Atara Biotherapeutics to Receive Additional Near-Term Milestone Payment Under Updated Tabelecleucel (Tab-cel®) Commercialization Agreement with Pierre Fabre
September 28 2022 - 4:01PM
Business Wire
Atara to Receive Additional USD 30 Million Upon
European Commission (EC) Approval and Filing of Tab-cel®
Marketing Authorization Transfer to Pierre Fabre
Responses Submitted to European Medicines
Agency for Final Day 180 List of Outstanding Issues
Anticipated Tab-cel® EC Approval on Track for
Q4 2022
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell
immunotherapy, today announced an update to its existing
collaboration agreement with Pierre Fabre for the commercialization
of tabelecleucel (tab-cel®) for Epstein-Barr virus (EBV)-positive
cancers.
Under the amended terms, Atara will receive an additional USD 30
million milestone payment upon tab-cel® EC approval and subsequent
filing of the Marketing Authorization Application (MAA) transfer to
Pierre Fabre in exchange for reduced tab-cel® royalties and supply
price mark-up for Pierre Fabre. Tiered royalties on sales remain at
a significant double-digit rate following this amendment.
“With an anticipated European approval in Q4 2022, tab-cel® is
positioned to become the first ever allogeneic off-the-shelf T-cell
therapy available for patients with significant need,” said Pascal
Touchon, President and CEO of Atara. “This update to our agreement
with Pierre Fabre reaffirms our strong partnership and shared
belief in the transformative potential of tab-cel®, while enabling
Atara to further extend our cash runway.”
In October 2021, Atara entered into an exclusive
commercialization agreement with Pierre Fabre for tab-cel® in
Europe, Middle East, Africa and other select emerging markets for
EBV-positive cancers, receiving an upfront payment of USD 45
million, and up to approximately USD 320 million in additional
regulatory and sales milestone payments. In addition to
responsibility for the pivotal ALLELE study in EBV+ post-transplant
lymphoproliferative disease (EBV+ PTLD) and securing European
Commission approval, Atara also remains responsible for the Phase 2
multi-cohort study, which is evaluating tab-cel® in six additional
patient populations with the goal of label expansion in other
EBV-driven cancers. Pierre Fabre will lead all commercialization
and distribution activities in the territories, as well as medical
and regulatory activities after the anticipated MAA approval in
Europe. Atara retains full commercialization rights to tab-cel® in
the United States and other major markets.
“Tab-cel® has the potential to be a transformational
product for EBV-positive cancers and is eagerly awaited by
physicians and patients in Europe with limited treatment options,”
said Eric Ducournau, CEO of Pierre Fabre. “This update to our
agreement with Atara confirms our confidence and commitment to
tab-cel® in Europe, where the Pierre Fabre team is excited to bring
the first allogeneic T-cell therapy to European patients in a rare
oncology condition.”
Atara is leveraging its first-in-kind allogeneic off-the-shelf
EBV T-cell platform to develop transformative therapies for
patients including tab-cel®, which is the Company’s lead candidate
in development for EBV-positive cancers, including EBV+ PTLD, where
it is currently being investigated in adults and children in the
Phase 3 ALLELE study. Tab-cel® has been granted Breakthrough
Therapy Designation by the U.S. Food and Drug Administration (FDA)
and Priority Medicines (PRIME) designation by the European
Medicines Agency (EMA).
Further information about Pierre Fabre can be found at
www.pierre-fabre.com and @PierreFabre.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in T-cell
immunotherapy leveraging its novel allogeneic EBV T-cell platform
to develop transformative therapies for patients with serious
diseases including solid tumors, hematologic cancers and autoimmune
disease. With our lead program in Phase 3 clinical development and
currently under review to support registration in Europe, Atara is
the most advanced allogeneic T-cell immunotherapy company and
intends to rapidly deliver off-the-shelf treatments to patients
with high unmet medical need. Our platform leverages the unique
biology of EBV T cells and has the capability to treat a wide range
of EBV-associated diseases, or other serious diseases through
incorporation of engineered CARs (chimeric antigen receptors) or
TCRs (T-cell receptors). Atara is applying this one platform, which
does not require TCR or HLA gene editing, to create a robust
pipeline including: tab-cel® (tabelecleucel) in Phase 3 development
for Epstein-Barr virus-driven post-transplant lymphoproliferative
disease (EBV+ PTLD); ATA188, a T-cell immunotherapy targeting EBV
antigens as a potential treatment for multiple sclerosis; and
multiple next-generation chimeric antigen receptor T-cell (CAR-T)
immunotherapies for both solid tumors and hematologic malignancies.
Improving patients’ lives is our mission and we will never stop
working to bring transformative therapies to those in need. Atara
is headquartered in South San Francisco, California.
For additional information about the company, please visit
atarabio.com and follow us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains or may imply “forward-looking
statements” within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934. For
example, forward-looking statements include statements regarding
Atara’s cash runway and statements regarding tab-cel®,including:
the timing of, and Atara’s plans for, and potential decision by,
the EMA regarding the MAA submission for EBV+ patients with PTLD,
the development, timing and progress of tab-cel®, the potential
characteristics and benefits of tab-cel®, and the progress and
results of, and prospects for, Atara’s collaboration with Pierre
Fabre involving tab-cel®, the commercial prospects and business
opportunity for tab-cel® in the territories licensed to Pierre
Fabre, and the potential financial and other benefits to Atara as a
result of the collaboration (and the amended terms of such
collaboration) with Pierre Fabre. Because such statements deal with
future events and are based on Atara’s current expectations, they
are subject to various risks and uncertainties and actual results,
performance or achievements of Atara could differ materially from
those described in or implied by the statements in this press
release. These forward-looking statements are subject to risks and
uncertainties, including, without limitation, risks and
uncertainties associated with the costly and time-consuming
pharmaceutical product development process and the uncertainty of
clinical success; the COVID-19 pandemic, which may significantly
impact (i) our business, research, clinical development plans and
operations, including our operations in South San Francisco and
Southern California and at our clinical trial sites, as well as the
business or operations of our third-party manufacturer, contract
research organizations or other third parties with whom we conduct
business, (ii) our ability to access capital, and (iii) the value
of our common stock; the sufficiency of Atara’s cash resources and
need for additional capital; and other risks and uncertainties
affecting Atara’s and its development programs, including those
discussed in Atara’s filings with the Securities and Exchange
Commission (SEC), including in the “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” sections of the Company’s most recently filed periodic
reports on Form 10-K and Form 10-Q and subsequent filings and in
the documents incorporated by reference therein. Except as
otherwise required by law, Atara disclaims any intention or
obligation to update or revise any forward-looking statements,
which speak only as of the date hereof, whether as a result of new
information, future events or circumstances or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20220928005787/en/
INVESTOR & MEDIA CONTACTS: Atara:
Investors Eric Hyllengren 805-395-9669
ehyllengren@atarabio.com Media Alex Chapman 805-456-4772
achapman@atarabio.com
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