Daily Newsletter

06 November 2023

Daily Newsletter

06 November 2023

Pierre Fabre and Atara expand licensing agreement for Epstein-Barr therapy

The expanded agreement grants Pierre Fabre marketing rights to Ebvallo in the US, Canada, and other remaining territories.

Phalguni Deswal November 03 2023

Atara Biotherapeutics has sold its marketing rights to Ebvallo (tabelecleucel) in North America, Asia Pacific, and Latin America to Pierre Fabre Laboratories, in a deal worth over $640m.

Ebvallo is an off-the-shelf, allogeneic T-cell immunotherapy, which has been approved as monotherapy by the European Commission (EC) for treating patients ages two years and above with Epstein‑Barr virus-positive post‑transplant lymphoproliferative disease (EBV+ PTLD).

The additional Ebvallo rights agreement grants Atara $30m in upfront payment, up to $100m in regulatory milestone-based payments and double-digit tiered royalties on net sales. The upfront payment also includes the cost for the initial inventory purchase for Ebvallo, as per the 3 November press release.

Additionally, Pierre Fabre will also reimburse Atara for Ebvallo’s global development costs. Atara plans to submit the biologics license application (BLA) for Ebvallo for treating EBV+ PTLD in Q2 2024. Following the BLA approval, Atara will transfer the BLA along with the associated manufacturing, clinical, and regulatory activities to Pierre Fabre.

In 2021, the French company acquired Ebvallo’s marketing rights in Europe, the Middle East, Africa, and other select emerging markets. At the time, Pierre Fabre announced it would pay $45m in upfront cost, up to $320m in milestone-based payments, and double-digit tiered royalties as a percentage of net sales.

"Pierre Fabre Laboratories have made oncology their top priority in medical care. Since 2019, we have almost tripled our revenues in this therapeutic field, and we expect to pass the €500m ($535.8m) bar this year,” said Eric Ducournau, CEO of Pierre Fabre Laboratories.   

“This expansion of our partnership with Atara will allow us to make a first step in the US, by far the largest oncology market in the world, and to reach even more patients in need for innovative treatments."

In September, the French company partnered with HitGen’s UK subsidiary Vernalis to identify and develop multiple oncology drugs. In April, it partnered with Scorpion Therapeutics to co-develop two epidermal growth factor receptor (EGFR) inhibitors that target EGFR mutations in non-small cell lung cancer (NSCLC).

Significant unmet need in the Diabetic nephropathy (DN) market for products that can treat DN effectively without side effects

With only a few approved drugs currently available to treat DN by means other than regulation of blood pressure, innovator products that can treat by targeting other factors such as treatment of dyslipidemia, hypertension, or angiotensin inhibition, among others, is a key area of R&D in the DN space and is likely to pave the way for novel therapies in the near future. However, the treatment landscape is expected to remain unchanged due to limited availability of products in the late-stage pipeline currently.

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