- neffy has potential to be the first non-injectable
medicine indicated to treat allergic reactions (type I) including
anaphylaxis in the U.S., if approved
Silverback Therapeutics, Inc. (Nasdaq: SBTX) (“Silverback”)
today announced that the U.S. Food and Drug Administration (FDA)
has accepted for review ARS Pharmaceuticals, Inc.’s (ARS Pharma)
New Drug Application (NDA) for neffy for the emergency
treatment of allergic reactions (type I) including anaphylaxis in
adults and children ≥30 kg (66 lbs). If approved by the FDA,
neffy would be the first non-injectable treatment available
to patients with allergic reactions (type I) including
anaphylaxis.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA)
target action date that is anticipated in mid-2023.
“The FDA acceptance of our NDA for neffy is a major
milestone in our efforts to bring to patients the ability to
deliver epinephrine with comparable pharmacokinetics to an
intramuscular injection, but in a needle-free and simple to
administer nasal spray,” said Richard Lowenthal, President and CEO
of ARS Pharma. “We appreciate that the FDA recognizes the potential
clinical benefit of this novel approach to treating patients with
severe allergies and look forward to working with the FDA during
this process, with the goal of potentially changing the treatment
paradigm for the millions of patients with or at-risk for severe
allergic reactions (type I).”
The NDA submission to the FDA was based on data from four
primary registration studies supporting that a 2 mg intranasal dose
of neffy met all clinical endpoints recommended by
regulators and that its pharmacokinetics were within the range of
approved epinephrine injection products. These data included
studies in adults, with self-administration and caregiver
administration, as well as in children with Type I allergies ≥30 kg
(66 lbs). In addition, neffy has been well-tolerated to date
with more than 500 individuals receiving at least one dose, and
many with repeat administration. The majority of adverse events in
clinical trials were mild in nature without any meaningful nasal
irritation or pain.
About Allergic Reactions (Type I) including
Anaphylaxis
Type I severe allergic reactions are serious and potentially
life-threatening events that can occur within minutes of exposure
to an allergen and require immediate treatment with epinephrine,
the only FDA-approved medication for these reactions. While
epinephrine autoinjectors have been shown to be highly effective,
there are well published limitations that result in many patients
and caregivers delaying or not administering treatment in an
emergency situation. These limitations include fear of the needle,
lack of portability, needle-related safety concerns, lack of
reliability, and complexity of the devices. There are approximately
25 to 40 million people in the United States who experience Type I
severe allergic reactions. Of those, only 3.3 million currently
have an active epinephrine autoinjector prescription, and of those,
only half consistently carry their prescribed autoinjector. Even if
patients or caregivers carry an autoinjector, more than half either
delay or do not administer the device when needed in an
emergency.
About ARS Pharmaceuticals, Inc.
ARS Pharma is dedicated to empowering at-risk patients and
caregivers to better protect themselves from severe allergic
reactions that could lead to anaphylaxis. The company is developing
neffy® (previously referred to as ARS-1), an intranasal
epinephrine product in clinical development for patients and their
caregivers with Type I allergic reactions including food,
medications and insect bites that could lead to life-threatening
anaphylaxis. For more information, visit www.ars-pharma.com.
About Silverback Therapeutics, Inc.
Silverback is a biopharmaceutical company focused on leveraging
its proprietary ImmunoTAC technology platform to develop
systemically delivered and tissue targeted therapeutics for the
treatment chronic viral infections, cancer, and other serious
diseases. Silverback’s platform enables the strategic pairing of
proprietary payloads that modulate key disease modifying pathways
with monoclonal antibodies directed at specific disease sites.
Silverback Therapeutics is located in Seattle, Washington. To learn
more, visit www.silverbacktx.com.
On July 21, 2022, Silverback and ARS Pharma announced that the
companies entered into a definitive agreement under which ARS
Pharma will merge with Silverback in an all stock transaction.
Following the proposed merger (the “Merger”) the combined company
will focus on the potential regulatory approval and
commercialization of neffy, ARS Pharma’s investigational
epinephrine nasal spray for the treatment of Type I allergic
reactions including anaphylaxis. The Merger is subject to customary
closing conditions, including the approval by Silverback’s
stockholders. The Merger is currently expected to close in the
fourth quarter of 2022.
