Aimmune Announces U.S. FDA Advisory Committee Meeting Date for AR101 for Peanut Allergy
May 16 2019 - 8:00AM
Business Wire
- Company Enters into Commercial Supply
Agreement for AR101 -
Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical
company developing treatments for life-threatening food allergies,
today announced that it has been informed by the U.S. Food and Drug
Administration (FDA) that the Allergenic Products Advisory
Committee (APAC) will review the Biologics License Application
(BLA) for AR101 at its meeting scheduled for September 13, 2019.
Aimmune is developing AR101, an investigational biologic drug for
use in oral immunotherapy, as a treatment to reduce the frequency
and severity of adverse events, including anaphylaxis, following
exposure to peanuts. Additionally, Aimmune has entered into a
commercial supply agreement with CoreRx, Inc., the Company’s
long-standing manufacturer of AR101.
Peanut allergy is one of the most common food allergies,
affecting more than 1.6 million children and teens in the United
States.1 It can be a chronic and life-long condition, and reactions
to peanut are severe and potentially life-threatening.2 The threat
of a severe reaction dominates families’ daily lives and interferes
with their quality of life.
“We have been preparing diligently, and will continue to refine
our preparations, for the September 13 APAC Meeting so that we are
in the best position to introduce AR101 to patients and their
families as the first-ever approved treatment for peanut allergy,
indeed for any food allergy,” said Jayson Dallas, M.D., President
and Chief Executive Officer of Aimmune. “As we have previously
communicated, we will be ready to launch AR101 by the fourth
quarter of this year. Our agreement with CoreRx will allow the
manufacturing of commercial AR101 supply to begin this week and
will ensure that there is sufficient supply at launch.”
The FDA accepted the BLA for AR101 in March 2019, and previously
informed Aimmune that completion of its review would be targeted by
late January 2020. The FDA granted AR101 Fast Track Designation in
September 2014 and Breakthrough Therapy Designation in June 2015
for peanut-allergic children and adolescents ages 4 to 17.
Aimmune’s AR101 commercial manufacturing facility, located on
the CoreRx campus, includes state-of-the-art air-handling systems
and equipment to prevent cross contamination of allergens, along
with controls and management systems to ensure safety and
compliance with U.S. and European pharmaceutical manufacturing
regulations. The CoreRx team has been responsible for the
manufacture of AR101 supply through the entire clinical development
program.
About AR101
AR101 is a new, investigational biologic drug for use in oral
immunotherapy in patients with peanut allergy. The drug, which is
manufactured in accordance with current Good Manufacturing
Practices (cGMP), delivers a daily dose of peanut protein with a
consistent protein profile, analyzed to ensure reliable major
allergen content. The amount of active ingredient in each AR101
capsule is controlled to ensure minimal variability of allergen
content across doses of a given strength. AR101 is administered as
an oral powder in graduated doses in pull-apart capsules or
foil-laminate sachets. The contents are mixed thoroughly with a few
spoonfuls of age-appropriate, unheated food of the patient’s
choice.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company
developing oral treatments for life-threatening food allergies. The
company’s Characterized
Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to
provide meaningful levels of protection against allergic reactions
resulting from exposure to food allergens by desensitizing patients
with defined, precise amounts of key allergens. Aimmune’s first
investigational biologic product, AR101, is being developed as a
treatment to reduce the frequency and severity and adverse events,
including anaphylaxis, following exposure to peanuts. The BLA for
AR101 is under review by the FDA, which in 2015 granted AR101
Breakthrough Therapy Designation for the desensitization of
peanut-allergic patients 4 to 17 years of age. Aimmune expects to
file for marketing approval of AR101 in Europe in mid-2019. Aimmune
has filed an IND application for its second product, AR201 for the
treatment of egg allergy, and intends to start a randomized phase 2
clinical trial in mid-2019. For more information, please see
www.aimmune.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding:
Aimmune’s expectations regarding the potential benefits of AR101;
Aimmune’s expectations regarding the potential commercial launch of
AR101, including the review period of the BLA for AR101; Aimmune’s
ability to be launch ready in the fourth quarter of 2019; CoreRx’s
ability to supply sufficient quantities of AR101 at launch;
Aimmune’s expectations regarding the planned timing and filing for
marketing approval of AR101 in Europe; Aimmune’s expectations
on the timing of initiating a phase 2 clinical trial for AR201; and
Aimmune’s expectations regarding potential applications of the
CODIT™ approach to treating life-threatening food allergies. Risks
and uncertainties that contribute to the uncertain nature of the
forward-looking statements include: the expectation that Aimmune
will need additional funds to finance its operations; Aimmune’s or
any of its collaborative partners’ ability to initiate and/or
complete clinical trials; the unpredictability of the regulatory
process; the possibility that Aimmune’s or any of its collaborative
partners’ clinical trials will not be successful; Aimmune’s
dependence on the success of AR101; Aimmune’s reliance on third
parties for the manufacture of Aimmune’s product candidates;
possible regulatory developments in the United States and
foreign countries; and Aimmune’s ability to attract and retain
senior management personnel. These and other risks and
uncertainties are described more fully in Aimmune's most recent
filings with the Securities and Exchange Commission, including
its Quarterly Report on Form 10-Q for the quarter ended March
31, 2019. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Aimmune
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
This press release concerns AR101, a product candidate that is
under clinical investigation, and AR201, a product candidate that
Aimmune expects will be under clinical investigation in 2019.
Neither AR101 nor AR201 has been approved for marketing by
the FDA or the European Medicines Agency (EMA).
AR101 and AR201 are currently limited to investigational use, and
no representation is made as to their safety or effectiveness for
the purposes for which they are being investigated.
___________________________________
1 Aimmune market research.
2 American College of Allergy, Asthma & Immunology.
Available here:
https://acaai.org/allergies/types/food-allergies/types-food-allergy/peanut-allergy.
Accessed May 15, 2019.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190516005497/en/
Investors:Eric Bjerkholt(650) 376-5582
orebjerkholt@aimmune.com
Media:Jerica Pitts(312) 858-3469jpitts@w2ogroup.com
Aimmune Therapeutics (NASDAQ:AIMT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aimmune Therapeutics (NASDAQ:AIMT)
Historical Stock Chart
From Apr 2023 to Apr 2024