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ctix..
Valeant Is On An Acquisition Spree - Will Prurisol Get Under Big Pharma's Skin?
The dermatological therapeutic business has recently had its landscape rearranged. Valeant Pharmaceuticals (VRX) has vaulted to the No. 1 position with substantial encouragement from its shareholders to continue. GlaxoSmithKline (GSK) attempted to remain in a growth mode, as it acquired a product. However, quietly and inconspicuously, India's second largest pharmaceutical, Dr. Reddy's Lab (RDY), has positioned itself quite smartly to get under the corporate skin of both Valeant and GlaxoSmithKline with regard to the dermatological therapeutic business.
Montreal-based Valeant announced on Sept. 3 a $2.6 billion takeover of Scottsdale, Ariz.-based Medicis (MRX). It was an all-cash offer that advances Valeant as the No. 1 company in the dermatological therapeutics market. If completed, the Medicis transaction will be the fiftieth acquisition that Michael Pearson has made since he became the CEO in 2009. Medicis had $721 million in revenue in 2011. The companies claim that the deal will save $225 million a year (to be recognized in six months) by combining operations. The two figures together approximate a revenue growth plus operational savings benefit of $946 million to Valeant. Wall Street and the up-and-coming Toronto Stock Exchange voted yes on Pearson's move by bidding up the acquiring Valeant's shares by 14.8%, to a NYSE close of $58.36 (as of Sept. 4, 2012).
Pearson sees margin protection and enhancement in the aesthetic dermatological business. Products that prove effective in the removal or delaying the onset of wrinkles or acne like Medicis' Solodyn and Dysport are more apt to be market priced to individuals, as most private and government insurance programs avoid reimbursement for many types of dermatological products -- especially cosmetic ones.
Valeant's acquisition of Medicis might be the largest therapeutic acquisition that a Canadian drug company has ever made of a U.S. pharmaceutical. Quite interestingly, it was driven in large part by a Canadian CEO's desire to better position his company's sails to the accelerating winds of the free market and away from the foundering shoals of government regulation.
Valeant CEO Pearson, however, has transformed the former Biovail, a Canadian company that was substantially shackled by the margin constraints of generic drugs, HMOs, and socialist health care pricing, into an exciting growing international company that has become akin to a Harvard Business School case study on how swiftly a sizable company can grow and transform its image. In doing so, Pearson has become a Maple Leaf Icon of Canadian entrepreneurship and international business.
After Valeant's $2.6 billion acquisition of dermatological company, Medicis, and GlaxoSmithKline's (Steifel Labs) $350 million June 12 acquisition of Basilea's (SIX) Toctino (alitretinoin), an FDA Phase III product for exzema, another event took place in conjunction with Dr. Reddy's Lab.
On June 13, 2012, Cellceutix (CTIX.OB) announced that after meeting with the FDA, it will be applying for Phase II trials for its anti-psoriasis compound, Prurisol (KM-133). Please note that Cellceutix's flagship compound Kevetrin has three separate trials planned for 2012-2013, with one beginning shortly. Two other Phase I trials are being funded by other entities, one at Harvard Beth Israel with Pfizer's multikinase inhibitors and an as-yet-unnamed large European pharmaceutical in tandem with a top 10 European university. Cellceutix's first FDA Phase 1 trial is at Harvard's Dana Farber. For a company with a capitalization of less than $125 million, Cellceutix is exceptionally rare (see "Pfizer Eyes Kevetrin" and Lynn Zehr's Seeking Alpha piece). Cellceutix is the smallest cap company to enter trials at the prestigious Dana Farber.
On Sept. 3, 2012, Dr. Reddy's Lab and Cellceutix announced a manufacturing agreement whereby Dr. Reddy's Lab would manufacturer Prurisol for Cellceutix' s clinical trials for KM-133. The announcement as it rippled through the blogs sounded very basic and matter of fact. Dr Reddy's Lab, a $5.4 billion cap international pharma performs this function not only for clinical trial compounds but also generic drug tablets and prescription compounds the world over. So the announcement appeared on the surface to deliver a small amount of high-margin business for Dr. Reddy's without reason for further excitement. However, as I researched Dr Reddy's, I stumbled upon a very interesting fact about Dr. Reddy's Lab that bears mentioning. Neatly tucked away within Dr. Reddy's high profile image as a contract drug manufacturer is a wholly owned subsidiary, Promius, that focuses exclusively on the "Development of Dermatological Drugs and Compounds."
If you know about Prurisol (KM-133) and study Promius you can certainly see that there is more than one reason why they would want to own all or the lion's share of Prurisol. Prurisol is described in this quote from Cellceutix's web site:
Prurisol was studied in SCID mice that were irradiated then grafted with human psoriatic tissue by inserting human psoriatic tissue under the skin using a trocar. Groups of ten mice were treated with Prurisol orally for 21 days with either 10 mg/kg Prurisol once/day or 10 mg/kg Prurisol twice/day, or with 7.5 mg/kg methotrexate IP once/day for five days. The mice were followed for 180 days. Endpoints were skin appearance, histological observations, PRINS expression, and blood levels of IL-20. For these parameters, Prurisol was compared to controls and methotrexate. In a second experiment, groups of 10 immunocompetent CD-1 mice were treated with one or two doses of 10 mg/kg Prurisol daily or 3 mg/kg efalizumab SC once per week for three weeks. CD4+ and CD8+ lymphocyte counts were also measured and compared to efalizumab. Result: Prurisol significantly reduced all psoriatic endpoints measured relative to control. The FDA has informed the Company that a 505(b)(2) application would be an acceptable approach for Prurisol™. Cellceutix has begun the preparatory work necessary for a Phase 2 clinical trial application for Prurisol™ based upon the FDA guidance.
