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Puma Biotechnology Reports Positive Outcome of European Opposition Proceedings

February 11, 2014

Puma Biotechnology, Inc., a development stage biopharmaceutical company, announced that the European Patent Office has upheld the claims in Puma's licensed European patent (EP 1848414), which were being opposed by Boehringer Ingelheim International GmbH.

In a release on February 6, the Company noted that the intellectual property portfolio that was licensed from Pfizer in 2011 when Puma licensed neratinib included issued patents in a number of countries including Europe (EP 1848414) as well as pending patent applications in several countries including the United States relating to methods of treating gefitinib and/or erlotinib resistant cancer. More specifically, the patent that was issued in Europe in April 2011 included specific claims that included a pharmaceutical composition for use in treating cancer in a subject with a cancer having a mutation in EGFR with a T790M mutation. On November 28, 2011, Boehringer Ingelheim International GmbH filed an opposition to this patent asking for this patent to be revoked.

The Oral Proceedings of the European Patent Office were held in Munich, Germany on February 4. The decision of the European Patent Office was to uphold the granted claims of the European patent that relate to the T790M mutation without any modification. This included specific claims that include 1) claims for the pharmaceutical composition comprising an irreversible EGFR inhibitor for use in treating cancer in a subject having a T790M mutation; and 2) claims for the pharmaceutical composition for use in the treatment of numerous cancers, including lung cancer and non-small cell lung cancer.

"We are very pleased with the outcome of the opposition proceedings and more specifically that the claims related to the T790M mutation have been upheld," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "Although we have no plans to develop neratinib in cancers with a T790M mutation, we recognize the value of this important patent in our overall patent estate and in the T790M landscape and we are committed to strengthening our patent portfolio for the Company. We look forward to the continued advancement of this patent portfolio for T790M in other countries and the potential benefit that it may bring to the Company."

Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops products for the treatment of various forms of cancer.

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