PHILADELPHIA, April 20, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) (the "Company” or "Hemispherx”) announced that it has signed a consulting agreement with Huron Consulting Group, a global consultancy with decades of experience in the life sciences market, to advance the company’s strategic plan to capitalize on business opportunities in the United States and in target countries around the world.
Huron Consulting Group provides a wide variety of advisory and professional services encompassing the entire scope of the life sciences and healthcare industries from investment, research, and strategic planning to commercialization and mergers and acquisitions. “Our agreement with Huron is an important part in the new direction for our company. Huron will provide us the strategic guidance and established connections critical to our quest for powerful co-development partners,” said Thomas K. Equels, CEO of Hemispherx Biopharma.
Huron’s effort will be led by Managing Director, Marc Tomassi, who has more than 25 years of experience in the Life Science space. His work spans the industry value chain that encompasses early research and technology strategy, portfolio management, clinical development planning and commercial strategy. Tomassi’s clients include major global pharma, biotech, specialty pharma, med tech, generics, life science services and healthcare informatics. In addition, Barry Frankel, a senior advisor to Huron with more than 35 years in the life sciences industry, including investment research, strategic planning/M&A, marketing, and strategy consulting, will also be part of the advisory team. “I have been familiar with Hemispherx Biopharma and Alferon® and Ampligen® technology platforms for a number of years,” said Frankel. “Our focus will be to assess the opportunities in immuno-oncology across indications.”
Hemispherx Biopharma recently made changes to its senior management team and implemented austerity measures which include the elimination of several highly compensated executives and contractors as well as non-essential personnel. These measures have resulted in a significant reduction in the burn rate. The company is now focusing on commercial success by seeking co-development partners and working closely with the research and regulatory communities to bring disease fighting technologies to the world.
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. and Argentina. Alferon N Injection® is approved for the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company’s Alferon® N 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.
About Huron Consulting Group
Huron is a global professional services firm focused on assisting clients with their most complex business issues by delivering high-value, quality solutions to support their long-term strategic objectives. Huron specializes in serving clients in the healthcare, higher education, life sciences, and commercial sectors as these organizations face significant transformational change and regulatory or economic pressures in dynamic market environments. With its deep industry and technical expertise, Huron provides advisory, consulting, technology, and analytic solutions to deliver sustainable and measurable results. Learn more at www.huronconsultinggroup.com
Disclosure Notice
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors; the Company’s ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; and numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. The production of new Alferon® API inventory will not commence until the validation phase is complete. While the facility is approved by FDA under the Biological License Application ("BLA”) for Alferon®, this status will need to be reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial sale of newly produced inventory product. The validation phase is delayed until we are able to repair the damage caused by a flood that occurred on January 5, 2016 at the facility. At this moment, there is no definitive timetable to have the facility back online. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. With regard to our NDA for Ampligen® to treat CFS, we note that there are additional steps which the FDA has advised us to take in our seeking approval. The final results of these efforts and/or any other activities could vary materially from Hemispherx’s expectations. 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. No assurance can be given that Huron’s endeavors on behalf of the company will enable the company to find a co-development partner or advance its ability to capitalize on business opportunities. No evidence is suggested that Ampligen® will be commercially approved for any treatment or that Alferon N Injection® will be commercially approved for potential new treatment indications or for new manufacturing procedures.
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 “potential,” “potentially,” “possible,” 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.