After Roche breakup, Blueprint Medicines finds Gavreto a new home at Rigel

2024-02-22

临床3期上市批准引进/卖出临床结果加速审批

After Roche breakup, Blueprint Medicines finds Gavreto a new home at Rigel

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来源: FiercePharma

The Gavreto baton is being passed on from Roche to Rigel Pharma.

As Roche officially abandoned cancer drug Gavreto, its former partner Blueprint Medicines has found the RET inhibitor RET inhibitor a new owner in the U.S.

Rigel Pharmaceuticals will pay Blueprint $15 million to gain U.S. rights to Gavreto, the two companies said Thursday, just as Blueprint and Roche ended their collaboration.

Under the new Rigel deal, Blueprint is also eligible to receive up to $102.5 million in future regulatory and commercial milestone payments, plus tiered royalties ranging from 10% to 30% depending on Gavreto’s sales level. In 2023, Gavreto generated about $28 million in U.S. sales, Rigel noted.

Roche announced its intention to cut off Gavreto a year ago, with the termination going into effect today. After paying $775 million upfront to in-license the drug on the cusp of an FDA approval in 2020, Roche found that the drug wasn’t living up to its sales expectations. Then in July 2023, Roche decided to pull an accelerated approval for Gavreto in RET-mutant medullary thyroid cancer, citing an infeasible confirmatory trial.

With Big Pharma support, Blueprint in January said it will discontinue work on Gavreto outside the U.S. and Great China, where CStone takes the charge. Thursday, Blueprint said it has also ended the ex-U.S. royalty interest deal it had signed with Royalty Pharma in mid-2022. The pact was based on Gavreto sales-related royalties from the Roche collaboration.

For Rigel, Gavreto grows the California company’s oncology portfolio. The FDA in December approved Rigel’s Rezlidhia—which Rigel in-licensed from Forma Therapeutics—to treat IDH1-mutated acute myeloid leukemia. Rigel’s commercial offerings also include Tavalisse, which is indicated to treat adults with low platelet counts due to chronic immune thrombocytopenia.

“The addition of Gavreto will be highly synergistic with our current product portfolio, leveraging our existing commercial infrastructure and enabling us to expand into solid tumors,” Rigel’s chief commercial officer, Dave Santos, said in a statement Thursday.

Rigel will go up against Eli Lilly in the RET field. Last year, Lilly’s rival drug Retevmo ginned up $254 million in sales, including $175 million from the U.S. Retevmo also boasts a unique FDA nod to treat RET fusion-positive tumors regardless of their location.

In October, phase 3 data showed that Retevmo reduced the risk of progression or death by 53.5% compared with the combination of Merck & Co.’s Keytruda and chemotherapy in patients with newly diagnosed RET fusion-positive non-small cell lung cancer. The Lilly med also aced its own confirmatory trial in RET-mutant medullary thyroid cancer.

By comparison, Gavreto’s phase 3 AcceleRET-Lung trial in front-line RET fusion-positive NSCLC has yet to read out.

Rigel and Roche have entered a transition period, in which Roche’s Genentech will still help ensure that patients can access Gavreto without interruption. Rigel expects to complete the transition and start recognizing sales from Gavreto in the third quarter of 2024.

For its part, Blueprint expects the wind-down will significantly lower its operating expenses around Gavreto, though with little impact on the company’s overall numbers. Blueprint is currently focused on the systemic mastocytosis treatment Ayvakit, for which the company just dialed up the peak sales target to $2 billion.

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