For most biotechs, the huge cost of a late-stage diabetes drug program is enough to shut down any discussion about pushing through alone to an approval. Intarcia, though, says it now has the money needed to do just that for new technology billed as a prospective game-changer for one of the world's most prevalent diseases.
Deep into a Phase III study of a new formulation of exenatide that can be pumped into diabetes patients over the course of a year via an implanted mini-pump, Boston-based Intarcia has rounded up a whopping $200 million round from a group of new and existing venture players led by RA Capital. This latest funding comes 17 months after Intarcia raised $210 million from some marquee biotech venture players.
RA was joined by Farallon Capital Management, Foresite Capital, Franklin Templeton, Fred Alger Management, New Leaf Venture Partners, Quilvest and three additional institutional investors.
Intarcia CEO Kurt Graves tells FierceBiotech that the money is enough to get through the late-stage program for ITCA 650, a stabilized formulation of exenatide, the active ingredient of the GLP-1 therapies Bydureon and Byetta, now owned by AstraZeneca ($AZN). Back in January, Graves laid out interim results for the first Phase III, saying that their new dosing approach led to a 3.2% mean reduction of HbA1c after 6 months among a group of patients with a poor record of controlling diabetes and a starting baseline HbA1c level of 10.9%. Now a slate of Phase III readouts for the FREEDOM program is due beginning this September and continuing on in 2015 to back a planned filing with regulators in 2016.
Intarcia is attempting an end run around a group of Big Pharma developers focused on new GLP-1 drugs. That segment is dominated by Novo's ($NVO) Victoza. But GlaxoSmithKline ($GSK) just days ago won European approval for albiglutide, with Eli Lilly ($LLY) touting positive data for dulaglutide.
Intarcia's approach, though, is "transformative, game-changing," says Graves, which is why investors have been willing to put up more than $400 million to get the drug through late-stage testing. The biotech is using an existing drug and an approved mini-pump for the therapy. The real innovation, says Graves, is the technology that was used to stabilize exenatide for a prolonged period. If the company can clear the FDA's high hurdle on diabetes drugs, he adds, their product will have a guaranteed niche among the large group of patients who have trouble staying compliant with their treatment regimen.
Back last fall Intarcia, a 2007 Fierce 15 company, relocated its headquarters to Boston, leaving its manufacturing facility in Hayward, CA. The company has about 80 staffers and Graves says he plans to start beefing up the Boston office, where 20 employees work now.
The plan now is to hang on to U.S. rights and build out a full biopharma company with its own marketing team and manufacturing capacity. Outside the U.S., says the CEO, Intarcia will be looking for partners.
"That such a large financing was done in the private markets demonstrates that form follows substance and that knowledgeable investors will support a strong team with great data and the right plan to whatever extent it needs via whatever financing structure is appropriate regardless of the general market conditions," said Peter Kolchinsky, Managing Director of RA Capital. "Intarcia has more options than ever for how it will go on to create greater value advancing its wholly-owned lead product and building a pipeline of additional transformational programs."
- here's the release
Special Report: 2007 Fierce 15 - Intarcia Therapeutics