Impel Pharmaceuticals (NASDAQ:
IMPL), a commercial-stage pharmaceutical
company developing transformative therapies for people suffering
from diseases with high unmet medical needs, today announced that
it will implement an operational streamlining plan that will
include a reduction of employee and non-employee expenses, largely
impacting the research and development functions of the
organization. The Company plans to reprioritize spend to capitalize
on the continued positive momentum in payor and prescriber uptake
of Trudhesa® (dihydroergotamine mesylate) nasal spray (0.725 mg per
spray).
“Today’s announcement is part of a measured
effort aimed at best positioning Impel to achieve its business
objectives by streamlining clinical development expenses in order
to focus resources on maximizing the growing commercial potential
of Trudhesa,” said Adrian Adams, Chairman of the Board and Chief
Executive Officer of Impel Pharmaceuticals. “I must emphasize that
this decision was not taken lightly, nor was it due to a lack of
hard work or dedication from the employees affected by this
reprioritization. We are grateful for their service and recognize
their contributions to Impel’s progress to date.”
The plan will halt research and development
efforts on INP105 (olanzapine) to address acute agitation and
aggression in autism spectrum disorder. The resulting reduction in
operating expenses is expected to be primarily driven by lower
non-employee-related general and administrative and research and
development expenses, and the 16 percent reduction in
headcount.
Aligned with this, the Company also announced
that Stephen Shrewsbury, M.D., current Chief Medical Officer, will
depart from the Company effective March 31, 2023.
“I would like to thank Dr. Shrewsbury for his
contributions to Impel and, more broadly, for helping increase our
understanding of the upper nasal space and positively changing
expectations about the therapeutic potential of nasally
administered medicines,” said Adams. “Dr. Shrewsbury, along with
the team under his leadership, played a pivotal role in developing
the Company’s proprietary Precision Olfactory Delivery (POD®)
technology and conducting the clinical development that led to the
successful first-cycle approval of Trudhesa by the FDA.”
Following these and other strategic measures,
the Company projects it will have sufficient capital to fund
operations into Q3 2023 and allow the Company to prioritize its
efforts to fully maximize the positive momentum and significant
commercial opportunity of Trudhesa in the large and rapidly growing
acute migraine market. Trudhesa has continued its strong launch
trajectory and finished 2022 with 58,424 prescriptions. Based upon
third-party data, it is estimated that at the end of 2022, after
its first full year of launch, Trudhesa already accounted for 4.3
percent of branded acute migraine prescriptions (nTRx) among
prescribers. In July 2022, Impel expanded its sales force by
50 percent, from 60 to 90 sales professionals, to capitalize on
prescription momentum and the large business opportunity. New
Trudhesa quarterly prescriptions increased by 58 percent from Q2 to
Q4 2022 driven by this expanded, more efficient sales force. In
addition, reimbursement of all shipments finished the year at over
60 percent and refill rates remained high with an average of 63
percent at the end of 2022.
Along with increased focus on the
commercialization of Trudhesa, Impel will continue with its
evaluation of strategic and financing initiatives and opportunities
to fully leverage the therapeutic potential of its proprietary POD
technology and expertise with both small and large molecules in
multiple disease areas.
About Impel
PharmaceuticalsImpel Pharmaceuticals is a commercial-stage
pharmaceutical company developing transformative therapies for
people suffering from diseases with high unmet medical needs. Impel
offers treatments that pair its proprietary POD® technology with
well-established therapeutics. In September 2021, Impel received
U.S. FDA approval for its first product, Trudhesa® nasal spray,
which is approved in the U.S. for the acute treatment of migraine
with or without aura in adults. In addition to Trudhesa, the
Company continues to address patient needs via licensing and
partnerships.
About Impel’s Precision Olfactory
Delivery (POD®) TechnologyImpel’s proprietary POD®
technology is able to deliver a range of therapeutic molecules and
formulations into the vascular-rich upper nasal space, believed to
be a gateway for unlocking the previously unrealized full potential
of these molecules. By delivering predictable doses of drug
directly to the upper nasal space, Impel’s precision performance
technology has the goal of enabling increased and consistent
absorption of drug, overriding the high variability associated with
other nasal delivery systems, yet without the need for an
injection. While an ideal target for drug administration, to date
no technology has been able to consistently deliver drugs to the
upper nasal space. By utilizing this route of administration, Impel
Pharmaceuticals has been able to demonstrate blood concentration
levels for its investigational therapies that are comparable to
intramuscular (IM) administration and can even reach intravenous
(IV)-like systemic levels quickly, which could transform the
treatment landscape for a broad range of disorders. Importantly,
the POD® technology offers propellant-enabled delivery of dry
powder and liquid formulations that eliminates the need for
coordination of breathing, allowing for self- or
caregiver-administration in a manner that may improve patient
outcome, comfort, and potentially, compliance.
