Pfizer’s Vizimpro, a drug approved in 2018 for EGFR-positive lung cancer but pushed into obscurity by AstraZeneca’s juggernaut Tagrisso, has delivered a victory of sorts. A US jury decided last week that Tagrisso infringes two US patents covering methods of treating Iressa-resistant NSCLC, as a result of which Astra must pay Pfizer $107.5m in damages. Still, the relevance of Vizimpro, whose sales are so insignificant Pfizer doesn’t break them out, is indirect, and during the case the drug’s standing as a competitor to Tagrisso was disputed. Vizimpro was developed as an irreversible, second-generation EGFR competitor to Iressa and Tarceva, but it never demonstrated activity in Iressa-resistant patients; that fell to Tagrisso, a third-generation drug, which subsequently moved into front-line use and wiped out the market for Iressa, Tarceva, Vizimpro and Gilotrif. The two patents at issue, ‘314 and ‘162, are assigned to the Pfizer subsidiary Wyeth, and as an aside they were included in a 2011 deal between Pfizer and Puma Biotechnology. Puma was originally a party to the dispute against Astra, but the 2011 deal’s focus was the small-molecule anti-HER2 drug Nerlynx, and in March Puma was ruled to have no standing in the case. The Pfizer vs Astra timelineMay 2003FDA approves Iressa for EGFR+ve NSCLC2006Wyeth patents 10,603,314 & 10,596,162 claim methods of treating Iressa-resistant NSCLCJan 2009Pfizer acquires WyethOct 2011Pfizer licenses neratinib, later approved as Nerlynx, to Puma, in a deal that includes the ‘314 & ‘162 patentsNov 2015FDA approves Tagrisso for EGFR T790M+ve NSCLCApr 2018FDA approves Tagrisso for 1st-line EGFR+ve NSCLCSep 2018FDA approves Vizimpro for 1st-line EGFR+ve NSCLC, based on PFS benefit vs IressaSep 2021Pfizer and Puma sue AstraZeneca, claiming that Tagrisso infringes the ‘314 & ‘162 patentsMar 2024The court agrees to dismiss the claim by Puma, which it deems to have no standing in the caseMay 2024Delaware jury awards Pfizer $107.5m in damages from AstraSource: company filings.
Pfizer’s Vizimpro, a drug approved in 2018 for EGFR-positive lung cancer but pushed into obscurity by AstraZeneca’s juggernaut Tagrisso, has delivered a victory of sorts. A US jury decided last week that Tagrisso infringes two US patents covering methods of treating Iressa-resistant NSCLC, as a result of which Astra must pay Pfizer $107.5m in damages. Still, the relevance of Vizimpro, whose sales are so insignificant Pfizer doesn’t break them out, is indirect, and during the case the drug’s standing as a competitor to Tagrisso was disputed. Vizimpro was developed as an irreversible, second-generation EGFR competitor to Iressa and Tarceva, but it never demonstrated activity in Iressa-resistant patients; that fell to Tagrisso, a third-generation drug, which subsequently moved into front-line use and wiped out the market for Iressa, Tarceva, Vizimpro and Gilotrif. The two patents at issue, ‘314 and ‘162, are assigned to the Pfizer subsidiary Wyeth, and as an aside they were included in a 2011 deal between Pfizer and Puma Biotechnology. Puma was originally a party to the dispute against Astra, but the 2011 deal’s focus was the small-molecule anti-HER2 drug Nerlynx, and in March Puma was ruled to have no standing in the case.
The Pfizer vs Astra timeline
| May 2003 | FDA approves Iressa for EGFR+ve NSCLC |
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| 2006 | Wyeth patents 10,603,314 & 10,596,162 claim methods of treating Iressa-resistant NSCLC |
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| Jan 2009 | Pfizer acquires Wyeth |
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| Oct 2011 | Pfizer licenses neratinib, later approved as Nerlynx, to Puma, in a deal that includes the ‘314 & ‘162 patents |
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| Nov 2015 | FDA approves Tagrisso for EGFR T790M+ve NSCLC |
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| Apr 2018 | FDA approves Tagrisso for 1st-line EGFR+ve NSCLC |
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| Sep 2018 | FDA approves Vizimpro for 1st-line EGFR+ve NSCLC, based on PFS benefit vs Iressa |
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| Sep 2021 | Pfizer and Puma sue AstraZeneca, claiming that Tagrisso infringes the ‘314 & ‘162 patents |
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| Mar 2024 | The court agrees to dismiss the claim by Puma, which it deems to have no standing in the case |
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| May 2024 | Delaware jury awards Pfizer $107.5m in damages from Astra |
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