Pierre Fabre to Lead Launch and
Commercialization Activities for EBVALLO™ In Europe Following
Transfer of European Commission Marketing Authorization from Atara
Biotherapeutics
EBVALLO™ is the Only Approved Therapy for the
Treatment of Relapsed or Refractory Epstein‑Barr Virus Positive
Post‑Transplant Lymphoproliferative Disease (EBV+ PTLD) in the
EU
Pierre Fabre and Atara Biotherapeutics, Inc. (Nasdaq: ATRA)
today announced the transfer of the European Commission (EC)
marketing authorization (MA) for EBVALLO™ (tabelecleucel) for
patients with relapsed or refractory Epstein‑Barr virus positive
post‑transplant lymphoproliferative disease (EBV+ PTLD) from Atara
to Pierre Fabre. From today, Pierre Fabre will lead all
commercialization, distribution, medical and regulatory activities
in Europe, Middle East, Africa and other selected markets. Pierre
Fabre is planning to launch EBVALLO™ in the first European
countries during quarter one of 2023.
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“We are delighted that, at Pierre Fabre, we will now be able to
make EBVALLO™ available to patients with Epstein‑Barr virus
positive post‑transplant lymphoproliferative disease (EBV+ PTLD) as
quickly as possible,” said Eric Ducournau, CEO of Pierre Fabre. “As
a Company, we are passionate in accelerating the development and
delivery of ground-breaking treatments for solid tumors,
hematologic malignancies and rare diseases. With EBVALLO™ being the
only approved therapy for EU patients affected by EBV+ PTLD, this
is a significant milestone for people diagnosed with this rare and
potentially deadly cancer and an important step forward in our
commitment to addressing clinical challenges with solutions once
considered unimaginable.”
On December 16, 2022, the EC granted marketing authorization for
EBVALLO™ as a monotherapy for the treatment of adult and pediatric
patients two years of age and older with relapsed or refractory
EBV+ PTLD who have received at least one prior therapy. For solid
organ transplant patients, prior therapy includes chemotherapy,
unless chemotherapy is inappropriate. The EC marketing
authorization is based on results from the pivotal Phase 3 ALLELE
study and additional supportive studies. Based on these results,
EBVALLO™ demonstrated a favorable risk-benefit profile.1
“Following the EU approval of EBVALLO™, Atara is the first
company to obtain regulatory approval for an allogeneic T-cell
immunotherapy, reinforcing the significant advantages of our EBV
platform and approach,” said Pascal Touchon, President and Chief
Executive Officer of Atara. “We are excited for Pierre Fabre to now
bring this innovative new treatment to EBV+ PTLD patients in Europe
who, until now, have had no approved therapeutic options and faced
just a few weeks to a few months median survival.”
EBVALLO™ 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).
Atara will continue to be responsible for the pivotal ALLELE
study in PTLD and the Phase 2 multi-cohort study, which is
evaluating EBVALLO™ in additional patient populations. Atara
retains full rights to EBVALLO™ in other major markets, including
North America, Asia Pacific, and Latin America.
About EBVALLO™ and EBV+
PTLD
EBVALLO™ (tabelecleucel) is an allogeneic, EBV-specific T-cell
immunotherapy which targets and eliminates EBV-infected cells in an
HLA-restricted manner. EBV+ PTLD is a rare, acute, and potentially
deadly hematologic malignancy that occurs after transplantation
when patient T-cell immune responses are compromised by
immunosuppression. It can impact patients who have undergone solid
organ transplant (SOT) or allogeneic 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.
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, ADerma, 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:
(1) the potential benefits, safety and efficacy of Ebvallo™; and
(2) Pierre Fabre’s activities relating to the commercialization of
Ebvallo™ in Europe and the progress 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 ongoing COVID-19 pandemic and
the war in Ukraine, which may significantly impact (i) Atara’s
business, research, clinical development plans and operations,
including Atara’s operations in Southern California and Denver and
at Atara’s clinical trial sites, as well as the business or
operations of Atara’s third-party manufacturer, contract research
organizations or other third parties with whom Atara conducts
business, (ii) Atara’s ability to access capital, and (iii) the
value of Atara’s 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.
1 Mahadeo KM, et al. New and Updated Results from a Multicenter,
Open-Label, Global Phase 3 Study of Tabelecleucel (Tab-cel) for
Epstein-Barr Virus-Positive Post-Transplant Lymphoproliferative
Disease (EBV+ PTLD) Following Allogeneic Hematopoietic Cell (HCT)
or Solid Organ Transplant (SOT) after Failure of Rituximab or
Rituximab and Chemotherapy (ALLELE). Blood. 2022;140(1):
10374–10376.
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INVESTOR & MEDIA:
Pierre Fabre: Laure Sgandurra +33 6 32 54 92 01
laure.sgandurra@pierre-fabre.com
Atara: Investors Eric Hyllengren 805-395-9669
ehyllengren@atarabio.com
Media Alex Chapman 805-456-4772 achapman@atarabio.com
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