| | SAN DIEGO, Oct. 18, 2021 /PRNewswire/ -- Neurelis, Inc., announced today that it has made the following additions to its leadership team: - Brittany Bradrick has been named Chief Financial Officer at Neurelis
- David Smith has been added to the company’s Board of Directors and named Chairman of the Neurelis Audit Committee
- George Stuart, who has served as Chief Financial Officer of Neurelis since its inception, has assumed the role of Chief Operating Officer at Aegis Therapeutics LLC, a wholly owned subsidiary of Neurelis
“Neurelis is passionately focused on improving patient lives by addressing unmet needs in CNS disorders,” said Craig C. Chambliss, President and Chief Executive Officer of Neurelis. “With our commercial success in making VALTOCO® (diazepam nasal spray) the new standard for seizure cluster (or episodes of frequent seizures) emergency care, clinical work to investigate VALTOCO in additional ages, and our recent acquisition of the Rho kinase [ROCK] inhibitor programs, we have further strengthened and advanced our business. In preparing for a dynamic future, we are excited to announce these changes and additions to our accomplished leadership.” Chambliss said the company’s capabilities have been further strengthened by the addition of Brittany K. Bradrick as the company’s new Chief Financial Officer. “Brittany joins us with 25 years of experience in finance, strategy and corporate development for life science companies, with both operational and advisory experience,” he said. “That experience is invaluable as we continue to scale our business operations moving forward. Her passion for a patient-focused strategy is a perfect fit for our culture and will ensure a meaningful impact with her broad responsibilities.” Prior to joining Neurelis, Bradrick was Chief Operating Officer & Chief Financial Officer at ViaCyte. She also previously served in strategy and corporate development positions for 10 years at Insulet and Abbott Diabetes Care, and was an investment banker to the life science industry for 10 years at Piper Jaffray, Credit Suisse and Chase Securities. In addition to adding Bradrick, Chambliss said Neurelis recently welcomed corporate finance veteran David V. Smith to the company’s Board of Directors. He was also named Chairman of the Neurelis Audit Committee. “David’s deep experience in financial management, corporate finance and corporate governance will be invaluable to Neurelis as we grow our business and pursue our passion to serve patients,” he said. “We are fortunate to have someone of David’s caliber join us and be aligned with our mission.” Most recently, Smith served as Executive Vice President and Chief Financial Officer at Five Prime Therapeutics, a publicly traded company focused on discovering and developing novel immuno-oncology protein therapeutics, acquired by Amgen this past April. Previously, Smith served as Chief Operating Officer of IntegenX and Chief Financial Officer of Thoratec, Chiron and Anergen, Inc. He has also held finance positions with Genentech, Inc., Syntex, and IBM. Smith is currently the Chair of the Audit and Strategy Committees of Codexis, Inc. Previously, he served as chair of the Audit Committee and a Director of OncoGenex Pharmaceuticals, Inc., and of Perlegen Sciences, Inc. Chambliss also announced the appointment of George Stuart, formerly Chief Financial Officer at Neurelis, to Chief Operating Officer at Aegis Therapeutics, a wholly owned subsidiary of Neurelis since 2018. “George has been an invaluable member of the Neurelis team since 2011,” Chambliss said. “His tireless work on the financial side of the business has been critical for our success to date and we look forward to his continued success in building out our capabilities with the Aegis technology offerings: INTRAVAIL®, PROTEK® and HYDROGEL™. With the success of VALTOCO and our partnered licensing initiatives, INTRAVAIL has demonstrated significant value as a revolutionary technology in the Aegis portfolio. George is ideally suited to advance these efforts.” Stuart has 20 years of experience in the specialty pharmaceutical and biotechnology industry. He has experience as a senior executive with both commercial and development stage pharmaceutical companies. Prior to his involvement with Neurelis, Stuart’s experience included management positions with Questcor Pharmaceuticals where he was Senior Vice President and Chief Financial Officer, Xcel Pharmaceuticals where he was Vice President and Chief Financial Officer and part of the founding team, and Ligand Pharmaceuticals where he was Director of Finance. About Neurelis
Neurelis, Inc., is a fully integrated neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need. In 2020, the FDA approved Neurelis’ VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual’s usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®. INTRAVAIL’s transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. In its approval of VALTOCO, the U.S. Food and Drug Administration also granted Neurelis Orphan Drug Exclusivity and recognized VALTOCO’s intranasal route of administration as a clinically superior contribution to patient care over the previously approved standard-of-care treatment (a rectal gel formulation of diazepam). For more information on VALTOCO, please visit www.valtoco.com. In addition to VALTOCO, Neurelis is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as a noninvasive acute therapy to stop seizures that have progressed to status epilepticus, and NRL-4 as a noninvasive rescue therapy to address the escalation of acute agitation symptoms associated with schizophrenia and bipolar 1 mania in adults. In addition, Neurelis is developing NRL-1049, an investigational, pre-clinical stage small molecule Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMs), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit www.neurelis.com. For the latest scientific information on VALTOCO, please visit www.neurelismedicalaffairs.com. Important Safety Information about VALTOCO: Indication
VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older. IMPORTANT SAFETY INFORMATION WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS - Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
- The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
- The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO.
Contraindications: VALTOCO is contraindicated in patients with: - Hypersensitivity to diazepam
- Acute narrow-angle glaucoma
Central Nervous System (CNS) Depression
Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma
Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative
VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including “gasping syndrome”, can occur in neonates and low-birth-weight infants treated with benzyl alcohol-preserved drugs, including VALTOCO. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions
The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance
To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch). Please read full Prescribing Information, including Boxed Warning, for additional important safety information. For More Information:
Mark Leonard
mark@reachthenextlevel.com
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