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
THOUSAND
OAKS, Calif. and CASTRES, France, Dec. 19,
2022 /PRNewswire/ -- 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 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.
![Pierre Fabre and Atara Logo Pierre Fabre and Atara Logo](https://mma.prnewswire.com/media/1970795/Pierre_Fabre_Atara_Logo.jpg)
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, Ebvallo® demonstrated a favorable
risk-benefit profile.
"The approval of Ebvallo® in Europe represents 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 represents 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 stem 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
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."
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). 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 in Phase 3 development for Epstein-Barr
virus-driven 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.
Pierre Fabre:
Laure Sgandurra
laure.sgandurra@pierre-fabre.com
Atara:
Investors
Eric
Hyllengren
ehyllengren@atarabio.com
Media
Alex
Chapman
achapman@atarabio.com
[1] https://doi.org/10.1182/blood-2021-147274
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