Pharmacyclics Signs Marketing and Distribution Agreement with E-Z-EM for GADOLITE Oral Suspension

Strategic Insights -

Pharmacyclics, a private company developing biometallic pharmaceuticals, has announced a marketing and distribution agreement with E-Z-EM, a leading manufacturer and distributor of oral and gastrointestinal contrast agents. Under the agreement, E-Z-EM will gain the right to sell, market, and distribute GADOLITE, an oral contrast agent candidate for improving MRI imaging of the abdomen and pelvis. The companies will collaborate on the development of additional oral contrast agents based on GADOLITE technology, with Pharmacyclics receiving payments upon completion of certain regulatory and commercial milestones.

Key Takeaways:

  • Pharmacyclics signed a marketing and distribution agreement with E-Z-EM for its patented GADOLITE Oral Suspension on August 23, 1995.
  • The agreement grants E-Z-EM the right to sell, market, and distribute GADOLITE in the United States, Canada, and Mexico.
  • Pharmacyclics will receive a license fee, payments upon completion of regulatory and commercial milestones, and a share of profits on net sales of GADOLITE.
  • The companies will collaborate on the development of additional oral contrast agents based on GADOLITE technology.
  • Pharmacyclics obtained exclusive licenses for GADOLITE oral suspension from The University of Texas at Dallas in 1991.
  • Marc L. Steuer, Vice President of Business Development and Chief Financial Officer of Pharmacyclics, stated that E-Z-EM's strong distribution system and commitment to serving the specialty will help GADOLITE reach key decision-makers for evaluation and purchase.
  • Phase III multi-center studies of GADOLITE were completed during the first quarter of 1995, and Pharmacyclics expects to file a new drug application (NDA) with the FDA by the end of 1995 for use of the product as an MRI contrast agent in the imaging of abdominal and pelvic disorders.

Statistics:

  • August 23, 1995: Date of the marketing and distribution agreement between Pharmacyclics and E-Z-EM.
  • 1991: Year Pharmacyclics obtained exclusive licenses for GADOLITE oral suspension from The University of Texas at Dallas.
  • 1995: Year Phase III multi-center studies of GADOLITE were completed.
  • Estimated FDA filing date for NDA: end of 1995.

Sources:

  • Business Wire, "Pharmacyclics, Inc. Announces Agreement with E-Z-EM for GADOLITE", August 23, 1995.
  • The text itself (as indicated in the original Business Wire release).