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Oh great, Now math doesn't matter. Wow.
Sorry, my articles were from 2014.
I'm comfortable with these numbers.
Assuming 15% margin. 5% market share.
If we get more great.
U.S. Pain Market 9,380,000,000
Elite Capture 5%
Elite ART Revenue 469,000,000
Existing Products(2015) 5,000,000
Total Rev. 474,000,000
Expense (85% of Rev) 402,900,000
Net Revenue 71,100,000
Share count 746,250,000
EPS 0.10
PE\Ratio 15
Share Price $1.43
http://www.bbc.com/news/business-28212223
Last year, US giant Pfizer, the world's largest drug company by pharmaceutical revenue, made an eye-watering 42% profit margin.
-----------------------------------
http://www.who.int/trade/glossary/story073/en/
The 10 largest drugs companies control over one-third of this market, several with sales of more than US$10 billion a year and profit margins of about 30%.
---------------------------------
http://www.statista.com/statistics/274572/gross-profit-margin-of-united-states-biotech-companies/
Gross profit margin of selected biotech and drugs companies as of Q3 2014
This statistic shows the gross profit margin of selected biotech and drugs companies as of third quarter of 2014. During this time, U.S. biotech company Amgen reported an profit margin of some 78.8 percent.
----------------------------------
http://ycharts.com/companies/TEVA/gross_profit_margin
Teva Pharmaceutical has a Gross Profit Margin (Quarterly) of 55.54%.
Did the author claim to be an expert?
It was not an instablog. It was a full article that had to comply with SA's editorial policy:
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No sir. It will be 2/17
Morning all.
Just a quick note.
Our CEO Nasrat Hakim has "Linked In" with Dr. Lynn Webster.
Those of us that have followed the abuse deterrent opioid story-line are familiar with Dr. Webster.
Check out:
http://prahs.com/
I meant IR, not IT
Good thought. Very good thought.
Obviously I can not speak to what you sent her.
I will say that Dianne has been the IT person at Elite for a long time and she has to deal with the occasional wing-nut investor.
So when you come at her with a bit more zeal than one might expect from a patient mature investor, she may default to a defensive mode.
That she is such an approachable and real person is one of the things I like about Elite.
I suggest you call her. Emails don't always translate well.
If you want to discuss directly feel free to email me at hikeleader@gmail.com
Dianne has appreciated many links I have sent over time.
Per Dianne:
Looks like the website reverted to an older version of itself so the Isradipine listing reverted back to "pending site transfer".
Per Dianne she is getting this resolved.
Please remain calm.
I have followed this stock for about ten years. Have attended share holder meeting. Listened to dozens of conference calls. Talk at least once a month with IR.
Yea, I know the difference.
I know. I gave a pass on the agonist/antagonist thing mixup.
More interested in pointing out the existence of naltrexone as pure opioid antagonist.
It blocks and reverses the physical effects of drugs such as morphine, hydromorphone, oxymorphone, heroin, meperidine, codeine, hydrocodone, oxycodone and other drugs classified as narcotics.
So Elite can make quite a few "ART" drugs using only naltrexone as the antagonist. Call it modular, call it "Plug and Play"...
Looks like they had issues with their development partner.
Also interesting to see they used Camargo.
http://www.law360.com/articles/545308/pisgah-labs-demands-100m-in-soured-painkiller-deal
Egalet jumps 24%
Egalet Announces Positive Top-Line Results from Oral Human Abuse Liability Study of Abuse-Deterrent Morphine, Egalet-001
Egalet-001 met primary endpoint of reduced drug liking compared to MS Contin®
Jan 22, 2015
Wayne, Penn. – January 22, 2015 – Egalet Corporation (Nasdaq: EGLT) (“Egalet”) today announced positive results from a Category 3 human abuse liability (HAL) study of Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The clinical HAL study demonstrated that in nondependent, recreational opioid users, the abuse potential of manipulated Egalet-001 taken orally was significantly lower than that for manipulated MS Contin (morphine sulfate controlled-release).
