Is Hemispherx BioPharma Undervalued? 6 comments
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HEB's experimental drug Ampligen completed a phase III for chronic fatigue syndrome [CFS] in 2004 and will file an NDA soon, says the company.
The Center for Disease Control [CDC] referred to CFS as a disabling disease, as disabling as other severe chronic conditions like MS, COPD and rheumatoid arthritis. This was in response to findings by a research team led by the CDC's Dr.s William Reeves and Suzanne Vernon, which published ground-breaking research that suggests a biological basis for CFS.
In recent weeks, the CDC has stepped up its public awareness campaign, broadcasting public service announcements on radio and television, as well raising the spotlight on its website. The Agency's new public service announcement states that CFS affects more than 1 million Americans annually.
While several of the multinational pharmaceutical companies have tackled the symptoms and causes of CFS, none to date have had measurable success in developing new drugs. Currently, there are no approved therapies for CFS.
In 2004 HEB completed the phase III clinical trial for use of Ampligen in the treatment of CFS. Clinical data on the primary endpoint exercise treadmill duration showed that patients receiving Ampligen for 40 weeks improved exercise treadmill performance by a medically and statistically significant amount compared to the placebo group. New data was presented on increases in exercise capacity with Ampligen and placebo which were correlated with an improved ability to utilize oxygen, so called, maximum oxygen consumption (or VO2max).
VO2max has been previously shown by others to be decreased with individuals with CFS. An abnormal exercise stress test, including a low VO2max, could help qualify CFS patients for disability under Social Security Administration rules. Additional data on subset analyses showed that both stratification cohorts (those with baseline exercise treadmill duration greater than or less than nine minutes) improved exercise capacity by over 6.5%, an amount considered medically significant in other chronic diseases.
Ampligen has received orphan drug product designation [FDA] (at a time when the real number of CFS patients was underestimated), emergency (compassionate) cost Recovery sales authorization [FDA] and "promising" clinical outcome recognition based on the evaluation of certain summary clinical reports (AHRQ, or the Agency Health Research Quality).
According to the latest annual report:
The main U.S. ME/CFS treatment patent (#6130206) expires October 10, 2017. The main patents covering HIV treatment (#4820696, #5063209, and #5091374) expired or expire on April 11, 2006, November 5, 2008, and February 25, 2009, respectively; Hepatitis treatment coverage is conveyed by U.S. patent #5593973 which expires on January 14, 2014. The U.S. Ampligen Trademark (#1,515,099) expires on December 6, 2008 and can be renewed thereafter for an additional 10 years. The FDA has granted us "orphan drug status" for our nucleic acid-derived therapeutics for ME/CFS, HIV, and renal cell carcinoma and malignant melanoma.
Orphan drug status grants them protection against competition for a period of seven years following FDA approval, as well as certain federal tax incentives, and other regulatory benefits. Patent coverage for the HIV indication following the expiration of patent #4820696, #5063209 and #5091374 is planned to be obtained from patent pending application #PCT/US 0239890. In the event that this patent application is not approved, they still have the marketing protection provided by the orphan drug designation for using Ampligen to treat HIV.
What's wrong with a company with these fundamentals and such a low PPS?
I don't know.
Can someone please tell me what I don't see?
By the way, on average it takes a biotech company 12 years after its IPO before it sees its first profit. (cf Science Business: the Promise, the Reality, and the Future of Biotech, Harvard business professor Gary P. Pisano).
Heb completed its IPO on November 2, 1995.
Disclosure: Author is long HEB.
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This article has 6 comments:
www.cdc.gov/cfs/PSAs/G...
HEB NDA Filing Guidance – 2004
sec.edgar-online.com/2......
Assuming the results are positive, we expect to finalize the data of our double-blind, placebo controlled AMP516 ME/CFC Phase III clinical trial and submit an NDA by year end 2004.
HEB NDA Filing Guidance 2005 –Early 2006
sec.edgar-online.com/2......
The single shortfall of our 2005 objectives was the delay in the filing of our NDA for Ampligen(R) for the treatment of CFS. Our targeted filing by 2005 year-end was based on an anticipated grant of FDA permission to submit a rolling or staged NDA application, which would allow us to file the safety and clinical sections of the NDA application in advance of the manufacturing section. Even though FDA permission to submit a rolling or staged NDA application has yet to be received, since we are scheduled to complete our manufacturing certifications late in the 2nd quarter of 2006, we should, in any event, file our NDA for Ampligen(R) for the treatment of CFS no later than the first part of the 3rd quarter of 2006.
