Avadel Pharmaceuticals plc (NASDAQ:AVDL) (“Avadel”), today
announced that it has entered into a license agreement with
Serenity Pharmaceuticals, LLC (“Serenity”). The agreement grants
Avadel the sole right to commercialize and further develop Noctiva
in the United States and Canada. Noctiva is a proprietary low-dose
formulation of desmopressin acetate administered through a
patent-protected intranasal delivery system. It is the first and
only product approved by the U.S. Food and Drug Administration
(“FDA”) for the treatment of nocturia due to nocturnal polyuria.
Key Highlights:
- Deal Includes $50 million upfront payment; funded by
cash on hand, and a near term expected improvement in the Company’s
effective tax rate.
- Current nocturia-treated patient pool
estimated at over $2B with no FDA approved
treatment options until now, and market growth
potential1.
- Long-term growth opportunity with current intellectual
property through mid-2030, and potential opportunities to extend
patent life.
- Balance sheet remains strong with no bank debt, and
adequate cash to fund ongoing operations, including completion of
the Company’s REST-ON Phase III trial.
Nocturia is a medical condition that affects
approximately 40 million2 people in the United States, and
represents a high unmet medical need. Nocturia results in frequent
nighttime urination, which may prevent patients from experiencing a
normal, restful sleep cycle. Nocturia is associated with a number
of co-morbidities and health-related consequences, including an
increase in the risk of nighttime falls and fractures, loss of
sleep, decreased work productivity, impaired daytime functioning
and compromised quality of life3.
Mike Anderson, Avadel’s Chief Executive Officer,
said, “Licensing Noctiva is an important step in our strategic
growth plan and positions Avadel as a fully-integrated specialty
pharmaceutical company, with a profitable base and a significant
ongoing Phase III trial. Noctiva is the first and only FDA approved
product to treat nocturia due to nocturnal polyuria, and aligns
with our mission of offering patients unique and differentiated
branded products. Noctiva has the potential to deliver significant
value to Avadel, the large, underserved patient population who
suffer from nocturia and our shareholders.”
Dr. Samuel Herschkowitz, Chief Executive Officer
of Serenity, said, “Approximately $200 million has been invested in
order to develop and gain FDA approval for Noctiva, which is the
first drug therapy shown to be safe and effective for the treatment
of nocturia. The clinical program for Noctiva included four Phase 3
studies and two long-term safety trials and demonstrated
significant reductions in the mean number of nocturic episodes, and
improved quality of life4. We believe Avadel is the right partner
with the experience, capability and commitment to bring Noctiva to
market for the benefit of patients, providers and payors.”
Terms of the final agreement, which can be found
in detail on Avadel’s 8-K filed with the S.E.C. on September 5,
2017, include an upfront payment of $50 million, $20 million due at
the earlier of full scale commercial launch or June 30, 2018,
performance-based milestones tied to specific Noctiva net sales
thresholds and a tiered royalty rate structure based upon
achievement of annual net sales. As a result of the licensing
agreement, the Company expects an improvement in its effective tax
rate, as expenses associated with the launch will partially offset
U.S. taxable income. Avadel’s strong balance sheet, with $173
million in cash and marketable securities and no bank debt at June
30, 2017, means the Company is able to self-fund the licensing
acquisition of Noctiva and subsequent near-term commercialization
plans.
The transaction is set to close upon expiration
of any applicable waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976. T.R. Winston & Company,
LLC, served as financial and strategic advisor to Serenity.
Conference Call:Avadel will host a conference
call and live audio webcast on Wednesday, September 6, 2017 at 8:30
am EDT to discuss this transaction. Interested parties may access
the conference call by dialing (844) 388-0559 (U.S. & Canada)
or (216) 562-0393 (International) and entering Conference ID#
79911607. The live audio webcast and slide presentation may be
accessed via the Investors section of the Avadel Pharmaceuticals
website at www.avadel.com. A replay of the webcast will be
available on the website for 90 days.
1 Data on file.2 Sources: (1) US census data 2016 estimates (2)
Lee, L. K., et al. "Potential benefits of diagnosis and treatment…”
International journal of clinical practice 70.1 (2016): 66-81.3
Data on file.4 New Drug Application for Noctiva. Data on file.
About Avadel Pharmaceuticals
plc: Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a
specialty pharmaceutical company that seeks to commercialize
differentiated pharmaceutical products that are safe, effective and
easy to take through formulation development, by utilizing its
proprietary drug delivery technology and in-licensing / acquiring
new products; ultimately, helping patients adhere to their
prescribed medical treatment and see better results. The Company is
headquartered in Dublin, Ireland with operations in St. Louis,
Missouri and Lyon, France. For more information, please visit
www.avadel.com.
About Noctiva™:Noctiva is a
vasopressin analog indicated for the treatment of nocturia due to
nocturnal polyuria in adults who awaken at least two times per
night to void. Noctiva™ is a preservative-free intranasal
formulation of desmopressin, administered as a single spray in one
nostril 30 minutes before bedtime, and is approved in two dosage
forms of 0.83 mcg and 1.66 mcg. (Full Prescribing Information
available here).
Important Safety Information and
Indication for Noctiva (desmopressin acetate)
WARNING: HYPONATREMIA:
- Noctiva can cause hyponatremia, which may be life-threatening
if severe.
- Noctiva is contraindicated in patients at increased risk of
severe hyponatremia, such as patients with excessive fluid intake,
with illnesses that cause fluid or electrolyte imbalances, or those
using loop diuretics or systemic or inhaled glucocorticoids.
- Ensure serum sodium is normal before starting or resuming
Noctiva. Measure serum sodium within seven days and approximately
one month after initiating therapy or increasing dose, and
periodically during treatment. More frequently monitor serum sodium
in patients 65 years of age or older and in patients at increased
risk of hyponatremia.
- If hyponatremia occurs, Noctiva may need to be temporarily or
permanently discontinued.
Noctiva should not be used in patients with
symptomatic congestive heart failure or uncontrolled hypertension
because fluid retention can worsen these underlying conditions. Use
of Noctiva should be discontinued temporarily in patients with
certain nasal conditions such as colds or allergies until those
conditions have resolved.
Noctiva is also not recommended for the
treatment of nocturia in pregnant women. Nocturia is usually
related to normal physiologic changes in pregnancy that do not
require treatment with Noctiva. Noctiva should not be used in
children.
The most common side effects of Noctiva in
clinical trials included nasal discomfort, cold symptoms
(nasopharyngitis), nasal congestion, sneezing, high or increased
blood pressure, back pain, nose bleeds, bronchitis and
dizziness.
Safe Harbor: This press release
may include forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. The words “will,” “may,”
“believe,” “expect,” “anticipate,” “estimate,” “potentially,”
“project” and similar expressions, and the negatives thereof,
identify forward-looking statements, each of which speaks only as
of the date the statement is made. Although we believe that our
forward-looking statements are based on reasonable assumptions
within the bounds of our knowledge of our business and operations,
our business is subject to significant risks and as a result there
can be no assurance that actual results of our research,
development and commercialization activities and our results of
operations will not differ materially from the results contemplated
in such forward-looking statements. These risks include the
following: (i) our internal analyses may overstate the market
opportunity in the United States and Canada for the drug
desmopressin acetate (the “Drug”), which we have licensed from
Serenity Pharmaceuticals, LLC, or we may not effectively exploit
such market opportunity; (ii) significant safety or drug
interaction problems could arise with respect to the Drug; (iii) we
may not successfully increase awareness of nocturia and the
potential benefits of the Drug; (iv) we may encounter problems with
the manufacture or supply of the Drug; (v) patents and proprietary
rights associated with the Drug may not provide adequate
protection; (vi) our costs to complete the commercialization of the
Drug could be more than planned and/or may not provide the intended
positive financial results; (vii) the need for management to focus
attention on the development and commercialization of the Drug
could cause our ongoing business operations to suffer; and (viii)
the other risks, uncertainties and contingencies described in the
Company's filings with the U.S. Securities and Exchange Commission,
including our annual report on Form 10-K for the year ended
December 31, 2016, in particular under the captions
“Forward-Looking Statements” and “Risk Factors,” including without
limitation: our dependence on a small number of products and
customers for the majority of our revenues; the possibility that
our Bloxiverz®,Vazculep® and Akovaz® products, which are not patent
protected, could face substantial competition resulting in a loss
of market share or forcing us to reduce the prices we charge for
those products; the possibility that we could fail to successfully
complete the research and development for pipeline products we are
evaluating for potential application to the FDA pursuant to our
"unapproved-to-approved" strategy, or that competitors could
complete the development of such products and apply for FDA
approval of such products before us; the possibility that our
products may not reach the commercial market or gain market
acceptance; our need to invest substantial sums in research and
development in order to remain competitive; our dependence on
certain single providers for development of several of our drug
delivery platforms and products; our dependence on a limited number
of suppliers to manufacture our products and to deliver certain raw
materials used in our products; the possibility that our
competitors may develop and market technologies or products that
are more effective or safer than ours, or obtain regulatory
approval and market such technologies or products before we do; the
challenges in protecting the intellectual property underlying our
drug delivery platforms and other products; and our dependence on
key personnel to execute our business plan. Except as may be
required by law, we disclaim any obligation to publicly update any
forward-looking statements to reflect events after the date of this
press release.
Contacts:
Michael F. Kanan
Chief Financial Officer
Phone: (636) 449-1844
E-mail: mkanan@avadel.com
Lauren Stival
Sr. Director, Investor Relations and Corporate Communications
Phone: (636) 449-5866
Email: lstival@avadel.com
Avadel Pharmaceuticals (NASDAQ:AVDL)
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