Aimmune Therapeutics Broadens and Extends Supply Agreement With Golden Peanut and Tree Nuts for AR101 for Peanut Allergy
January 10 2018 - 8:00AM
Business Wire
— Newly Expanded Global Agreement Secures
Exclusive Supply Relationship through 2033 —
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical
company developing treatments for potentially life-threatening food
allergies, today announced an expansion and extension of its
exclusive supply agreement with Golden Peanut and Tree Nuts
(Golden), a subsidiary of Archer Daniels Midland Company (ADM), to
support the anticipated potential commercialization of AR101.
Golden is a leading handler, processor and exporter of peanuts and
tree nuts and exclusively supplies the starting material for AR101,
Aimmune’s investigational biologic oral immunotherapy (OIT) for
desensitization of patients with peanut allergy. AR101 is currently
in Phase 3 clinical trials, with pivotal topline data expected in
February.
The expanded agreement secures Aimmune’s exclusive global use of
the starting material of AR101 for the oral treatment of peanut
allergy for 10 years, with an option to extend the agreement up to
an additional five years, through 2033. Further, it gives Aimmune
exclusive access to additional Golden products that could be
developed into peanut oral immunotherapies. As part of the
agreement, Aimmune has granted ADM a 300,000-share equity stake in
Aimmune.
“We’re honored and delighted to strengthen our alliance with
Golden Peanut,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “As
drug developers, we have a responsibility to thoroughly secure our
supply chain, and this exclusive agreement, with the largest and
most established supplier in the industry, fulfills that very well.
Golden Peanut shares our mission to protect people with peanut
allergies and has been a great partner for ensuring that we have a
consistent, stable, reliable source for our clinical trials and our
potential future commercial requirements.”
The batch-to-batch consistency of the AR101 starting material
Aimmune receives from Golden is an essential component of the AR101
manufacturing process, as Aimmune controls for both the quantity of
peanut protein and the relative concentrations of key peanut
proteins in the final drug product. Additionally, the Golden peanut
production process takes place in a peanut-only environment, from
field to shipment. This is an important safeguard for Aimmune’s
manufacture of an investigational peanut allergy treatment that is
free from other common food allergens, such as tree nuts, as some
people with peanut allergy are allergic to tree nuts as well.
“From the beginning of Golden’s involvement with Aimmune, our
companies have been aligned in wanting to see a successful
treatment to protect people with peanut allergy,” said Greg Mills,
President, Golden Peanut and Tree Nuts. “We are proud that our
high-quality products and processes can be part of a potential
solution, and we are excited to deepen our relationship with
Aimmune in support of helping peanut allergy patients.”
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage
biopharmaceutical company developing treatments for potentially
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.
About Golden Peanut and Tree Nuts
Golden Peanut and Tree Nuts, a subsidiary of Archer Daniels
Midland Company, is a leading handler and processor of peanuts and
tree nuts. Headquartered in Alpharetta, Georgia, the company has 13
processing facilities in the United States and one in Argentina. In
South Africa, Golden Peanut is the majority owner of peanut
processing plants in Hartswater, Hoopstad and Jan Kempdorp, and is
51-percent owner of pecan processor and marketer GPC Pecan S.A.
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 the
expanded and extended supply agreement with Golden Peanut Company
for the starting material for AR101; the ability of Golden Peanut
Company to supply batch-to-batch consistency of the starting
material for AR101; 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 September 30, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20180110005328/en/
Aimmune Therapeutics, Inc.InvestorsLaura Hansen, Ph.D.,
650-396-3814lhansen@aimmune.comorMediaStephanie Yao,
650-351-6479syao@aimmune.com
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