Deborah Dunsire's "retirement" didn't last long. Just two months after abruptly leaving Millennium as Takeda prepared to absorb its R&D work in its global research group and eliminate her position, Dunsire has been tapped as the new CEO at EnVivo Pharmaceuticals, a fast-growing drug developer in Watertown, MA, focused on a late-stage CNS program for Alzheimer's and schizophrenia.
Dunsire had a high profile during her 8-year stint as CEO of Millennium, which Takeda acquired for $8.8 billion. But she says moving to the much smaller biotech--with about 130 employees--presents plenty of big challenges. By the end of this year, she says, the staff is expected to swell to 150 as it advances not just the late-stage work but a pipeline that includes three other clinical-stage drugs as well as preclinical programs.
"The ability to work with a drug with a remarkable Phase II and go on to take it to the market, that's really an attractive thing to do," Dunsire tells FierceBiotech, adding that her goal is to grow a "purpose-built company to really develop drugs for unmet needs" involving neurology and psychiatry.
Unusual among biotechs, EnVivo has one primary backer: Fidelity Biosciences. And Stephen Knight, the president of Fidelity Biosciences, says that after the team decided to go at it alone into Phase III and position the company for a market launch, it was clear that the biotech needed new leadership.
EnVivo's big hope is that EVP-6124 can improve neuronal firing, the transmittal of a signal across neurons. It's designed to enhance synaptic transmission in the brain by sensitizing the alpha-7 receptor, improving cognition in patients. (Cognitive impairment is a problem for schizophrenics as well as Alzheimer's patients.) As such, the biotech is going a far different route than the beta amyloid drugs that have tried to influence the course of Alzheimer's by reducing the levels of the toxic protein in the brain. All late-stage attempts to do that have failed so far, most notably in Phase III trials of solanezumab and bapineuzumab.
What distinguishes EnVivo from many others in the field, says Dunsire, is that it didn't take a pair of rose-colored glasses to decide that the mid-stage data warranted another big step forward into an ambitious Phase III study. And while there's never a guarantee in Phase III, she feels EnVivo has a solid shot at developing a first-in-class therapy in a tough field. The company is also not a "one-trick pony," she adds, pointing to several other drugs in the pipeline.
EVP-6124 is currently in two Phase III studies for schizophrenia and will start a late-stage trial for Alzheimer's later this year. EnVivo was named a Fierce 15 company last year, when Kees Been was CEO. Robert Weisskoff stepped in as interim CEO after Been left suddenly and without explanation.
Knight adds that even though IPOs are all the rage these days, there are no plans for an initial public offering at EnVivo anytime soon.
- here's the press release
Special Reports: EnVivo Pharmaceuticals – 2012 Fierce 15 | Deborah Dunsire - Top 10 Women in Biotech 2010