RELEASE: Atara Biotherapeutics' Ebvallo® (tabelecleucel) Receives European Commission Approval as First Therapy for

(Information sent by the signatory company).

RELEASE: Atara Biotherapeutics' Ebvallo® (tabelecleucel) Receives European Commission Approval as First Therapy for

(Information sent by the signatory company)

Only approved therapy for EU patients with a rare and life-threatening cancer with a median survival of just a few months

Represents the first worldwide approval of an allogeneic T-cell immunotherapy

Pierre Fabre will lead the marketing 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 monotherapy for the treatment of adult and pediatric patients from two years of age with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (PTLD) who have received at least one prior treatment. For solid organ transplant patients, prior therapy includes chemotherapy, unless chemotherapy is inappropriate.

The approval follows a positive opinion issued in October by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to the 27 Member States of the European Union plus Iceland, Norway and Liechtenstein. The positive opinion of the CHMP is based on the results of the pivotal phase 3 study, ALLELE.[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 needs," said Pascal Touchon, President and CEO of Atara. "To be the first allogeneic or donor-derived T-cell immunotherapy to receive approval from any regulatory agency in the world represents a historic moment for Atara, our European partner, Pierre Fabre, and for the entire field of cell therapy." .

EBV PTLD is a rare, acute, and life-threatening hematologic malignancy that occurs after transplantation when the patient's T-cell immune response is compromised by immunosuppression. It can affect patients who have undergone a solid organ transplant (SOT) or an allogeneic hematopoietic stem cell transplant (HSCT). The median survival of EBV PTLD patients who have failed standard treatments is low, at 0.7 months and 4.1 months for HSCT and TOS, respectively, underscoring the great need for new therapeutic options.

Under a previously announced licensing agreement with Atara, Pierre Fabre will lead all marketing and distribution activities in Europe and other selected markets, in addition to medical and regulatory activities.

"Ebvallo® represents a significant moment in the field of cell therapy, and a breakthrough for European EBV PTLD patients," said Eric Ducournau, CEO of Pierre Fabre, Atara's European business partner. "We are proud and delighted to bring this innovative therapy to market, which will further strengthen Pierre Fabre's portfolio in oncology, hematology and rare diseases."

Ebvallo® has orphan drug designation in Europe. Orphan designation is reserved for medicines that treat life-threatening or chronically debilitating rare diseases that affect a small number of patients (less than five people in 10,000 in the EU). Authorized orphan drugs enjoy ten years of commercial exclusivity, which protects them from competition from similar drugs 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 marketing in the oncology industry. Its portfolio includes several medical franchises and international brands such as 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 as its top priority for healthcare RD and commercialization, with a focus on targeted therapies, biotherapies and immuno-oncology. Its portfolio spans colorectal, breast and lung cancers, melanoma and pre-cancerous conditions such as actinic keratosis, as well as hematology and rare diseases. In 2021, Pierre Fabre had a turnover of 2.5 billion euros, 66% of which came from international sales in more than 100 countries.

Established in the south-west of France since its creation, the Group manufactures more than 95% of its products in France and employs around 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 share plan. Pierre Fabre's approach to social responsibility has been assessed by the independent organization AFNOR Certification at the "Exemplary" level of the CSR label (ISO 26 000 standard for sustainable development).

More 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 EBV allogeneic T-cell platform to develop transformative therapies for patients with serious diseases, including solid tumors, hematologic cancers, and autoimmune diseases.

Through our flagship program, which has received marketing authorization in Europe, Atara is the most advanced allogeneic T-cell immunotherapy company, aiming to bring available treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T-cells and has the ability to treat a wide range of EBV-associated or other serious diseases by incorporating engineered CARs (Chimeric Antigen Receptors) or TCRs (T-cell receptors). . Atara is applying this platform, which does not require TCR or HLA gene editing, to create a robust portfolio of products including: tab-cel, in phase 3 development for post-transplant lymphoproliferative disease caused by Epstein-Barr virus ( PTEL EBV) and other diseases caused by EBV; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple new generation chimeric antigen receptor T (CAR-T) cell immunotherapies for both solid tumors and hematologic malignancies. Improving the lives of patients is our mission and we will never stop working to bring transformative therapies to those who need them. Atara is headquartered in Southern California. For more information about the company, visit atarabio.com and follow us on Twitter and LinkedIn.

Portal:

InversoresEric Hyllengrenehyllengren@atarabio.com

MediosAlex Chapmanachapman@atarabio.com

Pierre Fabre: Laure Sgandurralaure.sgandurra@pierre-fabre.com

[1] https://doi.org/10.1182/blood-2021-147274

Logo - https://mma.prnewswire.com/media/1970795...

View original content: https://www.prnewswire.com/news-releases/ebvallo-tabelecleucel-de-atara-biotherapeutics-recibe-la-aprobacion-de-la-comision-europea-como-primera-terapia-para-adultos-y-ninos-con-elptveb-301705940.html

Yorum yapabilmek için üye girişi yapmanız gerekmektedir.

Üye değilseniz hemen üye olun veya giriş yapın.

NEXT NEWS