Cerus Announces FDA Agreement on Modular Premarket Approval (PMA) Application Submission Process for INTERCEPT Platelets

  Cerus Announces FDA Agreement on Modular Premarket Approval (PMA)
  Application Submission Process for INTERCEPT Platelets

Business Wire

CONCORD, Calif. -- April 24, 2013

Cerus Corporation (NASDAQ: CERS) announcedtoday 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 anapplication 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 toleratedand demonstrated
therapeutic efficacy comparable to conventional plasma. Data have also
beencollected 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. INTERCEPTplatelets 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 theCerus'filings
with theSecurities and Exchange Commission(SEC), including inCerus'annual
report on Form 10-K for the year ended December 31, 2012, filed with
theSEConMarch 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.Cerusdoes not undertake any obligation to update any
forward-looking statements as a result of new information, future events,
changed assumptions or otherwise.

Contact:

Cerus Corporation
Lainie Corten, 925-288-6319
Sr Director, Global Marketing & Investor Relations
 
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