China, Deals

After EMA flop, Puma takes Nerlynx to China in new out-licensing deal

Facing a likely roadblock entering the European market, Puma Biotechnology $PBYI is inking a string of new deals in different regions for its cancer drug Nerlynx. Latest target: China.

Puma is buddying up on the deal with CANbridge Life Sciences, which will develop and commercialize the drug in mainland China, Taiwan, Hong Kong, and Macau. Puma gets a $30 million upfront payment, and biobucks of up to $40 million if certain regulatory milestones are met. Puma could also get double-digit royalties on sales, and extra milestones based on sales.

Alan Auerbach

“Puma is committed to providing access to Nerlynx to patients around the world, and greater China represents a very large market opportunity,” said Alan Auerbach, Puma’s president and CEO, in a statement. “While we continue to focus our commercial resources on the US market, we believe this new partnership with CANbridge will help patients in greater China to access Nerlynx at the earliest opportunity.”

Puma’s drug was approved by the FDA in July 2017 for preventing the return of breast cancer after therapy. The company planned to take the drug to Europe, but got slapped down by the EMA last month due to concerns its regulators had with the drug.

But that setback hasn’t stopped the company from trying to commercialize the drug outside the US. Late last month, Israel’s Medison Pharma signed an exclusive licensing deal to seek regulatory approval for and commercialize the breast cancer treatment. Medison execs said they expect to receive approval from the Israeli Ministry of Health in 2019.


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