Palatin Technologies and Molecular Biosystems Announce Corporate Growth Progress

Strategic Insights -

Palatin Technologies, Inc. and Molecular Biosystems, Inc. are moving forward with their corporate growth strategies as they prepare for a merger vote by stockholders. Palatin's LeuTech, a monoclonal antibody for imaging infection sites, has had its Biologics License Application accepted for full review by the FDA. Meanwhile, Molecular Biosystems' OPTISON, an ultrasound imaging agent, has had its manufacturing transfer approved by the FDA, allowing the company to focus on developing further indications.

Key Takeaways:

  • Palatin's LeuTech has been accepted for full review by the FDA after a 60-day initial review, with the company's BLA submitted in November 1999.
  • LeuTech has the potential to be Palatin's first commercial product, with the company planning multiple Phase 2 clinical trials to demonstrate its safety and effectiveness in diagnosing various infections.
  • Palatin has reached an agreement with Mallinckrodt Inc. to market and distribute LeuTech worldwide except in Europe.
  • The FDA has approved the transfer of fill and finish operations for OPTISON from Molecular Biosystems' San Diego facility to Mallinckrodt's Maryland Heights, Missouri plant.
  • Despite this development, Molecular Biosystems will focus on developing further indications for OPTISON, with the company expecting to complete the transfer of fill and finish operations by June 2000.
  • Palatin's CEO, Edward Quilty, expressed optimism about the strong synergies between the two companies, stating that the integration of the companies will further strengthen the opportunity for future stockholder growth.
  • Palatin continues to pursue PT14, a potential treatment for male erectile dysfunction, with the company aiming to file an IND by the end of 2000.
  • MBI reported a 43 percent growth in OPTISON sales over the same quarter in the previous year, with ongoing acceptance of OPTISON contributing to this growth.

Statistics:

  • Palatin's LeuTech has been submitted for full review by the FDA after a 60-day initial review.
  • The FDA guidelines call for most BLA's to be reviewed in 10 to 12 months.
  • Palatin has reached an agreement with Mallinckrodt Inc. to market and distribute LeuTech worldwide except in Europe.
  • The FDA has approved the transfer of fill and finish operations for OPTISON from Molecular Biosystems' San Diego facility to Mallinckrodt's Maryland Heights, Missouri plant.
  • MBI reported a 43 percent growth in OPTISON sales over the same quarter in the previous year.
  • OPTISON sales have shown an 18 percent growth from the fiscal 2000 second quarter.

Sources:

  • Business Editors & Health/Medical Writers BIOWIRE2K PRINCETON, N.J. and SAN DIEGO--(BW HealthWire)--Feb. 23, 2000
  • Palatin Technologies, Inc. (AMEX:PTN) and Molecular Biosystems, Inc. (OTCBB:MBIO)