After the Dr. Reddy's engagement was sealed, Cellceutix CEO Leo Ehrlich said in an Aug. 30, 2012, press release:
We have great expectations for this drug because it performed amazingly in lab studies. Our research showed Prurisol to be much more effective than methotrexate, a standard of care treatment for advanced psoriasis, as there was no recurrence of psoriasis on the animals. Visually, it eliminated all indications of psoriasis. We wanted to use only a world class manufacturer and Dr. Reddy's is internationally-renowned for their excellence in research, manufacturing and distribution.
As we continue to emerge as a leading drug developer, we are committed to working with companies and organizations that have high standards and a strong reputation. Dr. Reddy's is a perfect fit for Prurisol. Prurisol has a complex process for synthesizing and manufacturing in oral form and we are very pleased to have Dr. Reddy's handling those for Cellceutix.
Valeant, GlaxoSmithKline, and Dr. Reddy's are all moving with various strategies to either become or remain major players in the dermatology drug market. Whereas Valeant's and Glaxo's strategies have been synthetic and hence more observable, Dr. Reddy's appears slower and internally R&D driven, tucked away under it's primary pharmaceutical manufacturing business. In an NFL game we call Dr Reddy's Prurisol strategy a counterplay. However, all of us football fans know that a well timed counterplay can be one of the most exciting actions to view because suddenly, contrary to perceived expectation, a big play materializes and perhaps a touchdown is scored. Should Dr. Reddy's Lab's dermatology arm (Promius) capitalize on the informational advantage of their manufacturing business, Valeant and Mr. Pearson might have a very significant competitor in the dermatological therapeutic business that it currently dominates.
The psoriasis afflicted population in the U.S. alone is 7.5 million persons, with a U.S. treatment market value of approximately $2.5 billion a year. Remember that the Prurisol inventor, Dr. Krishna Menon, is not a marginal inventor. He was a distinguished Presidential Award winner at Eli Lilly, having had an illustrious career there. He assisted in the development of two oncolytic blockbusters that together produced billions in revenue in 2011.
At least as far as mice are concerned, Prurisol is the most effective psoriasis compound in the world today. Its invitation to proceed immediately into an advanced FDA Phase II trial is certainly validating. Fred Zucker in SEC Fillings.com on Sept. 10, 2012, said:
A good benchmark for the value of Prurisol can be gauged by the recent activity of Steifel Labs, a GlaxoSmithKline company. Steifel said it will be spending approximately $350 million to acquire rights to skin treatment drugs still in development from Welichem Biotech and Basilea Pharmaceutica"... It is noteworthy that Steifel's acquisition is for topical eczema treatments. Prurisol has been synthesized into an oral medication which should give it a value many multiples of the Steifel compound if a therapeutic benefit can be observed in humans. Steifel paid this price for a phase 3 dermatology drug that analysts expect will generate about 250 million dollars a year in revenue to GlaxoSmithKline.
I find Zucker's comparison to be yet below my best guess. One reason is because the topical treatments for Basilea's eczema drugs are expected to generate $250 million in revenue a year at best.
The current $2.6 billion a year U.S. psoriasis market is predicted to grow to be a $5.6 billion a year market come 2020. The Global market for psoriasis treatment is predicted to grow to 7.4 billion by 2020. Speculatively visualizing Prurisol as a drug that could command 15% of the global market, Prurisol could become a billion dollar annual revenue generator. However, assuming data similar to that of the animal preclinicals of Prurisol would be seen in humans, I believe that Prurisol's annual revenue expectancy would be multiples more than that of GlaxoSmithKline's Toctino (FDA Phase III), which is projected to be $250 million annually. Therefore, I would anticipate that as soon as FDA trials for Prurisol begin, a Glaxo/Toctino type structured deal would be the minimum for Prurisol. Prurisol could attract a suitor for multiples of what Glaxo offered for Toctino.
For those readers who follow Cellceutix and have been enthusiastic about Kevetrin, this article should help you to see that an acquisition and/or licensing valuation for Cellceutix that is based solely on Prurisol and using Zuckers conservative Prurisol valuation, could be upward of $2.00 per share. Therefore, in my opinion, everyone who buys Cellceutix under $2.00 will have obtained Kevetrin and Dr. Krishna Menon's six other preclinical drugs free. According to the end of the first quarter 2012 10Q, CTIX has approximately 133 million shares fully diluted. All this leaves in place Zucker's restrained comparison of Prurisol with a $350 million eczema product acquisition, when in fact the relevant market is far larger. And, of course, my assessment assumes positive Phase II data from Prurisol trials.
Dr. Reddy's potential counterplay with Prurisol, though it appears much less dramatic and sensational than either Valeants' bold acquisition or GlaxoSmithKline's hot product grab could, over the-intermediate term rival and or surpass either transaction. Indeed it's also possible that another pharmaceutical could step in and acquire Prurisol. In short, anyone who pays for Prurisol may just get a drug with multibillion-dollar potential (Kevetrin) for nothing.
Cellceutix - Durchbruch gegen Krebs? - (Breakthrough against Cancer?)
Quote:
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shot heard around the world ?????
is that what we have here ??
CTIX
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Yes.
Six page discussion on the Wallstreet Online German website.
CTIX - Cellceutix Corporation (OTC BB: CTIX.OB) (OTC:CTIX) Stock de recherche - Au cours de lOTC Bulletin Board OTCBB
Kevetrin réduit le volume tumorale de 72% : Cellceutix
Cellceutix's Kevetrin(TM) Slows Pancreatic Cancer Tumor Growth by 94%; Protocol Towards Clinical Trials Nearing End -Euroinvestor
come on..please respond....back up your statement or il be winner by default...i provided links and dd ...here is more...ctix...everybody get some!!
Cellceutix - Durchbruch gegen Krebs? - (Breakthrough against Cancer?)
Quote:
--------------------------------------------------------------------------------
shot heard around the world ?????
is that what we have here ??
