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PHILADELPHIA, Aug. 11, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), reported today that it has executed an agreement with Emerge Health Pty Ltd. ("Emerge") to seek approval of Alferon N Injection® in Australia and New Zealand and to commence distribution of Alferon in both countries on a named-patient basis, where deemed appropriate.
Hemispherx and Emerge will collaborate on seeking regulatory approval from Australia's Therapeutic Goods Administration ("TGA") and New Zealand's Medicines and Medical Devices Safety Authority ("Medsafe").
Under an exclusive license to sell, market, and distribute Alferon N Injection® in Australia and New Zealand, Emerge will implement regulatory-compliant programs to educate physicians about Alferon®. Hemispherx will support these efforts and will supply Alferon® at a predetermined transfer price.
Peter Davey and Chris Rossidis, Co-Founders of Emerge, both said "Having visited Hemispherx upgraded Alferon manufacturing facility and met some of the company's key people, we are impressed by what we saw and whom we met and believe that Alferon N Injection® represents a significant opportunity in Australia and New Zealand for patients with recurring genital warts and those refractory to recombinant interferon."
Thomas K. Equels, Executive Vice Chairman and CFO of Hemispherx said "We continue to make progress toward re-launching Alferon N Injection® and are very pleased to be collaborating with Emerge to provide Alferon under these unique access programs and to work with them to gain formal regulatory approval."
About Alferon N Injection®
Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. only for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older.
About Emerge Health Pty Ltd
Emerge Health Pty Ltd is an innovative, specialized Australian pharmaceutical company focused on the marketing and sales of niche, high quality medicines to the hospital sector. Emerge Health is dedicated to providing exceptional products and support to ensure they meet their customers' and partners' needs and priorities. Emerge Health has a unique, highly experienced management team with a track record of success in the Australian and New Zealand pharmaceutical markets. Their goal is to develop long term valuable relationships with suppliers and customers and to build trust through working collaboratively with their partners.
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 especially life-threatening viruses. 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 including cancers. 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. and Argentina. The FDA approval of Alferon® N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company's Alferon N Injection® approval in Argentina includes the use of Alferon N Injection® (under the brand name "Naturaferon") for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. 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.
The information in this press release includes certain "forward-looking" statements. While the facility is approved by the FDA under the Biological License Application ("BLA") for Alferon® and the production of new Alferon® API inventory commenced in February 2015, the facility's BLA status will need to be reaffirmed by an FDA pre-approval inspection. We will also need FDA's approval to release commercial product once we have submitted satisfactory stability and quality release data. If and when we obtain a reaffirmation of FDA BLA status, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect if and when commercial sales of Alferon® will recommence. The final results of any steps required by the FDA and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen® NDA in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® in the United States and other countries including Australia and New Zealand.
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, 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. The final results of these efforts could vary materially from Hemispherx's expectations. No evidence has suggested that Ampligen® will ever be commercially approved for the new potential treatment indications, including, but not limited, to the treatment of CFS.
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 "intends," "plans," and similar expressions are intended to identify forward-looking statements. 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. No evidence is suggested that Ampligen® will ever be commercially approved for the CFS treatment indications mentioned in this release into USA or other countries.
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