~ Strongbridge to Receive Upfront Payment of $145
Million and Tiered Royalty Stream from Novo Nordisk ~
Strongbridge Biopharma plc, (Nasdaq: SBBP), a global
commercial-stage biopharmaceutical company focused on the
development and commercialization of therapies for rare diseases
with significant unmet needs, today announced that the Company has
entered into an agreement for Novo Nordisk to acquire the rights to
MACRILEN™ (macimorelin) in the United States (U.S.) and Canada.
MACRILEN is the first and only FDA-approved oral drug indicated for
the diagnosis of adult growth hormone deficiency (AGHD).
“We are proud to enter into this MACRILEN
agreement with Novo Nordisk, a global leader in endocrinology, as
it aligns with our strategic objective to maximize the potential of
MACRILEN while we continue to prepare for the potential regulatory
approval of RECORLEV™ (levoketoconazole),” said Matthew Pauls,
president and chief executive officer of Strongbridge Biopharma.
“The upfront payment and equity investment from Novo Nordisk will
significantly strengthen the Company’s overall financial position
and marks a tremendous step forward in Strongbridge’s continued
evolution as a company dedicated to rare diseases,” Pauls
added.
Terms of the agreement include that:
- Strongbridge will receive an upfront payment of $145 million
from Novo Nordisk for the U.S. and Canadian rights to
MACRILEN;
- Strongbridge will receive tiered royalties related to the sales
of MACRILEN through 2027; and
- Novo Nordisk will leverage and fund Strongbridge’s rare
endocrine commercial field organization for MACRILEN for up to
three years.
In addition, Novo Nordisk will purchase
approximately 5,242,000 ordinary shares of Strongbridge Biopharma
plc at a purchase price of $7.00 per share, representing a premium
to the most recent market close share price. This investment will
result in gross proceeds of $36.7 million to Strongbridge.
These transactions are expected to close in
December 2018. MTS Securities, LLC served as Strongbridge’s
transaction advisor.
Conference Call
DetailsStrongbridge will host a conference call
on Wednesday, October 31 at 9:15 a.m. ET. To access the
live call, dial 844-285-7153 (domestic) or 478-219-0180
(international) with conference ID 9775249. The conference call
will also be audio webcast from the Company’s website
at www.strongbridgebio.com under the “Investor/Webcasts
and Presentations” section. A replay of the call will be made
available for one week following the conference call. To hear a
replay of the call, dial 855-859-2056 (domestic) or 404-537-3406
(international) with conference ID 9775249.
About Adult Growth Hormone Deficiency
(AGHD)AGHD is a rare disorder associated with increased
morbidity and mortality1,2 There are more than 50,000 adults with a
growth hormone (GH) deficiency diagnosis in the U.S.1 People who
have AGHD can include those who were GH deficient as children and
become adults with AGHD, or adults who become GH deficient. In
adults, GH deficiency can develop when the pituitary gland or
hypothalamus is damaged due, for example, to tumors, surgery,
radiation or traumatic brain injury (TBI).3 If left undiagnosed,
AGHD may lead to increased risk for premature mortality,
significant morbidities, including an increase in body fat,
increased rate of fractures, a decrease in muscle mass,
dyslipidemia, weakness and fatigue, cardiovascular disease,
osteoporosis, and impaired psychological well-being such as
isolation, anxiety, or depression.1,3 Except in the presence
of multiple other pityitary hormone deficiencies, AGHD cannot be
diagnosed by routine blood or other tests; growth hormone
stimulation testing is required to diagnose AGHD.4
About MACRILEN™
Important Safety Information
What is MACRILEN™? MACRILEN
(pronounced ma-kri-len) (macimorelin) is a prescription oral
solution that is used to test for adult growth hormone deficiency
(AGHD).
What should you know about MACRILEN?
- Taking MACRILEN with certain other medications may cause
irregular changes to your heart rhythm. Before taking MACRILEN,
tell your healthcare provider about all your medications, as you
may need to temporarily stop taking some medications before you
take MACRILEN.
- Some medications may cause a false positive result when taken
with MACRILEN. Before taking MACRILEN, tell your healthcare
provider about all the medications you take, including growth
hormone.
