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

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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,

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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

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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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