CTIX
--------------------------------------------------------------------------------
Yes.
Six page discussion on the Wallstreet Online German website.
CTIX - Cellceutix Corporation (OTC BB: CTIX.OB) (OTC:CTIX) Stock de recherche - Au cours de lOTC Bulletin Board OTCBB
Kevetrin réduit le volume tumorale de 72% : Cellceutix
Cellceutix's Kevetrin(TM) Slows Pancreatic Cancer Tumor Growth by 94%; Protocol Towards Clinical Trials Nearing End -Euroinvestor
hey...with all that info i sent you...was there enough to do your dd on?
First Patients Recruited and Enrolled in Cellceutix Clinical Trial of Novel Anti-Cancer Drug Kevetrin
Elsevier Business Intelligence Reports Cellceutix “Developing A Still-Secret Prodrug For Psoriasis” and a “Heralded Cancer Candidate”
BEVERLY, MA – October 29, 2012-- Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, is pleased to report that the first patients have been recruited and enrolled for the clinical trials of Kevetrin™, the Company’s novel cancer drug in development. The clinical trials are being conducted on patients with advanced solid tumors at Harvard University’s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center.
Based on dialogue with the clinical sites, the Company anticipates updating shareholders next week that dosing of the first patient has been administered.
“We are extremely pleased to hear that the first patients will begin therapy with Kevetrin™ in a matter of days,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Not only is this is a substantial milestone for Cellceutix and its shareholders, but we feel it is important to the field of oncology. As a novel compound that directly impacts p53, the “Guardian Angel of the Human Genome,” we look forward to a steady patient enrollment and future outcomes that potentially could change the landscape of cancer therapeutics.
Elsevier Business Intelligence
Cellceutix announced that Elsevier Business Intelligence has released a profile article on the Company for its latest edition of its publication “Start Up: Emerging Medical Ventures.”
Elsevier, a division of Reed Elsevier Group PLC, is the world’s leading provider of science and health information, serving more than 30 million scientists, students and health and information professionals worldwide.
In the article, Elsevier’s Deborah Erickson discusses the uniqueness of the Company’s Prurisol™ as a new therapeutic candidate for psoriasis, and the clinical trials at Dana-Farber Cancer Center and Beth Israel Deaconess on Kevetrin™ as a novel, p53-activating anti-cancer drug. Regularly referencing Cellceutix as “anything but a normal start-up,” the write-up provides a succinct overview of the Company, its “all-star” advisory staff and offers insight into Kevetrin and Prurisol.
Shareholders and interested parties are encouraged to view the article at: http://cellceutix.com/category/in-the-news/
“We are very pleased to have been approached by Elsevier. They have a tremendous global outreach and the additional exposure is positive for our company,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “I found it particularly interesting how attracted they were to Prurisol and the incredible potential that they see for the drug. Because of the p53 connection and strong possibilities for Kevetrin™, many people overlook how impactful and valuable Prurisol can be as well.”
About Kevetrin™
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin's unique ability to affect both wild and mutant types of p53 (often referred to as the "Guardian Angel Gene" or the "Guardian Angel of the Human Genome") and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein's protective function, which Kevetrin appears to be doing the majority of the time.
The clinical trial titled, "A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors," is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
About Prurisol
Prurisol is a small molecule, acting on the principles of immune modulation and PRINS reduction that has been found to be effective against psoriasis in animal models, both in induced psoriasis as well as a xenograft model with human psoriatic tissue. It is 25% orally bioavailable allowing the potential for oral administration. Prurisol was studied in SCID mice that were irradiated then engrafted with human psoriatic tissue by inserting human psoriatic tissue under the skin using a trocar. The results of the research showed that Prurisol significantly reduced all psoriatic endpoints measured relative to controls. More detailed information and images of the animal models can be found at: http://cellceutix.com/prurisol/
About Elsevier
Elsevier is a world-leading provider of scientific, technical and medical information products and services. The company works in partnership with the global science and health communities to publish more than 2,000 journals, including The Lancet and Cell, and close to 20,000 book titles, including major reference works from Mosby and Saunders. Elsevier's online solutions include ScienceDirect, Scopus, Reaxys, MD Consult and Mosby's Nursing Suite, which enhance the productivity of science and health professionals, and the SciVal suite and MEDai's Pinpoint Review, which help research and health care institutions deliver better outcomes more cost-effectively.
A global business headquartered in Amsterdam, Elsevier employs 7,000 people worldwide. The company is part of Reed Elsevier Group PLC, a world-leading publisher and information provider, which is jointly owned by Reed Elsevier PLC and Reed Elsevier NV. The ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today's cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission.
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
info@cellceutix.com
hey...HEY!!
Three "MUST READ" Seeking Alpha articles for newbies on why CTIX is a MUST BUY !!!!
http://seekingalpha.com/instablog/200555-qual...-this-week
http://seekingalpha.com/article/932741-valean...rma-s-skin
http://seekingalpha.com/article/802771-pfizer-eyes-kevetrin
Clinical Trials for Cellceutix Novel Anti-Cancer Drug Now Active at Leading Hospitals
Print
Alert
Cellceutix Corp (OTCBB:CTIX)
Historical Stock Chart
1 Month : From Sep 2012 to Oct 2012
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, announces an update on the status of clinical trials for the Company's novel anti-cancer drug candidate, Kevetrin™. The Company is very pleased to report that it has been advised by both Harvard University's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center that the trials are now active and that the process of recruitment, enrollment and dosing is set to begin. Clinicaltrials.gov has been notified to change the trial status to active.
About Kevetrin™
As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin's unique ability to affect both wild and mutant types of p53 (often referred to as the "Guardian Angel Gene" or the "Guardian Angel of the Human Genome") and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.