“This is the first Category 3 clinical human abuse liability study for Egalet’s Guardian™ Technology,” said Jeffrey Dayno, MD, chief medical officer at Egalet. “The study results demonstrate the robustness of Egalet’s differentiated technology, which is based not only on the principles of formulation and matrix design, but also on its unique manufacturing process that employs injection molding. These clinical data expand the abuse-deterrent profile of Egalet-001 which, in Category 1 studies, has shown strong abuse-deterrent characteristics by demonstrating resistance to common and rigorous methods of physical and chemical manipulation in a differentiated approach without introducing an additional pharmacologic agent.”
This Category 3 abuse-deterrent HAL study was conducted in accordance with the FDA draft guidance on Abuse-Deterrent Opioids: Evaluation and Labeling (January 2013). It was a single-center, randomized, double-blind, double-dummy, four-way crossover study which assessed the abuse potential of Egalet-001 versus MS Contin in 38 nondependent, recreational opioid users when taken orally. The primary objective was to compare the relative abuse potential of intact and manipulated formulations of Egalet-001 versus manipulated MS Contin. Since Egalet-001 is extremely hard and difficult to chew, the manipulation of the product involved a series of maneuvers using different household tools to try and reduce the particle size to maximally defeat the tablet. This procedure was based on the outcome of the first phase, physical tampering, of the Category 1 abuse-deterrent studies for Egalet-001.
A few highlights from the study include:
On the primary endpoint of drug liking as measured by Emax, the score for manipulated Egalet-001 was significantly lower than the Emax for manipulated MS Contin (p < 0.007);
There was no statistical difference on drug liking scores (Emax) between intact and manipulated Egalet-001, indicating that even after significant manipulation, Egalet-001 retains its abuse-deterrent characteristics;
The corresponding pharmacokinetic (PK) data from this study demonstrated a higher maximum plasma concentration (Cmax) and shorter time to maximum plasma concentration (Tmax) for manipulated MS Contin compared to manipulated Egalet-001; and,
The ‘Abuse Quotient,’ which is defined as the Cmax/Tmax, for each of the treatment arms, was as follows:
5.7 for intact Egalet-001
16.4 for manipulated Egalet-001 and
45.9 for manipulated MS Contin
“The data from this oral human abuse liability study demonstrate a clinically relevant decrease in drug liking for Egalet-001 compared to MS Contin when manipulated and taken orally,” said Lynn Webster, MD, principal investigator of the study and vice president scientific affairs, PRA International. “These clinical results, plus the difficulty that I have observed trying to defeat the Egalet-001 tablets in preparation for the study, suggest that Egalet-001 shows real promise as an abuse-deterrent, extended-release morphine product candidate to help address the ongoing challenge of opioid misuse, abuse, overdose and death.”
In addition to this Category 3 HAL study, Egalet presented positive results from Category 1 studies for Egalet-001 last year at PainWeek and will share the results from additional abuse-deterrent studies later this year.
Looks familiar.
http://www.hhs.gov/secretary/about/speeches/sp20150115.html
Common Interests; Common Ground
Finding a Way Forward, Together
HHS Secretary Sylvia Mathews Burwell
New America Foundation
Washington, D.C.
January 15, 2015
Reducing Substance Use Disorders and Overdose Deaths (Opioids)
Part of building a health care system that keeps us healthy is reducing substance use disorders and overdose deaths.
For millions of Americans who rely on prescription pain killers known as “opioids” that are prescribed to them by their doctors, these drugs can be the difference between constant chronic pain or some welcome relief.
However these drugs can be deadly: In 2009, drug overdoses overtook every other cause of injury death in the United States, outnumbering fatalities from car crashes for the first time.
Meanwhile, in 2012 alone, 259 million opioid prescriptions were written -- enough for every American adult to have a bottle.
Rural America, including my home state of West Virginia, knows this issue all too well.
Moving forward, we hope to work with Members of Congress from both parties on the goals we share for driving down opioid dependency and overdose deaths.
This is a critical and complex public health challenge that requires a multifaceted approach.
We have an opportunity to work together on improving opioid prescribing practices by enhancing prescription monitoring, data-sharing, and clinical decision-making.
We also want to incentivize the development of abuse-deterrent opioids and expand the utilization of naloxone– a drug that’s used to reverse overdoses. And there is more we can do together in the realm of medication assisted treatment to help those who are addicted break that cycle.
Last session, Congress introduced more than a dozen pieces of bipartisan legislation to try to address this problem, many proposing ideas that would help fuel progress in some or even all three of these areas. And we should continue to work together.
