SAN DIEGO, CA – March 10, 2021 – Neurelis, Inc.,
announced today that it has closed a $114 million round of Series D
preferred stock financing to support the commercialization of the
company’s lead orphan drug product, VALTOCO? (diazepam nasal spray), and to continue the development and expansion of the company’s neuroscience pipeline.
“We are excited about the immediate and long-term future at
Neurelis,” said Craig C. Chambliss, President and Chief Executive
Officer of Neurelis. “We have been able to assemble an impressive
leadership team with extensive experience in neurology that has enabled
VALTOCO’s clinical development, regulatory success, and commercial
launch in 2020. VALTOCO has become a trusted brand to people with
epilepsy. This new financing helps us build on a successful foundation
as we advance Neurelis as a best-in-class neuroscience company focused
on epilepsy. We are grateful to our exceptional investors and look
forward to bringing more innovative, life-changing products to the
patients who need them.”
Chambliss noted that the planned financing was oversubscribed and
that Neurelis is fortunate to see the major additions of Cormorant Asset
Management and Decheng Capital join existing investors LYZZ Capital and
HBM Healthcare Investments. Other investors were organized by Philos
& Partners SA, a Swiss-based asset manager.
In conjunction with this financing, Chambliss announced that
Alexander Kwit has been appointed to the company’s Board of Directors.
Kwit is a private investor who previously held the position of Executive
Vice President of Royalty Pharma, a publicly traded company that buys
royalty interests in biopharmaceutical products. Kwit was the Executive
Vice President and a Partner from August 2001 to January 2015 and a
Senior Advisor from January 2015 to his retirement in January 2016. He
was involved in negotiating the fund’s royalty transactions, structuring
Royalty Pharma’s novel financing programs, and leading its equity
“We are very pleased to have someone with Alex’s background and
experience join the Neurelis Board of Directors,” Chambliss said. “His
involvement will be extremely valuable as we navigate our path forward
and build on our success to date.”
VALTOCO is a proprietary formulation of diazepam incorporating the science of Intravail?.
Intravail 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). In a
long-term, open-label, repeat-dose clinical trial, the safety of VALTOCO
was evaluated and more than 4,000 seizures were treated. The clinical
trial included adult and pediatric patients aged 6 and older. VALTOCO
was generally safe and well tolerated during clinical studies. The most
common adverse reactions for diazepam (at least 4%) were somnolence,
headache, and nasal discomfort. For more information on VALTOCO, please
Neurelis, Inc., is an innovation-driven neuroscience company providing a highly differentiated approach to
target unmet medical needs. Neurelis is focused on the development and
commercialization of product candidates for epilepsy and the broader
central nervous system (CNS) market. On January 10, 2020, the FDA
approved Neurelis’ VALTOCO? (diazepam nasal spray) as an
acute treatment of intermittent, stereotypic episodes of frequent
seizure activity (ie, 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. In addition to VALTOCO, the
company 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. The Neurelis technology platform includes Intravail?, ProTek? and Hydrogel?, three proprietary, noninvasive drug-delivery and
stabilization technologies applicable to a wide range of molecules,
including therapeutic proteins, peptides, non-peptide macromolecules, and small molecules. For more information on Neurelis, please visit www.neurelis.com.
Important Safety Information about VALTOCO:
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.
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.
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.