Ipsen and Epizyme revealed today that they have signed a legally binding merger agreement that would see Ipsen purchase Epizyme. The boards of directors of both Ipsen and Epizyme unanimously authorised the deal, and it is anticipated that it will close by the end of the third quarter of 2022, provided that all closing requirements are met. A fully integrated, commercial-stage biopharmaceutical business called Epizyme creates and administers innovative epigenetic target-based revolutionary treatments for cancer patients.
The acquisition is focussed on the main drug, Tazverik® (tazemetostat), a first-in-class, chemotherapy-free EZH2 inhibitor that was given Accelerated Approval by the US Food and Drug Administration (FDA) in 2020.
“Through this agreement, we will expand our assets in oncology. Ipsen’s capabilities and resources in oncology combined with Epizyme’s will accelerate the growth of Tazverik to achieve its full potential in follicular lymphoma patients. The strength of data support Tazverik’s positioning in patients with both EZH2 mutation positive and wild-type follicular lymphoma. We are compelled by the potential of its efficacy and tolerability profile, especially for elderly and/or frail patients who are treated in the community-based setting. Furthermore, we are excited to bring on board epigenetic expertise and the SETD2 inhibitor, as well as several pre-clinical compounds into our portfolio,”said David Loew, Chief Executive Officer of Ipsen.
It is currently indicated for adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies and whose tumours are positive for an EZH2 mutation as detected by an FDA-approved test, as well as for adults and paediatric patients aged 16 years and older with metastatic or locally advanced epithelioid cancer.
“Epizyme was founded in 2007 with a commitment to rigorous scientific research and a vision of developing novel epigenetic therapies. I am incredibly proud of what our team has accomplished over the past 15 years, from the approval of Tazverik to advancing our next novel investigational agent, EZM0414, to the clinic, as well as the progress made on our preclinical compounds focused on both hematologic malignancies and solid tumors. We expect that this acquisition and Ipsen’s commitment to invest in the oncology space will ensure our epigenetic pipeline continues to advance in a way we could not have done on our own to bring transformative cancer therapies to patients in need,”said Grant Bogle, President and Chief Executive Officer of Epizyme.
In patients with relapsed or refractory FL who have undergone at least one previous treatment, Tazverik is now in the Phase III stage of a registrational confirmatory trial (SYMPHONY-1) in combination with rituximab and lenalidomide (R2). Initial findings from the study’s Phase III randomised component are anticipated in 2026.
As part of the transaction, Ipsen will also acquire EZM0414, a first-in-class oral SETD2 inhibitor development candidate from Epizyme. This candidate has received FDA Fast Track designation and is currently being evaluated in a Phase I/Ib trial in adult patients with relapsed or refractory multiple myeloma and diffuse large B-cell lymphoma.
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