~ MACRILEN is the First and Only FDA-Approved
Oral Drug Indicated For the Diagnosis of Adult Growth Hormone
Deficiency, a Rare Endocrine Disorder ~
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
acquired the U.S. and Canadian rights to MACRILEN™ (macimorelin)
from Aeterna Zentaris Inc. (Nasdaq:AEZS) (TSX:AEZS). On
December 20, 2017, the U.S. Food and Drug Administration (FDA)
granted marketing approval for MACRILEN, an oral growth hormone
secretagogue (GHS) receptor agonist, to be used in the diagnosis of
patients with adult growth hormone deficiency (AGHD), which affects
approximately 60,000 adults in the U.S. and Canada. MACRILEN has
been granted orphan drug designation in the U.S. and has patents
with expiration dates through late 2027.
“We are extremely proud to acquire the U.S. and
Canadian rights to MACRILEN, the first and only oral drug approved
in the U.S. to diagnose adult growth hormone deficiency, or AGHD.
MACRILEN has Orphan Drug Designation in the U.S. and was developed
to address important unmet needs in the diagnosis and
appropriate treatment of adult growth hormone deficiency, a
condition that we believe is too often under-recognized or
misdiagnosed, in part because of the lack of accurate, convenient
and safe diagnostic procedures,” said Matthew Pauls,
president and chief executive officer of Strongbridge
Biopharma. “The acquisition of MACRILEN builds upon our rare
endocrine disease franchise and establishes our commercial presence
in the space, marking an important step forward
for Strongbridge’s overall growth and evolution.
Importantly, this transaction occurs prior to the potential
regulatory approval and market introduction of
RECORLEV™ (levoketoconazole), currently in Phase 3 for
endogenous Cushing’s syndrome, a condition often treated by the
same endocrinologists who diagnose and treat AGHD,” Pauls
added.
Under the terms of the license and assignment
agreement, Strongbridge will make an upfront payment of $24 million
to Aeterna Zentaris within five days of the effective date of the
agreement. Strongbridge has agreed to pay tiered royalties in
the mid-to-high teens as a percentage of net sales as well as
milestone payments upon FDA approval of a pediatric indication and
the achievement of pre-determined sales levels. The license and
assignment agreement also provides Strongbridge with an exclusive
license to manufacture and commercialize MACRILEN in the U.S. and
Canada. Aeterna Zentaris will remain responsible for a pediatric
development program to support regulatory submission for
approval with Strongbridge sharing oversight and paying for 70
percent of the cost of the program, or approximately $4 million
over a three-year period. Strongbridge expects to commercially
launch MACRILEN in mid-year 2018.
“There is a significant unmet need in the
diagnosis and treatment of adult growth hormone deficiency, a
disorder typically caused by injury or insult to the pituitary
gland that often leads to metabolic, cardiovascular,
musculoskeletal, and mental health issues,” said Fredric Cohen,
M.D., chief medical officer of Strongbridge Biopharma. “Adult
growth hormone deficiency assessments have typically been very
onerous for doctors and patients alike. We believe that MACRILEN
will provide patients and physicians with a potentially safer, more
tolerable and more convenient option for making accurate AGHD
diagnoses, and we look forward to working with the endocrinology
community to bring MACRILEN to patients in the near future,” Dr.
Cohen added.
In conjunction with the acquisition of MACRILEN,
Strongbridge and CRG LP (“CRG”) have amended the Company’s existing
senior credit facility (“Facility”) to increase total potential
borrowing from $50 million to $100 million. Strongbridge has now
borrowed $85 million pursuant to the Facility, inclusive of the $45
million borrowed upon amending the Facility ("Second
Borrowing"). Under the amended Facility, the Company has
retained the option to borrow an additional $10 million based upon
the achievement of certain revenue and market capitalization
milestones on or prior to June 30, 2018 and now has an additional
option to borrow an additional $5 million based upon the
achievement of certain revenue and market capitalization milestones
on or prior to December 31, 2018. The term of the loan remains six
years, although the interest-only period has been extended by six
months to December 31, 2020. The Company has retained the
option to extend the interest-only period to six years based upon
the achievement of certain milestones during the interest-only
period. As a condition to the Second Borrowing, the Company issued
warrants with a seven-year term to CRG to purchase 1,248,250 of the
Company’s ordinary shares at an exercise price of $10.00 per share.
Strongbridge intends to use the upfront proceeds from the Second
Borrowing to fund the acquisition and commercialization of MACRILEN
as well as for corporate purposes and working capital.
Cantor Fitzgerald & Co. and MTS Health
Partners acted as co-advisors to Strongbridge with respect to the
transaction with Aeterna Zentaris, and Armentum
Partners served as financial advisor to Strongbridge for the
transaction with CRG.
Conference Call
DetailsStrongbridge will host a conference call today,
Wednesday, January 17 at 8:30 a.m. ET. To access the live
call, dial 844-285-7153 (domestic) or 478-219-0180 (international)
with conference ID 2567659. 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 2567659.
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 commercial portfolio
within its rare neuromuscular and rare endocrine franchises
includes KEVEYIS® (dichlorphenamide), the first and only
FDA-approved treatment for hyperkalemic, hypokalemic, and related
variants of Primary Periodic Paralysis, and MACRILEN™
(macimorelin), the first and only FDA-approved oral drug indicated
for the diagnosis of Adult Growth Hormone Deficiency. KEVEYIS has
orphan drug exclusivity status in the U.S. to August 2022. MACRILEN
has been granted orphan drug designation in the U.S. and has
patents with expiration dates through late 2027. The Company’s rare
endocrine franchise also includes a clinical-stage pipeline of
therapies: RECORLEV™ (levoketoconazole), a
cortisol synthesis inhibitor currently being studied for the
treatment of endogenous Cushing's syndrome, and veldoreotide, a
next-generation somatostatin analog being investigated for the
treatment of acromegaly, with potential additional applications in
other conditions amenable to somatostatin receptor activation. Both
RECORLEV and veldoreotide have received orphan designation from the
U.S. Food and Drug Administration and the European Medicines
Agency. For more information, visit www.strongbridgebio.com.
About MACRILEN™
Important Safety
Information
What is
MACRILENTM?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 were changed
sense of taste, dizziness, headache, fatigue, nausea, hunger,
diarrhea, upper respiratory tract infection, feeling hot, excessive
sweating, sore nose and throat, and decreased heart rate.
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.
Forward-Looking StatementsThis
press release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release,
are forward-looking statements. These statements relate to future
events and involve known and unknown risks, including, without
limitation, uncertainties regarding Strongbridge's strategy, plans,
anticipated investments, costs and results, product development and
commercialization efforts and objectives of management for future
operations. 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. 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 RelationsU.S.:The Trout Group Marcy
Nanus +1 646-378-2927 mnanus@troutgroup.com
Europe:First HouseMitra Hagen Negård+47 21 04
62 19strongbridgebio@firsthouse.no
USA 900 Northbrook Drive Suite 200 Trevose,
PA 19053 Tel. +1 610-254-9200 Fax. +1 215-355-7389
Strongbridge Biopharma (NASDAQ:SBBP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Strongbridge Biopharma (NASDAQ:SBBP)
Historical Stock Chart
From Jul 2023 to Jul 2024