EU Cites Hemispherx Patents as Precedent and Dominant 'Art' in Novel Hepatitis Treatments
12.08.1999, 15:03
Philadelphia (PROTEXT) - Hemispherx Biopharma, Inc. (Amex:
HEB) today said its patents that are designated as novel
treatments of hepatitis B and C have recently been singled out by
the European patent office as a dominant "art" against these
diseases.
The claims were made by the Examiner of the European patent
office when it was examining a group of new patent applications
submitted by another multinational pharmaceutical company for the
treatment of various forms of chronic hepatitis. The patents were
owned by Beaufour Ipsen, a multinational pharmaceutical firm.
In raising objections to the novelty and potential validity of
the Beaufour patent applications, Hemispherx said the independent
Examiners cited six different Hemispherx patents, each with
distinct and unique content. These patents, in fact, are already
issued and recognized in many parts of the world, including the
European Union. The Hemispherx patents were cited by the
Examiners more than 19 times as examples of prior art against the
pending therapeutic hepatitis claims of Beaufour.
The primary drug compound under examination, designated
polyadenur(R), is derived from a class of normally occurring
antiviral compounds, termed double- stranded RNAs. RNAs are part
of the body's molecular information bank, which includes the
related molecules, DNA, the cell's genetic material. Certain RNA
molecules can trigger many viral infected cells (including liver
cells, termed hepatocytes) to protect themselves by a novel
action, which includes specific stimulation of the immune system.
Hemispherx is the exclusive owner of all issued polyadenur(R)
patents in any major pharma market and intends to actively
cooperate with EU Examiners to insure the integrity of the EU
patent issuance process. Hemispherx said that it believed the
priority of its hepatitis treatment patents would be upheld and
preserved, thus ensuring long-term value of its shareholders.
Globally, Hemispherx has issued over 300 patents covering
medicinal technologies for the treatment of various viral and
immune dysfunction diseases including hepatitis B and hepatitis
C.
Phase II studies of polyadenur(R) recently performed in the EU
have reported significantly higher response rates in patients
receiving polyadenur(R) plus interferon versus interferon given
alone. These results include apparently higher "complete
response" rates; these therapeutic outcomes (i.e., no detectable
virus and no detectable residual viral damage) would be expected
also to decrease the incidence of liver cancer.
Hemispherx said that the present patent engagements were part
of a larger worldwide race to devise better treatment strategies,
which would increase the effectiveness of interferon. Interferon
is the approved, 'first line' treatment for both chronic
hepatitis B and chronic hepatitis C infections. However, in some
groups of patients, interferon alone helps less than 5% to 10% of
the afflicted individuals. Combinational treatment may have
significant value by prolonging or increasing the magnitude of
response. Worldwide, hepatitis afflicts more than 100 million
people and is indeed the leading cause of cancer (termed
"hepatoma").
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. ots Original Text Service: Hemispherx Biopharma,
Inc. Internet: http://www.newsaktuell.de Contact: William A.
Carter, M.D., CEO & Chairman of Hemispherx Biopharma, 215-988-
0080; or William Jenks, 212-232-2222, Fax: 212-232-3232; or
Sharon Will, Investor Relations, 212-572-0762, Fax: 212-572-0764;
both of Broadgate Consultants Web Site: http://www.hemispherx.com
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