Why Puma Biotech Could Get Acquired Between July to September of This Year

Published: May 30, 2017

Why Puma Biotech Could Get Acquired Between July to September of This Year May 26, 2017
By Alex Keown, BioSpace.com Breaking News Staff

LOS ANGELES – Following the go-ahead nod from a U.S. Food and Drug Administration advisory committee, Puma Biotechnology is riding high on the increased chances for approval of its experimental breast cancer drug neratinib.

Earlier this week, the advisory committee recommended approval for the drug in a 12-4 vote, although there were some calls for a narrowing of the drug’s label should it be approved. There were also concerns over one side effect–severe diarrhea. Despite that, the panel pushed the drug through.

Neratanib is being developed for the extended adjuvant treatment of HER2-positive breast cancer. PB272 is a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation. HER2-positive breast cancer is an aggressive form of the disease, which affects approximately one in five people with breast cancer and is associated with a poor prognosis if left untreated.

If the FDA does approve neratanib for adjuvant breast cancer care, that could put Puma into the crosshairs for an acquisition. In his latest column The Street’s Adam Feuerstein discusses the possibility of a Puma takeover with a bullish stakeholder. The stakeholder, who had a bet with Feuerstein about neratanib, said if a company is interested in acquiring Puma, it will strike between July and September of this year.

"The sweet spot to acquire the company is after approval and before launch," the stakeholder told Feuerstein. "You [the potential acquirer) want to control pricing and payer discounts, and you will know the third-line metastatic data versus lapatinib by then. That's July to September. Let's see who is interested."

Results of that third-line study should be revealed within the second quarter. In that study, neratanib is going head-to-head with GlaxoSmithKline ’s Tykarb in HER2-positive metastatic breast cancer patients who have received two or more prior HER2 therapies, Feuerstein noted. Endpoints of that trial are progression-free survival and overall survival.

Another factor could be Roche ’s Perjeta study. Data is expected to be presented in June at the American Society of Clinical Oncology meeting in Chicago. In March, Roche and its subsidiary Genentech announced positive results from its Phase III combination study of Perjeta, Herceptin and chemotherapy showed a statistically significant reduction in tumors returning or death. When that data is released, Feuerstein said it will be important to pay attention to the Perjeta's disease-free survival benefit to determine how clinically meaningful it is when compared to neratanib’s benefits. Neratinib showed a larger benefit in hormone-positive patients and almost no effect in hormone-negative patients, Feuerstein said. If Perjeta demonstrates efficacy in hormone-negative patients, but not in hormone-positive, Feuerstein said it is likely that neratanib will blunt the “competitive impact of Perjeta.”

Those data points could indicate whether or not Puma will be in-play for an acquisition later this year. Shares of Puma have nearly doubled this week, climbing from $39 on May 22 to a high of $79.90 per share on May 25. Shares are currently trading at $77.10 as of 10:48 a.m.

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