Zila, Inc. Signs European and Australian Licensing Agreement for Oral Cancer Diagnostic OraScan

Strategic Insights -

Zila, Inc. has announced a significant milestone in the global expansion of its oral cancer diagnostic, OraScan. A European and Australian licensing and distribution agreement has been signed with Block Drug Company, Inc., a U.S. Fortune 500 company. This agreement paves the way for the introduction of OraScan in Europe and Australia, where the market potential is expected to be considerably greater than in the U.S. due to higher rates of tobacco and alcohol consumption.

Key Takeaways:

  • Zila, Inc. has signed a European and Australian licensing and distribution agreement for its oral cancer diagnostic, OraScan.
  • The licensee is Block Drug Company, Inc., a U.S. Fortune 500 company with a large detailing force in the U.K.
  • The market potential for OraScan in Europe is expected to be significantly greater than in the U.S. due to higher per capita tobacco and alcohol consumption.
  • Smoking and drinking are the primary risk factors for oral cancer in the over-40 population.
  • Zila will receive initial license fees and additional funds and royalties keyed to sales in each country included in the agreement.
  • The formal regulatory approval and marketing license from the U.K.'s Medicines Control Agency (MCA) is expected to aid in gaining approvals in other international markets.
  • OraScan has been issued an IND by the FDA, and expedited approvals are being sought for other European Union member nations.

Statistics:

  • The market potential for OraScan in Europe is expected to be 50% greater than in the U.S.
  • The U.S. population has a higher rate of tobacco and alcohol consumption than Europe.
  • Smoking and drinking are the primary risk factors for oral cancer in the over-40 population.
  • Initial license fees and additional funds and royalties will be received by Zila.
  • The Medicines Control Agency (MCA) has granted OraScan a marketing license.
  • OraScan has been issued an IND by the FDA.

Sources:

  • PRNewswire
  • Zila, Inc.
  • Block Drug Company, Inc.
  • Stafford-Miller Limited
  • Medicines Control Agency (MCA)
  • FDA (U.S. Food & Drug Administration)