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Agreements

Date: 2016-11-04

Type of information: Development agreement

Compound: AR101 for peanut allergy

Company: Nestlé Health Science (Switzerland) Aimmune Therapeutics (USA - CA)

Therapeutic area: Allergic diseases

Type agreement:

development

Action mechanism:

immunotherapy product.

Disease: food allergies including peanut allergy

Details:

* On November 4, 2016, Nestlé Health Science and US-based Aimmune Therapeutics announced that they have entered into a strategic collaboration to accelerate the development of innovative oral immunotherapy biologics designed to desensitize people with food allergies and protect them from the consequences of accidental exposure. Aimmune’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach to treating life-threatening food allergies is based on extensive independent scientific research demonstrating that most patients with food allergies can become desensitized to the allergens, or proteins, in a particular food through the oral administration of gradually increasing amounts of the allergens. It aims to provide a transformative treatment option that goes beyond the current standard of care of diligent avoidance of food allergens and carrying epinephrine for administration in case of accidental exposure.
Aimmune’s lead CODIT product candidate, AR101 for peanut allergy, is a characterized, regulated, oral biological drug product containing the protein profile found in peanuts designed to desensitize patients with peanut allergy. AR101 has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age andThe ongoing Phase III trial, conducted by Aimmune, is expected to deliver results in 4Q2017, which – if positive – may support the filing of marketing authorization in the US and Europe. Per the terms of this collaboration agreement, Aimmune retains the rights to AR101 and all other pipeline assets developed with the CODIT approach.


Financial terms:

Nestlé Health Science announced that it will make an equity investment of $ 145 million in US-based Aimmune Therapeutics which corresponds to a 15% stake after completion of the transaction. The strategic investment launches a two-year strategic collaboration between Nestlé Health Science and Aimmune, the terms of which enable the parties to engage on Aimmune’s current and future oral immunotherapy development programs through a newly established pipeline forum. Nestlé Health Science will provide ongoing scientific, regulatory and commercial expertise and advice to Aimmune through the pipeline forum and in addition has a three-month exclusive right of first negotiation for any development program in the event Aimmune considers licensing or partnering such a program.

The investment extends Nestlé Health Science’s interests in the food allergy arena. Nestlé Health Science already has an established portfolio of nutritional solutions for pediatric food allergy and intolerances, especially Cow’s Milk Protein Allergy (CMPA), as well as a simple, fast and easy-to-use awareness tool – CoMiSS® (Cow’s Milk-related Symptom Score) – which enables primary healthcare professionals to earlier recognize and assess symptoms that may be related to CMPA in infants. Earlier this year the company partnered with DBV Technologies on the development of a skin-patch test tool for the improved diagnosis of CMPA.

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