Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, has entered
into an agreement with Pfizer Inc. (NYSE: PFE) for an exclusive
U.S. license to Pfizer’s clinical and nonclinical data, and
intellectual property for reboxetine, the active pharmaceutical
ingredient in AXS-12 which Axsome is developing for the treatment
of narcolepsy. The agreement also provides Axsome exclusive rights
to develop and commercialize esreboxetine, a new late-stage product
candidate now referred to as AXS-14, in the U.S. for the treatment
of fibromyalgia.
Under the terms of the agreement, Axsome will
receive from Pfizer an exclusive U.S. license to Pfizer data for
reboxetine and esreboxetine encompassing a full range of
nonclinical studies, and short-term and long-term clinical trials
involving more than five thousand patients. The licensed data
includes results of a positive Phase 3 and a positive Phase 2 trial
of esreboxetine in the treatment of fibromyalgia. Axsome will have
the exclusive right and sole responsibility of developing AXS-14
(esreboxetine) in the U.S. for the treatment of fibromyalgia and
for other indications.
Pfizer will receive shares of Axsome common
stock having a value of $8 million, based on the average closing
price of Axsome’s common stock for the 10 prior trading days, in
consideration for the license and rights. Pfizer will also receive
an upfront cash payment of $3 million, up to $323 million in
regulatory and sales milestones, and tiered mid-single to low
double-digit royalties on future sales. Pfizer will also have a
right of first negotiation on any potential future strategic
transactions involving AXS-12 and AXS-14.
Axsome recently completed and announced positive
results for a Phase 2 trial of AXS-12 in the treatment of
narcolepsy and is preparing to advance AXS-12 into Phase 3 trials
for the treatment of narcolepsy in 2020, as previously
disclosed.
“We are very pleased to announce this agreement
with Pfizer to help advance the development of AXS-12 for the
treatment of narcolepsy and of AXS-14 for the treatment of
fibromyalgia, two serious CNS disorders which currently have
limited treatment options,” said Herriot Tabuteau, MD, Chief
Executive Officer of Axsome. “The valuable clinical and nonclinical
data under this exclusive license will enable us to potentially
significantly accelerate our AXS-12 clinical program while reducing
development risk and costs. Furthermore, through this agreement, we
are able to expand our CNS pipeline with AXS-14, which has
demonstrated efficacy in completed Phase 3 and Phase 2 trials in
fibromyalgia. With the recently announced Phase 2 success of AXS-12
resulting in its planned advancement to Phase 3 this year, and with
the addition of AXS-14, our pipeline will now contain four
differentiated Phase 3-stage product candidates with the potential
to positively affect many of the millions of people living with
distressing CNS disorders.”
Summary of the Agreement
Reboxetine (AXS-12)
- Axsome will receive from Pfizer an
exclusive U.S. license to data from a full range of nonclinical
studies with reboxetine, to data from numerous short-term and
long-term clinical trials of patients treated with reboxetine, and
to other reboxetine intellectual property. Reboxetine is not
approved in the U.S. for any indication and is marketed by Pfizer
outside of the U.S. for the treatment of depression.
- Reboxetine is the active
pharmaceutical ingredient in AXS-12 which is being developed for
the treatment of narcolepsy. Axsome recently completed and
announced positive results for a Phase 2 trial of AXS-12 in the
treatment of narcolepsy, demonstrating statistically significant
improvements in cataplexy, excessive daytime sleepiness, as well as
cognitive function compared to placebo. Axsome is preparing to
initiate Phase 3 trials of AXS-12 in the treatment of narcolepsy in
2020, as previously disclosed.
- The licensed nonclinical and
clinical data are expected to reduce or eliminate the need for
Axsome to conduct certain studies thereby mitigating risk and
associated costs, and potentially significantly accelerating the
clinical development and commercialization timelines of
AXS-12.
- Axsome has Orphan Drug Designation
for AXS-12 in the treatment of narcolepsy, and 2 pending U.S.
patents covering AXS-12.
Esreboxetine (AXS-14)
- Axsome will receive from Pfizer an
exclusive license to develop and commercialize esreboxetine, now
referred to as AXS-14, in the U.S. for fibromyalgia and all other
indications. The license encompasses nonclinical and clinical data
for esreboxetine including results from a positive Phase 3 and a
positive Phase 2 trial of esreboxetine in the treatment of
fibromyalgia conducted by Pfizer.
- Esreboxetine, the SS-enantiomer of
racemic reboxetine, is the more selective and potent enantiomer,
which has been evaluated for the treatment of fibromyalgia.
