Only Approved Therapy for EU Patients with Rare
and Potentially Deadly Cancer Facing Median Survival of Only a Few
Months
Represents First Approval of an Allogeneic
T-Cell Immunotherapy Globally
Pierre Fabre to Lead Commercialization and
Distribution Activities in Europe
Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre
today announced that the European Commission (EC) has granted
marketing authorization for Ebvallo™ (tabelecleucel) as a
monotherapy for the treatment of adult and pediatric patients two
years of age and older with relapsed or refractory Epstein‑Barr
virus positive post‑transplant lymphoproliferative disease (EBV+
PTLD) who have received at least one prior therapy. For solid organ
transplant patients, prior therapy includes chemotherapy unless
chemotherapy is inappropriate.
The approval follows a positive opinion in October by the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) and is applicable to all 27
European Union member states plus Iceland, Norway, and
Liechtenstein. The CHMP positive opinion is based on results from
the pivotal Phase 3 ALLELE study.1 In this study, EbvalloTM
demonstrated a favorable risk-benefit profile.
“The approval of EbvalloTM in Europe is a medical breakthrough
for patients with significant unmet need,” said Pascal Touchon,
President and Chief Executive Officer of Atara. “As the first
allogeneic, or donor-derived, T-cell immunotherapy to receive
approval from any regulatory agency in the world, this marks a
historic moment for Atara, our European partner, Pierre Fabre, and
for the broader cell therapy field.”
EBV+ PTLD is a rare, acute, and potentially deadly hematologic
malignancy that occurs after transplantation when a patient’s
T-cell immune response is compromised by immunosuppression. It can
impact patients who have undergone solid organ transplant (SOT) or
allogeneic hematopoietic cell transplant (HCT). Poor median
survival of 0.7 months and 4.1 months for HCT and SOT,
respectively, is reported in EBV+ PTLD patients for whom standard
of care failed, underscoring the significant need for new
therapeutic options.
Under a previously announced License Agreement with Atara,
Pierre Fabre will lead all commercialization and distribution
activities in Europe and select other markets, in addition to
medical and regulatory activities following the transfer of the
EbvalloTM Marketing Authorization Application (MAA) from Atara to
Pierre Fabre.
“Ebvallo™ represents a significant moment in the cell therapy
space and a breakthrough for European patients with EBV+ PTLD,”
said Eric Ducournau, CEO of Pierre Fabre, Atara's commercialization
partner in Europe. “We are proud and excited to bring this
innovative therapy to the marketplace, which will reinforce Pierre
Fabre’s portfolio in oncology, hematology, and rare diseases.”
EbvalloTM has orphan designation in Europe. Orphan designation
is reserved for medicines treating life-threatening or chronically
debilitating diseases that are rare (affecting not more than five
in 10,000 people in the EU). Authorized orphan medicines benefit
from ten years of market exclusivity, protecting them from
competition with similar medicines with the same therapeutic
indication, which cannot be marketed during the exclusivity
period.
About Pierre Fabre Pierre Fabre is a French healthcare
company with over 35-years of experience in innovation,
development, manufacturing and commercialization in oncology. Its
portfolio includes several medical franchises and international
brands, namely Pierre Fabre Oncology, Pierre Fabre Dermatology,
Pierre Fabre Health Care, Eau Thermale Avène, Klorane, René
Furterer, A-Derma, Darrow, Glytone, Naturactive and Pierre Fabre
Oral Care. The company has declared oncology its top priority in
medical care R&D and commercialization, focusing on targeted
therapies, biotherapies and immuno-oncology. Its portfolio covers
oncology (colorectal, breast, lung cancers, melanoma and
pre-cancerous conditions like actinic keratosis), hematology and
rare diseases. In 2021, Pierre Fabre posted 2.5 billion euros in
revenues, 66% of which came from international sales in over 100
countries.
Established in the South-West of France since its creation, the
group manufactures over 95% of its products in France and employs
some 9,500 people worldwide. Pierre Fabre is 86%-owned by the
Pierre Fabre Foundation, a government-recognized public-interest
foundation, and secondarily by its own employees through an
international employee stock ownership plan. Pierre Fabre's social
responsibility approach has been assessed by the independent
organisation AFNOR Certification at the "Exemplary" level of the
CSR label (ISO 26 000 standard for sustainable development).
Further information about Pierre Fabre can be found at
www.pierre-fabre.com, @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 receiving marketing authorization 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 for Epstein-Barr virus positive
post-transplant lymphoproliferative disease (EBV+ PTLD) and other
EBV-driven diseases; 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 Southern 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 tab-cel®: 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, any collaboration involving tab-cel®, the commercial
prospects and business opportunity for tab-cel® in the territories
licensed to Pierre Fabre, Pierre Fabre’s ability to successfully
launch and commercialize tab-cel® and the potential financial
benefits to Atara as a result of the 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 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 (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.
1 https://doi.org/10.1182/blood-2021-147274
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version on businesswire.com: https://www.businesswire.com/news/home/20221218005055/en/
Atara: Investors Eric Hyllengren 805-395-9669
ehyllengren@atarabio.com
Media Alex Chapman 805-456-4772 achapman@atarabio.com
Pierre Fabre: Laure Sgandurra +33 6 32 54 92 01
laure.sgandurra@pierre-fabre.com
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