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Shares of Puma Biotechnology, Inc. (PBYI - Snapshot Report) soared 18.2% on favorable patent-related news from Europe. The company’s licensed European patent - EP 1848414 - was upheld by the European Patent Office. Boehringer Ingelheim was looking to get the patent revoked.


Puma Biotech had gained certain intellectual property portfolio from Pfizer (PFE - Analyst Report) in 2011 when it had licensed neratinib. This included patents related to methods of treating cancer resistant to Iressa (gefitinib) and/or Tarceva (erlotinib). While some patents were issued in Europe, Australia and several Asian countries, others are pending in countries like the U.S.

The EU patent for which the favorable ruling was made, was issued in Apr 2011, and included specific claims like a pharmaceutical composition for use in treating cancer in patients having a mutation in EGFR with a T790M mutation using an irreversible EGFR inhibitor.

Our Take

Puma Biotech is currently developing neratinib (oral) for the treatment of advanced breast cancer patients, non-small cell lung cancer patients and patients with HER2 mutation-positive solid tumors. Meanwhile, an intravenous version of neratinib is being developed for the treatment of advanced cancer patients.

At present, the company does not intend to develop neratinib for the treatment of cancer that has a T790M resistance mutation. However, the patent is important in the T790M landscape and could help the company garner patent-related royalties in future.

Puma Biotech said that the European patent is scheduled to expire in Feb 2026. The company could file for patent term expansion in which case the patent life could be extended by up to an additional 5 years. We expect investor focus to remain on the ongoing development of neratinib.

Puma Biotech currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the biotech sector include Biogen (BIIB - Analyst Report) and Alexion Pharmaceuticals (ALXN - Analyst Report). Both are Zacks Rank #1 (Strong Buy) stocks.

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