FDA Makes No Indication That Guidance for Abuse-Deterrent Labeling Will Be Finalized in 2015
http://claad.org/fda-makes-no-indication-that-guidance-for-abuse-deterrent-labeling-will-be-finalized-in-2015/
Posted On 19 Jan 2015
Tag: abuse-deterrence, Food and Drug Administration
Despite Congress’s calls for the Food and Drug Administration (FDA) to finalize labeling guidance for the manufacturing of abuse-deterrent opioids, the federal agency has made no indications that it plans to publish regulations in 2015. The FDA released draft guidance in January 2013 amid the national prescription drug abuse epidemic and, in its year-end spending bill, Congress gave the FDA until June 30 to finalize it. Should the FDA miss the deadline, Congress will redirect $20 million of the agency’s budget to assist law enforcement efforts to reduce opioid misuse and abuse.
Should FDA Pull Non-Abuse-Deterrent Generic Opioids off the Market? PhRMA, Bio Say Yes
http://www.raps.org/Regulatory-Focus/News/2015/01/20/21120/Should-FDA-Pull-Non-Abuse-Deterrent-Generic-Opioids-off-the-Market-PhRMA-Bio-Say-Yes/
Posted 20 January 2015
placeholder+image
The US biopharmaceutical industry's two largest trade groups are calling on the US Food and Drug Administration (FDA) not to approve—or to revoke approval for—generic equivalents of older, non-abuse-resistant painkillers if a drug manufacturer has since made improvements to a drug to make it harder to abuse.
Background
FDA's regulation of opioid painkillers has a long and complicated history. In recent years, FDA's regulation of opioids had attracted a significant amount of critical attention from legislators as the death toll associated with painkiller abuse has skyrocketed.
The agency has taken several actions since 2012 that have attracted significant attention:
Its October 2013 approval of the pure hydrocodone painkiller Zohydro, which prompted concern from legislators that the approval of the drug was tone-deaf and ignored its potential to cause overdoses. The agency has since approved an abuse-deterrent version of a similar drug, Hysingla, but has not removed Zohydro from the market.
A January 2013 guidance document calling on manufacturers to provide data indicating their opioid products are resistant to abuse by patients.
FDA's October 2013 recommendation that the Drug Enforcement Administration (DEA) regulate all hydrocodone combination products as Schedule II drugs under federal law, thereby making them more difficult to obtain in large quantities.
FDA's September 2013 policy change which requires safety labeling changes and postmarket studies for extended release (ER) and long-acting (LA) opioid analgesic products.
FDA's July 2012 launch of a class-wide Risk Evaluation and Mitigation Strategies (REMS) policy for opioid products, meant to train and educate prescribers on the safety use of opioids.
To date, FDA's strategy seems to be focused on two competing factors: Ensuring that patients who rely on painkillers to manage their severe and ongoing pain have ready access to the drugs they need; and ensuring that those same painkillers are not so easily available as to lead to rampant abuse.
The Problem with Generics
But even as FDA has grappled with how to best regulate new painkillers, it has also struggled to form a coherent policy regarding generic painkillers.
The problem is this: When FDA approves an opioid, often times the first version of that drug is a non-abuse-resistant version. Many times manufacturers then release subsequent reformulations which make the drug harder to abuse, and also serve the increase the amount of time a manufacturer can market a drug without competition. In many cases, the manufacturer will then remove the first version of the drug from the market, leaving only the new, abuse-deterrent version of the drug available to consumers.
This leaves FDA in a case-by-case conundrum. Because the non-abuse-resistant version of the drug was the first on the market, it is almost always the first to have its patents or marketing exclusivity expire, leaving it vulnerable to generic competition. Even if the drug has been withdrawn from the market, a company can file a petition with FDA for the agency to find that the drug was "not withdrawn from the market for reasons of safety or efficacy." If FDA finds the drug was not withdrawn for either reason, the generic manufacturer would then be permitted to file an application with FDA for approval of the generic version of the non-abuse-deterrent drug.
That case-by-case approach has led to some surprising decisions. For example, in June 2013 FDA said it would allow non-abuse-deterrent versions of the painkiller Opana ER to be sold. FDA said it could find no convincing proof that the subsequent, supposedly more abuse-deterrent version of the drug was actually any safer or harder to abuse than the original formulation.
