Ann Arbor, MI-based biotech startup Aastrom Biosciences (Nasdaq: ASTM) announced this week that president and CEO Tim Mayleben has retired and a new interim CEO, Dan Orlando, has been named by Aastrom’s board. Orlando was hired at Aastrom in August to be the company’s chief commercial officer, and Mayleben says his experience getting products to market is what makes him a good fit. “With his strong commercial background, we couldn’t find a better person to lead the company at this stage,” he adds. “I’m excited and the board is excited.”
Earlier this year, Aastrom began a Phase 3 clinical study of ixmyelocel-T, the company’s multicell therapy for patients with critical limb ischemia (CLI) who have no other treatment options. CLI is a severe form of cardiovascular disease in the legs in which blood vessels get so clogged up that doctors are forced to amputate.
Mayleben says that, though he’s retired, he’ll continue to play a very active role on the board and will help lead fundraising efforts, at least for the time being. “Over the past three years I’ve built a lot of relationships, and I’ll continue to leverage those for Aastom’s benefit. I’ll also help Dan with his transition. I told him I’ll be as helpful as he wants me to be but not so helpful that I’m in the way.”
Orlando says Mayleben’s position as president and CEO was never a “long-term aspiration,” as Mayleben had originally been a board member who was asked to step in and lead the company. Orlando spent 11 years with Abbott Park, IL-based Abbott Laboratories and 13 years with Japan-based Takeda Pharmaceutical. While at Takeda, Orlando was the brand director for pioglitazone hydrochloride (Actos), a top diabetes drug, and led commercialization efforts along with a $500 million round of financing. “Working on Actos gave me incredible clinical, commercial, and global launch experience,” he says.
Orlando says he was attracted to Aastrom because of its strengths on both the clinical and commercialization fronts. “Aastrom has a platform for manufacturing—that’s a big deal. A lot of companies get good data but then have no idea how to get that product to market,” he says.
In March, Aastrom announced a $40 million financing deal with Eastern Capital to support the research and development costs associated with the company’s Phase 3 REVIVE-CLI trial. Aastrom’s approach involves withdrawing a patient’s bone marrow cells and incubating them using a proprietary process to spur growth of adult stem cells and promote healing. Those beefed up cells get re-injected into the patient, where they are supposed to foster the growth of new blood vessels to improve circulation and prevent amputation.
Orlando admits that Aastrom is behind on patient recruitment for the Phase 3 REVIVE-CLI trial, but he says the Phase 2 dilated cardiomyopathy (DCM) trials are moving forward and he hopes to be able to announce a significant milestone soon.
“A company like [Aastrom] needs a commercialization guy like me, and still needs a financing guy like Tim, and then we need a [chief marketing officer],” Orlando explains. “It’s tricky stuff. This could be the first cell therapy approved for both of these conditions [CLI and DCM].” A CMO will be hired in 2013, and Orlando has brought in a former colleague from Takeda with “25 years of R&D dialogue with the FDA” to consult in the meantime. Orlando adds that he’s a candidate to be the permanent CEO, a hiring that is expected to take place during the first quarter of 2013.
Mayleben says that, though he announced his retirement, we shouldn’t expect him to disappear from the biotech scene. “I will find other things to stay busy,” he says. “I’m on the board of five companies, and very active in a couple of them. There’s a lot going on in the life science space.”