Item 8.01 Other Events.
On January 31, 2020, Aimmune Therapeutics, Inc. ("Aimmune" or the "Company")
issued a press release announcing that the U.S. Food and Drug Administration had
approved PALFORZIA™ (Peanut (Arachis hypogaea) Allergen Powder-dnfp). PALFORZIA
is the first approved treatment for patients with peanut allergy. PALFORZIA is
an oral immunotherapy indicated for the mitigation of allergic reactions,
including anaphylaxis, that may occur with accidental exposure to peanut.
PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut
allergy. Initial dose escalation may be administered to patients aged 4 through
17 years. Up-dosing and maintenance may be continued in patients 4 years of age
and older. PALFORZIA is to be used in conjunction with a peanut-avoidant diet.
The full text of the press release is filed as Exhibit 99.1 hereto and
incorporated herein by reference.
PALFORZIA is available only through a Risk Evaluation and Mitigation Strategy
("REMS"). Requirements of the REMS include: the prescribing physician and
patient must be enrolled in the REMS prior to initiation of treatment; the
initial dose escalation and the first dose of each up-dosing level must be
administered in a certified healthcare setting; epinephrine must always be
immediately available to patients; and pharmacies/distributors must be certified
with the REMS and dispense PALFORZIA only to certified healthcare settings or to
patients who are enrolled in the REMS. Consistent with approved immunotherapies
indicated to treat allergic conditions, the Prescribing Information for
PALFORZIA contains a boxed warning.
The wholesale acquisition cost for PALFORZIA in the United States will be $890
per month, and Aimmune plans to offer a patient co-pay program that could reduce
the patient's out-of-pocket costs to as low as $20 per month. This price will be
consistent regardless of whether the patient is in the up-dosing or maintenance
phase of treatment. Aimmune believes that this flat pricing model will provide
predictability for both patients and payers, and that this price reflects the
value that PALFORZIA offers as the first FDA-approved biologic therapy for
children and adolescents with peanut allergy. Aimmune also plans to offer a
patient assistance program, which will provide drug at no cost for those
eligible patients who do not have coverage by either a commercial plan or a
government-sponsored plan, such as Medicaid.
Cautionary note on forward-looking statements
Statements contained in this report 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 PALFORZIA; Aimmune's expectations regarding
the potential commercial launch of PALFORZIA in the United States; Aimmune's
expectations for the wholesale acquisition cost of PALFORZIA; and Aimmune's
plans to offer a co-pay program and a patient assistance program for patients.
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 dependence on the success
of PALFORZIA; Aimmune's ability to build a commercial field organization and
distribution network; the degree of acceptance of PALFORZIA among physicians,
patients, healthcare payors, patient advocacy groups and the general medical
community; Aimmune's ability to obtain favorable coverage and reimbursement from
third-party payors for PALFORZIA; Aimmune's reliance on third parties for the
manufacture of PALFORZIA; and Aimmune's ability to implement and comply with the
REMS for PALFORZIA. 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
September 30, 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No. Description
99.1 Press release dated January 31, 2020
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
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