– Company Enters into Commercial Supply Agreement for AR101 –
BRISBANE, Calif.–(BUSINESS WIRE)–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.
Contacts
Investors:
Eric Bjerkholt
(650) 376-5582 or
ebjerkholt@aimmune.com
Media:
Jerica Pitts
(312) 858-3469
jpitts@w2ogroup.com