CAMBRIDGE, Mass., Oct. 31, 2016 /PRNewswire/ -- Merrimack
Pharmaceuticals, Inc. (NASDAQ: MACK) today announced that the
U.S. Food and Drug Administration (FDA) has accepted for review the
Abbreviated New Drug Application (ANDA) for generic doxorubicin
hydrochloride (HCI) liposome injection submitted by its partner
Actavis LLC (an indirect, wholly owned subsidiary of Teva
Pharmaceuticals USA, Inc.). This
is the first product developed by Merrimack under a partnership
agreement with Actavis LLC pursuant to which Merrimack is
responsible for the development and commercial supply of bulk drug
product and Actavis LLC is responsible for fill/finish activities,
regulatory approvals and commercialization in the United
States.
Doxorubicin HCl liposome injection is marketed as DOXIL® in
the United States by Janssen
Products LP, a Johnson & Johnson company. The approved
indications for the product are ovarian cancer, AIDS-related
Kaposi's sarcoma and multiple myeloma. DOXIL generated
approximately $600 million annually
in global revenue prior to Johnson & Johnson's 2011
manufacturing disruption, which resulted in the placement of DOXIL
on the FDA's drug shortage list. While DOXIL was on the drug
shortage list, the FDA approved a generic version of doxorubicin
HCl liposome injection marketed by Sun Pharma Global FZE, and both
products now share the U.S. market. If approved, Merrimack is
eligible to receive a royalty rate in the mid-twenties of net
profits on sales of doxorubicin HCl liposome injection under the
agreement with Actavis.
"We are pleased to have achieved this important milestone with
our partner, Actavis," said Gary
Crocker, Chairman of Merrimack's Board of Directors and
interim President and CEO. "This collaboration leverages
Merrimack's proven expertise in the development of liposomal
products and provides the opportunity to maximize the use of our
state-of-the-art commercial liposomal manufacturing facility. It
also could allow us, if the product is approved, to generate an
additional revenue stream to not only offset costs but meaningfully
improve earnings. We look forward to the FDA's review of Actavis's
ANDA filing and providing further support as Actavis navigates the
regulatory approval process."
Merrimack is a leader in the development and manufacturing of
nanoliposomal products. In addition to the generic doxorubicin HCl
liposome injection for which the ANDA was just accepted, Merrimack
has developed or is developing several novel therapeutic
candidates. Merrimack's first commercial product, ONIVYDE®
(irinotecan liposome injection), is a novel liposomal formulation
of irinotecan that was approved by the FDA in the United States in October 2015.
Forward-looking Statements
To the extent that statements contained in this 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 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," "hope" and similar expressions. In this press
release, Merrimack's forward-looking statements include statements
about Merrimack's ability to develop future liposomal products,
potential future revenue streams and potential improvement to
earnings. Such forward-looking statements involve substantial risks
and uncertainties that could cause Merrimack's development
programs, 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, the uncertainties inherent in the initiation of
future clinical trials, availability of data from ongoing clinical
trials, expectations for regulatory approvals, development progress
of Merrimack's companion diagnostics, availability of funding
sufficient for Merrimack's foreseeable and unforeseeable operating
expenses and capital expenditure requirements, and other matters
that could affect the availability or commercial potential of
Merrimack's products, product candidates or companion diagnostics.
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 Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (SEC) on August 4, 2016 and other reports Merrimack files
with the SEC.
Contacts:
Geoffrey Grande, CFA
617-441-7602
ggrande@merrimack.com
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SOURCE Merrimack Pharmaceuticals, Inc.