As explained by Janet Woodcock in November 2014, FDA's director of the Center for Drug Evaluation and Research (CDER), the problem is that abuse-deterrent technologies are still very much in their "infancy," and that the mere presence of such a technology should not automatically preclude generic competition.
On the other hand, FDA has shown it is willing to say no to non-abuse-resistant copies of painkillers. In April 2013, the agency said it would not approve non-abuse-resistant generic versions of Purdue's Oxycontin, which it said had been removed from the market for reasons of safety or efficacy. FDA formally withdrew the drug application for the original formulation of Oxycontin several months later in August 2013.
In the meantime, FDA's varying decisions have attracted the attention of legislators, who in May 2014 asked FDA Commissioner Margaret Hamburg to explain why FDA has not yet finalized its January 2013 guidance document on abuse deterrence.
"It is important to ensure that the FDA does not apply a less stringent abuse standard for generic products," the four legislators wrote.
PhRMA and BIO: No Deterrence, No Approval
The legislators' stance is nearly identical to sentiments expressed last week to FDA by the trade groups PhRMA and BIO, who wrote to FDA in support of stricter standards of approval for generic non-abuse-resistant opioids.
"When an innovator has developed, and FDA has approved, such a [abuse-deterrent] formulation, FDA should not approve a generic formulation of the medicine that does not incorporate comparable abuse deterrence," the trade groups wrote.
The issue, they said in their 7 January 2015 letter to FDA, is as much about incentives for innovation as it is about promoting patient safety.
"We believe that permitting the approval of generic products that lack comparable abuse deterrence not only undermines the incentive for innovative biopharmaceutical companies to invest in important new abuse deterrent technologies, but more importantly, fails to mitigate a public and societal health risk," they wrote. In other words, if a company invests a significant amount of time and money into developing a drug which is safer than the original, why should FDA discount that investment and allow the harm to be perpetuated?
Both groups said FDA should exercise its authority to "remove from the market non-abuse-deterrent generic formulations of the same drug." Interestingly, the group mentions only generic drugs in that statement. It does not, for example, call for the removal of branded versions containing the same active ingredient without similar abuse-deterrent qualities.
"Under its existing regulatory authority, FDA has the ability to remove generic formulations that lack abuse deterrent characteristics from the market, when the additional relative safety of a new formulation of a medication with abuse deterrent properties is available," PhRMA and BIO continued. "We encourage FDA to exercise its authority to continue to protect the public health. FDA should incentivize the development of abuse deterrent formulations, which is in the best interest of patients."
- See more at: http://www.raps.org/Regulatory-Focus/News/2015/01/20/21120/Should-FDA-Pull-Non-Abuse-Deterrent-Generic-Opioids-off-the-Market-PhRMA-Bio-Say-Yes/#sthash.EJcv92PK.dpuf
What does POS stand for?
About 28 days actually.
Yes, cause 150% ROI really sucks.
#nopleasinsomepeople
Reminder to those interested:
Free Webinar: Can Isradipine Slow Down Parkinson's Disease?
NPF Sponsored Event
Description: Register now to join the National Parkinson Foundation on January 20 at 1:00 p.m. ET for a special webinar discussing STEADY-PD III, a novel approach to treatment in early Parkinson's disease.
Presenters: Tayna Simuni, MD & Kevin Biglan, MD, MPH
When: Tuesday, January 20, 2015, 1:00 PM to 2:00 PM
Fee(s): Free
Contact Name: NPF Helpline
Contact Phone: 1-800-473-4636
Contact Email: helpline@parkinson.org
Register for this Event: http://event.netbriefings.com/event/npf/Live/isradipine/register.html
Answers:
What other company manufactures and markets the generic referred to in the PR?
Actavis, thats it.
Is there a limit to how many Companies can be licensed to produce generic Isradipine in 2.5 and 5 mg immediate release capsules?
No
I know it is a 36 month study but if they were to show dramatic positive results early on could that possibly move up the time frame for Israpidine FDA approval for early Parkinsons treatment?
Perhaps. Bear in mind that Isradipine is already being prescribed as an "Off-label" usage for some Parkinsons patients by some doctors.
Considering this would that approval make Elite's investment in Isradipine much more valuable considering 450,000 new case of Parkinsons diagnosed each year?
Certainly possible. Three years is a long time to find out though.
