SEATTLE, Feb. 7, 2017 /PRNewswire/ -- Impel NeuroPharma ("Impel" or the "Company"), a Seattle-based clinical stage biotechnology company developing first-in-class intranasal drug treatments announced today that it has entered into service agreements with Camargo Pharmaceutical Services, LLC ("Camargo"). Camargo will be providing end-to-end regulatory consulting and strategic development services for Impel's pipeline of drug-device combination products built upon its Precision Olfactory DeliveryTM (PODTM) nasal delivery platform. The first programs will concentrate on treatments for migraines and Alzheimer's, including pre-Investigational New Drug (pre-IND) meeting planning and preparations through to New Drug Applications (NDA) submissions.
Camargo is the most experienced global strategist specializing in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act. Over the last decade, Camargo has established an unrivaled track record with 505(b)(2) IND and NDA preparations and submissions, including participation in more than 1100 FDA meetings and more than 200 FDA NDA and ANDA approvals.
"Camargo has a deep experience in 505(b)(2) strategy and combination product development which perfectly complements Impel's capabilities. Partnering with Camargo will allow Impel to take full advantage of our POD™ nasal drug delivery platform and efficiently develop multiple meaningful drug products," says John Hoekman, CEO and co-founder of Impel NeuroPharma.
"By bringing together Camargo's expertise with 505(b)(2) drug development and Impel Neuropharma's revolutionary POD™ technology, we are able to help enable effective new therapies for patients worldwide," says Ken Phelps, CEO of Camargo Pharmaceutical Services. "By utilizing the 505(b)(2) pathway and employing best strategies, Impel's products will move through approval and reach the market in the most cost- and time-effective manner."
About POD technology
Impel NeuroPharma's POD™ nasal drug delivery platform is designed to deliver drugs to the upper nasal cavity for improved biodistribution. By delivering therapeutics to the upper nasal cavity, the POD nasal delivery platform takes advantage of the vascular rich olfactory region for improved bioavailability and has the potential to target the brain via the olfactory and trigeminal nerves. Delivery of therapeutically meaningful levels of drugs may allow for development of more effective drugs and expand the range of treatment options available to patients.
About Impel NeuroPharma
Impel NeuroPharma, Inc. is a Seattle-based company developing intranasal drug treatments for central nervous system (CNS) disorders. Impel NeuroPharma has developed a novel drug delivery platform, the POD™ technology, that administers drug to the deep nasal cavity to improve the biodistribution of many drugs. Impel NeuroPharma's proprietary (POD) device technology enables entirely new categories of drugs, including biologics, to be administered using a cost-effective, disposable, non-invasive intranasal drug delivery device. To learn more about Impel NeuroPharma please visit our website: http://impelnp.com/
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com