Form 8-K for DUSA PHARMACEUTICALS INC
18-Jan-2008
Other Events
Item 8.01 Other Events.
In connection with the merger of Sirius Laboratories, Inc. ("Sirius") with DUSA Pharmaceuticals, Inc. ("DUSA"), the registrant, on March 10, 2006, DUSA became the assignee of a development, license and supply agreement between Sirius and Altana, Inc. ("Altana") entered into on June 13, 2005 (the "Agreement"). Under the Agreement, Altana developed a reformulated dermatology product pursuant to a supplement to an abbreviated new drug application ("ANDA") which was submitted by Altana to the U.S. Food and Drug Administration ("FDA"). DUSA has recently been informed by Altana that Altana received a non-approvable letter from the FDA with respect to its ANDA supplement.
Based on the FDA action which requires Altana to withdraw the ANDA supplement, DUSA will not receive pre-market approval to launch this product as previously anticipated. Furthermore, in light of preliminary market research data which was equivocal as to the potential acceptability of the product due to the changing competitive environment, DUSA no longer expects to launch this product.
Except for historical information, this report contains certain forward-looking statements that involve known and unknown risk and uncertainties, which may cause actual results to differ materially from any future results, performance or achievements expressed or implied by the statements made. These forward-looking statements relate to expectations regarding launch of the product. Furthermore, the factors that may cause differing results include the reliance on third parties, maintenance of DUSA's patent portfolio, the uncertainties of the regulatory process and other risks identified in DUSA's SEC filings from time to time.
surf's up......crikey
