Allergy Partners Announces Collaboration With Aimmune Therapeutics

Allergy Partners Announces Collaboration With Aimmune Therapeutics to Provide Palforzia® [Peanut (Arachis Hypogaea) Allergen Powder-DNFP] Directly to Patients

Collaboration strengthens patient access to PALFORZIA through Allergy Partners’ national network of specialty practices

Children and teenagers aged 4 through 17 years with a confirmed diagnosis of peanut allergy to benefit from direct access to high-quality treatment and improved specialty care

Important step forward for Allergy Partners, less than one year after its strategic partnership with B-Flexion, the long-term investor in the allergy sector

ASHEVILLE, N.C. & BRISBANE, Calif.–(BUSINESS WIRE)–Allergy Partners, the nation’s largest single specialty allergy practice group leading the development and delivery of high-quality health care for patients with asthma and allergic disease, today announced a strategic collaboration with Aimmune Therapeutics, Inc., a Nestlé Health Science company developing pharmaceutical therapies to prevent, manage, and treat food, gastrointestinal, and metabolic-related diseases, to provide Allergy Partners’ patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy with direct access to PALFORZIA, the first and only FDA-approved peanut allergy treatment.

PALFORZIA was approved in January 2020 by the U.S. Food and Drug Administration (FDA) as an oral immunotherapy (OIT) 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. It is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. PALFORZIA is to be used in conjunction with a peanut-avoidant diet.

Allergy Partners’ nation-wide care network provides high-quality health care for patients with asthma and allergic diseases, promoting education, research, and innovation in the field. As a result of this collaboration, Allergy Partners will begin to provide PALFORZIA directly to patients through its specialty pharmacy, Allergy Partners Therapeutics (APT), across its entire national network of 64 practices and 126 community locations in 19 states.

“Supported by the recent strategic investment from B-Flexion, our commitment will continue to be to provide the best possible care to our patients and improve health outcomes across an expanding allergy network, and this unique collaboration with Aimmune will enable us to improve patient access to this important treatment through APT and our network of dedicated providers,” said Dr. Bill McCann, Chief Medical Officer of Allergy Partners. “We are pleased to be working with Aimmune, which is at the forefront of developing allergy therapies like PALFORZIA that have the potential to help transform the lives of patients that often have few or no treatment options available to them.”

“PALFORZIA is an important treatment option for patients living with peanut allergy, helping to reduce the risk of severe allergic reactions due to accidental exposure, and enabling them to live with fewer restrictions,” said Andrew Oxtoby, President and CEO, Aimmune Therapeutics. “Aimmune is committed to help ensure that all eligible patients who wish to access PALFORZIA are able to do so, and the announcement today of our collaboration with Allergy Partners marks another step toward that goal.”

Please see the below Important Safety Information or visit www.PALFORZIA.com for the full Prescribing Information, including Boxed WARNING and Medication Guide.

What Is PALFORZIA?

PALFORZIA is a treatment for people who are allergic to peanuts. PALFORZIA can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA may be started in patients aged 4 through 17 years old. If you turn 18 years of age while on PALFORZIA treatment you should continue taking PALFORZIA unless otherwise instructed by your doctor.

PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction.

You must maintain a strict peanut-free diet while taking PALFORZIA.

Important Safety Information

PALFORZIA can cause anaphylaxis which may be life-threatening. You will receive your first dose in a healthcare setting under the observation of trained healthcare staff.

You will receive the first dose of all dose increases in a healthcare setting.

In the healthcare setting, you will be observed for at least 1 hour for signs and symptoms of a severe allergic reaction.

If you have a severe reaction during treatment, you will need to receive an injection of epinephrine immediately and get emergency medical help right away.

You will return to the healthcare setting for any trouble tolerating your home doses.

Stop taking PALFORZIA and get emergency medical treatment right away if you have any of the following symptoms after taking PALFORZIA:

• Trouble breathing or wheezing
• Chest discomfort or tightness
• Throat tightness
• Trouble swallowing or speaking
• Swelling of your face, lips, eyes, or tongue
• Dizziness or fainting
• Severe stomach cramps or pain, vomiting, or diarrhea
• Hives (itchy, raised bumps on skin)
• Severe flushing of the skin

Because of the risk of severe allergic reactions, PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. Talk to your healthcare provider for more information about the PALFORZIA REMS program and how to enroll.

You should NOT take PALFORZIA if you have uncontrolled asthma, or if you ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.

Tell your doctor if you are not feeling well prior to starting treatment with PALFORZIA. Your doctor may decide to delay treatment until you are feeling better. Also tell your doctor about any medical conditions you have and if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements.

Your doctor may decide that PALFORZIA is not the best treatment if:

• You are unwilling or unable to receive (or self-administer) injectable epinephrine.
• You have a condition or are taking a medication that reduces the ability to survive a severe allergic reaction.

What are the possible side effects of PALFORZIA?

The most commonly reported side effects of PALFORZIA were: stomach pain, vomiting, feeling sick, itching or burning in the mouth, throat irritation, cough, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itchy skin, hives, and/or itchy ears.

PALFORZIA can cause anaphylaxis which may be life-threatening. PALFORZIA can cause stomach or gut symptoms including inflammation of the esophagus (called eosinophilic esophagitis). Symptoms of eosinophilic esophagitis can include:

• Trouble swallowing
• Food stuck in throat
• Burning in chest, mouth, or throat
• Vomiting
• Regurgitation of undigested food
• Feeling sick

For additional information on the possible side effects of PALFORZIA, talk with your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Allergy Partners

Allergy Partners, PLLC which in December 2021 received a strategic investment from B-Flexion, the private investment firm managing funds on behalf of the Bertarelli Family, is the largest single specialty practice group, and recognized as leaders in the development and delivery of high-quality health care for patients with asthma & allergic disease. Our vast care network of providers works together to promote education, research & innovation in the field of allergy & asthma care. Learn more about www.allergypartners.com

About Aimmune Therapeutics

Aimmune Therapeutics, part of Nestlé Health Science, is a biopharmaceutical company that aspires to be a global leader in developing innovative medicines to prevent, manage, and treat food, gastrointestinal (GI), and metabolic-related diseases for those with few or no treatment options. Aimmune was built on the belief that families deserve standardized, regulatory-approved, science-driven treatments that reduce their daily burden and help them better manage these conditions.

For more information about Aimmune, please visit www.aimmune.com

Contacts

Blair Hennessy, Abernathy MacGregor
(212) 371-5999 / bth@abmac.com

Georgina Vincent, Head of External Communications
(747) 758-9524 / gvincent@aimmune.com

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