In wake of FDA rejection, Adventrx discontinues Exelbine until partner emerges
This article was originally published in Scrip
Adventrx Pharmaceuticals recent meeting with the US FDA about a complete response letter (CRL) the firm received in August on its application for Exelbine (vinorelbine injectable emulsion) as a treatment for non-small-cell lung cancer yielded little good news – an outcome in which investors were none-too pleased.
Indeed, shares of the San Diego-based firm tumbled 8.7% on 3 October, or 8 cents, before closing at 88 cents, a loss of 4 cents, or 4.35%.
The company has decided to focus its capital on its other compounds, ANX-188 and ANX-514, which it said reflect larger market opportunities, and plans to discontinue its Exelbine programme until it finds a partner or outside investor.
The cash and equivalents of $40.7 million as of 31 July, plus the cost savings from discontinuing the Exelbine programme will provide the company the capital to advance ANX-188, a purified, rheologic and antithrombotic compound initially being developed as a first-in-class treatment for pediatric patients with sickle cell disease in acute crisis, and ANX-514, a detergent-free formulation of Sanofi's cancer drug Taxotere (docetaxel), which recently went off-patent, into their respective pivotal clinical studies next year, Adventrx CEO Brian M Culley said.
"Additionally, we have taken and will continue to take measures to ensure that our contractors have the qualifications and experience needed to bring new therapies successfully through pivotal studies and make them available to patients," he added.
Exelbine is an emulsion formulation of the chemotherapy drug vinorelbine, which is sold as Navelbine in the US by GlaxoSmithKline under a license from Pierre Fabre Médicament.
The FDA's CRL stated that the authenticity of the experimental drugs used in Adventrx's study 530-01 could not be verified (scripintelligence, 10 August 2011).
During the meeting with the FDA, Adventrx said regulators indicated the clinical sites for study 530-01, which were selected in 2006 by a third-party contract research organization, failed to randomly select and retain reserve samples of Exelbine and reference standard Navelbine and the deficiency could not be overcome by alternative methods of verifying authenticity and reiterated that the bioequivalence study would need to be repeated.
Regulators said, however, that no clinical deficiencies were noted with study 530-01 and that there were no comments about the company's conclusion that Exelbine and Navelbine are bioequivalent based on the trial's data.
"Although we are pleased with the agency's assessment of the clinical data, we are disappointed it could not exercise discretion in our case to consider other methods of verifying the authenticity of the study drugs," said Mr Culley. "The agency's assessment of the clinical data gives us confidence that a repeat study would be successful and that Exelbine can be approved.”