Rodman & Renshaw, a New York investment bank, which helped them raise additional funding through private investments in a public entity (PIPE) deals. After raising about $2 million, the biotech announced in June that it would restart its development of ANX-530, a formulation of the chemotherapy drug vinorelbine (Navelbine) that Adventrx obtained with its 2006 acquisition of SD Pharmaceuticals. The strategy was appealing because vinorelbine already was approved by the FDA, and Adventrx had conducted studies showing its proprietary emulsion formulation could potentially reduce the incidence and severity of vein irritation and blistering associated with the drug’s intravenous delivery. Culley says the FDA also had been satisfied with so-called “bio-equivalence studies” that showed its formulation of the drug worked in the same way as the approved drug.
What remained to be done, Culley says, were “process validation” (PV) tests, which are intended to show the FDA that Adventrx could maintain tight manufacturing controls in producing its version of vinorelbine. Culley says the biotech ultimately raised about $3.4 million through its PIPE financings, and most of that was invested in the PV studies. “We took the capital we had, and it became a ‘bet the company’ kind of venture,” Culley says.
After completing the work, Culley says Adventrx had the final bit of data needed to complete a new drug application. But the company needed to raise about $11.3 million in additional funding, which was arranged last October through the sale of convertible preferred shares of Adventrx stock.
Even with the funding, though, Culley says Adventrx still had to prepare the new drug application (NDA) for the U.S. Food and Drug Administration. “We converted everyone who had worked with the company into a consultant,” Culley says. “We were really ruthless about it.”
Yet Culley says he dislikes characterizing Adventrx as