- Tell your healthcare provider if you were recently diagnosed
with hypothalamic disease, as this can cause a false negative
result with MACRILEN.
- You will need to fast (go without food) for at least 8 hours
before taking MACRILEN.
What are the most common side effects with
MACRILEN? The most common side effects in 3%-5% of
patients were changed sense of taste, dizziness, headache, fatigue,
nausea, and hunger.
These are not all of the possible side effects
of MACRILEN. Call your healthcare provider for medical advice about
side effects. You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch/ or call
1-800-FDA-1088.
Please see Full Prescribing Information.
About Strongbridge
BiopharmaStrongbridge Biopharma is a global
commercial-stage biopharmaceutical company focused on the
development and commercialization of therapies for rare diseases
with significant unmet needs. Strongbridge's rare endocrine
franchise includes RECORLEV™ (levoketoconazole), a cortisol
synthesis inhibitor currently being studied in Phase 3
clinical studies for the treatment of endogenous Cushing's
syndrome, and veldoreotide extended release, a pre-clinical
next-generation somatostatin analog being investigated for the
treatment of acromegaly and potential additional applications in
other conditions amenable to somatostatin receptor
activation. Both RECORLEV and veldoreotide have received
orphan drug designation from the FDA and
the European Medicines Agency. The Company’s rare
neuromuscular franchise includes KEVEYIS® (dichlorphenamide), the
first and only FDA-approved treatment for hyperkalemic,
hypokalemic, and related variants of primary periodic paralysis.
KEVEYIS has orphan drug exclusivity in the United
States.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the federal securities laws. The words "anticipate,"
"estimate," "expect," "intend," "may," "plan," "potential,"
"project," "target," "will," "would," or the negative of these
terms or other similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. All statements, other
than statements of historical facts, contained in this press
release, are forward-looking statements, including statements
related to the potential regulatory approval of RECORLEV,
Strongbridge's strategy, plans, outcomes of product development
efforts and objectives of management for future operations.
Forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
expressed in such statement, including risks and uncertainties
associated with clinical development and the regulatory approval
process, the reproducibility of any reported results showing the
benefits of RECORLEV, the adoption of RECORLEV by physicians, if
approved, as treatment for any disease and the emergence of
unexpected adverse events following regulatory approval and use of
the product by patients. Additional risks and uncertainties
relating to Strongbridge and its business can be found under the
heading “Risk Factors” in Strongbridge’s Annual Report on Form 10-K
for the year ended December 31, 2017 and subsequent
filings with the SEC. These forward-looking statements are
based on current expectations, estimates, forecasts and projections
and are not guarantees of future performance or development and
involve known and unknown risks, uncertainties and other factors.
The forward-looking statements contained in this press release are
made as of the date of this press release, and Strongbridge
Biopharma does not assume any obligation to update any
forward-looking statements except as required by applicable
law.
Contacts:
Corporate and Media Relations Elixir Health
Public Relations Lindsay Rocco +1 862-596-1304
lrocco@elixirhealthpr.com
Investor Relations U.S.: Solebury Trout Marcy
Nanus +1 646-378-2927 mnanus@soleburytrout.com
Europe: First House Geir Arne Drangeid +47 913 10 458
strongbridgebio@firsthouse.no
USA 900 Northbrook Drive Suite 200 Trevose,
PA 19053 Tel. +1 610-254-9200 Fax. +1 215-355-7389
1. Monson JP, Brooke AM, Akker S. Adult growth hormone
deficiency. In: De Groot L, Chrousos G, Dungan K, et al
(eds). Endotext [online]. South Dartmouth, MA;
MDText.com, Inc:
2000. https://www.ncbi.nlm.nih.gov/books/NBK278982/.
Accessed January 16, 2018.2. Gupta V. Adult growth hormone
deficiency. Indian J Endocrinol Metab. 2011;15(Suppl
3):S197-S202.3. Bujanova J, Cummings MH. Drug review: Management of
growth hormone deficiency in
adults. Prescriber. 2015. http://onlinelibrary.wiley.com/doi/10.1002/psb.1422/pdf.
Accessed January 15, 2018.4. Fukuda I, Hizuka N, Muraoka T,
Ichihara A. Neurol Med Chir (Tokyo). 2014;54(8):599-605.
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