4:56 PM
 | 
Nov 03, 2017
 |  BioCentury  |  Strategy

Broadening Novartis’ NET

Where Advanced Accelerator’s Lutathera fits into Novartis’ NET franchise

Novartis AG’s proposed acquisition of Advanced Accelerator Applications S.A. would broaden the pharma’s neuroendocrine tumor franchise by providing it with a second-line agent -- Lutathera -- that addresses patients with progressive, symptomatic disease.

On Oct. 30, Novartis offered to acquire Advanced Accelerator for $82 per ADS in a deal that values the company at $3.9 billion. The price is a 39% premium on its close of $59.76 on Sept. 27, before media reports said the two companies had entered M&A discussions.

The deal fits squarely within Novartis’ search for $2-$5 billion bolt-on acquisitions that could help the pharma fill the revenue gap created when cancer drug Gleevec imatinib went off patent in February 2016, flagging sales from its Alcon Inc. eye care business and slow uptake for heart failure drug Entresto sacubitril/valsartan.

Outgoing CEO Joe Jimenez has been voicing the pharma’s interest in such acquisitions across all of its divisions, including oncology, since early 2015.

Analyst estimates peg Lutathera’s global peak sales at $540-$600 million.

In September, the European Commission approved the IV radiolabeled somatostatin analog to treat unresectable or metastatic, progressive, well-differentiated somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

A resubmitted NDA for Lutathera to treat somatostatin receptor-positive GEP-NETs in adults has a Jan. 26 PDUFA date in the U.S.

FDA issued a complete response letter for Lutathera in December 2016. According to Advanced Accelerator, the agency had requested subgroup analyses, additional safety data and asked the company to resolve manufacturing concerns.

Advanced Accelerator CEO Stefano Buono said Lutathera will be positioned as a second-line treatment after progression under somatostatin...

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