In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein's protective function, which Kevetrin appears to be doing the majority of the time.
The clinical trial titled, "A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors," is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today's cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission.
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
Email Contact
gobs of research...go to their website etc.pump/dump...lol
your right its just junk...thats why trials are starting and phizer is working hand and hand with them...but you knew that already!!...and the doctor working with them helped get 2 big cancer drugs on the market place too...good well thought out post!!
there is zero research for kevetrin or thioureidobutyronitrile. the odds are so agaisnt this that it is probably a pump and dump otc.
CTIX clinical trials starting soon! some dd below
TheProgressive
Wednesday, September 26, 2012 5:11:25 PM
Re: umiak post# 7330
Post # of 10126
CTIX OVERVIEW AND ANALYSIS
Hi All,
This one is on the verge of a dramatic breakout. This company has been working towards starting clinical trials on its flagship cancer drug, kevetrin. In my opinion, this will be THE breakout drug that leads the next generation charge of cancer treatments.
Here is a top line summary about the company, for those wishing to start their own due diligence:
•Kevetrin works by doing something no other drug has ever done before, activating the P53 gene, often called "the guardian angel of the human genome" - this is a cancer fighting gene that is deactivated or corrupted in over 50% of all cancer cases world wide, regardless of cancer type
•Researchers have been trying to accomplish this feat for decades, Kevetrin is the first known non-geno toxic cancer drug that activates the P53 gene as the mechanism of action
•The man behind the drug, Dr Krishna Menon, is a world renowned cancer researcher who has already helped successfully bring to market multiple other billion dollar cancer drugs
•Kevetrin is set to start its already paid for phase 1 clinical trials at Harvard's Dana Farber Cancer Institute, IMO the world's premeire cancer reasearch and treatment facility
•Kevetrin will also concurrently be running an already paid for combined phase 1 trial with some of Pfizer's premiere cancer drugs
•Cellceutix is also in negotiations with one of Europe's most distinguished Leukemia research schools, for a trial that will also be paid for by the University, saving Cellceutix millions in trial costs
•Cellceutix is also working on starting an FDA fast tracked phase 2/3 trial for Prurisol, it's psoriasis compound, which has shown dramatic effectiveness in studies so far
•Prurisol is currently in production, with more info on commencement of clinical trials to come soon
This is just some relevant info to get some of you started if you are interested in looking into a potentially huge breakthrough in cancer treatment.
Here is a very good seeking alpha article that gives a good rundown of the potential of Kevetrin:
http://seekingalpha.com/article/309676-cellceutix-eyeing-a-5b-annual-market-with-potential-caner-research-breakthrough
Also, a very influential technology analyst, Patrick Cox from Agora Financial, just issued a buy recommendation for CTIX to all his subscribers (he runs an $800/month newsletter on breakthrough technology stocks) He is well known in the investing community for having a talent in finding the greatest and most profound breakthrough technologies and medicines of our time, and CTIX has gotten his attention and close personal review.
Here is an article Mr Cox posted last year that gives good insight into why he beleives this will be the next huge biotech breakthrough in cancer treatments:
Calling on Guardian Angels to Fight Cancer
By Patrick Cox | April 14, 2011 |
In this month’s issue, I have a very exciting company for you. Although the company is very early-stage, with no human clinical data yet, I believe the science is sound. This company has discovered a compound that modifies a well-studied cellular process implicated in a broad range of cancers. For many years, it has been a holy grail of cancer researchers.
Tens, if not hundreds, of millions of dollars have been spent by pharmaceutical companies in the quest to find a therapy to hit this molecular target — but in vain. The tiny biotech we’re presenting this month, however, truly appears to have discovered the compound that does so successfully.
Obviously, preclinical biotechnology innovators make for more speculative investments than those that have reached the stage of clinical trials. With greater risk, however, also comes the potential for greater reward. The biggest yields in pharmaceuticals come from picking winners before human data verify the safety and efficacy of a drug in humans. Of course, the flip side of that coin is the possibility that clinical trials will fail.
Most investors and analysts, therefore, tend to rely solely on human clinical studies as the only means of judging a drug candidate. This is simply because most people lack the time, background or confidence to study and grasp the core scientific platforms of preclinical companies. This creates opportunities for investors who are willing to do their homework and buy into companies before clinical results drive share prices up.
Fortunately, we’re not living in the 20th century anymore. With Google Scholar and a little patience, you can instantaneously access information that could be found only in large university libraries just a few decades ago.
So I would like to tell you about a number of factors that indicate this company’s pipeline has transformational potential. Beyond the core science, which I’ll describe below, there is also the reputation and decades of experience of its founder and chief scientist. Additionally, strong preclinical data and outside interest lead me to believe the probability of success justifies adding this company to your watch list of transformational technologies. However, I encourage you to consider this technology carefully.
P53, The Guardian Angel of the Genome
Before addressing the company, though, I would like to talk about cancer and the “guardian angel gene.” Known to geneticists as TP53, this gene encodes the transcription factor p53. Lately, you’ve been hearing the term “transcription factor” in this publication quite a lot. There’s a reason for that. As the human genome and the proteins expressed by genes are understood, more and more breakthroughs will be enabled.
When this protein was discovered in 1979, the tools did not exist to fully analyze and understand the TP53 gene or its protein transcription factor p53. The scientific community assumed, in fact, that p53 was causing cancers. Later research revealed a much more complex and interesting story.
P53 is, in fact, a cancer-suppressing transcription factor, rather than a cancer-causing one. After discoveries revealed its role in preventing cancers, the journal Science named p53 “Molecule of the Year” for 1993.
Additional discoveries are still being made about p53. This protein clearly operates as a transcription factor, controlling the conversion of DNA information to messenger RNA, or mRNA. It also, however, seems to act in a pharmacological manner. Regardless, p53 plays an extremely important role in guarding cell health.
