pardon me antihype but does this look right to you, if it does then heb was able to get cost recovery due to cdc's understatement of the number of cfs sufferers, then they revise number upwards 20 fold, heb keeps orphan status and reaps the benefits of 7 yr exclusivity.
Now that correct numbers have been released by cdc we as investors can see the giant need for heb's ampligen.
love those 2:45 am press releases heb does, guess even if webmasters dont work in middle of night, heb pr does
Hemispherx Retains Orphan Drug Status of Ampligen(R); Keeps Marketing Exclusivity Even Though CFS Afflicts 500,000 People
PR Newswire - October 15, 1998 02:45
NEW YORK, Oct. 15 /PRNewswire/ -- The following statement was issued today by Hemispherx Biopharma:
Hemispherx Biopharma (Amex: HEB) said today that the Orphan Drug status that the FDA previously granted for the Company's developmental drug Ampligen(R) provides exclusive marketing rights for the treatment of Chronic Fatigue Syndrome (CFS) for a seven-year period that would begin at the time of the drug's approval by the FDA.
This seven-year marketing exclusivity is not affected by the fact that the estimates of the incidence of CFS in the U.S. have increased by a factor of 20 times or more since the FDA granted the status to Ampligen(R). Under the Orphan Drug Act of 1983, companies retain their Orphan Drug incentives even if estimates of the incidence of the disease later increase.
In 1993, when the FDA granted Ampligen(R) Orphan Drug status for the treatment of CFS, the Centers for Disease Control's (CDC) estimate for CFS incidence in the U.S. was only 4-8 per 100,000 people, or approximately 10-20,000 Americans in total. These estimates qualified CFS for orphan drug status, which is defined by the FDA as a product that treats a rare disease affecting fewer than 200,000 Americans.
Even though the CDC (http://www.cdc.gov/ncidod/diseases/cfs/cfs_info2.htm) has since revised its estimates of CFS incidence in the U.S. to approximately half a million people, Orphan Drug regulations allow Ampligen(R) to continue to qualify for seven-year marketing exclusivity starting upon the drug's approval. Since Ampligen(R) is still in Phase III clinical trials, its seven-year period has not yet begun.
According to the FDA (http://www.fda.gov/cder/handbook/orphan.htm), the intent of the Orphan Drug Act is to stimulate the research, development, and approval of products that treat rare diseases that might not otherwise be financially attractive to drug companies to pursue. Other incentives that are part of Orphan Drug designation include tax incentives for clinical research, assistance from the FDA's Office of Orphan Products Development to help coordinate research study designs, and FDA encouragement to the Company to conduct open protocols which allow patients to be added to ongoing studies. According to the FDA, over 100 orphan drugs and biological products have been brought to market since the Orphan Drug Act was passed on January 4, 1983.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Accordingly, actual results may differ materially from those in any forward-looking statements.
SOURCE Hemispherx Biopharma, Inc.
/CONTACT: William A. Carter, M.D., CEO and Chairman of Hemispherx
Biopharma, 215-988-0080, or Media, William J. Jenks, 212-232-2222, for
Hemispherx; or Investors, Sharon Will, 212-572-0762, of Hemispherx/
/Web site: fda.gov
|
