Impel NeuroPharma and Veeva Systems today announced a strategic partnership as Impel continues advancing its pipeline of innovative medicines for central nervous system (CNS) diseases with high unmet needs. Veeva and Impel will collaborate on important pre-launch preparations for Impel’s migraine treatment INP104 which, if approved by the U.S. Food and Drug Administration (FDA), will be marketed under the trade name TRUDHESA™. With Veeva Commercial Cloud, Impel will have a complete commercial suite of data, software, and consulting services to drive its strategy and accelerate field engagement.
“In January we were pleased that the FDA accepted for review Impel’s new drug application (NDA) for TRUDHESA™. Given this milestone, this is the perfect time for us to enter this strategic collaboration as Veeva is a proven technology leader and the ideal partner to help us meet our aggressive commercial timelines,” said Adrian Adams, chairman and chief executive officer, Impel NeuroPharma. “We look forward to Veeva’s support and expertise to help us ensure an efficient, digital-first, and compliant approach to commercialization subject, of course, to approval by the FDA later this year.”
FDA review of Impel’s NDA for TRUDHESA™ marks a major advance toward commercialization of this novel therapy. TRUDHESA™ is the first and only product to utilize Impel’s first-of-its-kind, proprietary Precision Olfactory Delivery® (POD) technology to deliver treatment directly to the vascular-rich upper nasal space. Traditional nasal delivery systems, such as pumps or sprays, deliver medicine to the lower nasal cavity which can result in variability in efficacy because of unpredictable delivery and variable absorption into the bloodstream.
Studies have shown that Impel’s POD® technology allows for more predictable response due to the more consistent delivery and rapid absorption into the bloodstream, while being easy to use for patients. This new delivery technology may be particularly important for the majority of patients with migraine who experience nausea and vomiting during an attack.
To accelerate its market preparation, Impel will adopt Veeva’s suite of commercial applications, including multichannel Veeva CRM as the foundation for in-person and digital engagement with physicians and Veeva Data Cloud for longitudinal patient data to effectively segment right patients groups. Veeva business consulting will also help design and implement customer-centric strategies that will enable Impel sales professionals to increase the value of their targeted interactions with healthcare professionals.
“Impel is pioneering a new approach to treating CNS and other diseases with high unmet needs and Veeva is proud to assist with the commercialization of their innovative products,” said Peter Gassner, founder and CEO of Veeva. “We are committed to delivering the most advanced technology, data, and consulting that accelerates the industry’s move to digital and speeds the delivery of novel medicines to patients.”
Impel NeuroPharma is developing TRUDHESA™ with the goal to be a transformative new therapy for the acute treatment of migraine headaches. TRUDHESA™ aims to optimize dihydroergotamine mesylate (DHE) for fast and lasting whole migraine relief, regardless of when in the migraine attack it is administered, without an injection. Importantly, TRUDHESA™ is designed to deliver a lower dose of DHE compared to other nasally administered, FDA-approved and investigational products. This may enable patients to benefit from the established efficacy of DHE, without the undesired side effects that may be experienced with delivery to the lower nasal space.
TRUDHESA™ utilizes Impel’s propellant-enabled POD technology to conveniently and consistently deliver optimal doses of DHE deep into the vascular rich upper nasal space, an ideal target for efficient drug administration. This may be particularly important for the majority of patients with migraine who experience nausea and/or vomiting during an attack, which presents limitations for the use of oral therapies, including triptans, CGRP inhibitors and ditans as well as other non-specific medications used for the acute treatment of migraine.
About Impel NeuroPharma
Impel NeuroPharma, Inc. (impelnp.com) is a privately held, Seattle-based biopharmaceutical company focused on developing transformative therapies for people living with CNS and other disorders with high unmet medical needs. The Company is rapidly advancing a late-stage product pipeline that optimizes the effectiveness of proven treatments for neurological conditions, including TRUDHESA™ for the acute treatment of migraine, INP107 for OFF episodes in Parkinson’s disease, and INP105 for acute agitation associated with schizophrenia, bipolar I disorder and autism.
About Precision Olfactory Delivery or POD® Technology
Impel’s proprietary Precision Olfactory Delivery (POD®) system is able to deliver a range of therapeutic molecules and formulations into the vascular rich upper nasal space, believed to be a gateway for unlocking the previously unrealized full potential of these molecules. By delivering predictable doses of drug directly to the upper nasal space, Impel’s precision performance technology is designed to enable increased and consistent absorption of drug, with the potential to outperform the high variability associated with other nasal delivery systems. While an ideal target for drug administration, to date no other system has been developed to deliver drugs to the upper nasal space. By utilizing this route of administration, Impel NeuroPharma has been able to demonstrate blood concentration levels for its investigational therapies that are comparable to intramuscular (IM) administration and can even reach intravenous (IV)-like systemic levels quickly, which could transform the treatment landscape for many disorders.
Importantly, the POD technology offers propellant-enabled delivery of dry powder and liquid formulations that eliminates the need for coordination of breathing, allowing for self- or caregiver-administration in a manner that may improve patient outcome, comfort, and potentially, compliance.
IMPEL, POD and the IMPEL Logo are registered trademarks of Impel NeuroPharma, Inc.
About Veeva Systems
Veeva Systems, Inc. (veeva.com) is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 950 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America.
This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions (including the on-going impact of COVID-19), particularly within the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions,“Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in the company’s filing on Form 10-Q for the period ended October 31, 2020. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.
Contact: Melyssa Weible - Elixir Health Public Relations (for Impel NeuroPharma)
P: +1 201-723-5805 - E: mweible[.]elixirhealthpr.com.