Aimmune Therapeutics said today it will partner with Nestlé Health Science to develop food allergy immunotherapies, under a 2-year collaboration launched with a $145 million equity investment by the Nestlé unit in the Brisbane, CA, drug developer.
Aimmune develops treatments for life-threatening food allergies using its CODIT™ (Characterized Oral Desensitization ImmunoTherapy) system. The collaboration allows Aimmune to retain rights to all current and future pipeline assets developed through CODIT—including AR101, the company’s Phase III oral biologic desensitization therapy candidate for peanut allergy.
The investment and the collaboration do not include any development milestones, product marketing rights, or royalties, Ammune added.
“This significant investment will put us in a strong cash position of more than $300 million and enables important additional pipeline advancement activities beyond AR101 for peanut allergy,” Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D., said in a statement.
AR101 is the subject of the pivotal PALISADE trial, which the company said on September 20 had exceeded its target of 350 patients randomized in the U.S. and Canada, 3 months ahead of schedule, with final North American enrollment projected at between 425 and 450 patients. European enrollment is ongoing and is expected to complete by the end of the year, Aimmune said at the time.
Topline results from PALISADE are expected to come out in the fourth quarter of 2017—to be followed, Aimmune said, by U.S. and European regulatory submissions for marketing approval of AR101 in 2018.
Another clinical study of AR101, RAMSES (Real-World AR101 Market-Supporting Experience Study), is set to start enrolling patients in the first quarter.
As part of the companies’ collaboration, Nestlé Health Science CEO Greg Behar will join Aimmune’s board. Nestlé Health Science has agreed to provide ongoing scientific, regulatory, and commercial expertise and advice to Aimmune.
However, the companies agreed that during the collaboration, any information disclosed will remain the confidential information of Aimmune, which will also own the intellectual property related to any new ideas or inventions related to its products, Aimmune said.
Should Aimmune seek a partner or collaborator for one of its oral immunotherapy development programs during the term of the collaboration, Nestlé Health Science will have 3 months to negotiate exclusively with Aimmune.
Nestlé Health Sciences has agreed to buy 7,552,084 newly issued shares of Aimmune’s common stock at $19.20 per share, taking a 15% stake in Aimmune.
The deal has been approved by the boards of both companies, with the equity investment set to close by year’s end, subject to the expiration or termination of waiting periods under all antitrust laws, among customary closing conditions.