Ipsen has been reshaping its drug lineup by placing offers and its newest one is a $247 million settlement to purchase Epizyme, a most cancers drug developer with one commercialized product and a pipeline of extra therapeutic candidates.
The important thing piece of the acquisition is Tazverik, a third-line therapy for follicular lymphoma. Whereas that drug is the primary in a category of therapies that treats most cancers by concentrating on a specific enzyme key to tumor development, it has been a modest vendor since its 2020 FDA approval. Ipsen should now present it could actually develop gross sales of the product in an more and more aggressive follicular lymphoma market.
In line with monetary phrases introduced Monday, Paris-based Ipsen pays $1.45 per share to accumulate Epizyme. That value is a 52.6% premium to Epizyme’s closing inventory value on Friday however Ipsen remains to be choosing up the corporate for reasonable because the tough monetary markets proceed to batter share costs throughout the biotech sector. A yr in the past, Epizyme’s shares traded at round $8 apiece. The Cambridge, Massachusetts-based firm went public in 2013 at $15 per share.
Tazverik accounted for $30.9 million in income in 2021, a 19.4% enhance over 2020 gross sales. Within the first quarter of this yr, Epizyme reported $8.6 million in gross sales for the drug. The acquisition settlement pledges to pay Epizyme shareholders extra relying on Tazverik’s gross sales development. The deal features a contingent worth proper that may pay an extra 30 cents per share when the drug’s gross sales attain $250 million, excluding Japan and Higher China, for 4 consecutive quarters by the tip of 2026.
Progress of Tazverik’s gross sales might rely upon successful regulatory approval as an earlier line of therapy for follicular lymphoma. The drug has reached a Part 3 take a look at that’s evaluating the remedy together with Revlimid and rituximab, a drug mixture at the moment used as a second-line remedy for the most cancers. In line with the acquisition settlement, Ipsen pledges to pay one other 70 cents per share upon Tazverik securing regulatory approval as a second-line remedy for follicular lymphoma by Jan. 1, 2028. The pivotal examine is predicted to report preliminary information in 2026.
In a Monday morning investor presentation, Ipsen CEO David Loew mentioned that approval of Tazverik as a second-line remedy for follicular lymphoma might push the drug to $800 million in peak gross sales. He added that the drug’s efficacy and security profile make it significantly fitted to treating aged and frail sufferers, who’re usually handled in community-based settings.
Tazverik is a small molecule designed to focus on EZH2, an enzyme that performs a job within the improvement and development of most cancers cells. In follicular lymphoma, the drug is authorised for treating sufferers whose tumors are optimistic for an EZH2 mutation. Months earlier than the 2020 regulatory nod in follicular lymphoma, the FDA authorised the drug for treating epithelioid sarcoma, a uncommon soft-tissue most cancers.
In follicular lymphoma, Tazverik competes in opposition to Yescarta and Kymriah, CAR T cell therapies from Gilead Sciences and Novartis respectively. As a small molecule, Tazverik’s oral formulation affords a dosing benefit over the infused cell therapies, that are manufactured in a prolonged multi-step course of. However the follicular lymphoma market earlier this gained a brand new therapy possibility with the European approval of Roche’s Lunsumio, a bispecific antibody. That drug nonetheless awaits an FDA resolution.
The Epizyme pipeline contains EZM0414, a drug designed to dam an SETD2, an enzyme that performs a job within the course of through which cells change into cancerous. Epizyme has began a Part 1/1b trial in a number of myeloma and diffuse massive B-cell lymphoma that has relapsed or has not responded to an earlier line of remedy.
Ipsen booked €2.9 billion (about $3 billion) in gross sales final yr. Somatuline, an artificial hormone authorised to deal with the hormone dysfunction acromegaly in addition to tumors within the intestine and pancreas, is the corporate’s solely blockbuster vendor. The oncology portfolio additionally contains is Cabometyx, which has approvals for superior kidney, liver and thyroid cancers. The drug was developed by Alameda, California-based Exelixis. A 2016 collaboration that paid Exelixis $210 million up entrance gave Ipsen rights to the drug outdoors of North America and Japan. Different offers have introduced earlier-stage most cancers drug candidates to Ipsen’s pipeline. Final yr, the corporate acquired rights to a small molecule from BAKX Therapeutics in preclinical improvement for leukemia, lymphoma and strong tumors.
The Ipsen and Epizyme boards of administrators have authorised the Epizyme acquisition, which is predicted to shut by the tip of the third quarter of this yr.
Public area picture by the Nationwide Most cancers Institute
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