Novartis’ blockbuster $16 billion drug assets swap with GlaxoSmithKline could have some big-time implications for Boulder’s Array BioPharma Inc.
As Novartis and GSK navigated the deal and the regulatory waters aimed at preserving competition, Array was the recipient of two late-stage cancer drugs that potentially could allow the Boulder firm to commercialize its first product two years earlier than expected.
When the transaction closed last week, Novartis transferred the ownership rights of MEK inhibitor binimetinib (MEK162) and BRAF inhibitor encorafenib (LGX818) — which can be used in combination or separately in cancer therapies — and gave an $85 million up-front payment to Array.
Andrew Robbins, newly promoted as Array’s chief operating officer, spoke with the Daily Camera last week to give a sense of what the deal could mean for the Boulder firm.
The following has been edited for clarity and length:
Array’s newly acquired assets
Binimetinib (MEK162) — An oral, small-molecule MEK inhibitor invented by Array. MEKs can inhibit parts of the proteins that may be stuck in the “on” position of the mitogen-activated protein kinase/extracellular signal-regulated kinase pathway.
Binimetinib is enrolled in three Phase 3 trials with advanced cancer patients including those with low-grade serous ovarian cancer, BRAF-mutant melanoma and NRAS-mutant melanoma.
Encorafenib (LGX818) — A BRAF inhibitor that can be used independently or in combination with MEK inhibitors.
Encorafenib is in Phase 3 trials and has shown signs of efficacy in patients with BRAF-mutant advanced melanoma
1.) How long has Array been involved with the potential acquisition of these drug candidates?
Until last April, that was unexpected. When the acquisition was announced April 22, we at Array, we felt pretty confident that the end game was for Array to at least retain the MEK inhibitor. Throughout the latter half of 2014, we were obviously working closely with Novartis, with the FTC and European Commission to figure out exactly how the structure should look for (all parties).
We knew that, both contractually and also because of anti-competitive issues, the MEK inhibitor was rightfully (Array’s). Then the question was what would happen to the BRAF (because those drugs typically are paired with MEK inhibitors). It took a little bit of time, but it was determined that to preserve competition in the best fashion, really it would be Array’s.
2.) What potential, in the way of treatments, do these drug candidates have?
Right now, (binimetinib’s) first three pivotal trials are in two types of melanoma, cancer of the skin, and one in ovarian cancer. While the opportunity that’s right before us is really skin and ovarian cancers, in the next few years, Array has significant opportunities (with these drugs) to move into other indications.
3.) What’s the current status of the clinical trials?
The first pivotal trial (that will be completed), is in (patients with) NRAS melanoma, that’s with MEK162 alone. That trial, we expect results from it some time later in 2015, which would (lead to) an FDA submission in early 2016. That would support (commercialization) sometime around the end of 2016.
LGX(818) is in its pivotal trial in combination with MEK162 (for BRAF melanoma patients). That trial, from a timing perspective, is right around a year behind. We’d expect clinical results by the middle of 2016 and then following a (successful) regulatory submission, hopefully (receiving product approval) by the end of 2017.
4.) How does the acquisition of these two drugs affect Array’s operations?
(MEK162 and LGX818) become our top priority where they are in development, how close they are to the market and how important they are to patients. Array, we have 200 employees, we have broad capabilities. It doesn’t necessarily suggest that we have to stop doing (other programs).
Many of the other drugs in the pipeline, we’re in a great position and are currently enrolling trials or already working on the plans for subsequent trials. The nice part about the way that we got these two products is that for a significant period of time, Novartis agreed to running the trials, funding the majority of expenses and supplying us with assistance from a regulatory and strategy perspective.
The overall deal is very good for Array, but it’s extra good because we still have the benefit of working with Novartis.
5.) How much closer do these two drugs put Array toward its commercialization efforts?
Certainly Array is going to look very different two years from now as we have our first product launch and second product months away from launch. A sales force, which we currently do not have. We’ll make additions … to marketing talent, medical affairs talent. We’ll have additional clinical development work as we expect these drugs to have broad utility.
We do believe this will be a hiring opportunity and a talent acquisition opportunity for Array. Here in Boston, we opened an Array office in what is considered a (biopharmaceutical) center of excellence.
I think this probably accelerates our commercializing timeline by at least two years, if not maybe more. … This significantly advances our plans to become a fully integrated company.
Alicia Wallace: 303-473-1332, wallacea@dailycamera.com or twitter.com/dc_alicia
