CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today that the U.S. Food and
Drug Administration (FDA) has accepted its proposed modular Premarket
Approval application (PMA) shell for review of the INTERCEPT Blood
System for plasma. A PMA shell is an outline of the application process
that defines the structure, content and timing of each module. FDA and
the applicant need to agree on a shell prior to initiation of a modular
PMA submission.
”Our PMA shell proposal was designed to leverage our existing regulatory
dossier from European approvals and to begin the INTERCEPT plasma
regulatory submission in Q1 of 2013,” said Carol Moore, Cerus’ vice
president, regulatory affairs, quality and clinical. “FDA’s agreement
with our proposal means that we can target completing all four modules
in 2013, putting us in a position to receive U.S. approval as early as
2014.”
A modular PMA review process is based on submission of a compilation of
sections or "modules" at 90-day intervals that together become a
complete PMA. Under a modular approach, FDA is able to review each
module separately, allowing the applicant to receive timely feedback and
potentially resolve deficiencies earlier in the review process than
would be expected with a traditional PMA application.
Cerus recently announced its intention to pursue a modular PMA
submission after dialogue with the FDA indicated that the company could
proceed with an application for multiple indications of plasma use, not
just the thrombotic thrombocytopenic purpura (TTP) indication for which
Cerus received orphan drug designation last year.
“Approval in the U.S. would be a pivotal achievement for us,” said
Cerus' president and CEO, William ‘Obi’ Greenman. "We have already begun
launch planning activities for the U.S., benefiting from our many
years of experience in Europe commercializing the INTERCEPT Blood System
and working with INTERCEPT plasma customers."
The INTERCEPT Blood System for plasma received a CE mark in 2006, with
subsequent national approvals in France, Germany and Switzerland. In
clinical trials in patients with acquired coagulopathies, congenital
coagulopathies and TTP, INTERCEPT plasma was well tolerated and
demonstrated therapeutic efficacy comparable to conventional plasma.
Data have also been collected in Phase IV studies and hemovigilance
programs that support the safety and efficacy of INTERCEPT plasma in
routine use across a broad variety of indications. INTERCEPT plasma is
currently used by customers in Belgium, France, Germany, Italy,
Kazakhstan, Russia and Spain.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused on
commercializing the INTERCEPT Blood System to enhance blood safety. The
INTERCEPT system is designed to reduce the risk of
transfusion-transmitted diseases by inactivating a broad range of
pathogens such as viruses, bacteria and parasites that may be present in
donated blood. The nucleic acid targeting mechanism of action enables
INTERCEPT treatment to inactivate established transfusion threats, such
as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed
to inactivate emerging pathogens such as influenza, malaria and dengue.
Cerus currently markets and sells the INTERCEPT Blood System for both
platelets and plasma in Europe, the Commonwealth of Independent States,
the Middle East and selected countries in other regions around the
world. In the United States, Cerus is seeking regulatory approval of the
INTERCEPT Blood System for plasma, and is in discussion with FDA to
define the additional clinical data required for a regulatory submission
for the INTERCEPT Blood System for platelets. The INTERCEPT Blood System
for red blood cells is in clinical development. See http://www.cerus.com
for more information.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
This press release contains forward-looking statements. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements,
including, without limitation, statements relating to the timing of the
PMA review process by the FDA, the potential approval and future launch
of the INTERCEPT Blood System for plasma in the U.S., and the potential
benefits from applying our commercialization experience to a potential
launch in the U.S. These forward-looking statements are based upon
Cerus’ current expectations. Actual results could differ
materially from these forward-looking statements as a result of certain
factors, including, without limitation, the risk that the review by the
FDA may take longer than expected, that the FDA could require additional
data to support potential approval, or that the FDA may not approve the
INTERCEPT Blood System for plasma, risks associated with successfully
launching a commercial product in new territories and the related
potential demand for the INTERCEPT Blood System and other risks detailed
in the Cerus' filings with the Securities and Exchange Commission (SEC),
including in Cerus' quarterly report on Form 10-Q for the quarter ended
September 30, 2012, filed with the SEC on November 8, 2012. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press
release. Cerus does not undertake any obligation to update any
forward-looking statements as a result of new information, future
events, changed assumptions or otherwise.
Source: Cerus Corporation