Specifically, p53 monitors the DNA and activates cellular gene repair processes when a cell sustains genetic damage. If genetic damage proves too extensive for repair, p53 triggers the cell’s built-in self-destruct process, apoptosis.
For this reason, the p53 protein has been called the master watchman of the genome. As such, it prevents the mutations that turn healthy cells into cancer cells.
There is an Achilles’ heel to this process, however. If the p53-encoding gene, TP53, itself receives damage, there is no mechanism to repair it as p53 repairs other genes. Its tumor-suppressing functionality is curtailed. Similarly, if some other factor interferes with p53's normal functioning, the TP53 gene can no longer prevent cancers.
This is the reason that human papillomavirus (HPV) leads to an increased risk of cancer. When HPV infects a cell, it causes it to manufacture a protein that binds to p53, inactivating the master watchman. For some cancers, such as cervical cancers, HPV is believed responsible for 70% of cases.
In more than half of all human cancers, p53 is suppressed by mutations of the TP53 gene itself. The other cancers directly inhibit p53's molecular signaling pathway. P53 suppression, therefore, is implicated in almost all cancers. If some molecule could restore p53's activity in cancer cells, it is believed that the cancers would be naturally and nontoxically eliminated. Such a molecule would be a powerful new oncology drug. This is exactly what this month’s watch list company, Beverly, Mass.-based Cellceutix (PINK SHEETS: CTIX), has discovered.
In preparing this issue, my associate Ray Blanco and I had the pleasure of interviewing Dr. Krishna Menon, Cellceutix’s president and chief scientific officer, as well as Leo Ehrlich, CEO and CFO.
Important Scientist at the Helm
I have, by the way, been familiar with the work of Dr. Menon and Leo Ehrlich for quite some time. In addition to being the founder of Cellceutix, Dr. Menon is the chief regulatory officer for one of the most exciting companies in our portfolio, NanoViricides (OTCBB: NNVC). Formerly, Ehrlich helped found NanoViricides and served as its CFO. Dr. Menon also runs KARD Scientific, a contract research organization (CRO). KARD Scientific has been instrumental in testing and developing NanoViricides’ breakthrough antiviral nanovesicle technology.
CROs are an important and growing part of the drug discovery process. Because they specialize in performing tests and validation, pharmaceutical and biotech companies have found advantages and saving by outsourcing various aspects of the research process to these important organizations.
Pharmas have increasingly turned to CROs as a way to cut costs and manage the complexity of bringing new products to market. Since 2002, KARD Scientific has successfully helped its clients file eight investigative new drug applications with the FDA, thus launching them into human clinical trials.
Researchers at CRO facilities, therefore, see a wide range of platform technologies and candidate compounds from all over the industry. For CRO researchers, exposure to a large variety of different drug candidates can lead to a uniquely broad biotech perspective and expertise. As the head of his own CRO, Dr. Menon has been in the position to develop a very good sense of what will eventually make it to market and what won’t.
Dr. Menon, who has been described as a “lab workaholic,” also has decades of his own experience developing important anti-cancer compounds. His Ph.D. work, for example, laid the foundation for Eli Lilly’s blockbuster cancer drug Alimta. He was also a key developer for Gemzar, another billion-dollar cancer drug. For this and other contributions, he was honored with Eli Lilly’s President’s Award in 1999.
Therefore, his confidence in Cellceutix’s leading candidate, a first-in-class p53-activating cancer compound, has considerable significance. The genesis of the compound, in fact, has roots reaching back many years in Dr. Menon’s long professional career.
As a young man, before earning graduate degrees in medicine and pharmacology, Dr. Menon was the chief veterinarian for a Jamaican parish, which is comparable to an American state. On one occasion, he was called to do a postmortem analysis following the mysterious death of an expensive prize bull. The investigation revealed that the animal had been treated with an agent designed to kill external parasites, a common problem in tropical countries.
During the postmortem analysis, Dr. Menon discovered that the tick-and-mite-killing product acted as a cytotoxic agent, causing organ failure. More importantly, however, he also observed that the bull had suffered from subcutaneous tumors, but many had been eliminated by the product.
The event marked the beginning of his quest to develop anti-cancer compounds that combine low toxicity with high efficacy. This theme has marked much of his career, and has already led to the creation of breakthrough cancer drugs. It is now reaching its culmination in Cellceutix’s leading compound, called Kevetrin.
Kevetrin, a Potential P53-Activating Blockbuster
Discovered by Dr. Menon, Kevetrin is a pharmaceutical-grade salt of a molecule belonging to a class of chemicals known as thioureal compounds. Though widely used in industrial chemical processes, this class of compounds has never before been considered a promising source of drug candidates. The compound on which Kevetrin is based has been used for some time as a chemical intermediary for synthesizing more complex compounds. Before Menon began looking at it, however, its potential as a therapeutic drug was never considered.
Originally, Kevetrin was considered by Cellceutix’s scientific team to be a very interesting candidate for treating head and neck cancers. Follow-up research conducted at Boston’s Dana-Farber Cancer Institute revealed that it had a much broader potential, however.
Further tests performed on cancer-resistant cell lines grown in animal models revealed astonishing results. Tumor growth was delayed in many different kinds of cancers. In many cases, tumor shrinkage was observed. Seeking independent verification, Cellceutix sent its compound to bioscience giant Millipore. Millipore’s screening panels revealed strong data for Kevetrin in cancers ranging from leukemia to solid tumors.
Some published efficacy data follows below. These two charts were presented at the 102nd annual meeting of the American Association for Cancer Research in early April 2011. Both of these charts compare Kevetrin to one of the most common chemotherapy drugs, paclitaxel. Both are xenografts grown in mice. The first chart is for lung cancer tumor line A549:
In the A549 mouse model, Kevetrin delayed tumor growth by 33–100% compared to paclitaxel. It caused only a 3–4% decrease in animal weight, which is a proxy for toxicity in mice.
