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LOS ANGELES, CA - Puma Biotechnology, Inc. (NASDAQ:PBYI) announced a legal victory in its patent infringement lawsuit against AstraZeneca (NASDAQ:AZN) Pharmaceuticals LP, related to its cancer treatment drug, Tagrisso®. On Monday, a federal court ruled in favor of Puma's co-plaintiff Wyeth, a subsidiary of Pfizer Inc. (NYSE:PFE), upholding the validity of the patents in question and awarding $107.5 million in damages for past infringement.
The suit, originally filed on September 22, 2021, accused AstraZeneca of infringing on patents held by Puma and licensed exclusively from Pfizer, specifically United States Patent Nos. 10,603,314 and 10,596,162. These patents cover methods of treating non-small cell lung cancer resistant to certain other treatments. The jury found AstraZeneca's product infringed upon these patents and rejected AstraZeneca's claims that the patents were invalid.
The court's recent decision follows a jury trial from May 13-17, 2024, which concluded in favor of Wyeth. AstraZeneca's subsequent motions for a new trial and other claims were denied by Judge Matthew Kennelly. The ruling also dismissed AstraZeneca's counterclaims against Puma, removing the company from the case, while Wyeth remained as a plaintiff and counterclaim-defendant.
Despite Puma Biotechnology being dismissed as a plaintiff earlier in the case due to standing issues, the company maintains its contractual rights to recover monetary damages under its license agreement with Pfizer. This includes the $107.5 million awarded for past infringements up to December 31, 2023.
Additional motions filed by Wyeth seek supplemental damages for infringements occurring from January 1, 2024, until the judgment date, as well as ongoing royalties through the remaining patent term. The court's ruling on these motions is pending.
In other recent news, Puma Biotechnology announced its second quarter earnings for 2024, reporting a net loss of $4.5 million. The company's total revenue reached $47.1 million, with a significant contribution of $44.4 million coming from the drug NERLYNX. Despite a decrease in new patient starts and total prescriptions year-over-year, Puma expects its net NERLYNX product revenue to land between $183 million and $190 million for 2024. The company also anticipates a net income of $12 million to $15 million for the full year, while planning to reduce SG&A expenses.
In their ongoing efforts, Puma Biotechnology has successfully secured regulatory approvals for NERLYNX in Brazil and Saudi Arabia, demonstrating a focus on expanding the drug's use in the extended adjuvant setting. However, it's worth noting that the company experienced a 17% decline in ex-factory bottle sales of NERLYNX compared to the previous year. Despite these challenges, Puma Biotechnology remains committed to maintaining a positive net income and continues to place a strong emphasis on NERLYNX sales trends.
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