AUSTIN, Texas, May 8, 2017 /PRNewswire/ -- Savara
Inc. (NASDAQ: SVRA), a clinical-stage specialty pharmaceutical
company focused on the development and commercialization of novel
therapies for the treatment of serious or life-threatening rare
respiratory diseases, today announced the recent issuance of United
States Patent No. 9,572,774 for "Dry Powder Vancomycin Compositions
and Associated Methods" by the United States Patent and Trademark
Office. The patent will provide key intellectual property
protection in the U.S. for the AeroVanc program and will expire no
earlier than 2032. This affords Savara important composition
of matter protection for its AeroVanc program in the U.S., the
largest market for the product, and is a key component of the
Company's market protection strategy which also includes Orphan
Drug and Qualified Infectious Disease Product protection.
Savara has also received a Notice of Allowance from the Canadian
Intellectual Property Office for its Canadian Patent Application
No. 2,836,643 entitled "Dry Powder Vancomycin Compositions and
Associated Methods." This notice serves as official communication
that the examination of the patent application has been
successfully completed. Once issued, the patent will provide
protection for AeroVanc in Canada
until 2032. The Company also has corresponding patent applications
for AeroVanc in different stages of prosecution in other key
markets throughout the world.
About AeroVanc
The prevalence of methicillin-resistant Staphylococcus
aureus (MRSA) pulmonary infection in cystic fibrosis (CF)
patients has continued to rise in the
United States, and the infection has been associated with
increased use of intravenous, or IV, antibiotics, increased
hospitalizations, a faster decline of lung function, as well as
shortened life-expectancy. Despite inhaled antibiotics being
available to CF patients for over ten years to treat non-MRSA
infections, there is no approved inhaled antibiotic for the
treatment of MRSA in CF. AeroVanc is being developed to address
this unmet medical need in CF.
In a randomized, double-blind, placebo-controlled Phase 2 study
in CF patients with persistent MRSA infection, AeroVanc reduced
MRSA density in sputum, and showed encouraging trends of
improvement in lung function, and respiratory symptoms, as well as
prolongation of the time to use of other antibiotics, with best
responses in subjects under 21 years of age. Savara plans to
initiate a pivotal Phase 3 study of AeroVanc for the treatment of
MRSA in CF patients in the third quarter of 2017.
AeroVanc has been granted Orphan Drug Designation and Qualified
Infectious Disease Product, or QIDP, status for the treatment of
persistent MRSA lung infection in CF patients in the United States. The Orphan Drug Designation
makes AeroVanc eligible for seven years of exclusivity from
approval in the United States, and
ten years of exclusivity in the European Union and the QIDP
designation makes AeroVanc eligible for an additional five years of
exclusivity in the United
States.
About Savara
Savara Inc. is a clinical-stage specialty pharmaceutical company
focused on the development and commercialization of novel therapies
for the treatment of serious or life-threatening rare respiratory
diseases. Savara's pipeline comprises AeroVanc, a Phase 3 ready
inhaled vancomycin, Molgradex, a Phase 2/3 stage inhaled
granulocyte-macrophage colony-stimulating factor, or GM-CSF and
Aironite, an inhaled nebulized sodium nitrite solution to treat
HFpEF. Savara's strategy involves expanding its pipeline of
best-in-class products through indication expansion, strategic
development partnerships and product acquisitions, with the goal of
becoming a leading company in its field. Savara's management team
has significant experience in orphan drug development and pulmonary
medicine, in identifying unmet needs, creating and acquiring new
product candidates, and effectively advancing them to approvals and
commercialization. More information can be found at
www.savarapharma.com. (Twitter: @SavaraPharma)
Forward Looking Statements
Savara cautions you that statements in this press release that
are not a description of historical fact are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements may be identified by
the use of words referencing future events or circumstances such as
"expect," "intend," "plan," "anticipate," "believe," and "will,"
among others. Such statements include, but are not limited to,
statements regarding the potential future benefits of patent
protection, the impact of AeroVanc use, the timing of our AeroVanc
Phase 3 study and Savara's strategy and goals. Savara may not
actually achieve any of the matters referred to in such forward
looking statements, and you should not place undue reliance on
these forward-looking statements. Because such statements are
subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. These forward-looking statements are based upon
Savara's current expectations and involve assumptions that may
never materialize or may prove to be incorrect. Actual results and
the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of various risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with the ability to project future cash
utilization and reserves needed for contingent future liabilities
and business operations, the results and actual timing of clinical
studies for our product candidates, our actual ability to protect
our patented technology, the availability of sufficient resources
for Savara's operations and to conduct or continue planned clinical
development programs, the timing and ability of Savara to raise
additional equity capital to fund continued operations; the ability
to successfully develop Savara's product candidates, and the risks
associated with the process of developing, obtaining regulatory
approval for and commercializing drug candidates that are safe and
effective for use as human therapeutics. Risks and uncertainties
facing Savara are described more fully in Savara's filings with the
Securities and Exchange Commission including the Form 8-K filed on
April 27, 2017, other filings on Form
8-K, the Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 and the
Registration Statement on Form S-4 related to the Mast/Savara
merger. You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date on
which they were made. Savara undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as may be
required by law.
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SOURCE Savara Inc.