Hemispherx Alters European Union Marketing Approach
PHILADELPHIA, Apr 13, 2000 /PRNewswire via COMTEX/ -- Hemispherx Biopharma,
Inc. (Amex: HEB; HEBws) said today that its European subsidiary, Hemispherx
Biopharma Europe, NV/SA was withdrawing its CFS treatment application in order
to change its application for two economically-compelling reasons.
The CFS treatment application, originally filed in December, 1998, and deemed
"complete" in February, 1999, prescribed a freeze-dried product, manufactured in
limited quantities within small regional facilities. Subsequent to the original
filing, on December 1, 1999, the Company executed a manufacturing agreement with
Schering-Plough Products, L.L.C., providing for the manufacture of the product
in an easier to use, more economic, liquid form at Schering's San Juan, Puerto
Rico, facility, a major parenteral drug manufacturing plant.
On December 16, 1999, the European Parliament (EC Regulation 141/2000)
officially established new regulations for orphan medicinal products which
creates various important economic incentives for certain manufacturers
including a mandatory 10 year period of marketing exclusivity, financial support
of clinical research, waiver of various administrative fees, as well as
regulatory assistance in developing certain new drug products.
Under current EU laws, pending marketing applications cannot be amended, either
with respect to a change in manufacturing format or application of new Orphan
regulations, without withdrawal and resubmission.
A Company spokesperson said that the overall economic advantages of submitting
the application with a new manufacturing format and under the new regulations
guaranteeing 10 years of market exclusivity offered compelling economic
advantages which far outweighed any attendant delays in the overall review
process. The Company expects to file under the new Orphan regulations during the
second quarter of this year. The Company said that it was also pleased to
receive recent notice that its own Quality Assurance/Quality Control facility in
Rockville, Maryland, was deemed compliant with European Union Good Manufacturing
Practice regulations based on recent EU on-site inspection. The Company said
that its own facility was the pivotal control point for overall world-wide
manufacturing operations.
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. |
