
convenience. (Click here to see an animation of how the Staccato system works.)
ADASUVE (Staccato loxapine), Alexzas lead program, is being developed for the rapid treatment of
agitation in adults with schizophrenia or bipolar disorder. Alexza completed and announced
positive results from both of its Phase 3 clinical trials and initially submitted the ADASUVE NDA
in December 2009. In October 2010, the Company received a Complete Response Letter from the FDA
regarding the application. The Company completed an end-of-review meeting with the FDA in December
2010 and a Risk Evaluation and Mitigation Strategy (REMS) guidance meeting with the FDA in April
2011. The ADASUVE NDA was resubmitted on August 4, 2011, and has a Prescription Drug User Fee Act
(PDUFA) goal date of February 4, 2012. The FDA has indicated that it will likely present the
ADASUVE application to an Advisory Committee during the review period. The Company also plans to
file the ADASUVE Marketing Authorization Application (MAA) with the European Medicines Agency (EMA)
in the second half of 2011.
For more information about Alexza, the Staccato system technology or the Companys development
programs, please visit www.alexza.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve significant risks and
uncertainties. Any statement describing the Companys expectations or beliefs is a forward-looking
statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be
considered an at-risk statement. Such statements are subject to certain risks and uncertainties,
particularly those inherent in the process of developing and commercializing drugs, including the
prospects for regulatory approval to market ADASUVE in Europe, Latin America, Russia and the
Commonwealth of Independent States countries, the potential of the Companys ADASUVE NDA
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resubmission to adequately address the issues in the CRL, the timing of the FDAs review of the NDA
and the eventual prospects that ADASUVE will be approved for marketing. The Companys
forward-looking statements also involve assumptions that, if they prove incorrect, would cause its
results to differ materially from those expressed or implied by such forward-looking statements.
These and other risks concerning Alexzas business are described in additional detail in the
Companys Annual Report on Form 10-K for the year ended December 31, 2010, and the Companys other
Periodic and Current Reports filed with the Securities and Exchange Commission. Forward-looking
statements contained in this announcement are made as of this date, and the Company undertakes no
obligation to publicly update any forward-looking statement, whether as a result of new
information, future events or otherwise.
CONTACTS:
|
Thomas B. King | August J. Moretti | ||
President and CEO | Senior Vice President and CFO | |||
650.944.7634 | 650.944.7788 | |||
tking@alexza.com | amoretti@alexza.com |
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