This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Hemispherx Biopharma Gains Broad Treatment Expansion For Alferon N Injection(R) In Argentina

Stocks in this article: HEB

PHILADELPHIA, March 4, 2013 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), 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 use of Alferon N Injection ® (under the brand name "Naturaferon") in Argentina for any patient that fails or becomes intolerant to treatment with recombinant interferon. Alferon N Injection ® is an FDA-approved natural interferon and, as Naturaferon, is already approved in Argentina for the treatment of refractory or recurring external condylomata acuminata (genital warts).

Jorge Braver, President of GP Pharm SA and Hemispherx's partner in Argentina, said, "We are very pleased that the ANMAT approved the expansion of the labeling for Naturaferon. Now patients in Argentina with hepatitis C, multiple sclerosis, certain cancers and other diseases who should not be treated with recombinant interferon, including pegylated alpha interferons, will have access to our therapy. In many cases, these patients would have had no alternative." GP Pharm believes this approval will also result in expanded insurance coverage for patients who receive Naturaferon for these additional indications.

Thomas Equels, Executive Vice Chairman of Hemispherx, stated, "Hepatitis C affects over 800,000 people in Argentina and while the prevalence of multiple sclerosis there is much lower it can be severely debilitating, particularly in patients with a high rate of relapse. We view this progress in Argentina as continued demonstration of our efforts to expand the market for Alferon N Injection ® both geographically and by indication." Both the use of the Company's existing inventory of Alferon N Injection ® for sale in Argentina as well as the use of drug to be manufactured in the future when the Company's Alferon ® manufacturing facility in New Brunswick is completed will require FDA approval. Therefore the timelines for when drug can be shipped to Argentina and when resulting revenues in Argentina will occur cannot be determined at this time.  

Patients on recombinant interferon can become intolerant to treatment with the side effects outweighing the benefits of the therapy. In addition, patients can become refractory to such treatment because they develop antibodies to recombinant interferon which can dramatically reduce its effectiveness. In a peer-reviewed article published in the Journal of Interferon and Cytokine Research (Volume 32, pages 95-102; http://online.liebertpub.com/doi/abs/10.1089/jir.2011.0069?journalCode=jir ), Hemispherx provided an analysis of the incidence and clinical impact of neutralizing antibodies ("NABs") formed during treatment with recombinant interferons compared to natural interferons, such as Alferon N Injection ®, across a wide range of human diseases.  The fraction of relapsed and refractory patients was reported as statistically greater in NAB positive patients compared to NAB negative patients (p < 0.0001), whereas the percentage of responding patients was reported as higher in NAB negative patients (p < 0.001). Another analysis looked at relapsed and refractory NAB positive patients who were then switched to natural interferon. Across all the different diseases the authors reviewed, 33 out of 40 or 82% of these patients had their clinical response restored after switching to natural interferon.

DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements (explained below), including statements about the likelihood of the use of Naturaferon (Alferon N Injection ®) for the treatment of various diseases in Argentina and the timelines for when drug can be shipped to Argentina and when revenues will occur. 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.  The final results of these efforts could vary materially from Hemispherx's expectations.

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 ® 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, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen ® and Alferon ® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection ®), approved for sale in the U.S. for refractory or recurring external genital warts in patients 18 years of age or older. 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 .

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "hopes," "believes," "plans," "anticipates," and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's or GP Pharm's current beliefs and expectations and represent the Company's or GP Pharm's judgment as of the date of this release. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs