AVANIR CEO Reports Progress on Patent Extension Request for Abreva(TM) At Company's Annual Meeting
"We are pleased to see the FDA's determination that the applicable regulatory review period exceeded five years, indicating that our application for extension may be eligible for the maximum five years allowable by law," said AVANIR President and Chief Executive Officer Gerald J. Yakatan, Ph.D. "If our application for an extension is accepted, it will substantially extend the length of time AVANIR can expect to receive royalties on sales of Abreva and increase the value of our license agreement with GlaxoSmithKline."
The FDA approved Abreva (docosanol 10% cream) for marketing on July 25, 2000. Abreva is indicated for the treatment of cold sores and fever blisters and is the first and only FDA-approved product for this indication available without prescription. After Abreva's approval, AVANIR filed a patent term restoration application to the U.S. Patent and Trade Office (USPTO). Thereafter, the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration.
The FDA determined that AVANIR's patent term should be credited for a total of 3,270 days including time spent in both the testing phase and the regulatory review phase. The Drug Price Competition and Patent Term Restoration Act of 1984 and the Generic Animal Drug and Patent Term Restoration Act generally provide that a patent may be extended for a period of up to five years, if the product was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the maximum amount of extension an applicant may receive. Therefore, if the USPTO follows the FDA's determination, AVANIR could receive the maximum five-year extension allowable.
On February 28, 2002, the Federal Register (Vol. 67, No. 40, pg. 9303) published the FDA's determination, which starts a statutory 180-day public review period. Following the public review period, and provided the calculations are not challenged or modified, the USPTO will make a determination of the actual period for patent extension and publish a certificate of patent extension, which the Company expects to occur before the end of the year.
Abreva(TM) is the largest selling consumer healthcare product in the United States for the treatment of cold sores and was ranked number eight among all new consumer healthcare products introduced in the twelve-month period ended December 2001, according to AC Nielson data. AVANIR received its final $5 million milestone payment and its largest royalty revenues to date last quarter from its marketing partner GlaxoSmithKline. AVANIR has expanded its docosanol franchise to include Asia and the Middle-East and intends to file for regulatory approval in Europe and Japan.
Also at today's Annual Meeting, shareholders elected three Class I Directors, approved an amendment to the 2000 stock option plan and ratified Deloitte & Touche LLP as the Company's independent auditors.
Elected as Class I Directors are: Michael W. George, President, North America of Elan Pharmaceuticals; James B. Glavin, Chairman of the Immune Response Corporation; and Susan Golding, the former Mayor of San Diego. The membership of the Board remains at nine.
AVANIR Pharmaceuticals, based in San Diego, is a diversified biopharmaceutical company engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services. The company's website is http://www.avanir.com .
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 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 like "estimate," "anticipate," "believe," "plan" or "expect." The Company can make no assurances as to the length of the patent extension, if any, because final determination of the actual period for patent extension resides with the U.S. Patent and Trade Office and is outside the influence and/or control of the Company.
For further information, please contact: general information, Kristen McNally, +1-310-407-6548, firstname.lastname@example.org, or analyst/investor, Tricia Ross, +1-310-407-6540, email@example.com, or media, Al Orendorff, +1-312-640-6775, firstname.lastname@example.org, all of FRB Weber Shandwick, for AVANIR Pharmaceuticals; or Patrice Saxon, Investor Relations of AVANIR Pharmaceuticals, +1-858-622-5202, email@example.com.
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SOURCE AVANIR Pharmaceuticals
general information, Kristen McNally, +1-310-407-6548,
analyst/investor, Tricia Ross,
or media, Al Orendorff, +1-312-640-6775,
firstname.lastname@example.org, all of FRB Weber Shandwick,
for AVANIR Pharmaceuticals; or Patrice Saxon,
Investor Relations of AVANIR Pharmaceuticals,
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