Vivek Jayaraman promoted to Chief Operating
Officer
Dr. Nina Mufti promoted to VP Development and
Red Blood Cell Program Leader
Dr. Yasmin Singh promoted to VP Development and
Platelet/Plasma/Therapeutics Program Leader
Cerus Corporation (Nasdaq:CERS) today announced the promotion of
three key leaders within the Company in anticipation of the
Company’s expected continued growth prospects, the anticipated
approval and launch of multiple products over the next several
years, as well as the need to realize greater operational
effectiveness as the Company works to scale.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20200302005230/en/
Cerus Corporation announced the promotion
of chief commercial officer Vivek Jayaraman to chief operating
officer. (Photo: Business Wire)
“These promotions from within our senior leadership team are
intended to create an organizational structure that is focused on
the ownership of key deliverables, both commercially and across our
development portfolio, and are expected to provide Cerus with the
continued growth opportunities required to achieve its mission of
making INTERCEPT Blood System the global standard of care in
transfusion medicine,” said William ‘Obi’ Greenman, Cerus’
president and chief executive officer. “Nina, Yasmin, and Vivek
have led many of the activities that have been integral to Cerus’
recent achievements and I am excited to welcome them into new
leadership roles so that the organization can benefit from their
considerable experience and expertise. We expect this to be a
transformative year for the company as we partner with our U.S.
blood center customers as they adapt to comply with the recent FDA
Guidance on the bacterial safety of platelets.”
Vivek Jayaraman, Chief Operating Officer
Mr. Jayaraman has served as Cerus’ chief commercial officer
since August 2016. Since that time, global revenues have more than
doubled. In his expanded role, Vivek will continue to lead
commercial efforts while also providing leadership for the supply
chain, customer service and manufacturing operations teams. “Vivek
has played an instrumental role in our growth over the last several
years, and we are excited to promote him into this position. With
his advancement to chief operating officer, Vivek will have the
overall span of influence to deliver the comprehensive customer
experience required to potentially make INTERCEPT a success
globally,” said Greenman. “In addition to continuing to lead our
worldwide commercial teams, he will assume responsibility for our
operations efforts with a near-term focus on improved manufacturing
efficiencies and supply chain optimization.”
Mr. Jayaraman came to Cerus from TriVascular, where as vice
president, sales and marketing he oversaw TriVacular’s commercial
expansion as the company grew from a preclinical, venture-backed
startup into a publicly traded, global medical device company.
Prior to TriVascular, he served in roles of increasing
responsibility at Medtronic, including serving as vice president of
global marketing for Medtronic’s endovascular innovations business.
Vivek received his MBA from the Wharton School at the University of
Pennsylvania and holds dual bachelor’s degrees from the University
of Michigan.
Nina Mufti, VP Development and Red Blood Cell Program
Leader
Dr. Mufti, who started with Cerus in 2007, has served most
recently as Cerus’ vice president of development since 2012,
overseeing clinical studies in support of the premarket approval
(PMA) submissions and approvals for INTERCEPT platelets and plasma
during her tenure. With the Red Blood Cell (RBC) program advancing
towards a possible CE Mark approval and the phase 3 studies in the
U.S. progressing to support a potential PMA submission for
INTERCEPT System for RBCs, the Company is focusing her
responsibilities on Red Blood Cell program strategy and execution
from manufacturing scale-up to clinical study execution, as well as
commercial launch readiness. “With Nina’s strong technical
background and business development acumen, she is uniquely well
positioned to successfully oversee the program execution and to
position us for the best possible launch following potential
regulatory approvals,” said Greenman.
Prior to coming to Cerus, Dr. Mufti worked at Nektar
Therapeutics for over seven years holding roles of increasing
responsibility in program and project management. Dr. Mufti
completed her Ph.D. in Biochemical Engineering at Cornell
University, and her Bachelor of Science, Biochemistry and Bachelor
of Applied Science, Chemical Engineering at the University of
Ottawa.
