Phase II/III Clinical Trial to Begin in Fall 2000
Updated 8:29 AM ET August 9, 2000
Current quotes (delayed 20 mins.) AVN 2 3/4 1/16 (2.33%)
SAN DIEGO, Aug. 9 /PRNewswire/ -- AVANIR Pharmaceuticals (AMEX:AVN), today announced completion of a license agreement for exclusive worldwide rights to a proprietary drug product for the treatment of multiple central nervous system disorders including emotional lability, neuropathic pain and chronic cough. The product was licensed from Irisys Research and Development, a private San Diego contract research organization.
An Investigational New Drug (IND) application for the licensed product, a new formulation of dextromethorphan internally designated AVP-923, has been accepted by the U.S. Food and Drug Administration (FDA). Upcoming Phase II/III studies will assess the drug's efficacy in reducing the loss of emotional control, clinically known as emotional lability, in patients with neurodegenerative diseases such as Multiple Sclerosis (MS), Lou Gehrig's disease (ALS), Alzheimer's Disease (AD) and stroke.
Assuming successful initiation of Phase II/III clinical trials for emotional lability, the company plans to initiate product development for the additional indications, neuropathic pain and chronic cough. If all three indications are successfully developed and marketed by the company, the addressable market would be in excess of $1.5 billion.
"The license agreement is attractive to us because of the unmet therapeutic needs, market potential and the fact that there are no upfront payments by AVANIR," stated J. David Hansen, Vice President of Commercial Development. "Milestone payments would be made only upon FDA's acceptance of the filing of an NDA and for FDA marketing approvals for each indication. If we are successful in obtaining FDA approval and market the drug, we would pay a royalty based on product sales."
AVANIR is obligated to use commercially reasonable efforts to develop and commercialize two potential indications for AVP-923, including funding of all development costs. The company expects that no cash milestone payment would be paid before 2002, which should provide for more AVANIR resources to be focused on funding AVP-923 product development.
"AVP-923 provides AVANIR with the opportunity to develop the same or similar formulations for multiple indications allowing us to spread our development costs and risk across the multiple indications," said Mr. Hansen. "If we are successful in our strategy, we intend to build our own marketing and sales organization to sell these products to the specialty physician markets that diagnose and treat patients with emotional lability, neuropathic pain, or chronic cough."
AVP-923 is comprised of dextromethorphan and an enzyme inhibitor that significantly slows the metabolism of dextromethorphan. Currently, the therapeutic utility of dextromethorphan is limited due to its rapid metabolism. Phase I/II clinical trials have demonstrated that AVP-923 provides sustained therapeutic levels of dextromethorphan utilizing a dose already familiar to physicians.
In neurodegenerative disorders, one of the symptoms frequently experienced by the patient can be loss of emotional control. Although not physically harmful, the condition has a significant affect on the psychological health of both patients and their caregivers. Medical reports on the incidence of emotional lability estimate that up to 50% of ALS patients and 25% of MS and AD patients are affected by the loss of emotional control. In stroke patients the incidence is initially 20% within the first year of stroke with one-half of those patients recovering emotional control within the first year. Currently, there is no FDA-approved product for treating emotional lability. The FDA has indicated that if the company successfully performs clinical studies for emotional lability in at least two of the neurodegenerative diseases, a broad general indication for emotional lability could be obtained. Combined affected patient populations from all four diseases result in a patient pool up to 1,000,000 patients per year.
Dextromethorphan is a well known NMDA receptor antagonist and has been shown to reduce neuropathic pain such as that associated with diabetic neuropathy. The medical literature indicates that there are approximately seven million diabetics who suffer from diabetic neuropathy, 40% of whom suffer from moderate to severe disease. The company estimates the treatable patient pool is 1,000,000 people. Currently, the company knows of only one other non-narcotic product widely in use for treating the chronic pain associated with diabetic neuropathy, Warner-Lambert's anticonvulsant, Neurontin(R), which has sales over $800 million annually.
Dextromethorphan is well established as an effective and widely used non-narcotic cough suppressant that is effective for short periods after each dose. The company believes AVP-923 could find wide utility for the treatment of chronic cough typically caused by smoking, post-nasal drip, asthma, gastro esophageal reflux and chronic bronchitis, as well as intractable cough which is typically associated with lung cancer. While it is estimated that 11% of the approximate 30 million physician office visits each year involve the treatment of cough, the company estimates the treatable patient pool for chronic and intractable cough indication is much narrower, but still could be as high as 500,000 patients.
AVANIR Pharmaceuticals, a specialty pharmaceutical company, develops novel therapeutic products for the treatment of chronic diseases including docosanol 10% cream recently approved for marketing by the FDA. The company's product development pipeline includes a patented fully human monoclonal antibody technology under commercial development. Other programs include a drug discovery program in the advanced pre-clinical stage of development for the treatment of the underlying biological causes of allergy and asthma and preclinical work on novel approaches to discovering compounds with lipid lowering and anti-inflammatory activities.
The information contained in this press release, including any forward looking statements contained herein, should be reviewed in conjunction with the company's Annual Report on Form 10-K and other publicly available information regarding the company, copies of which are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and such statements, including risks and uncertainties related to drug development and clinical trials. Preliminary research findings are not always supportable by evidence obtained from subsequent clinical trials. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results for AVP- 923 are unpredictable and outside of the influence and/or control of the company.
Contact: Patrice Saxon of AVANIR Pharmaceuticals, 858-410-2660; or Bob
Stone, or Ken DiPaola, both of The Dilenschneider Group, financial media