Healthcare Industry News: immunotherapy
News Release - December 17, 2015
Aimmune Therapeutics Appoints Jeffrey H. Knapp as Chief Operating OfficerOperational Leadership and Deep Commercial Experience Key as Aimmune Launches Pivotal Phase 3 PALISADE Clinical Trial
BRISBANE, Calif.--(Healthcare Sales & Marketing Network)--Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing desensitization treatments for food allergies, today announced the appointment of Jeffrey H. Knapp as Chief Operating Officer. Mr. Knapp brings a nearly 30-year track record of achievement in both large pharmaceutical and small biotechnology companies, including deep commercial experience and first-product launches. Mr. Knapp will join Aimmune on or about February 1, 2016.
“Jeff is the ideal executive to lead Aimmune’s operations into our next phase of development, as we execute on our Phase 3 PALISADE trial and prepare to potentially bring an effective treatment to protect peanut-allergic children, adolescents and adults,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “I look forward to partnering with Jeff as we scale up our manufacturing operations, prepare our go-to-market strategies, and begin to build a world-class commercial organization.”
Over his career, Mr. Knapp has led strategy and execution for multiple product launches across several therapeutic areas. Prior to Aimmune, Mr. Knapp was Chief Operating Officer at Adamas Pharmaceuticals, which he joined as Chief Commercial Officer in early 2014. He was previously Chief Commercial Officer at Affymax Inc., where, over seven years in the role, he built out the company’s U.S. commercial organization and led the launch of its first product. Mr. Knapp also led sales and marketing at Abgenix, Pharmion, and EMD Pharmaceuticals. He spent the first half of his career at Eli Lilly and Schering-Plough in various sales, marketing and business development roles. Mr. Knapp earned his bachelor’s degree in biology from Wittenberg University.
“I’m extraordinarily excited to join Aimmune at this particular time as the pivotal Phase 3 PALISADE trial gets underway,” said Mr. Knapp. “The Aimmune team has made an enormous amount of progress in a short period of time, and I look forward to adding to the momentum as the company executes on the Phase 3 program and begins to plan for the potential launch of its first product. It’s incredibly compelling to work in an area of such great patient need that currently has no FDA-approved treatment options.”
Aimmune’s PALISADE (PEANUT ALLERGY ORAL immunotherapy STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS) pivotal trial for AR101 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial that is expected to enroll approximately 500 peanut-allergic children, adolescents and adults 4-55 years of age in 11 countries in North America and Europe. AR101 has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age.
About AR101 and CODIT™
Aimmune Therapeutics is developing AR101 as a potential desensitization therapy for patients with peanut allergy to provide them with protection from peanut allergens at a level believed to substantially exceed the amount typically encountered in an accidental exposure. AR101 is a complex formulation of naturally occurring peanut proteins and pharmaceutical-grade inactive ingredients. Aimmune tests AR101 for three key index allergenic proteins (Ara h1, h2 and h6), which are representative of the full range of peanut allergens. This process ensures the consistency of AR101 and enables the convenient dosing of consistent amounts of peanut protein with well-defined concentrations of peanut allergens. Patients ingest AR101 mixed into small amounts of palatable, age-appropriate food.
AR101 is part of Aimmune’s approach to treating food allergies using its characterized oral desensitization immunotherapy, or CODIT™, system. The CODIT system leverages extensive independent scientific research on oral immunotherapy, or OIT, demonstrating that food allergy patients can be desensitized to food allergens by being administered well-defined, gradually increasing doses of the allergen over a period of months. Aimmune’s CODIT system is designed to precisely control the amounts of the allergens administered in a systematic dosing regimen, beginning with very low doses of the allergens. Once a patient attains desensitization to a clinically meaningful level, the patient continues to take a daily maintenance dose of the CODIT system product in order to maintain the desensitization.
About Food Allergies
Food allergies are a significant and growing health problem in the United States, Europe and throughout the developed world. It is estimated that more than 30 million people in the United States and Europe have a food allergy, and more than five million people in the United States and Europe have peanut allergy, including more than two million children. The prevalence of peanut allergy in children in the United States is estimated to have increased at a constant annual growth rate of approximately 10 percent between 1997 and 2008, and experts believe it has continued to rise since 2008. For people living with food allergies, certain foods can cause severe allergic reactions, including potentially life-threatening anaphylaxis. There are no approved medical therapies to cure food allergies or prevent their effects. Currently, food-allergic patients manage their condition by strict allergen avoidance and carrying epinephrine auto-injectors for use in case of accidental exposure. Thus, in addition to the unmet medical need, food allergies can impose a significant quality of life burden. For more information, please see www.foodallergy.org and www.niaid.nih.gov/topics/foodallergy.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., founded in 2011 as Allergen Research Corporation (ARC), is a clinical-stage biopharmaceutical company developing treatments for peanut allergy and other food allergies. The company’s characterized oral desensitization immunotherapy (CODIT™) system, an approach to oral immunotherapy (OIT), uses rigorously characterized product candidates with gradual, controlled up-dosing protocols to obtain clinically meaningful desensitization to food allergens. Aimmune Therapeutics plans to initiate enrollment in a Phase 3 study of its lead product, AR101, a complex mixture of natural peanut proteins and pharmaceutical-grade ingredients for the treatment of peanut allergy, one of the most common food allergies, at the beginning of 2016. 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 commercialization plans; Aimmune’s development efforts, including the timing and size of the planned Phase 3 PALISADE trial; Aimmune’s expectations regarding the potential benefits of AR101; and Aimmune’s expectations regarding potential applications of the CODIT™ system. 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; the company’s ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s clinical trials will not be successful; the company’s reliance on third parties for the manufacture of the company’s product candidates; possible regulatory developments in the United States and foreign countries; and the company’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 the prospectus relating to the initial public offering dated August 5, 2015, and the Quarterly Report on Form 10-Q for the third quarter of 2015 filed on November 4, 2015. 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.
This press release concerns a product that is under clinical investigation and that has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.
Source: Aimmune Therapeutics
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