Despite the emergence of new biological treatments for cancer, Chemotherapy is still essential, and indispensable as a major treatment for malignancies. The adverse events caused by these chemicals were found to be acceptable as a risk versus the great reward of using chemotherapy. The technological evolution that took place in the past decade and the surfacing of state-of-the-art technologies such as nanotechnology, scientists believed possibilities exist now for improving the adverse effect profiles of these therapeutic molecules. Reformulating the existing products has become an increasingly common product lifecycle-management technique. We read that a 2004 report on the U.S. drug market from BCC, Inc. projected that reformulations would grow from 62% of the market in 2003 to 79% in 2008. Finding ways to modify and improve existing products’ side effect profiles has become feasible after being essential but unreachable goal.
Among today’s news, ADVENTRIX (ANX) announced that, based on information received from the FDA, it decided to resubmit its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion), or Exelbine™, a novel emulsion formulation of the approved cancer chemotherapy drug vinorelbine for approval for the sake of improving its side effects of the marketed drug. From the same press release we understood that the firm has met with the FDA and clarified certain matters regarding stability data necessary to file the Exelbine NDA and that the studies are ongoing and the emerging data will enable the firm to resubmit the NDA in the fourth quarter of this year.
Background: Adventrix had submitted an NDA for ANX-530 to the FDA in December 2009. The In March 1, 2010 it announced that it had received a refusal-to-file letter from the FDA regarding that submission. In the letter, the FDA indicated that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. The FDA identified only this one chemistry, manufacturing and controls (CMC) reason for the refusal to file. No clinical or nonclinical issues were otherwise identified.
The Drug: ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. Navelbine®, a branded formulation of vinorelbine, which is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union, or EU, to treat non-small cell lung cancer and advanced or metastatic breast cancer. Adventrix’ formulation emulsifies vinorelbine into a homogeneous suspension of nanoparticles that protect the venous endothelium during administration into a peripheral vein, thereby reducing irritation associated with administration of the drug. ANX-530 is supposed to lower the risk of phlebitis, erythema and pain at the site of injection, which occur in one third of patients treated with Novelbine, or its generic version.
There is more hope now in FDA approval of Adventrix’ drug ANX-530. We wish that firms with technologies capable of improving existing drugs would apply their technologies more frequently in making them as safer as they are effective. Better even would be that those firms who have very promising investigational drugs, but have nasty side effects to try to resort to firms that can reformulate them into safer drugs.
Adventrix’ stock is subjected to a 1-for-25 reverse stock split, which became effective on April 26, 2010.
Read Elan In the Prohost Letter #301 that will be posted tomorrow, Wednesday April 28, 2010.