Healthcare Industry News: orphan drug designation
News Release - December 3, 2018
Neurelis Announces Acquisition Of Aegis Therapeutics, A Leading Drug Delivery Technology CompanyAegis' Intravail® drug delivery technology utilized in Neurelis' VALTOCO™ Nasal Spray, a novel investigational treatment for epilepsy patients
SAN DIEGO, Dec. 3, 2018 -- (Healthcare Sales & Marketing Network) -- Neurelis, Inc. today announced the acquisition of Aegis Therapeutics, a San Diego-based drug delivery technology company. Aegis Therapeutics' proprietary portfolio includes Intravail®, ProTek® and Hydrogel™, three non-invasive drug delivery and stabilization technologies applicable to a wide-range of molecules including therapeutic proteins, peptides, non-peptide macromolecules and small molecules.
VALTOCO™ (diazepam nasal spray), Neurelis' lead product candidate, is a proprietary formulation of diazepam incorporating the unique combination of a vitamin E-based solution with Aegis' Intravail® transmucosal absorption enhancement technology. Intravail® has been shown to increase absorption and reduce variability of drugs when incorporated in the formulation, with no known negative impact on safety or tolerability. Neurelis anticipates FDA approval and commercial launch of VALTOCO in 2019.
"We have been very impressed by the performance of Intravail® in VALTOCO as well as other licensed programs initiated by Aegis," said Neurelis President and CEO Craig Chambliss. "Intravail® is a unique technology platform that we intend to fully integrate into our robust product pipeline which is targeted to address significant unmet needs in neurology." In addition to VALTOCO, Chambliss said the company's pipeline includes NRL-2 (a drug candidate being developed as on-hand rescue treatment for intermittent use to control acute anxiety episodes or panic attacks) and NRL-3 (a drug candidate being developed as a non-invasive acute therapy to stop seizures that have progressed to status epilepticus).
Ed Maggio, CEO of Aegis Therapeutics added, "We are thankful to have been a part of the important work in progressing these programs with our strategic partners over the years. In the coming months, we have the potential of seeing the first two products incorporating the Intravail technology approved by the FDA. Given our longstanding relationship with Neurelis and their appreciation for the value of Intravail, we are excited for the next chapters of success with these novel technologies."
Chambliss added that the acquisition of Aegis provides Neurelis an even more robust pipeline, including licensing deals with Dr. Reddy's Laboratories, Opiant Pharmaceuticals and others. He added that the company is excited to seek additional strategic partnerships for this portfolio of technologies, offering exceptional potential value in enhancing drug development and clinical performance.
More About VALTOCO
VALTOCO nasal spray is a proprietary formulation of diazepam, delivered via a nasal spray formulation, developed for the management of pediatric, adolescent, and adult patients who require intermittent use of diazepam to control bouts of increased seizure activity, also known as cluster or acute repetitive seizures. In clinical trials, VALTOCO demonstrated high bioavailability, low variability from dose to dose, and was well-tolerated with the most common adverse events being nasal discomfort (seen in 5% of patients in clinical trials). The FDA previously granted Neurelis both orphan drug designation for VALTOCO in November of 2015 and Fast Track designation in December of 2016. The NDA for VALTOCO is supported by an extensive clinical and pre-clinical package including studies in healthy volunteers and patients with epilepsy. In the patient studies, more than 1,600 seizures have been treated to date with VALTOCO nasal spray.
Neurelis, Inc. is a privately-held San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system (CNS) market. Neurelis is leveraging its expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates, such as VALTOCO, to address significant unmet medical needs. For more information on the company, please visit www.neurelis.com
About Aegis Therapeutics
Aegis Therapeutics LLC is a San Diego-based drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through strategic partnerships. Intravail® drug delivery technology enables the non-invasive, enhanced delivery of a broad range of protein, peptide and non-peptide drugs (up to 30,000 daltons in size) that can currently only be administered by injection. Intravail can be utilized via the oral, buccal, dermal, and intranasal administration routes of drug administration. ProTek® technology includes excipients that stabilize, prevent aggregation, and reduce unwanted immunogenicity and anaphylaxis of protein and peptide therapeutics while avoiding the oxidative damage caused by polysorbate surfactants.
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