Watching this to bottom out then could have a nice bounce. Could see some major lows. Potential interest for me is watching for the turn around and fixing their issues with the FDA and possible reimbursement from Esteve.
HEMISPHERX BIOPHARMA (AMEX:HEB)
Last Trade: 0.80 Trade Time: 2:36PM ET Change: 0.49 (37.99%) Prev Close: 1.29 Open: 0.99 Bid: N/A Ask: N/A 1y Target Est: 5.50
Hemispherx ending licensing deal in Spain, Portugal and Andorra Monday December 10, 10:05 am ET
Hemispherx Biopharma Inc. said Monday it plans to terminate a license agreement that gives Laboratorios Del Dr. Esteve the right to market Ampligen for chronic fatigue syndrome in Spain, Portugal and Andorra. ADVERTISEMENT
Ampligen has not been approved by regulators in those markets.
The Philadelphia biotechnology company said it notified Esteve of Barcelona, Spain, the basis for the termination was nonperformance of certain undisclosed contractually required clinical trials. Hemispherx (AMEX:HEB - News) officials said efforts to reach an amicable resolution were unsuccessful.
Esteve, as provided for under the terms of the licensing agreement, has applied for arbitration, seeking damages. Hemispherx believes the Esteve claim is without merit and intends to counterclaim, seeking damages.
Last week, Hemispherx received a notice from the Food and Drug Administration that the company's new drug submission for Ampligen was determined to be insufficiently complete.
The company said it plans to respond promptly in writing to all of the filing issues raised by the FDA and will request a guidance meeting to clarify any outstanding items.
---------------------=========-------------- Form 8-K for HEMISPHERX BIOPHARMA INC
Termination of a Material Definitive Agreement, Financial Statements and
Item 1.02 Termination of material definitive agreement. We notified Laboratorios Del Dr. Esteve, S.A. ("Esteve") of our intention to terminate the license agreement that gives Esteve the right to market Ampligen(R) for CFS in Spain, Portugal and Andorra. The basis of the termination was non-performance by Esteve of certain contractually required clinical trials. Negotiations were ongoing but amicable resolution could not be reached. Esteve, as is its right under the license agreement, has filed for arbitration seeking damages. We believe their claim is without merit and intend to counterclaim, seeking damages.
For more information, please see the December 10, 2007 press release attached hereto as exhibit 99.1
Number of Shares of Common Stock As of August 7, 2007 there were 72,826,971 shares of Hemispherx common stock issued and outstanding. If you need additional assistance or information regarding the company, contact Hemispherx Biopharma’s Investor Relations representative.
Item 8.01 Other Events.
On December 3, 2007 we received notice from the U.S. Food and Drug Administration (FDA) that our NDA submission for Ampligen(R) in Chronic Fatigue Syndrome (CFS) had been determined to be insufficiently complete to permit a substantive review under 21 CFR 314.101 (d). Specifically eleven deficiencies were noted in the Clinical Section and three in the Pre-Clinical Section. No deficiencies were cited in the Chemistry, Manufacturing and Controls Section (CMC).
We believe that several factors may influence the pace of the regulatory path: (1) Ampligen(R) (Poly I : Poly C12U) has a relatively long regulatory history (approximately twenty years) and regulatory guidelines suggest that longer clinical development histories may require more review; (2) Ampligen(R) is also the first drug of its class to apply for NDA review status; and (3) in some circumstances, clinical data reporting guidelines have changed since the initial studies on Ampligen(R), an experimental therapeutic, were executed in the late 1980s and early 1990s.
The Company will respond promptly in writing to all of the filing issues raised by the FDA and will request a guidance meeting to clarify any items outstanding.
For more information, please see the December 7, 2007 press release attached hereto as exhibit 99.1 -------------------------=============---------
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7754 | From: Virginia | Registered: May 2006
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Hemispherx Biopharma Announces Investors Conference Call Monday December 17, 9:00 am ET Discussion to Focus on Vaccine Licensing Agreements and Updates on CFS Filing Status
PHILADELPHIA, Dec. 17, 2007 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB - News) today announced that it has scheduled an Investor Conference Call and webcast to take place on Wednesday, December 19, 2007 at 4:00 p.m. EST. Dr. William Carter, Chairman and CEO, will discuss the recently announced licensing/research agreements with vaccine manufacturers for the use of the Company's experimental drug Ampligen(r) as an immune enhancer to influenza vaccines. The discussion will also include market data from PricewaterhouseCoopers which includes information on vaccine developments, Toll Like Receptors (TRL) under development, as well as the cost parameters of such development. As part of a continuation from last week's conference call, discussion will also focus on the pre-clinical comments cited by the U.S. Food and Drug Administration regarding the company's New Drug Application for the potential treatment of Chronic Fatigue Syndrome. Interested parties are encouraged to access the PricewaterhouseCoopers market data prior to the conference call. This information will be available on the company's website at http://www.hemispherx.net on Tuesday, December 18th.
To access the conference call:
U.S. Callers: 800-346-7359 International Callers: 973-528-0008 Conference Entry Code: 719555