Mirum Pharmaceuticals and GC Pharma Enter into Exclusive Licensing Agreement to Develop and Commercialize Maralixibat for Rare Liver Diseases in South Korea
July 26 2021 - 8:00PM
Business Wire
- GC Pharma to lead development and
commercialization in South Korea
- Mirum seeks to expand global availability of
maralixibat in rare liver diseases
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) and GC Pharma
(KRX:006280) today announced that they have entered into an
exclusive licensing agreement, pursuant to which GC Pharma has
agreed to develop and commercialize maralixibat in South Korea.
Maralixibat is an investigational, orally administered medication
being evaluated in Alagille syndrome (ALGS), progressive familial
intrahepatic cholestasis (PFIC), and biliary atresia (BA).
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Maralixibat targets the apical sodium dependent bile acid
transporter (ASBT) ultimately resulting in lower levels of bile
acids systemically. The U.S. Food and Drug Administration (FDA) has
accepted a New Drug Application (NDA) for maralixibat for the
treatment of cholestatic pruritus in patients with ALGS under
priority review. The European Medicines Agency is reviewing
maralixibat for the treatment of PFIC2. Mirum has commenced a
global Phase 2b maralixibat study (EMBARK) for the treatment of
BA.
Under the terms of the licensing agreement, GC Pharma has
obtained the exclusive right to develop and commercialize
maralixibat within South Korea for ALGS, PFIC, and BA. In exchange,
Mirum is entitled to receive an upfront payment of $5.0 million as
well payments for the achievement of future regulatory and
commercial milestones, with tiered double-digit royalties based on
product net sales in the region.
“GC Pharma shares a vision for creating and delivering
transformative treatments,” said Chris Peetz, president and chief
executive officer at Mirum. “We are excited about GC Pharma’s
proven track record commercializing treatments for rare diseases
and the potential to pursue an expedited approval pathway for
maralixibat for Alagille syndrome in South Korea.”
"This collaboration is another significant milestone in
delivering our vision for rare disorders,” said EC Huh, Ph.D.,
president of GC Pharma. “We look forward to leveraging our
capabilities to explore the development and commercialization of
maralixibat."
About Mirum Pharmaceuticals, Inc.
Mirum Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of a late-stage pipeline of novel therapies for
debilitating liver diseases. Mirum’s lead product candidate,
maralixibat, is an investigational oral drug in development for
Alagille syndrome (ALGS), progressive familial intrahepatic
cholestasis (PFIC), and biliary atresia. Mirum has submitted an NDA
for maralixibat in the treatment of cholestatic pruritus in
patients with ALGS. The NDA has been accepted for priority review
by the FDA with a PDUFA action date of September 29, 2021.
Additionally, Mirum’s marketing authorization application for the
treatment of pediatric patients with PFIC2 has been accepted for
review (validated) by the European Medicines Agency. Mirum is also
developing volixibat, also an oral ASBT-inhibitor, in primary
sclerosing cholangitis, intrahepatic cholestasis of pregnancy, and
primary biliary cholangitis. For more information, visit
MirumPharma.com.
To augment its pipeline in cholestatic liver disease, Mirum has
acquired the exclusive option to develop and commercialize gene
therapy programs VTX-803 and VTX-802 for PFIC3 and PFIC2,
respectively, from Vivet Therapeutics SAS, following preclinical
evaluation and investigational new drug-enabling studies.
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About GC Pharma
GC Pharma is a biopharmaceutical company that delivers
life-saving and life-sustaining protein therapeutics and vaccines.
Headquartered in South Korea, GC Pharma is the largest plasma
protein product manufacturer in Asia and has been dedicated to
quality healthcare solutions for more than half a century. Green
Cross Corporation updated its corporate brand as GC Pharma in early
2018. Green Cross Corporation remains the company's registered,
legal name. For more information, visit GCcorp.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 potential development and
commercialization by GC Pharma of maralixibat in within South Korea
for various indications, Mirum’s receipt of upfront, milestone and
royalty revenue in connection with the license agreement with GC
Pharma, as well as the regulatory approval pathway for maralixibat.
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,”
“could,” “would,” “potential” 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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Mirum Contacts:
Media: Erin Murphy media@mirumpharma.com
Investors: Ian Clements, Ph.D. ir@mirumpharma.com
GC Pharma Contacts:
Media/Investors: HyunGoo Kang gookang@gccorp.com
Yelin Jun yelin@gccorp.com
Sohee Kim shkim20@gccorp.com
Hansaem Kim hs.kim@gccorp.com
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