DUSA Pharmaceuticals Files PMA Supplement for Commercial Version of BLU-U Light Source

Strategic Insights -

DUSA Pharmaceuticals, Inc., a biopharmaceutical company, has filed a Pre-Market Approval (PMA) Supplement with the FDA for the commercial version of its BLU-U(TM) brand light source. This move follows the FDA's approval of the Company's Levulan(R) Kerastick(TM) 20% topical solution PDT of the face and scalp and the clinical trial version of the BLU-U(TM) in December 1999. The commercial version of the BLU-U(TM) is expected to be approved within two to three months, although the FDA has up to six months to review the supplement. Upon approval, DUSA's dermatology marketing partner, Schering AG, and its US affiliate, Berlex Laboratories, plan to launch the Levulan(R) Kerastick and the BLU-U(TM) in the US shortly after, targeting the second quarter of the year.

Key Takeaways:

  • DUSA Pharmaceuticals filed a PMA Supplement for the commercial version of its BLU-U(TM) light source on March 20, 2000.
  • The supplement follows FDA approval of the Company's Levulan(R) Kerastick(TM) 20% topical solution PDT of the face and scalp and the clinical trial version of the BLU-U(TM) in December 1999.
  • The FDA has up to six months to review the supplement, with approval anticipated within two to three months.
  • Schering AG and Berlex Laboratories, DUSA's dermatology marketing partners, plan to launch the Levulan(R) Kerastick and the BLU-U(TM) in the US shortly after FDA approval, targeting the second quarter of the year.
  • Berlex displayed the Levulan(R) Kerastick(TM) and representatives were present to describe Levulan(R) PDT at the recent American Academy of Dermatology (AAD) annual meeting in San Francisco.
  • Dr. Mark Ling, one of DUSA's Phase III investigators, reviewed the therapy at an AAD forum dedicated to PDT in dermatology, stating that, in his opinion, Levulan(R) PDT could become an important part of the management of AKs by dermatologists.
  • DUSA Pharmaceuticals is a biopharmaceutical company engaged primarily in the development of Levulan(R) Photodynamic Therapy (PDT) and Photodetection (PD) for multiple medical indications.

Statistics:

  • Date of PMA Supplement filing: March 20, 2000
  • Anticipated FDA review period: two to three months
  • Maximum FDA review period: six months
  • Targeted launch quarter: second quarter of the year

Sources:

  • DUSA Pharmaceuticals, Inc. (NASDAQ:DUSA) press release, March 27, 2000
  • American Academy of Dermatology (AAD) annual meeting, March 9-15, 2000
  • DUSA Pharmaceuticals, Inc. Form S-3 registration statement