About Trudhesa®
IndicationTrudhesa® is used to treat an active
migraine headache with or without aura in adults. Do not use
Trudhesa to prevent migraine when you have no symptoms. It is not
known if Trudhesa is safe and effective in children.
Important Safety
Information
Serious or potentially life-threatening reductions in blood flow to
the brain or extremities due to interactions between
dihydroergotamine (the active ingredient in Trudhesa) and strong
CYP3A4 inhibitors (such as protease inhibitors and macrolide
antibiotics) have been reported rarely. As a result, these
medications should not be taken together. |
Do not use Trudhesa if you:
- Have any disease affecting your
heart, arteries, or blood circulation.
- Are taking certain anti-HIV
medications known as protease inhibitors (such as ritonavir or
nelfinavir).
- Are taking a macrolide antibiotic
such as clarithromycin or erythromycin.
- Are taking certain antifungals such
as ketoconazole or itraconazole.
- Have taken certain medications such
as triptans or ergot-type medications for the treatment or
prevention of migraine within the last 24 hours.
- Have taken any medications that
constrict your blood vessels or raise your blood pressure.
- Have severe liver or kidney
disease.
- Are allergic to ergotamine or
dihydroergotamine.
Before taking Trudhesa, tell your doctor
if:
- You have high blood pressure, chest
pain, shortness of breath, heart disease; or risk factors for heart
disease (such as high blood pressure, high cholesterol, obesity,
diabetes, smoking, strong family history of heart disease or you
are postmenopausal, or male over 40); or problems with blood
circulation in your arms, legs, fingers, or toes.
- You have or had any disease of the
liver or kidney.
- You are taking any prescription or
over-the-counter medications, including vitamins or herbal
supplements.
- You are pregnant, planning to
become pregnant or are nursing, or have ever stopped medication due
to an allergy or bad reaction.
- This headache is different from
your usual migraine attacks.
The use of Trudhesa should not exceed dosing
guidelines and should not be used on a daily basis. Serious cardiac
(heart) events, including some that have been fatal, have occurred
following the use of dihydroergotamine mesylate, particularly with
dihydroergotamine for injection, but are extremely rare.
You may experience some nasal congestion or
irritation, altered sense of taste, sore throat, nausea, vomiting,
dizziness, and fatigue after using Trudhesa. Contact your doctor
immediately if you experience:
- Numbness or tingling in your
fingers and toes
- Severe tightness, pain, pressure,
heaviness, or discomfort in your chest
- Muscle pain or cramps in your arms
or legs
- Cold feeling or color changes in
one or both legs or feet
- Sudden weakness
- Slurred speech
- Swelling or itching
The risk information provided here is not
comprehensive. To learn more, talk about Trudhesa with your
healthcare provider or pharmacist. The FDA-approved product
labeling can be found at www.Trudhesa.com or 1-800-555-DRUG. You
can also call 1-833-TRUDHESA (1-833-878-3437) for additional
information.
Cautionary Note on Forward-Looking
StatementsThis press release contains “forward-looking”
statements within the meaning of the safe harbor provisions of the
U.S. Private Securities Litigation Reform Act of 1995, including,
but not limited to, the potential clinical benefits of Trudhesa®,
the market opportunities of Trudhesa within the migraine market,
the speed of uptake and market growth of Trudhesa, the
effectiveness of the Trudhesa sales force, and Impel’s cash runway.
Forward-looking statements can be identified by words such as:
“believe,” “may,” “will,” “potentially,” “estimate,” “continue,”
“anticipate,” “intend,” “could,” “would,” “project,” “plan,”
“expect” or the negative or plural of these words or similar
expressions. These statements are subject to numerous risks and
uncertainties that could cause actual results and events to differ
materially from those anticipated, including but not limited to,
Impel’s ability to maintain regulatory approval of Trudhesa, its
ability to execute its commercialization strategy for Trudhesa, its
ability to develop, manufacture and commercialize any other product
candidates including plans to address additional indications for
which Impel may pursue regulatory approval, whether results of
preclinical studies or clinical trials will be indicative of the
results of future trials, and the effects of COVID-19 on its
clinical programs and business operations. Many of these risks are
described in greater detail in Impel’s filings with the Securities
and Exchange Commission. Any forward-looking statements in this
press release speak only as of the date of this press release.
Impel assumes no obligation to update forward-looking statements
whether as a result of new information, future events or otherwise,
after the date of this press release.
Impel, POD and the Impel logo are trademarks of
Impel Pharmaceuticals Inc. To learn more about Impel
Pharmaceuticals, please visit our website at
https://impelpharma.com.
Contact: |
|
Investor Relations: |
Media Relations: |
Christina Tartaglia |
Melyssa Weible |
Stern Investor Relations |
Elixir Health Public Relations |
Phone: (1) 212-362-1200 |
Phone: (1) 201-723-5805 |
Email:christina.tartaglia@sternir.com |
Email:mweible@elixirhealthpr.com |
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