Chemotherapy drugs are powerful anti-cancer agents, but they can also cause adverse side effects such as rashes, nausea, and allergic reactions. Reformulating a popular drug offers pharmaceutical companies the opportunity to preserve a drug’s known strengths while reducing its weaknesses. Although reformulation can be a way for pharmaceutical companies to get more mileage out of a drug that’s about to go off-patent, it can benefit the patient as well. With a reformulation, patients receive a wider range of treatment options coupled with the reassuring familiarity of an existing, well-established drug.
Reformulation is the main business of Adventrx Pharmaceuticals (ANX). The San Diego-based company seeks to improve upon existing cancer therapeutics with its reformulations of the chemotherapy drugs Navelbine and Taxotere. In an October 2009 interview with the Wall Street Transcript, Adventrx CEO Brian M. Culley described the company’s approach as a “faster, lower-cost, lower-risk drug development strategy.”
Navelbine (also known as vinorelbine) is approved in the U.S. to treat non-small cell lung cancer. Patients taking vinorelbine may experience phlebitis (vein irritation), erythema (skin redness or rash), or pain at the injection site. ANX-530, currently in development at Adventrx, is a novel formulation of Navelbine that emulsifies the drug in nanoparticles to reduce venous irritation. The company submitted an NDA for ANX-530 to the U.S. Food and Drug Administration in December 2009 but was turned down due to insufficient evidence for a commercially viable expiration dating period. Adventrx is conducting a 12-month stability study and plans to resubmit its application to the FDA in the fourth quarter of calendar year 2010.
Taxotere (docetaxel) is approved to treat breast, non-small cell lung, prostate, gastric, and head and neck cancers. The drug has been known to cause side effects ranging from flushing and rash to severe hypersensitivity reactions and anaphylaxis. It is suspected that hypersensitivity reactions to Taxotere are caused by the presence of polysorbate 80 and other detergents in the drug. ANX-514, a Taxotere reformulation being developed by Adventrx, is formulated without these detergents. Adventrx is also developing a drug candidate to protect users against bacterial and viral infections such as the common cold and influenza. The company is currently exploring an expansion of its pipeline.