The second chart below is for a drug-resistant lung cancer tumor cell line, NCI-H1975:
Here, Kevetrin showed a 44–107% delay in tumor growth compared to paclitaxel, and there was no reduction in animal weight, indicating that the compound was not producing negative metabolic effects.
As you can see, Kevetrin compares very, very favorably against paclitaxel. Similar results are observed in leukemias and cancers of the colon and breast.
Most late-stage cancers, by the way, are those that have become resistant to the current arsenal of anti-cancer drugs. Cancer cells are extremely resilient, behaving almost as autonomous organisms. They have the ability to modify and adapt to their environment through spontaneous mutation. An investigational compound showing such strong results in so many different varieties of resistant cancers is a truly big deal. Kevetrin has the potential to be a mega blockbuster. Most of the new cancer drugs on the market treat specific kinds of cancers. Kevetrin has the potential to treat many of them. This is an enormous, multibillion-dollar market.
As you can well guess, such wide-ranging efficacy prompted questions about Kevetrin’s mechanism of action and led to further experimentation. Research into Kevetrin’s mechanism of action revealed that it acts on p53 and additional pathways, interrupting cancer progression by restoring normal cancer-fighting mechanisms. Essentially, Kevetrin re-awakens the “guardian angel” of the genome and causes apoptosis in cancer cells:
As I mentioned earlier, the discovery of p53's importance in cancers has prompted Big Pharma to spend untold millions trying to therapeutically activate the transcription factor. Their research, however, has been concentrated in a different class of compounds known as nutlins. Some are promising p53 activators, but unfortunately, all nutlin-based compounds have demonstrated unacceptably high levels of toxicity.
This has not been the case for Kevetrin. Toxicology studies completed this March by Toxicon, another third-party CRO, revealed a very benign profile. This clears the way for an investigational new drug application (IND) with the FDA and human clinical trials.
The Kevetrin Game Plan
The next logical step for Kevetrin is to file an IND with the FDA for Phase I clinical trials. As you know, Phase I trials are typically performed on healthy patients with the goal of establishing a drug’s safety. If a candidate compound passes this milestone, it can move on to Phase II, where efficacy becomes the major focus.
Because Cellceutix is seeking approval for the use of Kevetrin in late-stage drug-resistant cancers, it will likely be safety tested on people who have a life-ending form of the disease. Therefore, Kevetrin has the unusual opportunity to demonstrate not only safety in Phase I, but efficacy.
Since Kevetrin has reported strong performance on drug-resistant cancers in preclinical research, its Phase I trials will probably be performed on a population of very sick, end-stage cancer patients. For these patients, there isn’t much hope with existing therapies, so there is little to lose and much to potentially gain by using Kevetrin.
Cellceutix will have an early opportunity to demonstrate the healing power of Kevetrin. In fact, if the Phase I results are strong enough, there is even a chance that Kevetrin could skip Phase II and go directly to Phase III. The FDA has programs in place, like Fast Track, Accelerated Approval and Priority Review, to expedite new drugs that have shown the potential to satisfy large unmet needs. An effective therapy for drug-resistant cancers would almost certainly qualify.
Cellceutix is gearing up for the Kevetrin IND application now. It is already in the advanced stages of preparing the application for the FDA. Leo Ehrlich expects Cellceutix to be able to file in early May, once quality control documentation for Kevetrin production is completed.
If there are no objections on the part of the FDA, the plan is to apply to begin clinical trials at Dana-Farber Cancer Institute this summer, where Dr. Menon has extensive contacts. Dr. Emil Frei, a member of Cellceutix’s scientific advisory board, is currently emeritus physician-in-chief at this institution.
For a small biotech company like Cellceutix, a winning game plan usually involves collaboration with a large, deep-pocketed pharmaceutical company to help fund the clinical trials process. On the other side of that equation, the pharmaceutical companies have to collaborate to survive. Flagging in-house pipelines and expiring patent protections demand that they look to emerging biotechs for the next big products.
As a general rule, Big Pharmas express little interest in a compound until human data are released in Phase I or later studies. Kevetrin is an exception to this rule. Already, several big players have expressed interest, and one multibillion-dollar drug maker has even signed a nondisclosure agreement based on the strength of the preclinical data.
Ehrlich, however, tells us that Cellceutix is in no hurry to partner until the company is in a stronger position. While some investors might hope for an early Big Pharma deal, yields are maximized by taking drug candidates through the clinical trials process. This reduces risk for pharmas and increases competition among them for a partnership agreement. Phase I trials are usually the smallest and least expensive to run, and Ehrlich believes the company has the financial strength to carry it out on its own. This is good news for Cellceutix investors.
Kevetrin also has a strong intellectual property position. In the biotechnology business, strong patent protections are often the difference between success and failure. The patent for Kevetrin was published last year, and was written by Dr. Paul Ginsburg. Dr. Ginsburg, a patent attorney, has worked in senior positions at Pfizer and Schering. Among other important pharmaceutical patents, he wrote Claritin’s. It has never been challenged.
Moreover, because this class of chemicals has never been used in medicine, research into other pharmaceutical uses has barely begun. The number of potential uses is, in fact, vast. Cellceutix’s patent covers tens of thousands of possible chemical combinations for therapeutic use.
Growing Preclinical Pipeline
As promising as Kevetrin is, Cellceutix has other compounds with enormous potential waiting in the wings. Among those compounds is KM-391, which is targeted at autism.
As you know, autism is an enormous problem. In children with autism, there is a loss of brain function due to reduced brain plasticity and serotonin depletion. This, in turn, leads to various cognitive and behavioral disorders.
