Item 7.01 Regulation FD Disclosure.
On November 9, 2022, Merrimack Pharmaceuticals, Inc. ("Merrimack" or the
"Company") announced that Ipsen, SA ("Ipsen") issued a press release stating
that Onivyde® regimen demonstrated statistically significant improvement in
overall survival in previously untreated metastatic pancreatic ductal
adenocarcinoma. A copy of the press release is attached as Exhibit 99.1 to this
Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be
deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of
1934, as amended, or otherwise subject to the liabilities of that section, nor
shall they be deemed incorporated by reference in any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except as expressly set
forth by specific reference in such filing.
Item 8.01 Other Events.
On November 9, 2022, Merrimack announced that Ipsen issued a press release
stating that Onivyde® regimen demonstrated statistically significant improvement
in overall survival in previously untreated metastatic pancreatic ductal
adenocarcinoma.
The Ipsen press release stated that the trial "met its primary endpoint
demonstrating clinically meaningful and statistically significant improvement in
overall survival compared to nabpaclitaxel plus gemcitabine in 770 previously
untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) and
key secondary efficacy outcome of progression-free survival (PFS) also showed
significant improvement over the comparator arm. The safety profile of Onivyde
in the NAPOLI 3 trial was consistent with those observed in the previous phase
I/II mPDAC study."
Ipsen indicated in its press release that it intends to file a supplemental New
Drug Application with the U.S. Food and Drug Administration for Onivyde in
combination with oxaliplatin plus 5- fluorouracil/leucovorin for the treatment
of patients with previously untreated mPDAC following the Fast Track Designation
granted in 2020.
Forward Looking Statements
To the extent that statements contained in the Merrimack August 3, 2022 press
release are not descriptions of historical facts, they are forward-looking
statements reflecting the current beliefs and expectations of management made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, as amended. Forward-looking statements include any
statements about Merrimack's strategy, future operations, future financial
position, future revenues and future expectations and plans and prospects for
Merrimack, and any other statements containing the words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan," "predict," "project,"
"target," "potential," "will," "would," "could," "should," "continue" and
similar expressions. In this press release, Merrimack's forward-looking
statements include, among others, Merrimack's rights to receive payments related
to certain milestone events or whether such milestones will be achieved, if at
all, the sufficiency of Merrimack's cash resources and Merrimack's strategic
plan, including any potential distribution of additional cash. Such
forward-looking statements involve substantial risks and uncertainties that
could cause Merrimack's future results, performance or achievements to differ
significantly from those expressed or implied by the forward-looking statements.
Such risks and uncertainties include, among others: Positive information about
pre-clinical and early stage clinical trial results does not ensure that later
stage or larger scale clinical trials will be successful. For example, Onivyde®
may not demonstrate promising therapeutic effect or appropriate safety profiles
in current or later stage or larger scale clinical trials as a result of known
or as yet unanticipated side effects. The results achieved in later stage trials
may not be sufficient to meet applicable regulatory standards or to justify
further development. Problems or delays may arise prior to the initiation of
planned clinical trials, during clinical trials or in the course of developing,
testing or manufacturing that could lead Ipsen and Elevation Oncology and their
partners and collaborators to fail to initiate or to discontinue development.
Even if later stage clinical trials are successful, unexpected concerns may
arise from subsequent analysis of data or from additional data. Obstacles may
arise or issues may be identified in connection with review of clinical data
with regulatory authorities. Regulatory authorities may disagree with Ipsen and
Elevation Oncology's view of the data or require additional data or information
or additional studies. In addition, the planned timing of initiation and
completion of clinical trials based upon Onivyde and the anti-HER Program are
subject to the ability of each of Ipsen and Elevation Oncology, respectively, to
enroll patients, enter into agreements with clinical trial sites and
investigators, and overcome technical hurdles and other issues related to the
conduct of the trials for which each of them is responsible. Additionally, each
of Ipsen and Elevation Oncology are subject to the risk that they may not
successfully commercialize these development programs. Merrimack is also subject
to the risk that it may not have funding sufficient for its foreseeable and
unforeseeable operating expenses and capital expenditure requirements. In
addition, press releases and other public statements by Ipsen and Elevation
Oncology may contain forward-looking statements. Merrimack undertakes no
obligation to update or revise any forward-looking statements. Forward-looking
statements should not be relied upon as representing Merrimack's views as of any
date subsequent to the date hereof. For a further description of the risks and
uncertainties that could cause actual results to differ from those expressed in
these forward-looking statements, as well as risks relating to Merrimack's
business in general, see the "Risk Factors" section of Merrimack's Annual Report
on Form 10-K filed with the SEC on March 9, 2022, any subsequent quarterly
report on Form 10-Q filed by Merrimack and the other reports Merrimack files
with the Securities and Exchange Commission.
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