Puma (PBYI) Updates on Neratinib's Progress in Europe
Puma Biotechnology, Inc. PBYI announced that it has conducted a marketing authorization application (MAA) pre-submission meeting with the European Medicines Agency (EMA). Per its meeting, the company plans to submit an MAA for neratinib in the first half of 2016.
The EMA evaluated available data on the candidate and assessed that there were no critical concerns that may prevent Puma Biotech from submitting a complete MAA for European centralized review in support of neratinib for the extended adjuvant treatment of HER2-positive early-stage breast cancer in patients who were previously treated with a trastuzumab containing regimen.
Puma Biotech has made significant progress on its lead pipeline candidate, neratinib. Studies showed that extended adjuvant treatment with neratinib following adjuvant treatment with Roche’s RHHBY Herceptin (trastuzumab) in women with early-stage HER2 positive breast cancer reduced the risk of disease recurrence. Per company sources, there are approximately 36,000 patients in the U.S. and 34,000 patients in the EU suffering from newly diagnosed HER2-positive breast cancer. This represents an estimated total market opportunity for neoadjuvant HER2-positive breast cancer, between $1 billion and $2 billion.
Apart from HER2-positive breast cancer, neratinib is being evaluated for HER2-mutated non-small cell lung cancer, HER2-negative breast cancer that has a HER2 mutation, and other solid tumors that have a HER2 mutation. The company is also developing an intravenous formulation of neratinib for the treatment of patients with advanced cancer. The company plans to pursue collaboration agreements for commercialization of neratinib.
Currently, Puma Biotech carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK and Actelion Ltd. ALIOF. While Anika sports Zacks Rank #1 (Strong Buy), Actelion carries a Zacks Rank #2 (Buy).
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