Full Press Release Details
Mirum Pharmaceuticals Provides Corporate Update
- Completion of maralixibat rolling NDA targeted for Q1 2021
- Expecting first-patient-in for volixibat studies in ICP and PSC, and maralixibat study in biliary
- Launching volixibat primary biliary cholangitis program in H2 2021
- European commercial leader hired in anticipation of potential approval of maralixibat
FOSTER CITY, Calif. January 12, 2021 Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company
focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases, today provided a corporate update in advance of the company s presentation at the 39th Annual J.P. Morgan Healthcare Conference.
I am very excited about what 2021 holds for Mirum. In
the first quarter alone, we expect to complete our rolling NDA submission for maralixibat, taking us one step closer to making this medicine available to patients with Alagille syndrome, and expect to initiate three randomized studies of maralixibat
and volixibat in new indications, said Chris Peetz, president and chief executive officer at Mirum. Today we are announcing key progress in maralixibat launch readiness and further expansion of the volixibat program into
primary biliary cholangitis with an additional, potentially registrational, randomized study.
2021 Pipeline Highlights
Corporate Highlights - Strategically Financed for Growth
Global Launch Readiness
Today, the company announced the
appointment of Alexey Kutahov, MD as its general manager, EMEA, to lead its launch readiness activities for maralixibat in Europe. Dr. Kutahov will be responsible for all European activities related to market development and commercial launch
strategies, with direct oversight of marketing, market access and sales. Dr. Kutahov joins Mirum with 20 years leading biopharmaceutical development and commercialization programs, having served most recently as general manager of Europe for
Sarepta Therapeutics. Prior to Sarepta, Dr. Kutahov was head of market access innovation at Amgen. Before joining Amgen, he was head of central European market access at Novartis. Dr. Kutahov also held positions of increasing
responsibility at Eli Lilly and Sandoz.
In connection with his employment, the Compensation Committee of Mirum s Board of Directors
granted Dr. Kutahov an inducement award consisting of a non-qualified stock option to purchase 55,000 shares of common stock under Mirum s 2020 Inducement Plan. The Compensation Committee
of Mirum s Board of Directors approved the award as an inducement material to Dr. Kutahov s employment in accordance with Nasdaq Listing Rule 5635(c)(4).
The stock option has an exercise price per share equal to $19.44 per share, Mirum s closing trading price on January 11, 2020, and will
vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months,
subject to Dr. Kutahov s continued service relationship with Mirum through the applicable vesting dates. The award is subject to the terms and conditions of Mirum s 2020 Inducement Plan and the terms and conditions
of an award agreement covering the grant.
About Mirum Pharmaceuticals
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 initiated a rolling NDA submission for maralixibat in the treatment of cholestatic pruritus in patients with ALGS and expects to complete the submission in the first quarter of 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 and
intrahepatic cholestasis of pregnancy. For more information, visit MirumPharma.com.
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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 results, conduct and progress of Mirum s ongoing and planned studies for its product candidates and the
regulatory approval path for its product candidates, the strength of Mirum s balance sheet and the adequacy of cash and cash equivalents on hand, and commercial readiness activities. 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 plans, will, may, expects, 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.