About 1% of the population between the ages of 3–17 is diagnosed with autism spectrum disorder. The total annual cost for autism in the United States is estimated at $60 billion, but only 5% of private research funding targets autism. Everything that is currently approved for treatment of autism addresses only symptoms, rather than the root causes.
As former director for the ALS foundation, Dr. Menon has considerable experience with neurological diseases. When he came across KM-391, originally developed in India, he saw its value and purchased the rights. He also improved the original compound.
Preclinical tests, performed in autism animal models, indicate no apparent side effects from long-term administration of KM-391. Measures of efficacy, however, are very strong. One hundred days into KM-391 trials, brain plasticity showed an 85% improvement over control in rats. Plasticity, as you know, refers to the brain’s ability to adapt to changes. Additionally, brain serotonin increased to normal levels when compared to a healthy pair-matched animal’s:
Rats treated with KM-391 also showed improvements in tests for autism-related behavioral disorders. There were marked reductions in repetitive behavior, touch sensitivity and self-induced injury, as well as improvements in group dynamics, position correction time and curiosity.
Cellceutix is preparing to file an IND for KM-391. As a small biotech with limited resources, however, Cellceutix has to concentrate on its leading compound. A successful IND and Phase I for Kevetrin will clear the path for KM-391. If KM-391 shows positive results in humans, it could completely change the way autism is treated. Like Kevetrin, this compound has multibillion-dollar potential.
Cellceutix has other candidates in its pipeline. It has preclinical and developmental-stage compounds for the treatment of psoriasis, arthritis, asthma, ALS, cancer and hypertension.
As I mentioned earlier, preclinical companies are inherently more speculative than later-stage companies, but they also have the opportunity for much greater share price appreciation. Cellceutix has a lead candidate that could be a game changer in cancer treatment. It has a world-class scientist leading research and a CEO with experience in launching new biotechnology companies. The company plans to collaborate on its candidates when it becomes appropriate, and has attracted considerable interest at an early stage based on the strength of its data.
That being said, this company is far too small for us to recommend purchasing at this time. The exciting potential of their science, however, is something I will be keeping a close watch on.
This is the most illiquid stock we have ever discussed here. If you decide to buy at this time, you are on your own — but I would encourage you to be very careful and use a strict limit order.
In the mean time, I am going to add this company to our watch list. When it is time to issue an official buy order, you will be the first to know.
As i mentioned, this article is before he posted a buy recommendation, which had just become official in September 2012.
It is my humble belief, that this company, now trading around $1 per share, will be valuated with an over 10 billion dollar market cap, and will return a 4000%-5000% return on investment in the next 12-18 months, when a huge buyout takes place from a major pharmaceutical player, such as Roche or Pfizer.
Anyone that's interested in asst mod, message me. Must be willing to help keep an updated calendar in the ibox.
Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012
Date : 10/22/2012 @ 8:49AM
Source : GlobeNewswire Inc.
Stock : Hemispherx Biopharma, Inc. (HEB)
Quote : 0.4801 0.0 (0.00%) @ 2:05AM
Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") today announced that the U.S. Food and Drug Administration ("FDA") has scheduled for December 20, 2012 a meeting of the Arthritis Advisory Committee ("AAC") to discuss the Ampligen® New Drug Application for Chronic Fatigue Syndrome ("CFS") which is currently under review by the FDA. As previously announced, the Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review is February 2, 2013.
The AAC meeting will be held from 8 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Conference Center, the Great Room (Room 1503), Silver Spring, MD 20993-0002. Further details are available at https://federalregister.gov/a/2012-25878.
The announcement of the December 20, 2012 AAC meeting follows the FDA's September 13, 2012 teleconference on CFS and Myalgic Encephalomyelitis ("CFS/ME"), the transcript of which is available at http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf. In addition, on October 25, 2012, the FDA is holding a public meeting to discuss the patient-focused drug development initiative, one of its performance commitments under PDUFA V, which is intended to establish a more systematic approach to obtaining patient perspective on certain diseases. CFS is one of 39 diseases nominated for such review. Also, in the Spring of 2013, the FDA is scheduling a workshop on the development of treatments for CFS/ME.
Elite Pharmaceuticals: www.elitepharma.com/
Many of us have owned and followed ELTP for more than a year. It had some major upsets several years ago and was managed poorly, almost went bankrupt, and then was taken over by new management. Their progress over the past couple of years has been dramatic, and they should be cash-flow positive within a couple more quarters.
Below, I have pasted a post by "tangerine" from the ELTP board, which summarizes the upcoming catalysts. This is not pie in the sky stuff. There is little doubt that most or all of this will happen, but I will make no predictions on the timeline. Their opioid-resistant technology, for which they now have a patent, will be a game changer for the entire industry.
From ELTP board:
Breakdown of Known Upcoming Catalysts
Naltrexone Approval and then Launch
Phentermine 15mg and 30mg Launch –
Phendimetrazine Approval and then Launch
Approval of second Manufacturing Facility
New Financing deal
Approval of Epics first of 8 products
Additional Opioid ANDA is pending approval
Patent Pending Approval - 12/640,344 – Abuse resistance
Patent Pending Approval - 13/379,486 – Micro-Tabets - .25mm – 1mm – All types of medications
Patent Pending Approval - 13/379,481 – Use of the Micro-tablets to make abuse resistant products
Approval and Launch of HITKs generic of a 100m branded product
Approval and Launch of MIK001
Approval and Launch of HK Pharma product
Return of Lodrane
2nd Quarter revenue will show ~200% increase over the previous year
Profitability – Elite expects to hit cash flow neutral/positive in the 4th quarter this year.
