AVANIR PHARMACEUTICALS TO LICENSE WORLDWIDE
2/5/99 9:15
Rights for Drug to Treat ALS-Related Symptoms
Company Plans to Begin Phase II Clinical Trial in First Half of 1999
SAN DIEGO, Feb. 5 /PRNewswire/ -- AVANIR Pharmaceuticals (Nasdaq: AVNR),
announced today it has signed a letter of intent, subject to approval of a
definitive agreement, with IriSys Research & Development, LLC to license the
worldwide rights to a new drug to treat a condition associated with
Amyotrophic Lateral Sclerosis (ALS), more commonly known as Lou Gehrig's
disease. The new drug is a patented combination of dextromethorphan and an
enzyme inhibitor, for which the Food and Drug Administration (FDA) has
accepted an Investigational New Drug (IND) application. AVANIR expects to
start Phase II clinical trials in the first half of 1999. Two other
indications to be pursued include treatments of certain types of pain and
chronic intractable cough.
The terms of the agreement would require the Company to make milestone
payments in cash or stock to IriSys for successful filings of New Drug
Applications (NDA) and subsequent marketing approvals by the FDA. Thereafter,
royalties would be paid based on a percentage of product sales. The Company
expects that no cash milestone payment would be paid in the first two years of
signing the agreement.
"We are excited to develop a new drug for people who suffer from these
disease-related symptoms," commented Gerald J. Yakatan, Ph.D., AVANIR's
president and CEO. "Acquiring new product development opportunities is
consistent with our strategy of in-licensing compounds
already in clinical development to broaden our product pipeline."
"We are eager to proceed with this patent-protected product development
opportunity," said James E. Berg, vice president of clinical and regulatory
affairs at AVANIR. "Early stage clinical experience suggests three potential
applications of the drug -- in improving the quality of life in patients who
have ALS and other neurodegenerative diseases, in relief of neuropathic pain
associated with various diseases and in relief of chronic intractable cough."
Dextromethorphan is metabolized so rapidly in the human body that the
higher levels of this drug necessary to be beneficial in other indications are
never achieved for most people. By adding an inhibitor of the enzyme that
metabolizes dextromethorphan, higher drug concentrations can be maintained for
longer periods of time.
Preliminary research indicates the drug to be effective in treating
emotional lability, a debilitating condition in which a patient has apparently
unprovoked and uncontrollable episodes of crying or laughing, sometimes as
often as 100 times per day. These episodes can have a profoundly detrimental
effect on the quality of life of patients and their caregivers. Emotional
lability affects approximately 50% of those suffering from Lou Gehrig's
disease and is also associated with other neurodegenerative diseases such as
stroke and Multiple Sclerosis (MS).
There are approximately 30,000 people affected by Lou Gehrig's disease in
the United States, a number that could qualify this product for Orphan Drug
Status. An application for Orphan Drug Status has been filed with the FDA.
If granted, this could result in an expedited review of an NDA, the document
that seeks authorization to sell the drug in the United States, AVANIR
officials said.
Preliminary research also shows the drug has the potential to treat
neuropathic pain, an intensive chronic pain, which is related to nervous
system damage and currently is very difficult to treat. Neuropathic pain is
associated with a number of diseases and occurs in up to 62% of American
diabetics. Existing drugs are not effective in everyone, and even when
effective they often have substantial side effects.
Chronic cough, or cough lasting more than three weeks, is another
condition potentially treatable with the new product. Over 90% of chronic
cough cases are caused by smoking, post-nasal drip, asthma, gastroesophageal
reflux and chronic bronchitis. Intractable cough is typically associated with
lung cancer, of which there are nearly 200,000 new cases each year in the U.S.
alone.
The drug was invented by Richard A. Smith, M.D. at the Center for
Neurologic Study in San Diego, who has four patents issued in his name for the
drug. IriSys Research & Development, LLC is a San Diego based contract
formulation development company which currently holds the rights to the
patents. IriSys was founded in 1996 by Dr. Yakatan, who resigned as CEO when
he took over as the president and CEO of AVANIR in March 1998. Dr. Yakatan is
still the chairman and a major shareholder of the privately-held company.
AVANIR Pharmaceuticals, based in San Diego, develops novel therapeutic
products for the treatment of chronic diseases. The company recently entered
into a $10 million equity line agreement intended to provide working capital
to support its goal of bringing a product to market in 1999, to continue its
allergy and asthma research programs, and to provide funding for potential
in-licensing and acquisition of new pharmaceutical products to fill its drug
pipeline.
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 are
unpredictable and outside of the influence and/or control of the Company.
SOURCE AVANIR Pharmaceuticals
-0- 02/05/99
/CONTACT: Gregory Hanson, CFO of AVANIR Pharmaceuticals, 619-410-2670; or
Bob Stone of The Dilenschneider Group, 212-922-0900, or home, 914-591-5534,
for AVANIR Pharmaceuticals/
/Web site: avanir.com
(AVNR) |
