Press Release: Nestle: Nestlé completes acquisition of Aimmune Therapeutics
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Vevey, October 14, 2020
Nestlé completes acquisition of Aimmune Therapeutics
Nestlé announced today the successful completion of its acquisition
of Aimmune Therapeutics, Inc. (Nasdaq: AIMT). Joining Nestlé Health
Science (NHSc) as a stand-alone business unit called Aimmune
Therapeutics, a Nestlé Health Science company, it will manage
NHSc's global pharmaceutical business.
"Nestlé Health Science's acquisition of Aimmune Therapeutics marks
an important milestone in our constant pursuit of innovative,
science-bassed nutritional solutions to support healthier lives," said
Greg Behar, CEO of NHSc. "Aimmune's PALFORZIA(R), the first medication
approved for treating peanut allergy, is a game-changer and it's only
the beginning. Aimmune's pharmaceutical expertise and infrastructure
will complement our existing research and development to further drive
growth globally."
Aimmune will continue to be run from Brisbane, California. Andrew Oxtoby
has been named as Aimmune's President & CEO, along with a new executive
leadership team. Oxtoby was previously Aimmune's Chief Commercial
Officer.
The development program for Aimmune -- which consists of the potential
use of PALFORZIA in toddlers and adults, multiple clinical development
programs in other allergies, and the development of the monoclonal
antibody AlMab7195 -- will proceed as planned.
PALFORZIA [Peanut (Arachis hypogaea) Allergen Powder-dnfp] was approved
by the U.S. Food and Drug Administration (FDA) in January 2020 as an
oral immunotherapy for the mitigation of allergic reactions, including
anaphylaxis, that may occur with accidental exposure to peanut in
patients aged 4 through 17 years with a confirmed diagnosis of peanut
allergy. In Europe, Aimmune's marketing authorization application for
AR101 is under review with the European Medicines Agency (EMA), with a
decision anticipated in 2020. A Swiss Agency for Therapeutic Products
(SwissMedic) review of AR101 also is ongoing, with a decision expected
in 2021.
The previously announced tender offer for all of the outstanding shares
of Aimmune common stock, other than shares held by Nestlé and its
affiliates, for a price of US$34.50 per share in cash expired as
scheduled at midnight, Eastern Time, on October 9, 2020. The minimum
tender condition and all of the other conditions to the offer were
satisfied and on October 13, 2020, Nestlé through a wholly owned
subsidiary (Purchaser), accepted for payment all shares validly tendered
and not properly withdrawn.
Following its acceptance of the tendered shares, Nestlé caused
Purchaser to merge with Aimmune. As a result of the merger, all Aimmune
shares not purchased in the tender offer (other than (i) shares owned by
Nestlé or Purchaser, (ii) shares held by Aimmune and (iii) shares
as to which the holder thereof has properly exercised appraisal rights
under Delaware law) were converted into the right to receive the same
US$34.50 per share in cash (without interest and subject to applicable
withholding taxes) that would have been paid had such shares been
purchased in the tender offer. Aimmune common stock has ceased to be
traded on the NASDAQ Global Market.
INDICATION
In the US, 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.
Limitations of Use: Not indicated for the emergency treatment of
allergic reactions, including anaphylaxis.
IMPORTANT SAFETY INFORMATION
Boxed WARNING:
PALFORZIA can cause anaphylaxis, which may be life threatening and can
occur at any time during PALFORZIA therapy.
Prescribe injectable epinephrine, instruct and train patients on its
appropriate use, and instruct patients to seek immediate medical care
upon its use.
Do not administer PALFORZIA to patients with uncontrolled asthma.
Dose modifications may be necessary following an anaphylactic reaction.
Observe patients during and after administration of the Initial Dose
Escalation and the first dose of each Up-Dosing level, for at least 60
minutes.
PALFORZIA is available only through a restricted program called the
PALFORZIA REMS.
CONTRAINDICATIONS
PALFORZIA is contraindicated in patients with uncontrolled asthma, or
with a history of eosinophilic esophagitis and other eosinophilic
gastrointestinal disease.
WARNINGS AND PRECAUTIONS
Anaphylaxis
PALFORZIA can cause anaphylaxis, which may be life threatening.
