Just two weeks after winning FDA approval and one month ahead of its previous launch timeline, Puma Biotechnology has introduced new breast cancer medication Nerlynx to the market. The company's quick move to hit the market is raising questions about how likely a buyout will be for the drugmaker.
Without disclosing price, Puma said in a Monday announcement that Nerlynx is commercially available in the U.S. The development comes a month ahead of the company’s previous plan to launch Nerlynx in September, RBC Capital Markets analyst Matthew Eckler pointed out in a note Monday evening.
“The bear case for an early launch is that an acquisition of Puma must not be imminent, otherwise why go ahead and launch early? And on your own?” Eckler questioned in his note.
“We’d tend to agree that if a deal was only days or weeks away, it’s hard to understand why the company would push ahead with commercialization,” Eckler continued.
Puma CEO Alan Auerbach told Eckler that the company is introducing the medication due to an “incoming volume of physician interest." The full launch is planned for next month.
With that considered, “the read-through of today’s announcement to any potential deal could ultimately be negligible,” according to the analyst. He noted that the "biggest impact of today’s announcement is likely to be how it shapes the debate around the probability of a takeout ... rather than on the actual commercial launch."
Two weeks ago, Nerlynx won FDA approval in HER2-positive breast cancer to prevent recurrence in women previously treated with Roche’s Herceptin. Throughout its development and during last month’s FDA advisory committee meeting, it’s been hit with questions of efficacy and safety. Some panelists weren’t completely convinced with the med, but the group ended up recommending approval.
Still, the drugmaker secured a label that’s “generally best-case scenario,” Ecker wrote last month. He predicted the drug will reach $1.7 billion in peak sales.
Some market watchers speculated after Nerlynx’s approval that Puma could be a target for a buyout as Big Pharma scouts a new cancer drug predicted to grow into a blockbuster. Gilead Sciences, for one, has said it’s eyeing the cancer field.
Puma hasn’t announced a price for its new drug, but Cowen Group analyst Chris Shibutani wrote after the approval he was informed Nerlynx would carry a sticker of $10,500 per month. Eckler listed the same figure from another source, Price Rx, in his note Monday, while cautioning that price hasn’t been confirmed by the company.