Just because a biotech company has landed a high-profile chief executive, does that mean its product is going to work? I’ve been asking myself that question in the wake of the unexpected July 11 announcement of the hiring of a biotech superstar, the Novartis veteran and former Millennium Pharmaceuticals CEO Deborah Dunsire, by Boston-area biotech company EnVivo Pharmaceuticals. Dunsire takes the reins in mid-August.
At the very least, the hiring of Dunsire is a bullish sign for EnVivo’s late-stage drug candidate for central nervous system disorders. The product, an alpha-7 nicotinic receptor agonist called EVP-6124, is in the midst of two 700-patient, late-stage clinical trials for patients with schizophrenia, a tough-to-treat mental illness. Given the lack of new therapeutics for schizophrenia, that is exciting enough, but the real potential for EVP-6124 is in the even more challenging group of patients with Alzheimer’s disease, the condition that robs 5 million Americans of their memory, cognition, and ability to carry out functions of daily living. Two Phase 3 trials are scheduled to start enrolling Alzheimer’s patients by the end of 2013 and run through 2015.
It is impossible to say today whether any of these trials will result in an approved drug. But Dunsire’s choice to join EnVivo was deeply surprising to a Boston biotech community that had eagerly awaited news of her next move. A look at the reasons so many were caught by surprise will illuminate the risks in drug development for tough neurological indications; the side benefits that will accrue if the drug works; and the synergies inherent in the combination of Dunsire and EnVivo.
When I considered why Dunsire’s choice was so unexpected, I came up with three basic reasons:
(1) EnVivo has flown a bit under the radar. With a single VC investor, the company is anything but a “Boston mafia” biotech investment with all the usual big-name VC firms on board. Under the steady-handed direction of its former CEO Kees Been, EnVivo has quietly grown from perhaps 30 people when I briefly consulted there in 2005 to a recent headcount of 130. So it has competed successfully in the region’s ever-sharper “war for talent.” But in terms of its stakeholders at least, it is far from the biotech mainstream.
(2) EnVivo is exclusively pursuing treatments for neurological diseases. It’s not going after cancer. That seems like a jump for Dunsire, who focused on oncology for much of her time at Novartis and all of her time at Millennium.
(3) Unlike at Novartis, where Dunsire was in a position to work with a whole portfolio of therapies and focus on the ones likely to perform the best, and unlike at Millennium, where the blockbuster product bortezomib (Velcade) was already approved and on a path to success when she joined in July, 2005. Here, Dunsire is jumping into a tough field where the underlying disease biology is less well understood, betting most of her chips on a single product and doing so without the benefit of experience developing drugs for central-nervous system diseases.
Let’s take those one by one. They’re easy to demolish. First
