Neurobiological Technologies, Inc. Announces Approval Of Memantine (Ebixa®) in Europe for Alzheimer's Disease
RICHMOND, Calif., May 28 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc., NTI® (Nasdaq: NTII) today announced that Memantine has been approved for the treatment of Alzheimer's Disease by the regulatory authorities in the European Union.
"We are delighted that our strategic partners, Merz Pharma KgaA and H. Lundbeck A/S, have received approval for the sale of Memantine in Europe to treat Alzheimer's Disease. It will be marketed under the name Ebixa®," commented Paul E. Freiman, president and chief executive officer of NTI. "The approval clearly validates the importance of Memantine as a new class of drugs which will be useful in dealing with this debilitating disease."
Mr. Freiman continued, "This event will trigger a $1.4 million payment to NTI at the end of July 2002. In addition, we will receive royalty payments once sales commence."
On May 23, 2002, Lundbeck issued the following press release:
"The EU commission issues marketing authorisation for Ebixa(R)
"On the basis of a recommendation from the Committee for Proprietary Medicinal Products (CPMP), the EU commission has now issued a marketing authorisation for Ebixa® covering all EEA countries. Marketing of Ebixa® will commence second half of 2002.
"Ebixa® is the first in a new class of medicine for the treatment of Alzheimer's disease, NMDA receptor antagonists. Ebixa elicits a clinically significant effect in patients with moderately severe and severe Alzheimer's disease. Ebixa® is expected to fulfill unmet needs within this group of patients -- for whom no approved therapy has been available until now.
"Alzheimer's disease affects approximately 5 per cent of the population above 65 years and more than 20 per cent in the age group above 85. Currently less than 50 per cent of the people suffering from Alzheimer's disease are diagnosed correctly and of these only 10-30 per cent receive proper treatment. There are considerable variations among countries.
"Alzheimer's disease is a neurodegenerative disease characterised by progressive cognitive impairment such as failing memory, reduced perception and language derangement, which ultimately leads to the patient not being able to look after him- or herself. In later stages of the disease behavioural disturbances appear such as anxiety, confusion and anger.
"Lundbeck has in-licensed memantine from Merz Pharma, a German research based pharmaceutical company. Lundbeck has acquired exclusive rights to a number of European markets as well as Canada, Australia and South Africa. Under a co-marketing agreement with Merz, Lundbeck has acquired semi-exclusive rights on the remaining markets worldwide exclusive of USA and Japan. Forest Laboratories, Inc. holds the rights to the US market."
NTI is an emerging drug development company focused on the clinical development and regulatory approval of neuroscience drugs. The Company's strategy is to in-license and develop early-stage drug candidates that target major medical needs and which can be rapidly commercialized. The Company's experienced management team oversees the human clinical trials necessary to establish preliminary evidence of efficacy and seeks partnerships with pharmaceutical and biotechnology companies to complete development of and market its product candidates.
NOTE: Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including our dependence on Merz and its marketing partners for the successful development of Memantine, our ability to receive required regulatory approval and successfully commercialize Memantine and other potential products, as well as other risks detailed from time to time in our Securities and Exchange Commission filings. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. We disclaim, however, any intent or obligation to update these forward-looking statements.