- Transaction reduces royalty and milestone
obligations for LIVMARLI® and volixibat
- Cash flow positive transaction
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that
it has acquired Satiogen Pharmaceuticals, Inc., a San Diego-based
company. Satiogen, now a wholly-owned Mirum subsidiary, was an
existing licensing partner for LIVMARLI® (maralixibat) oral
solution and volixibat. Through the transaction, Mirum obtained all
Satiogen licensing payments and Satiogen-owned intellectual
property relating to LIVMARLI and volixibat.
“The acquisition of Satiogen is a strategic step that
consolidates the economics of our commercial and pipeline
programs,” said Chris Peetz, president and chief executive officer
of Mirum. “The Satiogen team laid some of the foundational
groundwork for the potential for IBAT inhibitors in liver disease
that is now translating to substantial benefits for patients and a
successful launch of LIVMARLI in Alagille syndrome. We thank the
Satiogen team as we build on their work to continue to advance
important therapies for rare disease.”
The transaction will result in a reduction of total licensing
royalty obligations for LIVMARLI and volixibat to high single digit
to low teens. The total potential consideration for the acquisition
consisted of a combination of 841,792 shares of common stock,
199,993 of which is subject to achievement of a milestone, and
approximately $2.8 million in cash in respect of an equivalent
amount of cash on the books of Satiogen acquired by Mirum at the
closing. Mirum will wholly own the Satiogen subsidiary, which will
receive a 2% royalty.
About LIVMARLI® (maralixibat) oral solution
LIVMARLI® (maralixibat) oral solution is an orally administered,
once-daily, ileal bile acid transporter (IBAT) inhibitor approved
by the U.S. Food and Drug Administration for the treatment of
cholestatic pruritus in patients with Alagille syndrome (ALGS) one
year of age and older and is the only FDA-approved medication to
treat cholestatic pruritus associated with Alagille syndrome. For
more information, please visit LIVMARLI.com.
LIVMARLI is currently being evaluated in late-stage clinical
studies in other rare cholestatic liver diseases including
progressive familial intrahepatic cholestasis (PFIC) and biliary
atresia. LIVMARLI has received Breakthrough Therapy designation for
ALGS and PFIC type 2 and orphan designation for ALGS, PFIC and
biliary atresia. To learn more about ongoing clinical trials with
LIVMARLI, please visit Mirum’s clinical trials section on the
company’s website.
IMPORTANT SAFETY INFORMATION
LIVMARLI can cause serious side effects, including:
Changes in liver tests. Changes in certain liver tests
are common in patients with Alagille syndrome and can worsen during
treatment with LIVMARLI. These changes may be a sign of liver
injury and can be serious. Your healthcare provider should do blood
tests before starting and during treatment to check your liver
function. Tell your healthcare provider right away if you get any
signs or symptoms of liver problems, including nausea or vomiting,
skin or the white part of the eye turns yellow, dark or brown
urine, pain on the right side of the stomach (abdomen) or loss of
appetite.
Stomach and intestinal (gastrointestinal) problems.
LIVMARLI can cause stomach and intestinal problems, including
diarrhea, stomach pain, and vomiting during treatment. Tell your
healthcare provider right away if you have any of these symptoms
more often or more severely than normal for you.
A condition called Fat Soluble Vitamin (FSV) Deficiency
caused by low levels of certain vitamins (vitamin A, D, E, and K)
stored in body fat. FSV deficiency is common in patients with
Alagille syndrome but may worsen during treatment. Your healthcare
provider should do blood tests before starting and during
treatment.
Other common side effects reported during treatment were bone
fractures and gastrointestinal bleeding.
Prescribing information
About Volixibat
Volixibat is an oral, minimally absorbed agent designed to
selectively inhibit the ileal bile acid transporter (IBAT).