Fibromyalgia is a chronic disorder characterized by widespread
pain, fatigue, disturbed sleep, depression, and cognitive
impairment. The condition affects approximately 5 million Americans
of whom approximately 90% are women. It is considered to be
mediated mainly in the CNS. Treatment options for fibromyalgia are
limited with only three pharmacologic treatments currently approved
by the FDA.
- In a Phase 3 trial conducted by
Pfizer in 1,122 patients with fibromyalgia treated with
esreboxetine or placebo for 14 weeks, the study met the two primary
endpoints demonstrating statistically significant improvements
compared to placebo in the weekly mean pain score (p<0.001,
p<0.001, and p=0.025, for 4 mg, 8 mg and 10 mg daily doses,
respectively), and the Fibromyalgia Impact Questionnaire (FIQ)
total score (p<0.001, p<0.001, and p=0.023, for 4 mg, 8 mg
and 10 mg doses, respectively). Esreboxetine also resulted in
statistically significant improvements as compared to placebo on
the Patient’s Global Impression of Change (PGI-C) scale (p=0.002,
p=0.001, and p=0.007, for 4 mg, 8 mg and 10 mg doses,
respectively), and in fatigue as measured using the Global Fatigue
Index (p=0.001 and p=0.001, for 4 mg and 8 mg daily doses,
respectively).1
- In a Phase 2 trial conducted by
Pfizer in 267 patients with fibromyalgia treated with esreboxetine
(dose escalated to 8 mg/day) or placebo for 8 weeks, the study met
its primary endpoint demonstrating statistically significant
improvements compared to placebo in the weekly mean pain score
(p=0.006). The study also demonstrated statistically
significant improvements in additional efficacy outcomes including
the FIQ total score (p<0.001), the PGIC scale (p<0.001), and
fatigue as measured using the Multidimensional Assessment of
Fatigue scale (p<0.001).2
- AXS-14 expands Axsome’s late-stage
pipeline of product candidates for difficult-to-treat CNS
disorders.
- Axsome has 3 pending U.S. patents
covering AXS-14.
Financial Terms
- Pfizer will receive shares of
Axsome common stock having a value of $8 million, based on the
average closing price of Axsome’s common stock for the 10 prior
trading days. Pfizer will also receive an upfront cash payment of
$3 million.
- Pfizer will receive up to $323
million in regulatory and sales milestones, and tiered mid-single
to low double-digit royalties on future sales.
- Pfizer will have a right of first
negotiation on any potential future strategic transactions
involving AXS-12 or AXS-14.
Conference Call Information
Axsome will host a conference call and webcast
with slides today at 8:30 AM Eastern to discuss the agreement with
Pfizer. To participate in the live conference call, please dial
(844) 698-4029 (toll-free domestic) or (647) 253-8660
(international), and use the passcode 4656867. The live webcast can
be accessed on the “Webcasts & Presentations” page of the
“Investors” section of the Company’s website at axsome.com. A
replay of the webcast will be available for approximately 30 days
following the live event.
About Narcolepsy
Narcolepsy can be a serious and debilitating
neurological condition that causes dysregulation of the sleep-wake
cycle and is characterized clinically by excessive daytime
sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis,
and disrupted nocturnal sleep. Narcolepsy afflicts an estimated
185,000 individuals in the U.S. Cataplexy is seen in an estimated
70% of narcolepsy patients and is a sudden reduction or loss of
muscle tone while a patient is awake, typically triggered by strong
emotions such as laughter, fear, anger, stress, or excitement.
Narcolepsy interferes with cognitive, psychological, and social
functioning, increases the risk of work- and driving-related
accidents, and is associated with a 1.5 fold higher mortality rate.
Depression is reported in up to 57% of patients.
About Fibromyalgia
Fibromyalgia is a chronic disorder often
characterized by widespread pain, fatigue, disturbed sleep,
depression, and cognitive impairment. Other symptoms of this
disorder can include tingling in the hands and feet and headaches.
Fibromyalgia is considered to be mediated mainly in the central
nervous system. Approximately 5 million Americans, 90% of whom are
women, are estimated to suffer from fibromyalgia. Treatment options
for fibromyalgia are limited with only three pharmacologic
treatments currently approved by the FDA.