PALFORZIA is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS
because of the risk of anaphylaxis. Only prescribers, healthcare
settings, pharmacies, and patients certified and enrolled in the REMS
Program can prescribe, receive, dispense or administer PALFORZIA.
Anaphylaxis has been reported during all phases of PALFORZIA dosing,
including Maintenance and in subjects who have undergone recommended
Up-Dosing and dose modification procedures.
Do not initiate PALFORZIA treatment in a patient who has had severe or
life-threatening anaphylaxis within the previous 60 days. PALFORZIA may
not be suitable for patients with certain medical conditions that may
reduce the ability to survive anaphylaxis, including but not limited to
markedly compromised lung function, severe mast cell disorder, or
cardiovascular disease. In addition, PALFORZIA may not be suitable for
patients taking medications that can inhibit or potentiate the effects
of epinephrine.
All Initial Dose Escalation doses and the first dose of each Up-Dosing
level must be administered in a certified health care setting.
Patients may be more likely to experience allergic reactions following
PALFORZIA administration in the presence of cofactors such as exercise,
hot water exposure, intercurrent illness (e.g., viral infection), or
fasting. Other potential cofactors may include menstruation, sleep
deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled
asthma. Patients should be proactively counseled about the potential for
the increased risk of anaphylaxis in the presence of these cofactors. If
possible, adjust the time of dosing to avoid these cofactors. If it is
not possible to avoid these cofactors, consider withholding PALFORZIA
temporarily.
Asthma
Uncontrolled asthma is a risk factor for a serious outcome, including
death, in anaphylaxis. Ensure patients with asthma have their asthma
under control prior to initiation of PALFORZIA.
PALFORZIA should be temporarily withheld if the patient is experiencing
an acute asthma exacerbation. Following resolution of the exacerbation,
resumption of PALFORZIA should be undertaken cautiously. Re-evaluate
patients who have recurrent asthma exacerbations and consider
discontinuation of PALFORZIA.
Eosinophilic Gastrointestinal Disease
Discontinue PALFORZIA and consider a diagnosis of eosinophilic
esophagitis in patients who experience severe or persistent
gastrointestinal symptoms, including dysphagia, vomiting, nausea,
gastroesophageal reflux, chest pain, or abdominal pain.
Gastrointestinal Adverse Reactions
Gastrointestinal adverse reactions were commonly reported in
PALFORZIA-treated subjects, and dose modification should be considered
for patients who report these reactions. For severe or persistent
gastrointestinal symptoms consider a diagnosis of eosinophilic
esophagitis.
ADVERSE REACTIONS
The most common adverse events reported in subjects treated with
PALFORZIA (incidence = 5% and = 5% than placebo) are abdominal pain,
vomiting, nausea, oral pruritus, oral paresthesia, throat irritation,
cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea,
pruritus, urticaria, anaphylactic reaction, and ear pruritus.
Please see full Prescribing Information, including Boxed WARNING, and
Medication Guide at www.PALFORZIA.com.
For more information about PALFORZIA, please call 1-844-PALFORZ
(1-844-725-3679) or visit www.PALFORZIA.com.
About Nestlé Health Science
Nestlé Health Science (NHSc), a globally managed business unit of
Nestlé, is a recognized leader in the field of nutritional science.
At NHSc we are committed to empowering healthier lives through nutrition
for consumers, patients and their healthcare partners. We offer an
extensive consumer health portfolio of industry-leading medical
nutrition, consumer and VMS brands that are science-based solutions
covering all facets of health from prevention, to maintenance, all the
way through to treatment. NHSc is redefining the way we approach the
management of health in several key areas such as pediatric health,
allergy, acute care, oncology, metabolic health, healthy aging,
gastrointestinal health, and inborn errors of metabolism. Headquartered
in Switzerland, NHSc employs over 5,000 people around the world who are
committed to making a difference in people's lives, for a healthier
today and tomorrow. www.nestlehealthscience.com
About Aimmune
Aimmune Therapeutics, Inc. is a biopharmaceutical company that aspires
to become the global leader in developing curative therapies and
solutions for patients with food allergies. With a mission to improve
the lives of people with food allergies, Aimmune is developing and
commercializing oral treatments for potentially life-threatening food
allergies. The Company's Characterized Oral Desensitization
ImmunoTherapy (CODIT(TM)) approach is intended to provide meaningful
levels of protection against allergic reactions resulting from
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