It's nice and all but ART is still where its at.
Do you know what a warrant liability is?
Don't know to be honest.
I could use the entertainment.
OK
Just spoke with Dianne, the accelerated filing status does not kick in yet. It will beginning with either the following quarter or at the filing of the 10-K. She is checking with Carter. I jumped the gun there, my apologies.
So this upcoming 10-Q must be filed by 2/17. (2/16 being a holiday).
Still waiting on feedback from the FDA on ELI-200. Otherwise, even if they require efficacy studies we are still on track for launch end of 2015. Nasrat has the efficacy studies ready to start if that is what the FDA requests.
The little delay on Isradipine was due to a label request change by Epic. They had to reprint the labels. Stuff happens.
Don't forget the possible Parkinsons benefit.
Check out this webinar:
http://www.parkinson.org/Community/Events/Free-Webinar--Can-Isradipine-Slow-Down-Parkinson-s
Free Webinar: Can Isradipine Slow Down Parkinson's Disease?
NPF Sponsored Event NPF Sponsored Event
Description: Register now to join the National Parkinson Foundation on January 20 at 1:00 p.m. ET for a special webinar discussing STEADY-PD III, a novel approach to treatment in early Parkinson's disease.
Presenters: Tayna Simuni, MD & Kevin Biglan, MD, MPH
When: Tuesday, January 20, 2015, 1:00 PM to 2:00 PM
Fee(s): Free
Contact Name: NPF Helpline
Contact Phone: 1-800-473-4636
Contact Email: helpline@parkinson.org
Register for this Event
ELITE PHARMACEUTICALS ANNOUNCES FIRST SHIPMENT OF GENERIC ISRADIPINE CAPSULES
Northvale, New Jersey, January 15, 2015: Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) today announced the first shipments of generic Isradipine 2.5 mg and 5.0 mg capsules. Isradipine is a calcium channel blocker prescribed for hypertension. Annual U.S. sales for immediate release Isradipine 2.5 mg and 5.0 mg capsules are approximately $5.5 million for the twelve months ending June 30, 2014 according to IMS Health Data. Currently there is a single generic product marketed in the U.S for immediate release Isradipine 2.5 mg and 5.0 mg capsules.
Isradipine is one of the twelve products that Elite acquired from Mikah Pharma and which Elite licensed to Epic Pharma ("Epic”) last year. Epic will distribute the product and Elite will manufacture the product under the Manufacturing and License Agreement between the parties. The first shipment triggers a milestone payment to Elite.
"We are pleased to have reached this important milestone of launching Isradipine,” said Nasrat Hakim, President and CEO of Elite. "While Elite’s primary focus is the development and approval of our abuse deterrent products, management remains dedicated to enhancing shareholder value by expanding our portfolio of generic products. Elite is creating both a diverse range of opioid abuse-deterrent products using our proprietary technology and building a foundation of attractive niche generic drugs.”
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite has eight commercial products currently being sold, eleven additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA. Elite’s lead pipeline products include abuse-deterrent opioids utilizing the Company’s patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site transfer, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
This news release contains "forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, its ability to obtain FDA approval of the transfers of the ANDAs or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These risks and other factors, including, without limitation, the Company's ability to obtain sufficient funding under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Company’s ability to operate as a going concern, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements.
Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
Just a note to all.
Now that ELTP has to file as an accelerated filer (due to their increase in market cap) their 10Q is now due within 40 days, rather than 45 days as was previous. So the next 10-Q is due by 2/9.
Old news
Not approved either so....yawn
If you bought right after March 2013 I'd say you did pretty damn well.
Good
I give it no weight
Well it's a mystery ... Sigh
Thanks for proving my point. Well it's a mystery. Thanks.
I wish the Gods of TA would post their buys and sells so I could begin to kinda sorta maybe have some belief in all of their hullaballo.
Insights into numbers of buys, number of sells, painting the tape up or down, L2 visions, MM manipulation theories, are all wonderful bits of well, theories.
If you want to prove your karate is better than someone else, post your buys and sells before or at least as they happen, not after.
Elite is a company that has produced great long term returns for those willing to have stuck with them over the last four years. From .04 to .23.
Elite is on the verge of launching their first NDA which could herald the launch of several NDA's.
The possibility of a two, three or four times return on the current price is great. It's happened already and can happen again.