About AXS-12
AXS-12 (reboxetine) is a highly selective and
potent norepinephrine reuptake inhibitor for the treatment of
narcolepsy. AXS-12 modulates noradrenergic activity to promote
wakefulness, maintain muscle tone and enhance cognition. AXS-12 has
been granted Orphan Drug Designation by the U.S. FDA for the
treatment of narcolepsy. AXS-12 is an investigational drug product
not approved by the FDA.
About AXS-14
AXS-14 (esreboxetine) is a highly selective and
potent norepinephrine reuptake inhibitor for the treatment of
fibromyalgia and other conditions. Esreboxetine, the SS-enantiomer
of reboxetine, is more potent and selective than racemic
reboxetine. AXS-14 is an investigational drug product not approved
by the FDA.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders for which
there are limited treatment options. Axsome’s core CNS product
candidate portfolio includes five clinical-stage candidates,
AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is currently in
a Phase 3 trial in treatment resistant depression (TRD), a Phase
2/3 trial in agitation associated with Alzheimer’s disease (AD),
and is being developed for major depressive disorder (MDD). AXS-05
is also being developed for smoking cessation treatment. AXS-07 is
currently in a Phase 3 trial for the acute treatment of migraine.
AXS-12 is being developed for the treatment of narcolepsy. AXS-14
is being developed for the treatment of fibromyalgia. AXS-05,
AXS-07, AXS-09, AXS-12, and AXS-14 are investigational drug
products not approved by the FDA. For more information, please
visit the Company’s website at axsome.com. The Company may
occasionally disseminate material, nonpublic information on the
company website.
Forward Looking Statements
Certain matters discussed in this press release
are “forward-looking statements”. We may, in some cases, use terms
such as “predicts,” “believes,” “potential,” “continue,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“could,” “might,” “will,” “should” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. In particular, the Company’s statements
regarding trends and potential future results are examples of such
forward-looking statements. The forward-looking statements include
risks and uncertainties, including, but not limited to, the
success, timing and cost of our ongoing clinical trials and
anticipated clinical trials for our current product candidates,
including statements regarding the timing of initiation, pace of
enrollment and completion of the trials (including our ability to
fully fund our disclosed clinical trials, which assumes no material
changes to our currently projected expenses), futility analyses and
receipt of interim results, which are not necessarily indicative of
the final results of our ongoing clinical trials, and the number or
type of studies or nature of results necessary to support the
filing of a new drug application (“NDA”) for any of our current
product candidates; our ability to fund additional clinical trials
to continue the advancement of our product candidates; the timing
of and our ability to obtain and maintain U.S. Food and Drug
Administration (“FDA”) or other regulatory authority approval of,
or other action with respect to, our product candidates (including,
but not limited to, FDA’s agreement with the Company’s plan to
discontinue the bupropion treatment arm of the ADVANCE-1 study in
accordance with the independent data monitoring committee’s
recommendations); the potential for the MOMENTUM clinical trial to
provide a basis for approval of AXS-07 for the acute treatment of
migraine in adults with or without aura, pursuant to our special
protocol assessment; the potential for the ASCEND clinical trial,
combined with the GEMINI clinical trial results, to provide a basis
for approval of AXS-05 for the treatment of major depressive
disorder and accelerate its development timeline and commercial
path to patients; the Company’s ability to successfully defend its
intellectual property or obtain the necessary licenses at a cost
acceptable to the Company, if at all; the successful implementation
of the Company’s research and development programs and
collaborations; the success of the Company’s license agreements,
including the potential for the clinical and nonclinical data
available under the Company’s exclusive license agreement with
Pfizer to significantly accelerate development of AXS-12 for the
treatment of narcolepsy while reducing development risk and costs,
and the potential future development or commercialization of AXS-14
for the treatment of fibromyalgia and other indications; the
acceptance by the market of the Company’s product candidates, if
approved; the Company’s anticipated capital requirements, including
the Company’s anticipated cash runway; and other factors, including
general economic conditions and regulatory developments, not within
the Company’s control. The factors discussed herein could cause
actual results and developments to be materially different from
those expressed in or implied by such statements. The
forward-looking statements are made only as of the date of this
press release and the Company undertakes no obligation to publicly
update such forward-looking statements to reflect subsequent events
or circumstance.
Axsome Contact: Mark Jacobson
Senior Vice President, Operations Axsome Therapeutics, Inc. 200
Broadway, 3rd Floor New York, NY 10038 Tel: 212-332-3243
Email: mjacobson@axsome.com www.axsome.com
1 Arnold et al., Arthritis Rheum. 2012
Jul;64(7):2387-972 Arnold et al., Clin Ther. 2010
Aug;32(9):1618-32
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