Philadelphia, PA, Thursday, January 26, 2012: Hemispherx
Biopharma, Inc. (NYSE Amex: HEB) (the "Company" or
"Hemispherx") today announced that ANMAT (Administracion
Nacional de Medicamentos, Alimentos y Tecnologia Medica), the
agency responsible for the national regulation of drugs,
foods and medical technology in Argentina, has approved the
sale and distribution of Alferon N Injection® (under the
brand name "Naturaferon") in Argentina. In June 2010,
Hemispherx agreed to provide GP Pharm an option to market
Alferon N Injection®, its FDA-approved natural interferon, in
Argentina and other Latin America countries. In December
2010, GP Pharm exercised this right and in July 2011 GP Pharm
submitted an application for approval to ANMAT. Alferon N
Injection® (Interferon alfa-n3 (human leukocyte derived)) is
already approved in the US for the treatment of refractory or
recurring external condylomata acuminate (genital warts) in
patients 18 years of age or older. A major multi-million
dollar investment scale-up of Alferon N Injection®
manufacturing is underway at Hemispherx's New Brunswick, NJ
facility.
According to a World Health Organization report on Human
Papillomavirus (HPV), "Genital warts are very common and are
highly infectious, and between 90% and 100% are caused by HPV
genotypes 6 and 11. Although they do not usually result in
death, genital warts cause significant morbidity and entail
substantial health care costs. Recurrence is common."
Mr. Thomas Equels, Executive Vice Chairman of Hemispherx,
stated "This approval is the result of Hemispherx's global
business development initiatives which it plans to continue
and to expand. It also reflects the increased capability of
Hemispherx clinical and regulatory team to manage regulatory
environments outside the US and to gear up to comply with
import-export regulations in various countries. We are
confident about the commercial opportunities for Alferon N
Injection® in Argentina and pleased with the progress GP
Pharm has made as is evidenced by this approval and parallel
programs planned for Latin America."
Dr. Jorge Candal, Medical Director of GP Pharm, said "We are
pleased that ANMAT has understood the effectiveness of the
unique technology platform represented by Alferon N
Injection®. We believe it can make a significant health
impact in the lives of numerous patients in Argentina."
Jorge Braver, President of GP Pharm, said "We are very
excited about the approval of Alferon N in Argentina, and we
look forward to providing it to patients in Argentina who
will benefit from this unique, natural interferon."
Hemispherx continues to undertake its projected approximately
$6.5 million expansion to its Good Manufacturing Process
(GMP) manufacturing facility in New Brunswick, New Jersey
including capital improvements, system upgrades and the
introduction of building management systems to enhance
production of our three products: Alferon N Injection®,
Alferon® LDO and Ampligen®. One of the primary goals for
these enhancements to our FDA licensed facility is to
accommodate larger production volumes of Alferon N Injection®
for anticipated global requirements.
About GP Pharm
GP Pharm SA headquarters are located in Barcelona, Spain with
operations in each major country in Latin America either
directly or through local partners. Its activities are
focused on research; development and marketing of its
injectable products made by others and by GP Pharm SA based
on its proprietary drug delivery systems including
microspheres and liposomes. GP Pharm's new production plant
recently achieved EU GMP approval and started manufacturing
operations, producing the first batches of own products and
also for some contract manufacturing partners. Its facilities
are also designed to be FDA GMP compliant. GP Pharm also has
a centralized free-zone distribution facility in Uruguay for
its own products as well as its partners' products.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty
pharmaceutical company engaged in the manufacture and
clinical development of new drug entities for treatment of
seriously debilitating disorders. Hemispherx's flagship
products include Alferon N Injection® (FDA approved for a
category of sexually transmitted diseases) and the
experimental therapeutics Ampligen® and Alferon® LDO.
Ampligen® is an experimental RNA nucleic acid being developed
for globally important debilitating diseases and disorders of
the immune system. Hemispherx's platform technology includes
components for potential treatment of various severely
debilitating and life threatening diseases. Hemispherx has
patents comprising its core intellectual property estate and
a fully commercialized product (Alferon N Injection®). The
Company wholly owns and exclusively operates a GMP certified
manufacturing facility in the United States for commercial
products. For more information please visit
www.hemispherx.net.
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 risk of competition, changing market conditions, change 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. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications. The scale-up of Alferon N manufacturing could be delayed by various critical steps including those involved in construction, GMP compliance, formulation, packaging and labeling, as well as potential issues related to 3rd party vendors including without limitation various "fill and finish" procedures.
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