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What Awaits Aimmune Therapeutics Tomorrow?

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The FDA's Allergenic Products Advisory Committee, or APAC, is slated to determine whether or not to recommend approval of AR101, with a proposed trade name Palforzia, an experimental peanut allergy drug, developed by Aimmune Therapeutics Inc. (AIMT), on September 13, 2019.

Palforzia is a powder made from shelled, dry roasted peanut, proposed as a treatment to reduce the incidence and severity of allergic reactions, including anaphylaxis after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.

In a pivotal trial involving peanut-allergic children and adolescents ages 4-17, Palforzia treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo. According to the Company, 67% of Palforzia-treated patients tolerated a single dose of at least 2 peanuts compared to 4% in the placebo arm. Among the Palforzia patients who completed the trial, 85 percent tolerated this level, which is equivalent to 3-4 peanuts of total exposure. Also, 50% of Palforzia patients tolerated the highest challenge level, a single dose equivalent to 3-4 peanuts (7-8 peanuts total exposure).

When the FDA Committee meets tomorrow to review the Palforzia biologics license application, it will be asked whether the efficacy and safety data support approval of Palforzia as a treatment to reduce the incidence and severity of allergic reactions.

According to a briefing document posted on the FDA's website ahead of the panel meeting, Palforzia treatment group had an increased number of discontinuations, systemic allergic reactions and reports of eosinophilic esophagitis compared to the placebo-treated group, though both groups followed a peanut avoidance diet. Twelve subjects treated with Palforzia were diagnosed with eosinophilic esophagitis (EoE) in the entire clinical development program while no subjects in the placebo group of the controlled safety population received a diagnosis of EoE.

The briefing documents are used as the basis for discussion by the FDA panel members.

Another company that is developing a treatment for peanut allergy is DBV Technologies S.A. (DBVT).

DBV Technologies' investigational peanut allergy is Viaskin Peanut, a patch applied daily to the upper back that delivers 250 mcg of peanut antigen.

The Biologics License Application for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years was submitted by DBV Technologies in October 2018. However, the application was withdrawn last December as the Company was required by the FDA to submit additional data on manufacturing procedures and quality controls. DBV Technologies resubmitted the Viaskin Peanut Biologics License Application last month.

Now, getting back to Aimmune Therapeutics' Palforzia, the final FDA decision on the drug is expected by January 2020.

If approved, Palforzia will be the first medicine for peanut allergy. The market opportunity for Palforzia is estimated to be in excess of $1 billion peak sales in the U.S. alone.

Will it be a smooth sailing for Palforzia?

AIMT closed Wednesday's (Sep.11) trading at $25.46, up 15.41%.

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