Inhalation

INH0223

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Following “lower than expected demand,” Nestlé is “exploring strategic options” for Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] the first and only drug approved by the United States Food and Drug Administration (FDA) for the treatment of peanut allergy in children ages 4 to 17. 36 February 2023 Inhalation BACK PAGES Nestlé reconsidering only FDA-approved peanut allergy drug for children due to slow adoption Following "lower than expected demand," Nestlé is "exploring strategic options" for Palforzia [Peanut (Arachis hypogaea) Aller- gen Powder-dnfp] the first and only drug approved by the United States Food and Drug Adminis- tration (FDA) for the treatment of peanut allergy in children ages 4 to 17. According to BBC News and End- points News, the announcement by Nestlé CEO Mark Schneider was made only two years after Nestlé acquired the drug's man- ufacturer Aimunne erapeu- tics. "e review is expected to be completed in the first half of 2023," BBC News noted, quoting a Nestlé release. In 2017, Nestlé purchased more than $470 million worth of Aimmune erapeutics stock, resulting in approximately 25% ownership, then acquired the company in 2020 following the FDA approval. Analysts pro- jected Palforzia sales of more than $1 billion. However, Schneider "noted in an investor call…that the drug has proven to be more 'niche therapy' than blockbuster," BBC News stated. "Both patient retention and allergist adoption [have] been lower than expected," Schneider added. Contributing factors Several causes may have contrib- uted to the slow adoption. e COVID-19 pandemic began shortly after the Palforzia approval, preventing many patients from visiting doctors' offices. Also, "some patients are not able to commit to the bi-weekly visits required for several months of treatment," Panida Sriaroon, med- ical director of the Johns Hop- kins All Children's Food Allergy Clinic, told BBC News. Schneider also noted the frequency of doc- tor's visits and additional time required when escalating doses (see sidebar article). In addition, "complicated billing procedures have discouraged many providers from offering the treatment, mak- ing it difficult for some patients to access," said BBC News. Nevertheless, Kenneth Men- dez, president and CEO of the Asthma and Allergy Foundation of America (AAFA) told Endpoints News that "Palforzia is covered by many insurance plans whereas non-FDA approved therapies often have high out-of-pocket costs that limit access to those who can afford it. We hope that Palfor- zia continues to be an option for people and families managing food allergies." Implications of a sale A Nestlé spokesperson told BBC News that "the company could not speculate on 'next steps' for the medication or…the conse- quences of selling the drug to another company…." BBC News also provided a dif- ferent perspective, from Tim van Biesen, managing partner of con- sulting firm Bain & Company's Global Healthcare practice. "Sell- ing Palforzia could actually make the treatment more widely avail- able as a new company would seek to recruit as many patients as possible," he suggested. "But if the company is unable to find a buyer, that could be a cause for concern among patients," he added. Concerns about future drug development BBC News also explained that the drug's disappointing sales have sparked concerns about future investment in the broader food

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