BERKELEY HEIGHTS, N.J., March 16 /PRNewswire-FirstCall/ -- Genta Incorporated announced today that the Company has received notification from the European Medicines Agency (EMEA) that it has been granted designation as a Small/Medium Enterprise (SME). The SME program is a new initiative by the EMEA that is designed to assist small companies applying for European approval of medicinal products. The SME designation offers substantial advice during the application process and potential reduction or deferral of application-related fees. Genta’s Marketing Authorization Application (MAA) for Genasense(R) (oblimersen), the company’s lead anti-cancer drug, is currently undergoing scientific review by the EMEA.
“With this new procedure having been established only in November 2005, we are pleased to be one of the first companies to receive this designation,” commented Dr. Raymond P. Warrell, Jr., Chief Executive Officer of Genta. “We have been actively working with regulatory authorities in Europe during their review of the Genasense MAA, and we greatly appreciate the assistance accorded us with the SME designation.”
The MAA proposes the use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. Summary data that support this application can be viewed at: www.genta.com. Additional information on the SME program is available from the EMEA website at: http://www.emea.eu.int/SME/SMErelated.htm.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company’s research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA-based medicines) and small molecules. Genasense(R) (oblimersen sodium) Injection is the Company’s lead compound from its oligonucleotide program. The Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The leading drug in Genta’s small molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: www.genta.com.
This press release contains forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company’s Annual Report/Form 10-K for 2005.
Genta Incorporated
CONTACT: Investor Relations, TS Communications Group, LLC, info@genta.com,or +1-914-921-5900, or Media Relations, Greg Tiberend of Richard LewisCommunications, +1-212-827-0020
