Atara Biotherapeutics Announces Closing of Expanded Global Tab-cel® Partnership with Pierre Fabre Laboratories
20 Diciembre 2023 - 3:01PM
Business Wire
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell
immunotherapy, leveraging its novel allogeneic Epstein-Barr virus
(EBV) T-cell platform to develop transformative therapies for
patients with cancer and autoimmune diseases, today announced the
closing of the expanded global partnership with Pierre Fabre
Laboratories for tabelecleucel (tab-cel® or EBVALLOTM). Building on
the earlier partnership announced in October 2021 to commercialize
tab-cel in Europe, this transaction provides Pierre Fabre
Laboratories with the development, manufacturing, and
commercialization rights for tab-cel in the United States and all
remaining markets.
“We are pleased to announce the closing of the transaction with
Pierre Fabre Laboratories who are committed to expanding the reach
of tab-cel to patients in the U.S. and across the globe,” said
Pascal Touchon, President and Chief Executive Officer of Atara.
“Atara’s priority is to now submit the tab-cel BLA filing package,
while initiating our first clinical study with ATA3219, a potential
best-in-class allogeneic off-the-shelf CD19 CAR T with unique
features.”
With the closing of the transaction, Atara will receive
approximately USD 27 million in cash upfront and initial inventory
purchase. Under the agreement, Atara has the potential to receive
up to a total of USD 640 million and significant double-digit
tiered royalties on net sales, including up to USD 100 million in
potential regulatory milestones through BLA approval. In addition,
Pierre Fabre Laboratories will reimburse Atara for expected tab-cel
global development costs through the Biologics License Application
(BLA) transfer, and purchase future tab-cel inventory through the
manufacturing transfer date.
Substantially all tab-cel manufacturing, clinical, and
regulatory activities are planned to transition from Atara to
Pierre Fabre Laboratories at the time of BLA transfer.
Atara plans to submit the BLA to the U.S. Food and Drug
Administration (FDA) for tab-cel for the treatment of
post-transplant lymphoproliferative disease (PTLD) in the second
quarter of 2024.
About Atara Biotherapeutics, Inc.
Atara is harnessing the natural power of the immune system to
develop off-the-shelf cell therapies for difficult-to-treat cancers
and autoimmune conditions, that can be rapidly delivered to
patients within days. With cutting-edge science and differentiated
approach, Atara is the first company in the world to receive
regulatory approval of an allogeneic T-cell immunotherapy. Our
advanced and versatile Epstein-Barr virus (EBV) T-cell platform
does not require T-cell receptor or HLA gene editing and forms the
basis of a diverse portfolio of investigational therapies that
target EBV, the root cause of certain diseases, in addition to
next-generation AlloCAR-Ts designed for best-in-class opportunities
across a broad range of non-EBV-associated liquid and solid tumors.
Atara is headquartered in Southern California. For more
information, visit atarabio.com and follow @Atarabio on X (formerly
known as 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:
(1) the development, timing and progress of tab-cel®, including a
potential BLA, the potential characteristics and benefits of
tab-cel®, and the progress and results of, prospects for, and
closing of the expanded global partnership with Pierre Fabre
Laboratories involving tab-cel®, and the potential financial
benefits to Atara as a result of the expanded global partnership
with Pierre Fabre Laboratories; (2) the development, timing and
progress of Atara’s AlloCAR-T programs, including ATA3219; (3)
Atara’s cash runway; and (4) Pierre Fabre Laboratories’ activities
relating to tab-cel and the timing thereof. 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 and the wars
in Ukraine and the Middle East, which may significantly impact (i)
our business, research, clinical development plans and operations,
including our operations in Southern California and Denver 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 , 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/20231220458866/en/
Investor and Media Relations: Alex Chapman Vice
President, Corporate Communications & Investor Relations (805)
456-4772 achapman@atarabio.com Jason Awe, Ph.D. Senior Director,
Corporate Communications & Investor Relations (805) 217-2287
jawe@atarabio.com
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