Aimmune Therapeutics Discusses AR101’s Cost-Effectiveness and Demonstrated Clinical Benefits at ICER Meeting

Company to Share Updated Clinical Data on AR101 and Provide
Perspective on Its Value to Society

BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company
developing treatments for life-threatening food allergies, will present
at the Institute for Clinical and Economic Review’s (ICER) Public
Meeting reviewing the effectiveness and value of treatments for peanut
allergy, to be held today in Oakland, California. Aimmune is developing
AR101, an investigational biologic drug for use in oral immunotherapy as
a treatment to reduce the frequency and severity of allergic reactions
following exposure to peanuts.

Cost per QALY, or quality-adjusted life year, measures the economic
value of a health care intervention; the lower the cost per QALY, the
higher the value of the treatment. Using only clinical data from the
landmark Phase 3 PALISADE trial, ICER found AR101 to be cost-effective
well-below ICER’s traditional threshold of $100,000-$150,000 per QALY.
Additionally, when factoring in the societal perspective, ICER found
AR101 to be even more cost-effective compared to avoidance alone. This
early analysis does not include recent efficacy and safety data from the
Phase 3 ARTEMIS trial or long-term patient reported outcomes.

“We are committed to delivering AR101 to patients and families with
peanut allergy, and we look forward to providing our perspective at
today’s meeting about the important value AR101 will provide to
patients, payers, healthcare systems and society as a whole,” said
Jayson Dallas, M.D., President and Chief Executive Officer of Aimmune.
“We have been working collaboratively with ICER over the last eight
months to provide data about the strong value proposition of AR101
which, if approved, will be the first-ever treatment for peanut allergy.”

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 symptoms from accidental
exposures to peanut are often severe and potentially life-threatening.²
The threat of a severe reaction dominates families’ daily lives and
interferes with their quality of life.

Stephen Tilles, M.D., Senior Director of Medical Affairs, will represent
Aimmune at today’s meeting. A board-certified allergist and immunologist
and recent past president of the American College of Allergy, Asthma and
Immunology (ACAAI), Dr. Tilles will discuss the critical need for
rigorously developed, clinically tested, approved treatment for peanut
allergy.

In his statement, Dr. Tilles will note that, “For more than 20 years, as
the peanut allergy epidemic has continued to grow, I have shared in the
sadness and frustration of young patients and their families about the
lack of any approved options for treatment. Avoidance has ruled the day
– but it is the opposite of a patient-centered treatment because it
often prevents children from living a normal childhood. For example,
data from a new study found that 40% of teens believe they have a high
likelihood – and some believe a certainty – of dying from an accidental
exposure to peanuts. Avoiding peanuts in the real world is a difficult
and ineffective way of managing peanut allergy. Accidental exposures are
inevitable, traumatic – and can be fatal. With this in mind, Aimmune has
deployed an oral immunologic approach that uses defined, precise amounts
of key allergens to address the broad spectrum of scenarios that could
cause exposure.”

New data released at the 2019 European Academy of Allergy and Clinical
Immunology (EAACI) Congress reinforce the clinical profile of AR101 and
demonstrate improved safety and immunomodulation with continued
longer-term daily treatment.

Dr. Dallas added, “While Aimmune has provided ICER with additional
evidence to support an accurate evaluation of AR101, data continue to
emerge suggesting improved efficacy and decreased adverse effects over
time. This pattern is identical to subcutaneous immunotherapy for pollen
allergy and stinging insect allergy, both of which have been shown to
result in disease modification after three to five years of therapy.
Therefore, although ICER finds AR101 to be cost-effective well within
standard thresholds, we believe the value estimates for AR101 in ICER’s
evidence report are overly conservative, especially as the potential for
disease modification was not considered.”

The FDA’s Allergenic Products Advisory Committee (APAC) will review
Aimmune’s Biologics License Application (BLA) for AR101 at its meeting
scheduled for September 13, 2019. 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.

About AR101
AR101 is a new, peanut-derived investigational
oral 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 characterized protein profile, analyzed to ensure consistent
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 of adverse
events following exposure to peanut. The BLA for AR101 is under review
by the U.S. 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 its presentation at the ICER meeting
and statements made by Aimmune representatives at such meeting;
Aimmune’s expectations regarding the potential benefits of AR101,
including the potential benefit of continued therapy; Aimmune’s
expectations regarding the overall value of therapy with AR101,
including the value estimate of AR101 made by ICER; Aimmune’s
expectations regarding the review of the BLA for AR101 by the FDA and
APAC; 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: 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
[email protected]

Media:
Jerica Pitts
(312) 858-3469
[email protected]