Cautionary Statement Regarding Forward-Looking
Statements
This communication contains forward-looking statements which
include, but are not limited to, statements regarding the potential
benefits of neffy, the expected PDUFA target action date, the
expected timing, completion and effects of the Merger and the
expected focus of the combined company following the Merger. These
forward-looking statements are subject to the safe harbor
provisions under the Private Securities Litigation Reform Act of
1995. Silverback’s expectations and beliefs regarding these matters
may not materialize. Actual outcomes and results may differ
materially from those contemplated by these forward-looking
statements as a result of uncertainties, risks, and changes in
circumstances, including but not limited to risks and uncertainties
related to: the ability of the parties to consummate the proposed
Merger in a timely manner or at all; the satisfaction (or waiver)
of closing conditions to the consummation of the proposed Merger,
including with respect to the approval of Silverback’s
stockholders; potential delays in consummating the proposed Merger;
the ability to obtain and maintain regulatory approval for neffy;
the impact of health epidemics, including the COVID-19 pandemic, on
the parties’ respective businesses and the actions the parties may
take in response thereto; the occurrence of any event, change or
other circumstance or condition that could give rise to the
termination of the merger agreement; the effect of the pendency of
the proposed Merger on Silverback’s business relationships,
operating results and business generally; costs related to proposed
Merger; and the outcome of any legal proceedings that may be
instituted against Silverback, ARS Pharma or any of their
respective directors or officers related to the merger agreement or
the proposed Merger. Additional risks and uncertainties that could
cause actual outcomes and results to differ materially from those
contemplated by the forward-looking statements are included under
the caption “Risk Factors” and elsewhere in Silverback’s most
recent filings with the U.S. Securities and Exchange Commission
(“SEC”), including its Quarterly Report on Form 10-Q for the
quarter ended June 30, 2022 and any subsequent reports on Form
10-K, Form 10-Q or Form 8-K filed with the SEC from time to time
and available at www.sec.gov. These documents can be accessed on
Silverback’s web page at https://ir.silverbacktx.com/ by clicking
on the link “Financials & Filings.”
The forward-looking statements included in this communication
are made only as of the date hereof. Silverback assumes no
obligation and does not intend to update these forward-looking
statements, except as required by law.
Additional Information and Where to Find It
In connection with the proposed Merger, Silverback filed with
the SEC the preliminary proxy statement on August 11, 2022 and a
definitive proxy statement on October 6, 2022 relating to the
proposed Merger and other relevant documents. The definitive proxy
statement has been mailed to Silverback’s stockholders as of
September 19, 2022, the record date established for voting on the
proposed Merger and any other matters to be voted on at the special
meeting of Silverback’s stockholders. BEFORE MAKING ANY VOTING
DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE
PRELIMINARY AND DEFINITIVE PROXY STATEMENTS, ANY AMENDMENTS OR
SUPPLEMENTS THERETO AND ANY OTHER DOCUMENTS TO BE FILED WITH THE
SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY
REFERENCE IN THE PROXY STATEMENTS WHEN THEY BECOME AVAILABLE
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SILVERBACK,
ARS PHARMA, AND THE PROPOSED MERGER. Investors and security holders
may obtain free copies of these documents (when they are available)
on the SEC’s web site at www.sec.gov, on Silverback’s website at
https://ir.silverbacktx.com/ or by contacting Silverback’s Investor
Relations via email at IR@silverbacktx.com or by telephone at (206)
736-7946.
Participants in the Solicitation
Silverback and its directors and certain of its executive
officers may be deemed participants in the solicitation of proxies
from the stockholders of Silverback in connection with the proposed
Merger and any other matters to be voted on at the special meeting.
Information regarding the names, affiliations and interests of such
directors and executive officers have been included in the
preliminary and definitive proxy statements related to the proposed
Merger. Additional information regarding such directors and
executive officers is included in Silverback’s definitive proxy
statement on Schedule 14A for the 2022 Annual Meeting of the
Stockholders, which was filed with the SEC on April 28, 2022.
Information regarding the persons who may, under SEC rules, be
deemed participants in the solicitation of proxies of Silverback’s
stockholders in connection with the proposed Merger and any other
matters to be voted upon at the special meeting are set forth in
the preliminary and definitive proxy statements for the proposed
Merger.
These documents are available free of charge as described in the
preceding paragraph.
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version on businesswire.com: https://www.businesswire.com/news/home/20221021005114/en/
Silverback Media Contacts: Jason Spark Canale
Communications jason.spark@canalecomm.com
Silverback Investor Contacts: Miguel Arcinas Silverback
Therapeutics ir@silverbacktx.com
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