Out of the Ordinary: The Commercial Field Team Reaches the Summit
When the commercial team gathered to plan the PAM Phase Training last summer, there was a distinct desire to do something different. This, after all, was the first-to-market therapy for peanut allergy and the first in its field, with meaningful levels of protection against allergic reactions. And it would be armed with FDA approval. For most of 2019, Richard Smith, Vice President, Commercial Development, knew he had to build a team of 80 exceptional “Practice Account Managers,” unlike a typical pharma team of Product Account Managers. This work requires much more than simple sales; it requires an individual, personalized approach that takes into account a longer learning curve and a generous amount of support time to meet each individual allergist, patient and family’s needs. Richard was excited; he had gathered what he thought was the most uniquely talented group to meet this challenge and couldn’t wait to have them all gather and meet for the first time.
A Much Better Mood in Florence: The PAAM Conference
Pepper, the gender-neutral robot who debuted at EAACI last June, made a repeat appearance at the Pediatric Allergy and Asthma Meeting (PAAM), the second largest European meeting after EAACI. PAAM alternates each year, in the fall, with the Food Allergy Anaphylaxis Meeting (FAAM). This year, staff from both London and Brisbane attended the conference and supported numerous activities from October 17th to 19th in Florence, Italy. Not much time for sightseeing however; with ~50% of the focus this year on food allergy and the patient, it was a perfect time to introduce Aimmune to approximately 150 target European physicians attending.
How the Oscars Have Changed Since I Went in 1990
Twenty years ago, I sat on the front row at the Academy Awards, and when Jodi Foster called out the name of the Best Actor, I pushed a shocked Lewis out of his seat to receive his Oscar for his role in My Left Foot. That felt like my own reward for championing the underdog film, as acquisitions executive for the young and independent Miramax, the new kid on the Hollywood block. The movie was also up for ~ Eilm, in a lineup that included Born on the Fourth of July, Driving Miss Daisy (the winner) Dead Poets Society and Field of Dreams. After that, a stream of independent dramatic films began infiltrating the old system, and the distributors who represented them ingeniously used the Oscar nominations to market their smaller films, which historically did not do as well at the box office.
Q3 Report - On Target
Aimmune's Third Quarter report was given on November 6 by webcast/conference call to active investors, potential investors, and the financial analysts covering Aimmune for Wall Street. The main message reported in the call was: Aimmune's business is on track for an approval in January.
Jayson Dallas opened the call, saying this is an exciting time for Aimmune since the recommendation of PALFORZIA™ by the Ad Comm panel on September 13 . The company is deep in preparations for a potential approval in January 2020 and commercial launch shortly thereafter.
BLA Accepted
Aimmune received notification from the FDA that our BLA for AR101 has been accepted for review. We had anticipated hearing from the agency near the end of March, but the notice came earlier than expected, which is an encouraging sign of the pace of engagement with the agency as we move forward.
As Jayson Dallas said in the press release we issued on Monday: "Today is a significant milestone for Aimmune. The FDA's acceptance of our BLA is a crucial step forward in delivering AR101 to children, teens and families living with the serious, daily risk of allergic reactions to accidental exposure to peanuts.
First Quarter Report to Wall Street
Aimmune announced its First Quarter Financial Results on May 8 with robust data from recent clinical trials, a scheduled FDA Advisory Committee date in September, and enough funding to take AR101 through commercialization in both the U.S. and Europe. With our AR201 egg allergy phase 2 trial expected to initiate mid-2019, the pipeline is growing, which should expand the value of the CODIT platform as we go forward.
In his comments on our Q1 earnings call, Jayson Dallas focused on what is at hand: "We are well on track to introduce AR101 as potentially the first-ever approved treatment for peanut allergy, a significant milestone for our Company, the allergist community, and the millions of people who live with the daily risk of serious reactions to accidental peanut exposure."
Aimmune Makes Global Move with Submission of MAA for AR101 to the European Medicines Agency
“This is an important milestone for us as a company, as well as for people across Europe living with peanut allergy, a growing worldwide health problem that significantly affects the quality of life of both patients and their families,” Jayson Dallas was quoted on June 28th, the day Aimmune submitted a Marketing Authorization Application to the European Medicines Agency. “We are continuing to expand our organization across Europe to prepare for potential approval of AR101 in key markets and engaging in reimbursement discussions to expedite access for patients upon approval.”
The Phase 3 ARTEMIS study, which represents a key component of the MAA submission, reinforced the consistent clinical profile of AR101 after six months of dose escalation and a three-month therapeutic dosing phase.
UK Summer Party
The Paddington office came together on July 4th to hold an afternoon ‘All Hands Meeting’ which was then followed by the ‘Summer Party’. Colleagues from the UK and EU joined in to celebrate milestones over the past six months and to review goals coming up for each of the teams in the next two quarters with presentations given from across departments.
EAACI - Stepping into the Future of Food Alergy
The future was very much present at the Aimmune booth at the EAACI conference in Lisbon June 1 – 5. Anyone entering the booth was immediately drawn to a four foot, solid white, human-looking robot named Pepper. Pepper’s instruction booklet recommends gender neutrality with respect to robots, but it was clear by many Aimmune staff that with such smooth curves and an alto voice, they strongly identified Pepper as a she. Pepper was ready to answer any questions about Aimmune, sort of like a Siri in person.
New Locations, Real and Virtual
Aimmune is on the move. In the last several weeks, employees held ribbon cutting ceremonies for two new office locations: in London, England and Durham, NC. (see pictures below).
And in the digital world, we are also celebrating a new "Locations" tab at the upper right hand corner of the Home Page. Three sites, for each office location, are designed to support the local needs of each office and their visitors.
Workshopping for a Commercial Launch
The "Strategic Brand Planning Workshop" was held for six days between April 3 and April 10 at the Doubletree Hotel near the Brisbane office. The subject was preparing for the commercial launch of AR101; the goal was for Aimmune teams involved in the commercial launch to clearly understand what are the key elements that must be thoroughly executed for success. Participants drilled down on exactly "Who is our Target Patient?", "Which Allergists are our Key Targets?" and "What Strategies Are Most Important?".
Aimmune at Home in AAAAI
Aimmune's hometown presence was very much felt at this year's AAAAI Conference, held at the Moscone Center in San Francisco from February 22 – 25 . Aimmune staff engaged with over 600 healthcare professionals in a variety of well-coordinated educational and social events, with the message of AR101's consistently positive data going forward in an event-rich year ahead.