Yasmin Singh, VP Development and Platelet, Plasma and
Therapeutics Program Leader
Previously the vice president of program and portfolio
management, in her new role, Dr. Singh will lead the development
portfolio for the INTERCEPT platelets, plasma and therapeutics
business in a year that anticipates the submission of important PMA
supplements for platelet label claims and the expected submission
and possible approval of the first product in the therapeutics
portfolio. Dr. Singh will be responsible for advancing the
development of the full portfolio for these products as Cerus works
to iterate on the current marketed products to increase blood
center ease of use and to expand its label claims for these
components to meet the needs of its customers globally.
“Yasmin has a long, proven track record of managing complex
product development activities and has a comprehensive
understanding of the global regulatory and clinical development
landscape for the INTERCEPT products. I am excited to have her in
this new leadership role as we expand our product portfolio with
new therapeutic offerings,” said Greenman.
Prior to joining Cerus, Dr. Singh spent a year at Zogenix where
she headed project management, and before that she spent eight
years in project management at Jazz Pharmaceuticals where she led
the department for the last 6 years as executive director, project
management. Dr. Singh spent eight years at Cerus earlier in her
career, initially as a toxicologist. She was subsequently promoted
to plasma project team leader where she led the development of the
INTERCEPT plasma project through CE Mark submission and approval in
2006. Dr. Singh ended her first term at Cerus as INTERCEPT project
team leader before rejoining the Company in 2017. Dr. Singh
received her Bachelor of Science in Biological Sciences and Ph.D.
in Pharmacology and Toxicology from U.C. Davis.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Based in Concord, California, our employees are
dedicated to deploying and supplying vital technologies and
pathogen-protected blood components for blood centers, hospitals
and ultimately patients who rely on safe blood. With the INTERCEPT
Blood System, we are focused on protecting patients by delivering
the full complement of reliable products and expertise for
transfusion medicine. Cerus develops and markets the INTERCEPT
Blood System and remains the only company in the blood transfusion
space to earn both CE Mark and FDA approval for pathogen reduction
of both platelet and plasma components. Cerus currently markets and
sells the INTERCEPT Blood System in the United States, Europe, the
Commonwealth of Independent States, the Middle East and selected
countries in other regions around the world. The INTERCEPT Red
Blood Cell system is in clinical development. For more information
about Cerus, visit www.cerus.com.
Forward Looking Statements
Except for the historical statements contained herein, this
press release contains forward-looking statements concerning the
anticipated benefits of Cerus’ recently-announced management
promotions; continued growth prospects; the anticipated approval
and launch of multiple products by Cerus over the next several
years; Cerus’ mission of making INTERCEPT Blood System the global
standard of care in transfusion medicine and for INTERCEPT to be a
success globally; the Company’s expectations for 2020 as it relates
to their U.S. blood center customers; possible CE Mark approval for
the Red Blood Cell (RBC) program; advancing the RBC program toward
phase 3 studies in the U.S. to support a potential PMA submission;
the potential approval and launch of the INTERCEPT Blood System for
RBCs; the anticipated submission of important PMA supplements for
platelet label claims and the expected submission and possible
approval of the first product in the therapeutics portfolio; Cerus
working to iterate on its current marketed products to increase
blood center ease of use and to expand its label claims for these
components; and any other statements that are not historical facts.
Actual results could differ materially from these forward-looking
statements as a result of certain factors, including, without
limitation: risks associated with the commercialization and market
acceptance of, and customer demand for, the INTERCEPT Blood System,
including the risks that Cerus may not (a) grow sales globally,
including in its U.S. and European markets, and/or realize expected
revenue contribution resulting from its U.S. and European market
agreements, (b) realize meaningful and/or increasing revenue
contributions from U.S. customers in the near term or at all,
particularly since Cerus cannot guarantee the volume or timing of
commercial purchases, if any, that its U.S. customers may make
under Cerus’ commercial agreements with these customers, and/or (c)
realize any revenue contribution from its pipeline product
candidates, whether due to Cerus’ inability to obtain regulatory
approval of its pipeline product candidates, or otherwise; risks
associated with Cerus’ lack of commercialization experience in the
United States and its ability to develop and maintain an effective
and qualified U.S.-based commercial organization, as well as the
resulting uncertainty of its ability to achieve market acceptance
of and otherwise successfully commercialize the INTERCEPT Blood
System for platelets and plasma in the United States, including as
a result of licensure requirements that must be satisfied by U.S.