Anything to do with a sale of Novel Labs – Elite Owns 10%
Anything to do with the closing of Elite’s debt issue with NJEDA
Naltrexone Approval – Way over due - Was part of the now completed inspections from about 1 month ago and noted on the CC– Was part of the deal along with the now approved Hydromorphone and was forced to undergo the same change of facility nonsense. $12m generic on the drug shortage list with few competitors. Market has likely grown as new uses are being discovered and tested for everything from AIDS, Parkinson’s and Crohn’s disease.
http://money.cnn.com/news/newsfeeds/articles/globenewswire/200584.htm
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314741.htm
http://www.lowdosenaltrexone.org/
Undisclosed Opioid ANDA – Way overdue - Also from the same timeframe and completed inspections as above as discussed on the CC. Based on some subtraction using the data in the PRs, this looks like an 80m Generic Opioid
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79189212
Phendimetrazine ANDA Approval – Way overdue - This product has been undergoing transfer of facility too, and for a long time. Also part of the recently completed inspections as noted on the CC call. This product is being marketed by Actavis through their designee Mikah. YES THAT ACTAVIS!! Revenue on this product only shows $3m from the best old data I can fine. It is a diet drug for obesity and it is all over the web despite very, very few manufacturers. I think this was also USA only and Actavis is worldwide. Lots of questions here but the partner is absolutely huge. I believe Elite has paid all the up-front costs here and will receive a milestone payment once the approval is complete. If you click on the link, you will see many manufacturers but almost all of these have discontinued production some time ago.
http://www.globenewswire.com/newsroom/news.html?d=223706
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Approval of second Manufacturing Facility – Way overdue - This is the second 15k square foot facility to manufacture FDA, DEA approved controlled substances. Equipment has been deployed, warehousing is available for use and I believe the packaging line is also pending approval here but that may already be approved. This will lower Elite’s costs in several ways and of course be needed because of all the products as they go from 4 to 7 to 9 to 12 FDA approved products. Also this approval will include allowing Phentermine and Methadone to me made there so that much larger batches can be made. As noted on the CC, these products are growing rapidly, especially Phentermine so this will lower costs and increase profits as will Elite handling all their own packaging.
Financing Deal Is expected soon whether it be Socius or another structure as noted on the CCs. CFO stated “Expect something in the near future." That was some time ago. This money will likely go to more Studies and Trials. Seems the loan from the CEO is sufficient for now per the President of Elite.
Epics 1st or 8 Products is pending approval – We don’t know what this product is yet but I suspect it will be marketed through TAGI Pharma
Additional Opioid ANDA is pending approval – This has been pending for some time. We don’t know much about it except it’s another opioid/controlled substance.
Launch of the 5 Drugs listed above approximately 1-3 months from approval
Patent Pending Approval
12/640,344 – Second abuse resistance patent – This one is likely to be approved soon based on the non-final rejection. Seems like a formality at this point.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79335188
13/379,486 – Micro-tablets down to .25mm size. This is for dozens and dozens medications. Sent up to examiner for review/approval
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79310230
13/379,481 – Use of the Micro-tablets to make abuse resistant products
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79271751
Approval and Launch of HITKs generic of a 100m branded product
In scale-up and almost 2 years in the works
http://www.globenewswire.com/newsroom/news.html?d=210753
Approval and Launch of MIK001 – This is an NDA in the works for Mikah/Actavis – yes again that Actavis!! Timeline is tough to know here. This has been in the works for quite some time
“Mikah Pharma has contracted Elite Pharmaceuticals to develop and manufacture our top leading products. Elite will develop MIK001’s formulation, analytical methodology, and manufacture, test and release the clinical supplies necessary for our clinical trials and NDA approval.”
http://www.mikahpharma.com/index_files/pProducts.htm
Approval and Launch of HK Pharma product – This is an NDA being developed by Elite for a Hong Kong Pharma company. This seems to be an opioid, approved and marketed overseas being launched in the United States
http://www.globenewswire.com/newsroom/news.html?d=250006
Return of Lodrane – The latest info is that ECR is still dealing with the FDA and cannot provide a launch date. Elite was profitable on Just Lodrane 2011
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79216213
2nd Quarter revenue will show ~200% increase over the previous year. I believe revenue was ~278k one year ago. Last Q was 578k and increasing as the 4 products grow. Manufacturing revenues grew 20% over previous Q which would be ~$700k. If they continue to grow at that rate as they are all just getting established and Elite gets a milestone payment for Phendimetrazine, they should hit ~750k on revenue. If Elite launches another product, they will go over that number.
Phentermine - Launched - April 2011
Hydromorphone - Launched March 2012
Methadone - Launched Jan 2012
Lodrane D - Launched Aug 2011
Note: Phentermine Sales rapidly growing and larger batches will be made in new facility pending approval now. Same with Methadone.
Isradipine Approval and Launch – Also with Mikah/Actavis
Profitability – Elite expects to hit cash flow neutral/positive in the 4th quarter this year. With 7 or more products and only being 400k this past quarter from that number and 4 relatively new and growing FDA approved generic drugs, it is easy to see why the CEO thinks this will happen. This does not include any monies spent on the BE studies for the abuse resistant product line.
Anything to do with a sale of Novel Labs – Elite Owns 10% - Here is some info on Novel Labs
http://www.novellabs.net/
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79145196
Anything to do with the closing of Elite’s debt issue with NJEDA
– Elite has been in default on the NJEDA loan – This is with the state of NJ. They have been making the interest payments and replenishing the debt reserve which they are allowed to do. They have also waited for a response for a long, long time now on a plan they submitted. I think NJ is content to continue to continue to get their interest payments. The total debt is only 3.3m and the principal owed is something like 700k. I believe the plan was to repay the entire debt in 2013. That was about 4 conference calls ago.
HEB-Inside buy in August by Director was a clue of things to come (confidence)
http://openinsider.com/search?q=heb
Aug 10 02:14pm
Aug 8 2012
HEB
Hemispherx Biopharma Inc
Kiani Iraj Eghbal
Director
368,345
Other Purchase at $0.26
$95,770
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