AMAG Pharmaceuticals Announces Changes to Medical Development Organization
March 04 2020 - 6:58AM
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced changes
to its medical development organization. Effective March 31, 2020,
Julie Krop, M.D., Executive Vice President and Chief Medical
Officer, will be leaving the Company. As AMAG initiates a search
for a permanent Chief Medical Officer, the Board of Directors and
management will continue to work closely with the medical
development organization on key priorities, including working with
the U.S. Food and Drug Administration (FDA) to find a path to
retain patient and provider access to Makena® and advancing the
ciraparantag and AMAG-423 clinical development programs.
“Tenured leadership across our medical development organization
has helped us achieve our most recent regulatory approvals and the
team remains focused on supporting our portfolio of products to
address unmet medical needs,” said William Heiden, AMAG’s President
and Chief Executive Officer. “We appreciate all the contributions
that Dr. Krop has made to our organization and wish her well in her
future endeavors.”
Over the past several years, AMAG has built out a fully
integrated development organization to support the Company’s
pipeline of development-stage products. The Company will leverage
the team’s expertise and experience across clinical operations,
medical affairs, biostatistics, regulatory affairs and
pharmacovigilance as it works with the FDA to retain patient access
to Makena and advance the ciraparantag and AMAG-423 clinical
development programs.
Additionally, former board member Lesley Russell, MBChB, MRCP
will provide further, interim expertise as Clinical Consultant,
effective immediately. Dr. Russell has three decades of experience
in clinical development and regulatory affairs, and will advise the
company during the transition to a new CMO.
ABOUT AMAG AMAG is a pharmaceutical
company focused on bringing innovative products to patients with
unmet medical needs. The company does this by leveraging its
development and commercial expertise to invest in and grow its
pharmaceutical products across a range of therapeutic areas. For
additional company information, please visit
www.amagpharma.com.
FORWARD-LOOKING STATEMENTS This press release
contains forward-looking information about AMAG Pharmaceuticals,
Inc. within the meaning of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. Any statements
contained herein which do not describe historical facts, including,
among others: AMAG’s expectations for the leadership transition,
including the planned timing for the search for a new chief medical
officer; expectations that AMAG’s Board of Directors, remaining
management team and Dr. Russell will continue to work with the
company’s medical development organization on the company’s key
priorities during the search for a new chief medical officer and
successfully support AMAG’s products; AMAG’s expectations regarding
continued patient and provider access to Makena and the advancement
of its clinical development programs for ciraparantag and AMAG-423;
expectations that Dr. Milton will continue to lead AMAG’s
regulatory strategy to retain patient access to Makena during the
search for a new chief medical officer; and expectations and
beliefs regarding AMAG’s ability to successfully achieve benefits
from its leadership transition plan, including managing the search
for and transition to a new chief medical officer, are
forward-looking statements which involve risks and uncertainties
that could cause actual results to differ materially from those
discussed in such forward-looking statements.
Such risks and uncertainties include, among others, risks that
the FDA will withdraw approval of Makena in line with the
recommendation of the Advisory Committee; that the FDA could take
other adverse action related to Makena given the findings and
recommendation of the Advisory Committee; that AMAG may not be able
to generate additional efficacy data that will be satisfactory to
the FDA (if the FDA permits AMAG to submit additional data to
support or as a condition to the continued commercialization of
Makena); that healthcare providers may be reluctant to continue to
prescribe the Makena auto-injector or the FDA may require that the
Makena label include information on the PROLONG study, restrictions
to the current indication or the insertion of new warnings or
precautions; that AMAG is unlikely generate sufficient cash to
satisfy its debt obligations and could face challenges undertaking
fundraising, restructuring or strategic transactions in order to
meet these obligations, including under convertible notes due June
1, 2022; that AMAG will be significantly dependent on sales of
Feraheme to support its ongoing operations, including its
development pipeline, and Feraheme could face increased competition
in the near term, including as a result of the recent approval of
Monoferric® or if Sandoz’s ANDA is approved; that AMAG will face
difficulties or delays in appointing a chief executive officer to
succeed Mr. Heiden or a chief medical officer to succeed Dr. Krop
or otherwise be unable to successfully execute its leadership
transition plan; that AMAG will not be able to identify or effect
any transaction to divest Intrarosa or Vyleesi in the expected
timeframe, or at all, or that any transaction will be on terms that
are favorable to AMAG or that yield any value for its shareholders;
that the anticipated benefits of such a divestiture, including
anticipated expense reductions, will not be realized at expected
levels, or at all; that AMAG may be unable to gain approval of its
product candidates, including AMAG-423 and ciraparantag, on a
timely basis, or at all; that such approvals, if obtained, will
include unanticipated restrictions or warnings and that the costs
and time investments for AMAG’s development efforts will be higher
than anticipated, or that AMAG has over-estimated the market and
potential revenues for its products and product candidates, if
approved, including AMAG-423 and ciraparantag; that AMAG will be
unable to successfully identify and enter into partnerships with
out-licensees for its product candidates in ex-U.S. territories,
which could delay the commercialization of those product candidates
in certain geographies, as well as those risks identified in AMAG’s
filings with the U.S. Securities and Exchange Commission (SEC),
including its Annual Report on Form 10-K for the year ended
December 31, 2018, its Quarterly Report on Form 10-Q for the
quarters ended March 31, 2019, June 30, 2019 and September 30,
2019, and subsequent filings with the SEC (including its upcoming
Annual Report on Form 10-K for the year ended December 31, 2019),
which are available at the SEC’s website at www.sec.gov. Any
such risks and uncertainties could materially and adversely affect
AMAG’s results of operations, its profitability and its cash flows,
which would, in turn, have a significant and adverse impact on
AMAG’s stock price. AMAG cautions you not to place undue reliance
on any forward-looking statements, which speak only as of the date
they are made.
AMAG disclaims any obligation to publicly update or revise any
such statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward‐looking statements.
AMAG Pharmaceuticals®, the logo and designs, are registered
trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered
trademark of AMAG Pharma USA, Inc.
AMAG CONTACTS:Investors: Linda
Lennox908-627-3424
Media: Sarah Connors(781) 296-0722
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