MyoKardia Regains Global Rights to Mavacamten and MYK-491 Programs from Sanofi
January 02 2019 - 8:00AM
MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical
company pioneering precision medicine for the treatment of
cardiovascular diseases, today announced it has regained worldwide
rights to all programs covered under its license and collaboration
agreement with Sanofi. The collaboration will not be extended
beyond the initial research term, which ended on December 31, 2018,
and will conclude in its entirety effective April 1, 2019. As a
result, MyoKardia now has global rights to all programs in its
portfolio, including lead clinical-stage candidates, mavacamten and
MYK-491.
“We are grateful for Sanofi’s support over the
past four years in what was a highly productive relationship. Since
entering into the collaboration, MyoKardia has become a leading
research and development organization with a robust pipeline of
targeted cardiovascular therapeutics,” said Tassos Gianakakos,
MyoKardia’s chief executive officer. “Regaining worldwide rights
enables us to capture the full value of the data being generated in
the next 12-24 months as we prepare for the potential registration
of mavacamten in obstructive hypertrophic cardiomyopathy and obtain
proof-of-concept for MYK-491 in patients with dilated
cardiomyopathy. Importantly, consolidated control over our entire
portfolio allows us to make decisions about how we advance each of
our therapeutic candidates in alignment with our precision medicine
approach.”
MyoKardia and Sanofi initiated their
collaboration in 2014 to advance up to three programs through
discovery and into clinical development for the treatment of
hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM).
Over the course of the collaboration, MyoKardia received
approximately $230 million in funding from Sanofi and has advanced
mavacamten from preclinical development into a late-stage pivotal
study for the treatment of HCM, and MYK-491 from discovery to a
Phase 2 proof-of-concept study in patients with DCM. During
the period leading up to the end of the research term, it was
important for MyoKardia to maintain 100 percent of the U.S.
commercial rights for mavacamten in HCM as well as additional
rights in expanded indications. Sanofi subsequently provided
MyoKardia with notification of its decision to conclude the
collaboration in conjunction with the end of the research term.
MyoKardia is positioned to achieve several
significant clinical milestones over the next 12 to 24 months and
reaffirmed timing for anticipated data read-outs:
- 6-month and 12-month data for mavacamten in obstructive HCM
(oHCM) from the ongoing PIONEER open-label extension study
- Data from the Phase 2 MAVERICK study in non-obstructive HCM in
the second half of this year
- Topline data from the Phase 3 EXPLORER-HCM clinical trial of
mavacamten in obstructive HCM (oHCM) in the second half of
2020
- Phase 2a proof-of-concept data for MYK-491 in DCM before the
end of the year
The company anticipates that current cash, cash
equivalents and investments are sufficient to fund operations past
the read-out of EXPLORER-HCM data in the second half of 2020. This
reflects an anticipated increase in R&D expenses due to the
termination of the Sanofi collaboration agreement. As of September
30, 2018, MyoKardia had cash, cash equivalents and investments
totaling $412 million. MyoKardia will report fourth quarter and
year-end 2018 financial results in late February of 2019.
Conference Call and Webcast
InformationMyoKardia management will host a conference
call today at 8:30 a.m. ET to discuss today’s announcement.
Investors and analysts are invited to participate in the call by
dialing +1-844-494-0193 (U.S.) or +1-508- 637-5584 using the
conference ID 8546868. The webcast may be accessed live on the
Investor Relations section of the MyoKardia website at
http://investors.myokardia.com. A replay of the webcast will be
available on MyoKardia’s website for 90 days following the
call.
About MyoKardiaMyoKardia is a
clinical-stage biopharmaceutical company pioneering a precision
medicine approach to discover, develop and commercialize targeted
therapies for the treatment of serious and rare cardiovascular
diseases. MyoKardia’s initial focus is on the development of small
molecule therapeutics aimed at the cardiac muscle proteins that
modulate cardiac muscle contraction and underlie diseases of
systolic and diastolic dysfunction. Based on an in-depth
understanding of disease biology, MyoKardia applies a precision
medicine approach to develop its therapeutic candidates for patient
populations with shared characteristics, such as causal genetic
mutations or disease subtypes. MyoKardia’s most advanced product
candidate is mavacamten (formerly MYK-461), a novel, oral,
allosteric modulator of cardiac myosin intended to reduce
hypercontractility. Mavacamten has advanced into a pivotal Phase 3
clinical trial, known as EXPLORER-HCM in patients with symptomatic,
obstructive hypertrophic cardiomyopathy (HCM). MyoKardia is also
developing mavacamten in a second indication, non-obstructive HCM,
in the Phase 2 MAVERICK-HCM clinical trial. MYK-491, MyoKardia’s
second product candidate, is designed to increase cardiac output
among patients with systolic heart dysfunction by increasing the
overall extent of the heart’s cardiac contractility. MyoKardia is
currently evaluating MYK-491 in a Phase 1b/2a study in stable heart
failure patients.
MyoKardia’s mission is to change the world for
patients with serious cardiovascular disease through bold and
innovative science.
Forward-Looking
StatementStatements we make in this press release may
include statements which are not historical facts and are
considered forward-looking within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which are usually
identified by the use of words such as "anticipates," "believes,"
"estimates," "expects," "intends," "may," "plans," "projects,"
"seeks," "should," "will," and variations of such words or similar
expressions. We intend these forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act and
Section 21E of the Securities Exchange Act and are making this
statement for purposes of complying with those safe harbor
provisions. These forward-looking statements, including statements
regarding the clinical and therapeutic potential of mavacamten,
MYK-491 and other product candidates that the Company may identify
and pursue, the progress of and availability of data from the
Company’s ongoing Phase 3 EXPLORER-HCM trial of mavacamten in oHCM
patients, Phase 2 MAVERICK-HCM trial of mavacamten in nHCM patients
and PIONEER-OLE study of mavacamten, the progress of and
availability of data from the Company’s ongoing Phase 1b/2a study
of MYK-491 in DCM patients, the Company’s late-stage development
plans for MYK-491, the advancement of the Company’s research
programs into clinical development, as well as the timing of these
events, and the Company’s expected cash runway, reflect our current
views about our plans, intentions, expectations, strategies and
prospects, which are based on the information currently available
to us and on assumptions we have made. Although we believe that our
plans, intentions, expectations, strategies and prospects as
reflected in or suggested by those forward-looking statements are
reasonable, we can give no assurance that the plans, intentions,
expectations or strategies will be attained or achieved.
Furthermore, actual results may differ materially from those
described in the forward-looking statements and will be affected by
a variety of risks and factors that are beyond our control
including, without limitation, risks associated with the
development and regulation of our product candidates, as well as
those set forth in our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2018, and our other filings with the
SEC. Except as required by law, we assume no obligation to update
publicly any forward-looking statements, whether as a result of new
information, future events or otherwise.
Contacts:Michelle CorralSenior
Director, Corporate Communications and Investor RelationsMyoKardia,
Inc.650-351-4690ir@myokardia.com
Hannah Deresiewicz (investors) Stern Investor Relations,
Inc.212-362-1200hannahd@sternir.com
Steven Cooper (media)
Edelman415-486-3264steven.cooper@edelman.com
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