— Florida Plant Can Produce AR101 for Peanut Allergy for Global
Market —
BRISBANE, Calif.--(BUSINESS WIRE)--Jun. 7, 2017--
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company
developing treatments for life-threatening food allergies, today hosted
a ribbon-cutting ceremony to celebrate the completion of its commercial
manufacturing facility in Clearwater, Florida. The facility will produce
AR101, Aimmune’s investigational biologic oral immunotherapy for
desensitization of patients with peanut allergy, which is currently in
Phase 3 clinical studies.
The new manufacturing facility contains more than 20,000 square feet of
space and will handle full-scale cGMP (current Good Manufacturing
Practices) commercial production of AR101 in anticipation of potential
regulatory approvals. It will also supply future clinical trials of
AR101 as well as trials of future product candidates. The facility
includes state-of-the-art air-handling systems and equipment, which will
prevent cross contamination of allergens from one suite to another,
along with controls and management systems to ensure safety and
compliance with U.S. and European pharmaceutical manufacturing
regulations.
“Our work in 2017 has been intensely focused on the two critical paths
of drug development — manufacturing and clinical development,” said
Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “The completion of this
world-class commercial manufacturing facility is a significant
milestone. Next, we will complete qualification and validation
activities and scale up to full functionality, so by early 2018 we will
have the capacity to manufacture approximately 450 million capsules of
AR101 per year. Meanwhile, on the clinical path, we are fast approaching
completion of the up-dosing phase of PALISADE, and the RAMSES trial is
underway, to be followed soon by the ARTEMIS trial in Europe. These are
all timely and essential steps toward potentially being able to offer an
approved treatment for patients with peanut allergy.”
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical
company developing treatments for life-threatening food allergies. The
company’s Characterized Oral Desensitization ImmunoTherapy
(CODIT™) approach is intended to achieve meaningful levels of protection
by desensitizing patients with defined, precise amounts of key
allergens. Aimmune’s first investigational biologic product using
CODIT™, AR101 for the treatment of peanut allergy, has received the
FDA’s Breakthrough Therapy Designation for the desensitization of
peanut-allergic patients 4-17 years of age and is currently being
evaluated in Phase 3 clinical trials. 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 for its commercial
manufacturing facility for AR101, including expectations that the
facility will be cGMP compliant, capable of producing commercial
supplies of AR101 and clinical supplies for additional product
candidates, prevent cross-contamination of allergens and produce
approximately 450 million capsules of AR101 per year; Aimmune’s
expectations that qualification and validation activities at the new
manufacturing facility will be completed in early 2018; Aimmune’s
expectation that completion of the up-dosing phase of its PALISADE trial
of AR101 will occur soon; Aimmune’s expectation that its ARTEMIS trial
of AR101 will begin soon; Aimmune’s expectation that AR101 may receive
regulatory approvals in the United States and Europe; Aimmune’s
expectations regarding the potential benefits of AR101; 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; the company’s ability to initiate and/or
complete clinical trials; the unpredictability of the regulatory
process; the possibility that Aimmune’s clinical trials will not be
successful; Aimmune’s dependence on the success of AR101; the company’s
reliance on third parties for the manufacture of the company’s product
candidates; possible regulatory developments in the United States and
foreign countries; and the company’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, 2017. 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 a product that is under clinical
investigation and that has not yet been approved for marketing by the
U.S. Food and Drug Administration (FDA) or the European Medicines Agency
(EMA). It is currently limited to investigational use, and no
representation is made as to its safety or effectiveness for the
purposes for which it is being investigated.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170607005468/en/
Source: Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc.
Investors
Laura Hansen, Ph.D.,
650-396-3814
lhansen@aimmune.com
or
Media
Stephanie
Yao, 650-351-6479
syao@aimmune.com
