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OTHER PRODUCT CANDIDATES OR POTENTIAL PRODUCT CANDIDATES

Lead Product Candidates

We are currently focused on developing and seeking regulatory approval for two late-stage product candidates, ANX-530 (vinorelbine injectable emulsion), or Exelbine™, and ANX-514 (docetaxel lyophilized emulsion for injection), which are novel emulsion formulations of currently marketed chemotherapy drugs. We believe Exelbine and ANX-514 may improve the safety of and have greater commercial potential than the currently marketed reference products, Navelbine® (vinorelbine tartrate) Injection and Taxotere® (docetaxel) Injection Concentrate, respectively, by:

  • Reducing the incidence and severity of adverse effects; and
  • Improving their pharmacoeconomics and convenience to healthcare practitioners and patients.

Reformulating existing pharmaceutical products is an increasingly common product lifecycle-management technique. 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 new markets for and ways to modify and improve existing products is often an essential element of pharmaceutical companies' efforts to innovate and improve treatment outcomes in the context of patent expirations and competitive pressures.

Navelbine and Taxotere are intravenously-injected chemotherapy drugs commonly used to treat solid tumors. We believe the current formulations of these drugs have limitations, such as phlebitis, erythema, hypersensitivity reactions and fluid retention, that present opportunities for improvement. We are developing novel ways to formulate the active ingredient underlying each of these drugs that we believe will improve their safety profiles without adversely affecting efficacy. In addition, we believe our formulations may provide benefits to patients and practitioners that do not manifest themselves in traditional measures of safety or efficacy.




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