AVANIR Signs Neurodex Clinical Research And Marketing Agreement With Medison Pharma
SAN DIEGO, Aug 08, 2002 /PRNewsire-FirstCall via Comtex/ -- AVANIR Pharmaceuticals (Amex: AVN) announced that it has entered into an agreement with Medison Pharma, Ltd. for clinical research, marketing and distribution rights for Neurodex in Israel. The agreement provides for Medison to conduct clinical trials in Israel for the treatment of emotional lability in patients with multiple sclerosis (MS) and grants Medison a license to market and sell Neurodex in Israel, if it is approved for marketing.
Under the terms of this agreement, Medison will manage a Phase III clinical trial intended to examine the safety and efficacy of Neurodex in the treatment of emotional lability in MS patients. Medison will also be responsible for managing and funding all necessary regulatory registrations for Neurodex in Israel. Upon regulatory approval of the product, Medison will be the exclusive distributor of Neurodex in Israel for the treatment of emotional lability. AVANIR will receive royalties on product sales if the drug is approved for marketing in that country. Financial terms of the agreement were not disclosed.
"Medison Pharma is an experienced contract research organization that has established relationships with the major MS clinics in Israel, but equally as important, Medison is well positioned to market Neurodex to the country's neurologist community," said AVANIR President and Chief Executive Officer Gerald J. Yakatan, Ph.D. "We look forward to working with Medison and feel they will be very effective in both endeavors."
The clinical trial to be conducted by Medison is expected to run concurrently with a Phase III trial of Neurodex in MS patients with emotional lability in the U.S. These studies follow a successful Phase II/III clinical trial investigating the safety and effectiveness of Neurodex in treating emotional lability in patients with amyotrophic lateral sclerosis (ALS).
"We are very pleased with the collaboration with AVANIR for the promising new product, Neurodex," said Shmuel Berkovich, Medison Pharma's Chief Executive Officer. "This product will strengthen our position in the CNS field, especially in the MS market, in which we are marketing Biogen's Avonex, currently the most common treatment for MS."
Neurodex is a patented, orally administered combination of dextromethorphan (DM) and an enzyme inhibitor and is the first drug product in clinical development specifically intended to treat emotional lability. Emotional lability, also known as pseudobulbar affect, is a symptom complex experienced by patients with neurodegenerative diseases and is characterized by uncontrollable episodes of laughter and/or crying which may be out of context to the social setting. These episodes may or may not be provoked and are not necessarily associated with the patient's underlying emotion.
Medison Pharma Ltd. is a privately held Israeli pharmaceutical company headquartered in Petach-Tikva, Israel. Medison represents other biotechnology companies such as Biogen, Shire, Transkarotic Therapies, and Beaufour Ipsen in Israel and has established arrangements ranging from conducting clinical studies to marketing and distribution of products.
AVANIR Pharmaceuticals, based in San Diego, is a biopharmaceutical drug discovery and development company with an FDA-approved product. AVANIR is engaged in research, discovery, development and licensing of innovative drug products and, through its subsidiary Xenerex Biosciences, antibody generation services. The Company's website is http://www.avanir.com .
AVANIR press releases and presentations, including any forward-looking statements contained therein, should be reviewed in conjunction with the company's most recent Annual Report on Form 10-K and other publicly available information regarding the company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and technology. Forward-looking statements often contain such words as "estimate," "anticipate," "intend," "plan" or "expect." Research findings are not always supportable by evidence obtained from subsequent clinical trials and the Company can make no assurances that the Neurodex clinical trials will yield positive results. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are unpredictable and outside the influence and/or control of the company.
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