Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced the appointment of Andrew Oxtoby as Chief Commercial Officer. Mr. Oxtoby, a proven pharmaceutical executive with two decades of experience in the healthcare and consumer products industries, will join Aimmune in the newly created role on Tuesday, January 22.
“Andrew has a terrific track record of accomplishment in leading U.S. and global commercial organizations to successfully launch novel medicines and build innovative patient solutions in large disease areas, which will be tremendously valuable to Aimmune as we prepare to address the emerging food allergy therapeutic space,” said Jayson Dallas, M.D., Aimmune President and CEO. “I’m excited to welcome Andrew to Aimmune and look forward to working with him in this new role on our potential launch of AR101 and the development of our pipeline. His appointment further strengthens our leadership team as Aimmune enters a transformational time in our mission to improve the lives of people with food allergies.”
Mr. Oxtoby joins Aimmune from Eli Lilly and Company, where he most recently had responsibility for Lilly’s U.S. insulin business as Vice President of U.S. Diabetes Connected Care and Insulins, an innovative, patient-focused business unit, after having served as Vice President of U.S. Diabetes Sales. In his more than 16 years with Lilly, Mr. Oxtoby also spent five years in oncology, including as Vice President of the International Oncology business; served as General Manager of Lilly’s Netherlands operation; and held positions of increasing responsibility in marketing and sales. Mr. Oxtoby began his career at Procter & Gamble, where he spent four years in the engineering and manufacturing organizations. Mr. Oxtoby holds an M.B.A. from Harvard Business School and a B.S. in mechanical engineering from Purdue University.
“I’m thrilled to join the Aimmune leadership team and contribute to its commitment to protect kids with peanut allergy from life-threatening reactions,” said Mr. Oxtoby. “This is a tremendous opportunity to build a therapeutic space aimed at addressing the needs of food-allergic patients, who currently have no approved treatment options, and to make a profound difference in their and their families’ lives.”
AR101 is a complex biologic drug under investigation for the treatment of children and adolescents with peanut allergy. The U.S. Food and Drug Administration (FDA) granted AR101 Fast Track Designation for peanut allergy in September 2014 and Breakthrough Therapy Designation for peanut allergy in ages 4–17 in June 2015.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4–17 years of age. Aimmune’s regulatory filing for marketing approval of AR101 in the United States (submitted 4Q18) and Europe (1H19) are based on data from the pivotal Phase 3 PALISADE clinical trial of AR101, which in 4–17-year-old subjects met its primary and key secondary endpoints, and additional ongoing and completed AR101 clinical trials. Aimmune has filed an IND application for its second product, AR201, for the treatment of egg allergy and intends to start a randomized Phase 2 clinical trial in the first half of 2019. For more information, please see www.aimmune.com.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations regarding the expected contributions of its new chief commercial officer; Aimmune’s expectations regarding the potential benefits of AR101; Aimmune’s expectations regarding the potential commercial launch of AR101, including the timing of a potential approval of AR101; Aimmune’s expectations on regulatory submissions for marketing approval of AR101 for peanut allergy in Europe; Aimmune’s expectations on the timing of initiating a Phase 2 clinical trial for AR201; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; Aimmune’s or any of its collaborative partners’ ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s or any of its collaborative partners’ clinical trials will not be successful; Aimmune’s dependence on the success of AR101; Aimmune’s reliance on third parties for the manufacture of Aimmune’s product candidates; possible regulatory developments in the United States and foreign countries; and Aimmune’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune’s most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2018. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Neither AR101 nor AR201 has been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). AR101 and AR201 are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
Laura Hansen, Ph.D.