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 (PMA) application shell for review of the INTERCEPT Blood
System for platelets. 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.
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 application. 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
currently has a PMA application with respect to its plasma system that
is being submitted in four modules. The PMA application shell accepted
by the FDA for the platelet system provides for three modular
submissions, with the first module scheduled for submission at the end
of September.
“Our platelet PMA shell proposal was designed to leverage synergies with
our ongoing modular PMA submissions for our plasma system, allowing us
to target completion of all three platelet modules by March 2014,” said
Carol Moore, Cerus’ senior vice president, regulatory affairs, quality
and clinical. “With the scheduled submission of the final INTERCEPT
plasma module planned for the fourth quarter of this year, we have the
possibility of receiving U.S. approvals for both products as soon as the
second half of 2014.”
Cerus recently announced its intention to pursue a modular PMA
submission for the INTERCEPT Blood System for platelets after dialogue
with the FDA indicated that the company could proceed with
an application based on the existing dossier of clinical and routine use
data, along with a post-marketing study commitment, rather than being
required to complete an additional Phase III clinical study.
“The platelet PMA submission timeline accepted by the FDA means we may
be able to launch INTERCEPT platelets and plasma virtually
simultaneously in the U.S.,” said Cerus' president and CEO, William
‘Obi’ Greenman. "Cerus is focused on succeeding at this goal, and
maximizing the global impact we believe a U.S. market entry can create."
The INTERCEPT Blood System for platelets received a CE mark in 2002,
with subsequent national approvals in France, Germany and Switzerland.
In clinical trials, INTERCEPT platelet components were well
tolerated and demonstrated therapeutic efficacy comparable to
conventional plasma. Data have also been collected in Phase IV clinical
studies and hemovigilance programs that support the safety and efficacy
of INTERCEPT platelets in routine use across a broad variety of
indications. INTERCEPT platelets are currently used by customers in
Austria, Belgium, Chile, France, Italy, Kazakhstan, Kuwait, Norway,
Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Saudi Arabia,
Turkey.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused on enhancing
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 platelets and for plasma. The INTERCEPT red
blood cell system 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 submission of
PMA modules to the FDA, including the timing thereof, the timing of the
PMA review process by the FDA, the potential approval and future launch
of the INTERCEPT Blood System for plasma and platelets in the U.S., and
the potential impact a U.S. approval will have globally. 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, risks
related to the commercialization and market acceptance of, and customer
demand for, the INTERCEPT Blood System, that the review by the FDA may
take longer than expected, that Cerus may encounter unanticipated
difficulties complying with the prescribed submission timing or other
modular PMA requirements related to the INTERCEPT Blood System for
plasma or for platelets, that the FDA could require additional clinical
data to support potential approval and that if additional clinical
development is required, it will require funding that Cerus does not
currently have, that the FDA may not approve the INTERCEPT Blood System
for plasma or for platelets, risks associated with successfully
launching a commercial product in new territories, the potential demand
for the INTERCEPT Blood System , adverse market and economic conditions
and other risks detailed in the Cerus' filings with the Securities and
Exchange Commission (SEC), including in Cerus' annual report on Form
10-K for the year ended December 31, 2012, filed with the SEC on March
12, 2013. 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