customers prior to their engaging in interstate transport of blood
components processed using the INTERCEPT Blood System; risks
related to Fresenius Kabi’s efforts to assure an uninterrupted
supply of platelet additive solution (PAS); risks related to how
any future PAS supply disruption could affect INTERCEPT’s
acceptance in the marketplace; risks related to how any future PAS
supply disruption might affect current commercial contracts; risks
related to Cerus’ ability to demonstrate to the transfusion
medicine community and other health care constituencies that
pathogen reduction and the INTERCEPT Blood System is safe,
effective and economical; the uncertain and time-consuming
development and regulatory process, including the risks (a) that
Cerus may be unable to comply with the FDA’s post-approval
requirements for the INTERCEPT platelet and plasma systems,
including by successfully completing required post-approval
studies, which could result in a loss of U.S. marketing approval
for the INTERCEPT platelet and/or plasma systems, (b) related to
Cerus’ ability to expand the label claims and product
configurations for the INTERCEPT platelet and plasma systems in the
United States, including for pathogen-reduced cryoprecipitate,
which will require additional regulatory approvals, (c) that Cerus
may be unable to submit its planned PMA supplements to the FDA in a
timely manner or at all, and even if submitted, such planned PMA
supplements may not be accepted or approved in a timely manner or
at all, (d) that Cerus may be unable to obtain CE Mark approval, or
any other regulatory approvals, of the INTERCEPT Blood System for
RBCs in a timely manner or at all, (e) that applicable regulatory
authorities may disagree with Cerus’ interpretations of the data
from its clinical studies and/or may otherwise determine not to
approve Cerus’ regulatory submissions, including Cerus’ planned PMA
supplement submissions and Cerus’ CE Mark submission, in a timely
manner or at all, and (f) even if Cerus’ regulatory submissions are
approved, Cerus may not receive label claims for all requested
indications or for indications with the highest unmet need or
market acceptance; risks associated with Cerus’ lack of experience
in marketing products directly to hospitals and expertise complying
with regulations governing finished biologics; risks associated
with the uncertain nature of BARDA’s funding over which Cerus has
no control as well as actions of Congress and governmental agencies
which may adversely affect the availability of funding under Cerus’
BARDA agreement and/or BARDA’s exercise of any potential subsequent
option periods, such that the anticipated activities that Cerus
expects to conduct with the funds available from BARDA may be
delayed or halted and that Cerus may not otherwise realize the
total potential value under its agreement with BARDA; risks related
to product safety, including the risk that the septic platelet
transfusions may not be avoidable with the INTERCEPT Blood System;
risks related to adverse market and economic conditions, including
continued or more severe adverse fluctuations in foreign exchange
rates and/or weakening economic conditions in the markets where
Cerus currently sells and is anticipated to sell its products;
Cerus’ reliance on third parties to market, sell, distribute and
maintain its products; Cerus’ ability to maintain an effective,
secure manufacturing supply chain, including the ability of its
manufacturers to comply with extensive FDA and foreign regulatory
agency requirements, and Cerus’ ability to maintain its primary kit
manufacturing agreement and its other supply agreements with its
third party suppliers; Cerus’ ability to identify and obtain
additional partners to manufacture pathogen-reduced
cryoprecipitate; risks associated with Cerus’ ability to meet its
debt service obligations and its need for additional funding; the
impact of legislative or regulatory healthcare reforms that may
make it more difficult and costly for Cerus to produce, market and
distribute its products; risks related to future opportunities and
plans, including the uncertainty of Cerus’ future capital
requirements and its future revenues and other financial
performance and results; as well as other risks detailed in Cerus’
filings with the Securities and Exchange Commission, including
Cerus’ Annual Report on Form 10-K for the year ended December 31,
2019, filed with the SEC on February 21, 2020. Cerus disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained in this press release.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200302005230/en/
Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
Cerus (NASDAQ:CERS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cerus (NASDAQ:CERS)
Historical Stock Chart
From Apr 2023 to Apr 2024