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Hemispherx Biopharma, Inc. (HEB)
Q3 2016 Earnings Conference Call
November 15, 2016 11:00 AM ET
Thomas Equels – President and Chief Executive Officer
Dianne Will – Investor Relations
» Hemispherx Biopharma's (HEB) CEO Thomas Equels on Q4 2015 Results - Earnings Call Transcript
» Foamix Pharmaceuticals' (FOMX) CEO Dov Tamarkin on Q3 2016 Results - Earnings Call Transcript
To the extent that statements on this conference call are not strictly historical, as such statements are forward-looking, are based upon the current beliefs and expectations of the Company's management, are subject to significant risks and uncertainties, and are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. We are obliged by law to provide certain legal and binding disclaimers before we begin.
Words such as intends, plans, potential, beliefs, 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 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 these contemplated in these forward-looking statements.
For example, because numerous risks and uncertainties exists despite our efforts and belief regarding approvals, we cannot assure Ampligen will ever be commercially approved for any treatment, or that Alferon N Injection will ever be commercially approved for potential new treatment indications, or for the new manufacturing procedures underway.
Examples of such risks and uncertainties include 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 forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligations to update or revise the information discussed on this conference call, whether as a result of new information, future events or circumstances or otherwise revised or update this release to reflect events or circumstances after the date hereof.
With that covered, it is now my pleasure to turn the floor over to your host, Mr. Thomas Equels, President and Chief Executive Officer of Hemispherx Biopharma. Sir, the floor is yours.
Good morning welcome to Hemispherx's third quarter 2016 conference call. We have made significant progress on a number of initiates this past quarter. The new Hemispherx has begun to lay the groundwork for long-term success in our belief.
Thank you to those of you who have submitted questions in advance as requested in our press release. We have received many questions and many of you had the same or similar questions. Accordingly we have grouped them into three sections.
First I will discuss the progress we have made with Ampligen. Second I will review our corporate and business highlights. And finally I will give you a financial overview for the third quarter.
As to Ampligen on August 23, this quarter we announced a major breakthrough. Ampligen was approved by ANMAT. ANMAT is the FDA of the Republic of Argentina. It was approved for the treatment of severe cases of Chronic Fatigue Syndrome.
This is the first commercial approval for Ampligen and it also represents a significant milestone for our Company. Ampligen is the first drug to receive approval for CFS anywhere in the world.
Since the ANMAT of Argentina is a well respected regulator in South America the approval of Ampligen opens new pathways for potential new drug approvals in other South American countries. We are now working closely with our partner GP Pharm in order to move forward with the necessary post approval steps to initiate a commercial launch of Ampligen in Argentina and then in other countries as approved in South America. We expect this process to take approximately 12 months to 18 months.
In Europe we are aggressively moving our early access programs forward. The first shipment of Ampligen was sent to myTomorrows and we are currently working closely with our European partner myTomorrows.
A top priority is to reach agreement with certain European government authorities to gain early access program reimbursement approvals for the treatment of severe cases of ME/CFS in those countries. We are currently manufacturing, in the process of manufacturing lots of Ampligen now to fill that need which we expect will begin in 2017.
In the U.S., we recently met with the FDA in the first of a series of meetings. In order to identify and develop a path forward for Ampligen in the Chronic Fatigue Space and to confirm and finalize a protocol for any kinds of further confirmatory trials that the FDA may require. We believe that we have a compelling case for Ampligen and we hope to update you on our discussions with the FDA in the coming months.
We have also executed an agreement with Nitto Denko Avecia, which is formally known as Avrio Biopharmaceuticals. And that's to use them as an additional contract manufacturer for the compounding and fill and finish of sterile clinical and commercial grade Ampligen that process is underway and moving nicely.
The addition of Avecia, will help to supply the needs for the Company's ongoing domestic clinical studies as well as the early access programs in Europe and Turkey.
In October, we successfully completed the technology transfer, which is an engineering run basically, of all information necessary for the manufacturing of Ampligen and associated assays. With the test engineering run completed, we anticipate the first lots of Ampligen to be filled and finished this month. With release in late December or early January for the Early Access Program in Europe and other clinical issues.