Peanut allergy therapy Palforzia, which Nestlé acquired in a multi-billion dollar deal, has been sold to allergy product company Stallergenes Greer. Palforzia was the first FDA-approved drug for peanut allergy, but its sales were hampered by the Covid-19 pandemic.
Nestle already owns a 25.6% stake in Aimmune worth $473 million, and the deal brings the total value of that investment to $2.6 billion. An analyst wrote that the deal's closing should be "smoother than a fresh jar of Skippy" and was not expected to meet antitrust or competitive hurdles.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
An analyst called the patch "dead in the water," also noting that the ongoing Covid-19 pandemic could challenge the rollout of a competing therapy, Aimmune's Palforzia, which the FDA approved in January.
Palforzia is the first drug to win approval to treat a food allergy. The approval follows a favorable, though not unanimous, vote by an FDA advisory committee in September.
The company said Friday that the agency had accepted for review its application for Viaskin Peanut, designed to reduce the risk of allergic reactions in children aged 4-11. An FDA advisory committee voted in favor of a competing treatment last month.
The FDA’s Allergenic Products Advisory Committee voted 7-2 in favor of supporting the efficacy profile of Palforzia, or AR101. Some committee members expressed concerns about a lack of diversity in the Phase III clinical trial.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Although the study of AR101 met its primary endpoint, patients on the drug had more allergic reactions than those on placebo. An allergy expert explained that the disparity reflects time needed to build up tolerance to peanut allergen.
The report found that Aimmune's AR101 and DBV's Viaskin Peanut lacked sufficient evidence to demonstrate that their benefits outweighed short-term risks. Aimmune and an allergy advocacy group criticized the report.