INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the
development, manufacture and commercialization of pharmaceutical
cannabinoids and spray technology, today provided an update on its
product pipeline, which includes cannabidiol (CBD) oral solution as
well as epinephrine and naloxone nasal sprays.
“Our strategic shift in focus away from opioids
and to pharmaceutical-grade cannabinoids and novel drug delivery
systems continues to gain momentum and has been driven by our
strong commitment to advancing our diverse product pipeline,” said
Saeed Motahari, president and chief executive officer of INSYS
Therapeutics. “Through this intense focus on our reprioritized
pipeline over the last year, which has been anchored by a
patient-centric mission and commitment, we are radically
transforming this company. As we look forward, we have the
potential to submit six new drug applications over the next three
years, two of which are scheduled for 2019.”
STRATEGIC ALTERNATIVE REVIEW
UPDATE
INSYS previously announced plans to begin a
strategic alternative review of its opioid-related assets and the
process remains on schedule. Nine companies have signed
confidential disclosure agreements and have begun a review of
confidential information materials. The company will provide an
update on the process during the fourth quarter 2018 earnings call
in early 2019.
PIPELINE UPDATES
INSYS anticipates that it will have a number of
critical interim steps and proof points across its diverse product
portfolio over the next several months. This includes two
potentially life-saving investigational products using its spray
technology that are in advanced stages of clinical development: a)
naloxone nasal spray for opioid overdose, and b) epinephrine nasal
spray for anaphylaxis. It also includes clinical development
efforts focused on cannabinoids: a) CBD oral solution as an
investigational treatment for childhood absence epilepsy (Phase 2),
b) infantile spasms (Phase 3), c) Prader-Willi Syndrome (Phase 2);
and, d) dronabinol inhalation as a potential treatment for a
variety of conditions, including anorexia in cancer. The following
information updates important upcoming milestones for each of these
innovative molecules and novel drug delivery systems.
Naloxone
Results of a pharmacokinetic (PK) study reported
in early November showed a distinctive profile for the company’s
naloxone nasal spray product candidate in comparison to the current
standards, including intramuscular (IM) injection. INSYS believes
that the characteristics of its drug hold particular relevance in
the context of rising rates of overdose from highly potent
synthetic opioids, as standard doses of currently approved naloxone
products may not be sufficient due to the drug’s relatively short
half-life.
INSYS is currently completing a required
nonclinical juvenile toxicity study related to naloxone, which has
been fully enrolled, and expects the results of that program in
early March of 2019. Pending positive results from that study, the
current target timeframe for NDA submission remains around the end
of the first quarter of 2019.
Epinephrine
As a needle-free delivery method, INSYS’
epinephrine nasal spray represents a potential alternative to
intramuscular injection. As reported in June 2018, the
proof-of-concept study for the company’s epinephrine nasal spray
product candidate showed that the drug as formulated was readily
absorbed through the nasal mucosa. Subsequently, the FDA granted
Fast Track designation for this investigational product in August
of 2018 and provided specific guidance for clinical development and
filing requirements at the end-of-Phase 2 meeting in August.
Given clinical and regulatory progress to date,
INSYS believes the epinephrine NDA remains on track for filing
during the fourth quarter of 2019, pending successful completion of
a confirmatory PK study and no additional clinical studies
requested by the FDA. The confirmatory PK study will follow
completion of the now fully enrolled 48-patient dose-finding study
that is expected to report results in March. Considering the Fast
Track designation, INSYS plans to meet again with the FDA early in
the second quarter to confirm the design of the subsequent clinical
development program.
Also of note, data from the product candidate’s
clinical development program will be presented at the American
Academy of Allergy, Asthma and Immunology 2019 annual meeting in
late February 2019. The abstract, titled “A Phase 1, Single-Dose,
Open-Label, 5-Treatment, Crossover, Pharmacokinetic Study of
Comparative Bioavailability of Epinephrine Nasal Spray and EpiPen®
in Healthy Adults with Seasonal Allergies,” has been accepted as a
poster presentation.
Cannabidiol
All three trials with CBD oral solution are
enrolling patients, including a Phase 2 study of childhood absence
epilepsy, a Phase 3 study of infantile spasms, and a Phase 2 study
of Prader-Willi syndrome.
- The company expects to show initial results from the Phase 2
trial in childhood absence epilepsy late in the first quarter 2019
as the company continues to enroll patients.
- Results of the long-term safety study of CBD in refractory
pediatric epilepsy were reported on Dec. 3 at the American Epilepsy
Society 2018 annual meeting and showed that the company’s
proprietary formulation of the drug was generally well-tolerated,
even at high doses, through 48 weeks of follow up.
- The company is continuing to enroll patients in a Phase 2 study
of Prader-Willi Syndrome across seven clinical sites with a plan to
add additional sites in 2019. The company expects full results of
this study in the second half of 2019.
- Enrollment in the company’s Phase 3 study of infantile spasms
has occurred at a slower pace than anticipated, and the company
will provide an update once it has better visibility into
enrollment.
Additionally, the company is committed to
supporting three studies planned by the University of California
San Diego School of Medicine’s Center for Medicinal Cannabis
Research (CMCR) for initiation in 2019. The investigational new
drug (IND) for CMCR’s autism study has been opened, and the INDs
for the studies of early psychosis and anxiety in anorexia nervosa
are expected to be opened in the first half of 2019—in the first
and second quarters, respectively. Meanwhile, the company’s support
for a study of CBD in cocaine dependence continues at the
University of Montreal.
Lastly, alternative oral-dose formulations of
CBD are in early development. With results from nonclinical studies
expected in the first quarter, the next phase of development,
including clinical trials targeting additional chronic indications,
is scheduled to commence in the latter part of 2019.
Dronabinol
Regarding dronabinol inhalation, which
successfully completed the initial human proof-of-concept study in
September 2018, an advisory board meeting with clinical experts is
planned for the first quarter of 2019. The meeting’s primary
purpose is to discuss the development path going forward for this
investigational product concept.
About INSYS
INSYS Therapeutics is a specialty pharmaceutical
company that develops and commercializes innovative drugs and novel
drug delivery systems of therapeutic molecules that improve
patients’ quality of life. Using proprietary spray technology and
capabilities to develop pharmaceutical cannabinoids, INSYS is
developing a pipeline of products intended to address unmet medical
needs and the clinical shortcomings of existing commercial
products. INSYS is committed to developing medications for
potentially treating anaphylaxis, epilepsy, Prader-Willi syndrome,
opioid addiction and overdose, and other disease areas with a
significant unmet need.
Forward-Looking
Statements
This news release contains forward-looking
statements based on management’s expectations and assumptions as of
the date of this news release; actual results may differ materially
from those in these forward-looking statements as a result of
various factors, many of which are beyond our control. These
factors include, but are not limited to, risk factors described in
our filings with the United States Securities and Exchange
Commission, including those factors discussed under the caption
“Risk Factors” in our Annual Report on Form 10-K for the year ended
Dec. 31, 2017 and subsequent updates that may occur in our
Quarterly Reports on Form 10-Q. Forward-looking statements speak
only as of the date of this news release, and we undertake no
obligation to publicly update or revise these statements, except as
may be required by law.
CONTACT: |
Investor
Relations & Corporate Communications |
|
Jackie Marcus or Chris
Hodges |
|
Alpha IR Group |
|
312-445-2870 |
|
INSY@alpha-ir.com |
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