FDA Extends PDUFA Date for Polyphenon® E Ointment* to October 31, 2006
· Deadline extended by 90 days to review additional documents
· MediGene expects approval and market launch in 2007
· MediGene adjusts corporate planning and annual forecast
Martinsried/Munich – San Diego, June 30, 2006. The German-American biotech company MediGene AG (Frankfurt, TecDAX: MDG) announced that the US regulatory authority FDA (Food and Drug Administration) has extended the deadline for the completion of its review of the NDA for MediGene’s Polyphenon® E Ointment* for the treatment of genital warts to October 31, 2006. The original Prescription Drug User Fee Act (PDUFA) date was July 28, 2006. According to the FDA, the reason for this 90 days deadline extension is that the documents submitted by MediGene at the request of the FDA have been classified as a major amendment. The FDA’s review has not been completed up to now. On the PDUFA date, the FDA will notify MediGene whether the drug under review will be approved for marketing, or whether or not it may be approved after fulfillment of additional conditions imposed. Due to the modified time schedule, MediGene now expects approval and market launch of the Polyphenon® E Ointment not earlier than in 2007.
Upon approval of the Polyphenon® E Ointment, MediGene will be entitled to receive a milestone payment from Bradley Pharmaceuticals, its U.S. marketing partner (NYSE: BDY) that was included in the company’s hitherto existing revenues forecast. Due to the extended deadline and to management’s recent decision to commit additional financial resources into MediGene’s main value driving project EndoTAG, MediGene adjusts corporate planning and the forecast for the year 2006. The company expects to generate revenues of 20-25 million Euros and a net loss of 10-15 million Euros in 2006 (original forecast: revenues 30 million Euros, loss 0 Euro).
Dr. Peter Heinrich, Chief Executive Officer of MediGene AG, comments: “We are working closely with the FDA to support an expeditious review of our NDA. The deadline extension will not affect the prospect of success for our Polyphenon® E Ointment. However, the PDUFA date extension to the fourth quarter of the year reduces the probability of obtaining formal approval before the end of this year. Therefore we expect to obtain approval for the Polyphenon® E Ointment next financial year, and include the respective revenues in our forecast for 2007.”
Polyphenon® E Ointment: The active substance in Polyphenon® E Ointment is an extract from green tea leaves with a defined catechine composition, produced by means of a specific purification process. MediGene is developing this drug for the treatment of various skin tumor diseases. The New Drug Application for the indication genital warts currently under review in the USA is mainly based on two international phase III trials in more than 1,000 patients.
This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. EndoTAGTM and MediGeneTM are trademarks of MediGene AG, Polyphenon® E is a trademark of Mitsui Norin.
* temporary name while under development
- Ends -
MediGene AG is a publicly quoted (Frankfurt: TecDAX), German-American biotechnology company located in Martinsried, Germany and San Diego, USA. MediGene is the first German biotech company with a drug on the market. The NDA for a second drug, Polyphenon® E Ointment, has been submitted. In addition, MediGene has several oncological drug candidates undergoing clinical development, and possesses innovative platform technologies for drug development. MediGene’s core competence lies in research into and development of novel approaches for the treatment of various cancer and tumor diseases.
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