San Diego’s Adventrx Pharmaceuticals (NYSE Amex: ANX) has sprung back from the dead before, but it will be hard for the biotech to recover from the plunge in its share price in after-hours trading yesterday—after Adventrx said the FDA has refused to accept its latest new drug application for the anti-cancer drug vinorelbine injectable emulsion (Exelbine).
FDA regulators told the company its inspectors could not verify the authenticity of drug products used in Adventrx’s pivotal bioequivalence trial, “which placed the results of the trial into question.” In its statement, issued after the close of regular trading, Adventrx says the FDA has determined the costly early stage bioequivalence study must be repeated to address the deficiency.
By 8 pm ET yesterday, Adventrx’s stock had plunged by $1.49—or nearly 59 percent—to $1.05 a share.
In addition, Adventrx says the FDA requested information about its product quality, or chemistry, manufacturing, and controls (CMC). In its statement, Adventrx says, in effect, “We already addressed these concerns” in previous responses the company submitted to the FDA.
The San Diego biotech has been developing improved formulations of existing cancer treatments that address side-effects associated with their safety and use. By early 2009, however, Adventrx was hemorrhaging cash. A few months later, with the U.S. economy still bouncing along the bottom, Adventrx said it planned end its business operations. The company laid off all but two employees that year.
By January, 2010, however, Adventrx had rebounded, saying it raised $19 million and had submitted a new drug application for its formulation of the chemotherapy drug vinorelbine (Navelbine). Adventrx CEO Brian Culley told me at that time that the company’s proprietary emulsion formulation could potentially reduce the incidence and severity of vein irritation and blistering associated with the drug’s intravenous delivery.
Culley also told me that the FDA was satisfied at that time with the company’s bio-equivalence studies, which showed the Adventrx formulation of the chemotherapy drug worked in the same way as the approved drug.
But the company has not been able to clear its FDA stumbling block. The agency refused to accept the biotech’s first application for vinorelbine. The company revised its new drug application, and submitted it again to the FDA last November.
Adventrx CEO Culley told Keith Darcy of The San Diego Union-Tribune that with almost $41 million in available cash (as of July 31), Adventrx will have enough capital to shift its focus to other drugs in its pipeline, even if it eventually postpones or cancels its development of vinorelbine injectable emulsion.
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