Volixibat may offer a novel approach in the treatment of adult
cholestatic diseases by blocking the recycling of bile acids,
through inhibition of IBAT, thereby reducing bile acids
systemically and in the liver. Phase 1 and Phase 2 studies of
volixibat demonstrated on-target fecal bile acid excretion, a
pharmacodynamic marker of IBAT inhibition, in addition to decreases
in LDL cholesterol and increases in 7αC4 which are markers of bile
acid synthesis. Volixibat has been evaluated in more than 400
individuals across multiple clinical trials. The most common
adverse events reported were mild to moderate gastrointestinal
events observed in the volixibat groups.
Volixibat is currently being evaluated in Phase 2b studies for
primary sclerosing cholangitis (VISTAS Phase 2b clinical trial),
intrahepatic cholestasis of pregnancy (OHANA Phase 2b clinical
trial), and primary biliary cholangitis (VANTAGE Phase 2b clinical
trial).
About Mirum Pharmaceuticals
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company
dedicated to transforming the treatment of rare liver diseases.
Mirum’s approved medication is LIVMARLI® (maralixibat) oral
solution which is approved in the United States for the treatment
of cholestatic pruritus in patients with Alagille syndrome one year
of age and older.
Mirum’s late-stage pipeline includes two investigational
treatments for debilitating liver diseases affecting children and
adults. LIVMARLI, an oral ileal bile acid transporter (IBAT)
inhibitor, is currently being evaluated in clinical trials for
pediatric liver diseases and includes the MARCH Phase 3 clinical
trial for progressive familial intrahepatic cholestasis (PFIC) and
the EMBARK Phase 2b clinical trial for patients with biliary
atresia. In addition, Mirum has an expanded access program open
across multiple countries for eligible patients with ALGS and
PFIC.
Mirum has submitted a Marketing Authorization Application to the
European Medicines Agency for LIVMARLI for the treatment of
cholestatic liver disease in patients with Alagille syndrome.
Mirum’s second investigational treatment, volixibat, an oral
IBAT inhibitor, is being evaluated in three potentially
registrational studies including the VISTAS Phase 2b clinical trial
for adults with primary sclerosing cholangitis, the OHANA Phase 2b
clinical trial for pregnant women with intrahepatic cholestasis of
pregnancy, and the VANTAGE Phase 2b clinical trial for adults with
primary biliary cholangitis.
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About Satiogen Pharmaceuticals
Satiogen was founded in late 2007 and has been operating as a
virtual company by outsourcing all activities required to validate
the bile acid brake concept. Satiogen’s focus has been on
preclinical experiments for proof-of-concept, on collaborating in
clinical trials that confirm effects in humans, and on assembling
an intellectual property portfolio. For more information, visit
www.satiogen.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such forward-looking statements include statements
regarding, among other things, the expected reduction to Mirum’s
total licensing royalty obligations, the expected benefits of the
acquisition transaction on Mirum’s business and operations,
including consolidation of the economics of Mirum’s commercial and
pipeline programs, the anticipated impact for patients with liver
disease and the launch of LIVMARLI, Mirum’s continued advancement
of therapies for rare disease and the potential success and impacts
of Mirum’s IBAT programs. Because such statements are subject to
risks and uncertainties, actual results may differ materially from
those expressed or implied by such forward-looking statements.
Words such as “will,” “anticipate,” “expect,” “potential,” “intend”
and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon Mirum’s
current expectations and involve assumptions that may never
materialize or may prove to be incorrect. Actual results could
differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with Mirum’s business in general, the impact of the COVID-19
pandemic, and the other risks described in Mirum’s filings with the
Securities and Exchange Commission. All forward-looking statements
contained in this press release speak only as of the date on which
they were made and are based on management’s assumptions and
estimates as of such date. Mirum undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20220523005396/en/
Investor Contacts: Ian Clements, Ph.D. ir@mirumpharma.com
Sam Martin Argot Partners ir@mirumpharma.com
Media Contact: Erin Murphy media@mirumpharma.com
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