The most lucrative drug to ever come from Seattle is etanercept (Enbrel) for autoimmune diseases. The most famous drug from Seattle is tadalafil (Cialis) for erectile dysfunction.
Now the Seattle biotech cluster can start taking credit for one of the world’s best cancer drugs in development.
Gilead Sciences (NASDAQ: GILD), the Foster City, CA-based biotech giant, made big news yesterday with an announcement about its flagship cancer drug acquired from Seattle-based Calistoga Pharmaceuticals. Gilead said it stopped a clinical trial earlier than expected for patients with chronic lymphocytic leukemia who were getting idelalisib. Normally, that’s bad news, because trials sometimes are stopped because of safety concerns, or because they are obvious duds. In this case, it was good news. Gilead stopped the study early because the drug, in combination with rituximab (Rituxan) was clearly superior to rituximab alone, and based on pre-determined stopping criteria, it would basically have been wrong to continue randomly assigning patients to get an inferior therapy.
Gilead didn’t present any detailed results of this 220-patient pivotal trial, known as the 116 study, but the main goal was to show the new drug could keep tumors from spreading for a longer period of time than rituximab. Gilead has told the FDA about the result, and plans to seek FDA clearance to market the product as a new treatment for chronic lymphocytic leukemia. Detailed results are being submitted for presentation at a scientific meeting.
Shares of Gilead climbed $3.31, or 5.6 percent, to $62.21 at 1:18 pm Eastern time after the announcement.
“This is great news and much nicer to write about than trials unfortunately stopped due to futility!” wrote Sally Church, an influential cancer consultant, in a note to subscribers to her Pharma Strategy Blog.
While the name idelalisib doesn’t exactly roll off the tongue, readers with long memories will recognize it by its previous name of CAL-101, the franchise product developed by Seattle-based Calistoga, which spun out of the labs at Bothell, WA-based Icos. Gilead acquired Calistoga for as much as $600 million in 2011 so that it could obtain this drug, which is designed to work by inhibiting the delta isoform of the PI3 kinase biological pathway. Cancer biologists have been excited about the PI3 kinase pathway for years because of its increasingly well-known role in tumor growth, proliferation, and migration.
Analysts are updating their financial models today to reflect greater sales potential for idelalisib. Last month, Gilead sought FDA clearance of the product for patients with indolent (slow-growing) non-Hodgkin’s lymphoma. Every year, between 5,000 and 10,000 new patients develop relapsed forms of chronic lymphocytic leukemia in the U.S., and 15,000 to 20,000 are newly diagnosed with the disease, according to analyst Mark Schoenebaum with ISI Group. Before yesterday’s good news from the chronic lymphocytic leukemia trial, analysts has been expecting idelalisib to generate $100 million in sales in 2015, $450 million in 2016, and $800 million in 2017, Schoenebaum wrote. “We believe that consensus numbers will likely go up in the near term,” he said.
The sales estimates will naturally be more like guesstimates until Gilead presents the full data from the 116 study, and analysts have a chance to compare the data with what’s been presented by competitors like Sunnyvale, CA-based Pharmacyclics (NASDAQ: PCYC) and Cambridge, MA-based Infinity Pharmaceuticals (NASDAQ: INFI). But given the drug’s current position, it’s not hard to imagine the drug being taken by tens of thousands of patients with blood cancers.
“It warms my heart to see the difference a dedicated team can make in patients lives,” says Mike Gallatin, the co-founder and former president of Calistoga.
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