February 10, 2017
By Mark Terry, BioSpace.com Breaking News Staff
There are any number of high-risk, high-reward biopharma companies with potential big hits or misses this year. Examples include Esperion Therapeutics , GlycoMimetics , Seattle Genetics , and Array BioPharma (ARRY). Todd Campbell, writing for The Motley Fool, talks about why Array BioPharma might be the one to watch.
Mostly it comes down to drugs for melanoma.
According to the National Cancer Institute (NCI), there are 76,000 new melanoma cases diagnosed each year and many will die within five years.
Array has filed with the U.S. Food and Drug Administration (FDA) for binimetinib, a MEK inhibitor for advanced melanoma patients with NRAS-mutation. “It also,” Campbell writes, “plans to file for approval of a combination therapy for BRAF mutation patients that includes binimetinib and another drug, encorafenib, a BRAF inhibitor. If approved, binimetinib could be used in about 20 percent of melanoma patients, and binimetinib and encorafenib could be used in about half of all melanoma patients.”
In Phase III trials, patients receiving binimetinib every three weeks had 2.8 months of progression-free survival. And patients that received the drug who had previously been treated with immunotherapy had progression-free survival of 5.5 months as opposed to 1.6 months on dacabarzine.
Campbell writes, “In BRAF-mutation patients, patients receiving encorafenib and binimetinib had progression-free survival of 14.9 months, while patients receiving Roche Holdings’ Zelboraf had progression-free survival of 7.3 months.”
So how much is this drug worth to Array? Who knows? But Campbell notes there’s a good possibility it would be nine figures. “Existing therapies cost $10,000 per month or more, and as a result, Roche and Novartis ’ are reporting hundreds of millions in sales for their two-drug combinations. In 2016, Roche reported Zelboraf sales of $215 million and Cotellic sales of about $45 million, at current exchange rates. Meanwhile, Novartis reported a combined $178 million in Mekinist and Tafinlar sales in the fourth quarter.”
Array projects the MEK/BRAF inhibitor market at about $1 billion per year.
Campbell thinks the future of treatment for melanoma is likely to be three-drug combination therapies that use a MEK inhibitor, a BRAF inhibitor, and a checkpoint inhibitor. And companies such as Roche are looking at those combinations. It has an ongoing trial using Zelboraf and Cotellic with its checkpoint inhibitor, Tecentriq. Array is evaluating binimetinib and encoraffenib with Keytruda.
If approved, Array’s drug could be part of the first-in-line treatment for patients with advanced melanoma.
The company’s is currently trading at $11.98, but it’s been on the climb for a while now and recently took a big jump. It gained 17.38 percent yesterday, largely on the basis of its fiscal second-quarter 2017 earnings report.
Much of that good news revolves around a timeline for a new drug application (NDA) for binimetinib and encorafenib. Array, after discussions with the FDA, expects to submit the application in June or July of this year.
Corey Renauer, also writing for The Motley Fool today, says, “If it earns a widely expected approval, investors will want to keep an eye on its sales trajectory for hints of the combination’s performance. Following today’s run-up, Array’s market cap of around $2.1 billion suggests further upside ahead if its combination becomes a popular new option for melanoma patients worldwide.”
