Sign in Subscribe
Pharmaceutical industry

Coulter Pharmaceutical and SmithKline Beecham Announce FDA Request for Modifications to Bexxar Marketing Application

Strategic Insights

— 2 min read

Coulter Pharmaceutical, a biotechnology company specializing in therapeutic antibodies and targeted oncologics, has partnered with SmithKline Beecham, one of the world's leading healthcare companies, to develop and market Bexxar, a novel monoclonal antibody conjugated to a radioisotope. The U.S. Food and Drug Administration (FDA) has requested modifications to the Biologics License Application (BLA) for Bexxar, submitted for marketing approval for the treatment of relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Coulter's most advanced product candidate, Bexxar, is part of their targeted oncologics program, which aims to develop a tumor-activated peptide pro-drug version of doxorubicin to treat certain solid tumor cancers. SmithKline Beecham's collaboration with Coulter has also led to the development of other programs, including an antibody-based approach to block the Type I interferon receptor for the treatment of autoimmune diseases.

Key Takeaways:

  • The FDA has requested modifications to the Biologics License Application (BLA) for Bexxar, a novel monoclonal antibody conjugated to a radioisotope, submitted for marketing approval for the treatment of relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma.
  • Bexxar is part of Coulter Pharmaceutical's targeted oncologics program, which aims to develop a tumor-activated peptide pro-drug version of doxorubicin to treat certain solid tumor cancers.
  • The partnership between Coulter Pharmaceutical and SmithKline Beecham has led to the development of multiple programs, including an antibody-based approach to block the Type I interferon receptor for the treatment of autoimmune diseases and transplahtm.
  • Hycamtin (topotecan hydrochloride) is another product in development by Coulter Pharmaceutical, with Kd in this news release highlighting its potential as a treatment for certain solid tumor cancers.
  • Coulter Pharmaceutical's efforts in targeted oncologics are focused on developing novel therapies for a range of cancers, including solid tumor cancers and non-Hodgkin's lymphoma.
  • SmithKline Beecham's collaboration with Coulter Pharmaceutical has facilitated the development of multiple programs across a range of therapeutic areas.

Statistics:

  • The FDA has requested modifications to the BLA for Bexxar, which was submitted for marketing approval on August 30, 1999.
  • The U.S. Securities and Exchange Commission (SEC) filing of Coulter Pharmaceutical's Annual Report on Form 20-F for 1998 includes information on the company's operations and risk factors.
  • The company's Form 10-K for the year ended December 31, 1998, filed with the SEC, also includes information on the company's operations and risk factors.

Sources:

  • Coulter Pharmaceutical, Inc. (Nasdaq:CLTR) and SmithKline Beecham (NYSE:SBH) press release, August 30, 1999.
  • Exhibit 99 to Coulter Pharmaceutical's Annual Report on Form 20-F for 1998, filed with the U.S. Securities and Exchange Commission.
  • Coulter Pharmaceutical's Form 10-K for the year ended December 31, 1998, filed with the U.S. Securities and Exchange Commission.

Read more