Novartis sneaks up on Pfizer with CDK4/6 cancer challenger

Pfizer ($PFE) and its much-discussed palbociclib lead the way in the race to cash in on the blockbuster potential of a new pathway to treat breast cancer, but Novartis' ($NVS) rival drug has quietly closed the gap, promising to compete much sooner than expected.

Novartis revealed that LEE011, which inhibits the CDK 4 and 6 enzymes, will enter Phase III in December, rocketing it into contention with Pfizer's drug, which is in midst of late-stage studies in breast cancer. Much like Pfizer is doing with palbociclib, Novartis will test LEE011 in combo with its own letrozole in ER-positive, HER2-negative breast cancer, the company said.

Just last month, the rap on LEE011 was that Novartis had a preclinical asset it believed could eventually best palbociclib, but only after years of catch-up time. Now, as Bernstein analyst Tim Anderson pointed out in an investor note, Novartis has suddenly and stealthily forced its way into the CDK4/6 conversation, possibly imperiling the sales future of a Pfizer drug expected to pull in between $1 billion and $5 billion a year, depending on whom you ask.

On account of LEE011's undetailed Phase II, little is known of the drug's efficacy or safety profile. The oral compound charted impressive antitumor activity in preclinical mouse studies, according to Novartis, and global oncology head William Sellers said LEE011, "to our knowledge, is the most selective CDK4/6 inhibitor to date."

How Novartis kept LEE011's development under wraps and snuck up on its rival is unclear, and even the announcement came in via an unromantic bullet item in a press release to set the table for its investor day Friday.

Meanwhile, the industry's biggest R&D spender is counting on its innovation engine to deliver 14 or more blockbusters by 2018, led by its promising cancer pipeline and flanked by in-development drugs in dermatology, heart failure, respiratory and cell therapy. Novartis has picked up three FDA breakthrough therapy designations this year, including for the Phase III non-small cell lung cancer treatment LDK378, which is one of 10 new oncology drugs or indications the company hopes to launch by 2017.

- read Novartis' statement
- check out its oncology investor day slides (PDF)