Item 7.01. Regulation FD Disclosure.
AMAG
Pharmaceuticals, Inc. (“AMAG”), Palatin Technologies,
Inc.’s (“Palatin”) exclusive North American
licensee of Vyleesi™ (bremelanotide), has been in discussions
with the U.S. Food and Drug Administration (the “FDA”)
regarding its review of the New Drug Application
(“NDA”) submission for Vyleesi. The FDA has requested
that additional data be generated from a small Phase 1 study with
premenopausal volunteers assessing 24-hour ambulatory blood
pressure with short term daily use of Vyleesi. As part of its
ongoing review, the FDA has indicated that these data are required
to help characterize the impact of frequent dosing, including to
help inform the Vyleesi label. Palatin and AMAG believes that this
study can be conducted and data submitted prior to March 23, 2019,
the currently scheduled Prescription Drug User Fee Act
(“PDUFA”) date. The FDA will assess the need for an
Advisory Committee meeting after receipt and review of the
requested data, and has informed AMAG that the previously
communicated January 2019 Advisory Committee meeting will not take
place. Although AMAG’s discussions to date with the FDA are
preliminary, and AMAG will continue to have further discussions
with the FDA on this matter, AMAG believes that this submission of
additional data could cause a delay of the potential approval of
Vyleesi by three to six months.
This
report contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the
Securities Exchange Act of 1934 and as that term is defined in the
Private Securities Litigation Reform Act of 1995. Any statements
contained herein or therein which do not describe historical facts,
including, among others, expectations as to the FDA’s
requests;beliefs that the additional study can be conducted and
data submitted prior to the PDUFA date; the impact on the timeline
of the potential approval of Vyleesi; and expectations as to
further discussions with the FDA 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, the risk that the
FDA will require additional or more comprehensive study data, or
issue a complete response letter, which could cause a further delay
or challenges to the approval of the Vyleesi NDA, or which could
result in unanticipated restrictions or warnings on the product
label, if approved, and the risk that the costs associated with
such efforts will be higher than anticipated, as well as those
risks identified in Palatin’s filings with the U.S.
Securities and Exchange Commission (the “Commission”),
including its Annual Report on Form 10-K for the year ended June
30, 2018 and subsequent filings with the Commission, including its
Quarterly Report on Form 10-Q for the quarter ended September 30,
2018, which are available at the Commission’s website at
www.sec.gov. Any such risks and uncertainties could materially and
adversely affect Palatin’s results of operations, its
profitability and its cash flows, which would, in turn, have a
significant and adverse impact on Palatin’s stock price.
Palatin cautions you not to place undue reliance on any
forward-looking statements, which speak only as of the date they
are made. Palatin 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.