HEB NDA Guidance November 7, 2006
www.pharmalive.com/New......
The net loss for the Company's third quarter, ended September 30, was approximately $3,807,000 or $(0.06) per share, compared to a loss of $2,643,000 or ($0.05) per share, for the same period in 2005. The year-over-year increase in loss of $1,164,000, primarily reflected a combination of factors including 1) an increase of $215,000 in manufacturing costs, especially in connection with a production ramp-up and the preparation of an NDA filing for the Company's experimental drug Ampligen(R) to treat Chronic Fatigue Syndrome, with that filing expected by the end of this calendar year or the first quarter of calendar 2007; and 2) a $1,525,000 increase in research and development due to the continued development of RNA based experimental therapeutics.
HEB 10-Q November 7, 2006
biz.yahoo.com/e/061107......
We continue our efforts with respect to preparing a New Drug Application ("NDA") for submission to the Food and Drug Administration ("FDA") for using Ampligen(R) to treat patients afflicted with Chronic Fatigue Syndrome ("CFS"). The preparation of the NDA is a time consuming and laborious process….. We have experienced technical teams assigned to preparing each of these three segments. When completed these three technical documents will be consolidated into the common technical document for submitting to the FDA. While the results of our AMP 516 Phase III clinical study is the basis for filing the NDA we must also include the safety data collected on all patients that ever received Ampligen(R) (some 800 patients from clinical trials for CFS, HIV, Hepatitis, cancer, etc.) All of this is time consuming as our clinical monitors and research assistants must visit and audit the records of clinical investigators involved in our Ampligen clinical studies conducted over the last 15 years.
CONFERENCE CALL November 15, 2006
HEB filing to be INITIATED by December 31, 2006.
HEB Investor E-mail Re: BOENNING & SCATTERGOOD.INC Initial Coverage (12/4/2006)
We anticipate an NDA filing no latter than the first quarter of 2007. (Spelling error in press release.)
www.boenningandscatter......
Note: Web site says NDA filing will be SOON!
December 31, 2006 – NO NDA WAS FILED IN 2006. Company guidance incorrect again. Company insists “NDA filing is on-track”.
The author has also failed to mention that Hemispherx has in its past received two warning letters from the FDA demanding it stop all promotion and declarations of Ampligen being safe and effective.
www.fda.gov/cder/warn/...
www.fda.gov/cder/warn/...
The author also fails to mention that Hemispherx through its CEO have made outrageous claims involving investment into the company. One such claim occurred in 2002 when its CEO Dr. Carter claimed that the Royal Family of the United Arab Emirates (UAE) had made a multi-million dollar investment in the company. This announcement occurred at the 2002 HEB shareholders meeting when the stock was at an all-time low.
www.fool.com/news/foth...
The author also fails to mention that the Hemispherx CEO Dr. William Carter is a quack who once approached Phillip Morris to promote the introduction of Ampligen into cigarettes to treat disease.
tobaccodocuments.org/p...
Folks...Ampligen was "discovered" 36 years ago has been in multiple clinical trials for AIDS, CFS, Hep C, WNV, Bird Flu...you name it and HEB's CEO Dr. Carter has promoted it as a use for...and it has NEVER proven worthwhile for anything except for increasing liver toxicity.
You wish to lose your investment? By all means buy some HEB stock.
The author also fails to mention that Hemispherx through its CEO have made outrageous claims involving investment into the company. One such claim occurred in 2002 when its CEO Dr. Carter claimed that the Royal Family of the United Arab Emirates (UAE) had made a multi-million dollar investment in the company. This announcement occurred at the 2002 HEB shareholders meeting when the stock was at an all-time low.
A lie...
Folks...Ampligen was "discovered" 36 years ago has been in multiple clinical trials for AIDS, CFS, Hep C, WNV, Bird Flu...you name it and HEB's CEO Dr. Carter has promoted it as a use for...and it has NEVER proven worthwhile for anything except for increasing liver toxicity.
Another lie...
In the phase II one patient had elevated liver enzymes... that patient was removed from the study then reentered without incident...
conclusion ampligen had no part in the liver enzymes.....
This did not occur in the larger phase III...
niall has been proven a liar.....